Tutkimus, jossa arvioitiin encorafenibin ja setuksimabin yhdistelmää verrattuna irinotekaaniin/setuksimabiin tai infuusiovalmisteeseen 5-fluorourasiilin (5-FU)/foliinihapon (FA)/irinotekaanin (FOLFIRI)/setuksimabin yhdistelmään kiinalaisilla potilailla, joilla on BRAF V600E -mutantaalinen syöpäsolu. (NAUTICALCRC)
keskiviikko 8. huhtikuuta 2026 päivittänyt: Pierre Fabre Medicament
Monikeskus, satunnaistettu, avoin, 2-haarainen, vaiheen II tutkimus, jossa on turvallisuutta koskeva aloitusvaihe, jossa arvioidaan enkorafenibin ja setuksimabin yhdistelmää vs. irinotekaanin/setuksimabin tai infuusiona käytettävän 5-fluorourasiilin (5-FU)/foliinihapon (FA) yhdistelmä /Irinotekaani (FOLFIRI)/Setuksimabi kiinalaisilla potilailla, joilla on BRAF V600E -mutantti metastaattinen kolorektaalisyöpä.
Encorafenibia kehitetään parhaillaan (binimetinibin kanssa tai ilman) yhdessä setuksimabin kanssa aikuispotilaiden hoitoon, joilla on B-RAF-proto-onkogeeni, seriini/treoniinikinaasi V600E-mutantti (BRAF V600E) metastaattinen paksusuolen syöpä (mCRC). saanut aikaisempaa systeemistä hoitoa.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
107
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100730
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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Beijing, Beijing Municipality, Kiina, 100036
- Beijing Cancer Hospital
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Fujian
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Fuzhou, Fujian, Kiina, 350014
- Fujian Medical University - Fujian Provincial Cancer Hospital
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Xiamen, Fujian, Kiina, 361001
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Foshan, Guangdong, Kiina, 528010
- The First People's Hospital of Foshan
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Guangzhou, Guangdong, Kiina, 510095
- Cancer Center of Guangzhou Medical University
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Guangzhou, Guangdong, Kiina, 510655
- The Sixth Affiliated Hospital Sun Yat-sen University
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Shantou, Guangdong, Kiina, 515041
- Cancer Hospital Affiliated to Shantou University Medical College
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Shenzhen, Guangdong, Kiina, 518036
- Peking University Shenzhen Hospital
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Hebei
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Baoding, Hebei, Kiina, 071000
- The Affiliated Hospital of Hebei University
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Heilongjiang
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Harbin, Heilongjiang, Kiina, 150040
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Kiina, 450052
- The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, Kiina, 450008
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Kiina, 430071
- Zhongnan Hospital of Wuhan University
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Wuhan, Hubei, Kiina, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Wuhan, Hubei, Kiina, 430030
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Kiina, 410008
- Xiangya Hospital Central South University
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Jiangsu
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Changzhou, Jiangsu, Kiina, 213003
- The First People's Hospital of Changzhou
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Jiangxi
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Ganzhou, Jiangxi, Kiina, 341001
- First Affiliated Hospital of Gannan Medical University
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Nanchang, Jiangxi, Kiina, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, Kiina, 330006
- The Second Affiliated Hospital of Nanchang University
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Jilin
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Changchun, Jilin, Kiina, 130021
- The First Hospital of Jilin University
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Liaoning
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Jinzhou, Liaoning, Kiina, 121011
- The First Affiliated Hospital of Jinzhou Medical University
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Shenyang, Liaoning, Kiina, 110001
- The First Hospital of China Medical University
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Shenyang, Liaoning, Kiina, 110042
- Liaoning Cancer Hospital & Institute
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Shaanxi
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Xi'an, Shaanxi, Kiina, 710068
- Shaanxi Provincial People's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kiina, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Shanghai Municipality, Kiina, 200040
- Huashan Hospital Fudan University
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Shanghai, Shanghai Municipality, Kiina, 200092
- Xinhua Hospital Affilliated to Shanghai Jiaotong University School of Medicine
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Shanghai, Shanghai Municipality, Kiina, 200120
- Shanghai East Hospital, Tongji University
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Sichuan
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Neijiang, Sichuan, Kiina, 641000
- The Second People's Hospital of Neijiang
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kiina, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kiina, 310003
- The First Affiliated Hospital - Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Kiina, 310016
- Sir Run Run Shaw Hospital - Zhejiang University School of Medicine
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Molekyylien esiseulonnan mukaanottokriteerit:
Seuraavien osallistumiskriteerien on täytyttävä, jotta osallistuja voi suorittaa molekyylikasvaimen esiseulonnan:
- Kiinalainen mies- tai naispuolinen osallistuja, jonka ikä on ≥ 18 vuotta tietoisen suostumuksen ajankohtana.
- Histologisesti tai sytologisesti vahvistettu paksusuolen syöpä (CRC), joka on metastaattinen.
- Oikeus saada setuksimabia kiinalaisen hyväksytyn etiketin mukaisesti kasvaimen rotan sarkoomaviruksen onkogeenihomologin (RAS) mutaatiostatuksen (ts. hyväksytty Rat Sarcoma Viral Oncogene Homologie Wild Type (RAS wt) -statuksella).
- Pystyy tarjoamaan riittävän määrän edustavaa kasvainnäytettä B-RAF-proto-onkogeenin, seriini/treoniinikinaasi (BRAF) mutaatiostatuksen sekä retrospektiivisen RAS-wt-tilan ja mikrosatelliitin epävakauden (MSI) testaukseen.
Hoitojakson osallistumiskriteerit:
Seuraavat osallistumiskriteerit on täytettävä, jotta osallistuja voi osallistua tähän tutkimukseen:
- Kiinalainen mies- tai naispuolinen osallistuja, jonka ikä on ≥18 vuotta tietoisen suostumuksen ajankohtana.
- Histologisesti tai sytologisesti vahvistettu CRC, joka on metastaattinen ja ei-leikkattavissa tutkimukseen tullessa (ts. ei sovellu täydelliseen kirurgiseen resektioon seulonnan yhteydessä).
- BRAF V600E -mutaation esiintyminen kasvainkudoksessa, joka on määritetty aiemmin paikallisella määrityksellä milloin tahansa ennen seulontaa tai keskuslaboratoriossa.
HUOMAA: Muut protokollalla määritellyt sisällyttämiskriteerit voivat olla voimassa
Molekyylien esiseulonnan poissulkemiskriteerit:
Osallistujat, jotka täyttävät jonkin seuraavista kriteereistä, eivät ole oikeutettuja molekyylikasvainten esiseulomiseen:
- Aikaisempi anti-epidermaalinen kasvutekijäreseptori (anti-EGFR) -hoito
- Enemmän kuin kaksi aikaisempaa hoitoa metastaattisissa olosuhteissa.
- Tunnettu vasta-aihe setuksimabin tai irinotekaanin saamiselle suunnitellulla annoksella viimeisimmän setuksimabin ja irinotekaanin paikallisten ohjeiden mukaan.
- Tunnettu Gilbertin oireyhtymä tai jolla tiedetään olevan jokin seuraavista genotyypeistä: uridiini-5'-difosfoglukuronosyylitransferaasi (UGT)1A1*6/*6, UGT1A1*28/*28 tai UGT1A1*6/*28.
- Leptomeningeaalinen sairaus.
Hoitojakson poissulkemiskriteerit:
- Aiempi hoito millä tahansa Proto oncogene -seriini/treoniini-proteiinikinaasin (RAF) estäjillä, setuksimabilla, panitumumabilla tai muilla EGFR-estäjillä.
- Oireellinen metastaasi aivoissa.
- Leptomeningeaalinen sairaus.
- Kaikkien kasviperäisten lääkkeiden/lisäravinteiden tai lääkkeiden tai elintarvikkeiden käyttö, jotka ovat kohtalaisia tai voimakkaita sytokromi P450 (CYP)3A4/5:n estäjiä tai indusoijia ≤ 1 viikko ennen tutkimustoimenpiteen aloittamista.
- Tunnettu akuutti tai krooninen haimatulehdus 6 kuukauden sisällä ennen tutkimustoimenpiteen aloittamista.
HUOMAA: Muut protokollalla määritellyt poissulkemiskriteerit voivat olla voimassa
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Enkorafenibi ja setuksimabi
SLI-vaihe: 28 päivän jaksot: enkorafenibi kerran vuorokaudessa (QD) 300 mg (4 x 75 mg oraalikapseli) ja setuksimabi 400 mg/m² aloitusannos (120 minuutin infuusio), sitten 250 mg/m² (60 minuutin infuusio) sen jälkeen kerran viikossa Satunnaistettu (vaihe II) vaihe: 28 päivän jaksot: enkorafenibi kerran vuorokaudessa (QD) 300 mg (4 x 75 mg oraalikapseli) ja setuksimabi 400 mg/m² aloitusannos (120 minuutin infuusio), sitten 250 mg/m² (60 minuutin infuusio) sen jälkeen kerran viikossa |
oraalinen kova kapseli
Muut nimet:
suonensisäinen infuusio
Muut nimet:
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Kokeellinen: Irinotekaani ja setuksimabi tai FOLFIRI ja setuksimabi
Satunnaistettu (vaihe II) vaihe: Joko irinotekaani ja setuksimabi tai FOLFIRI ja setuksimabi 28 päivän sykleissä. Irinotekaani ja setuksimabi:
TAI FOLFIRI ja setuksimabi:
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oraalinen kova kapseli
Muut nimet:
suonensisäinen infuusio
Muut nimet:
Yhdistelmä: irinotekaani (tunnetaan myös nimellä: Camptosar, Camptothecin-11 ja CPT-11) suonensisäinen infuusio, foliinihappo (tunnetaan myös nimellä: 5-formyylitetrahydrofoolihappo ja leukovoriini) suonensisäinen infuusio ja 5-FU (tunnetaan myös nimellä fluorourasiili) suonensisäinen bolus /suonensisäinen infuusio
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Safety Lead-in Phase (SLI): Incidence of Dose Limiting Toxicities (DLTs)
Aikaikkuna: Cycle 1 (up to 28 days)
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DLT rate was estimated based on data from DLT-evaluable participants during the DLT-evaluation period (which is the first 28 days after the first dose of study intervention in the SLI) to assess the safety and tolerability of the doublet arm.
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Cycle 1 (up to 28 days)
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Randomized Phase 2: Progression-free Survival (PFS) by Blinded (to Treatment Received) Independent Central Review (BICR) at the Primary Completion Date
Aikaikkuna: From first dose to the earliest documented progression or death due to any cause, with a minimal participant's follow-up of 36 weeks and a maximum treatment exposure of 68 weeks
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PFS was defined as the time from the date of randomization to the earliest documented disease progression (PD) as determined by BICR assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause.
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From first dose to the earliest documented progression or death due to any cause, with a minimal participant's follow-up of 36 weeks and a maximum treatment exposure of 68 weeks
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Randomized Phase 2: Progression-free Survival (PFS) by Blinded (to Treatment Received) Independent Central Review (BICR) at the Final Analysis
Aikaikkuna: From first dose to the earliest documented PD or death due to any cause, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
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PFS was defined as the time from the date of randomization to the earliest documented disease progression as determined by BICR assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause.
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From first dose to the earliest documented PD or death due to any cause, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Safety Lead-in Phase: Confirmed Objective Response Rate (cORR) Per BICR
Aikaikkuna: Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 111 weeks
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cORR as determined by Blinded (to treatment received) Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, was defined as the proportion of participants with a best overall response of either complete response (CR) or partial response (PR), where CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Confirmed Objective Response Rate (cORR) Per Investigator
Aikaikkuna: Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 111 weeks
|
cORR as determined by investigator assessment per RECIST version 1.1, was defined as the proportion of participants with a best overall response of either complete response (CR) or partial response (PR), where CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Duration of Response (DOR) Per BICR
Aikaikkuna: From time of response to the earliest documented PD or death due to underlying disease, with a maximum treatment exposure of 111 weeks
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DOR was defined for confirmed responders (CR or PR) only, as the time from the date of the first documented response to the earliest date of disease progression (PD) as determined by BICR per RECIST Version 1.1, or death due to any cause.
PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
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From time of response to the earliest documented PD or death due to underlying disease, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Duration of Response (DOR) Per Investigator
Aikaikkuna: From time of response to the earliest documented PD or death due to underlying disease, with a maximum treatment exposure of 111 weeks
|
DOR was defined for confirmed responders (CR or PR) only, as the time from the date of the first documented response to the earliest date of disease progression (PD) as determined by investigator assessment per RECIST Version 1.1, or death due to any cause.
PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
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From time of response to the earliest documented PD or death due to underlying disease, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Overall Duration of Exposure to Study Treatment
Aikaikkuna: Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
|
Exposure to the study intervention was defined as the time interval between the actual date of first study intervention administration (included) and the actual date of last study intervention administration (included), i.e., as the quantity "date of last study intervention administration date of first study intervention administration + 1 day".
Duration of exposure by treatment arm was computed as the maximum of all durations of exposure for each drug of the assigned regimen.
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Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Aikaikkuna: Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
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A TEAE is any untoward medical occurrence in a participant temporally associated with the use of study drug, whether or not considered related to the study drug.
Number of participants reporting TEAEs were reported in this outcome measure.
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Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Number of Participants With Serious TEAEs
Aikaikkuna: Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
|
A serious TEAE is a TEAE that results in significant health consequences, such as death, hospitalization, or permanent disability.
Number of participants reporting serious TEAEs were reported in this outcome measure.
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Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs)
Aikaikkuna: Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 68 weeks
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An AE is any untoward medical occurrence in a participant, whether or not considered related to the study intervention.
Number of participants with dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure.
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Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 68 weeks
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Safety Lead-in Phase: Number of Participants With Clinically Notable Vital Sign Abnormalities
Aikaikkuna: Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
|
Clinically notable changes were defined as participants meeting the elevated or low values criterion compared to baseline.
The criterion for clinically notable elevated values included: systolic blood pressure (BP): ≥ 160 millimeters of mercury (mmHg) and an increase ≥ 20 mmHg from baseline; diastolic BP: ≥ 100 mmHg and an increase ≥ 15 mmHg from baseline; heart rate : ≥ 120 beats/min (bpm) with increase from baseline of ≥ 15 bpm; weight (kg) increase from baseline of ≥ 10 percent; body temperature [degree Celsius (deg C)] ≥ 37.5 deg C. The criterion for clinically notable low values included: systolic BP: ≤ 90 mmHg with decrease from baseline of ≥ 20 mmHg; diastolic BP: ≤ 50 mmHg with decrease from baseline of ≥ 15 mmHg; heart rate: ≤ 50 bpm with decrease from baseline of ≥ 15 bpm; weight: ≥ 20 percent decrease from baseline; body temperature [deg C]: ≤ 36 °C.
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Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Aikaikkuna: Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
|
Clinically notable ECG changes were defined as participants meeting the criterion for QT interval, QT interval corrected for heart rate using Fridericia's formula (QTcF), and heart rate compared to baseline.
The criterion for QT interval and QTcF included: increase from baseline > 30 msec (ms); increase from baseline > 60 ms, new > 450 ms, new > 480 ms, new > 500 ms.
The criterion for heart rate included: increase from baseline > 25 percent to a value > 100 beats per minute (bpm), decrease from baseline > 25 percent and to a value < 50 bpm.
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Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
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Safety Lead-in Phase: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters
Aikaikkuna: Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
|
Clinically notable shift was defined as a worsening from baseline by at least 2 Grades, or to Grade 3 or above based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03.
'Low' laboratory parameter thresholds are defined as values falling below the institutional Lower Limit of Normal (LLN) that meet the criteria for a Grade 1 or a higher decrease.
'High' laboratory parameter thresholds are defined as values exceeding the institutional Upper Limit of Normal (ULN) that meet the criteria for a Grade 1 or higher increase.
Where, Grade 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death.
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Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
|
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Safety Lead-in Phase: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters
Aikaikkuna: Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
|
Clinically notable shift was defined as a worsening from baseline by at least 2 Grades, or to Grade 3 or above based on NCI-CTCAE version 4.03.
'Low' laboratory parameter thresholds are defined as values falling below the institutional Lower Limit of Normal (LLN) that meet the criteria for a Grade 1 or a higher decrease.
'High' laboratory parameter thresholds are defined as values exceeding the institutional Upper Limit of Normal (ULN) that meet the criteria for a Grade 1 or higher increase.
Where, Grade 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death.
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Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
|
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Safety Lead-in Phase: Number of Participants With Notable Dermatological Abnormalities
Aikaikkuna: From screening and every 8 weeks from Cycle 1 Day 1 (i.e. on Day 1 of Cycles 1, 3, 5, 7…), the end of treatment visit and the 30-day safety follow up visit, with a maximum treatment exposure of 111 weeks
|
Dermatological examination was performed to monitor for the possible development of keratoacanthoma and/or squamous cell carcinoma and primary melanoma, as these have been reported to occur with selective B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitor treatment.
[1] The category "Other" includes all other dermatological findings identified during examination (e.g.
rash acneiform, skin hyperpigmentation...).
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From screening and every 8 weeks from Cycle 1 Day 1 (i.e. on Day 1 of Cycles 1, 3, 5, 7…), the end of treatment visit and the 30-day safety follow up visit, with a maximum treatment exposure of 111 weeks
|
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Safety Lead-in Phase: Measurement of Performance Status Using the Eastern Co-operative Oncology Group (ECOG) Scale
Aikaikkuna: Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 68 weeks
|
The performance status of participants was assessed using the Eastern Co-operative Oncology Group (ECOG) scale.
The scale was defined with the range from 0 to 5 with lower score mean a lower functional impairment, and a higher score (e.g. 5) corresponding to death.
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Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 68 weeks
|
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Safety Lead-in Phase: Evaluation of the Plasma Concentrations of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day I) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
|
First day of treatment (Cycle 1 Day I) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
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Safety Lead-in Phase: Evaluation of the Serum Concentrations of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
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Safety Lead-in Phase: Evaluation of the Area Under the Curve (AUC) Derived From Plasma Concentration of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
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Safety Lead-in Phase: Evaluation of the Area Under the Curve (AUC) Derived From Serum Concentration of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
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First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
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Safety Lead-in Phase: Evaluation of the Maximum Concentration (Cmax) Derived From Plasma Concentration of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
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First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
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Safety Lead-in Phase: Evaluation of the Maximum Concentration (Cmax) Derived From Serum Concentration of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Safety Lead-in Phase: Evaluation of the Minimum Concentration (Cmin) Derived From Plasma Concentration of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Safety Lead-in Phase: Evaluation of the Minimum Concentration (Cmin) Derived From Serum Concentration of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Progression-free Survival (PFS) by Investigator
Aikaikkuna: From first dose to the earliest documented PD or death due to any cause, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
|
PFS was defined as the time from the date of randomization to the earliest documented date of PD as determined by investigator assessment per RECIST Version 1.1, or death due to any cause.
PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
|
From first dose to the earliest documented PD or death due to any cause, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Confirmed Objective Response Rate (cORR) in ENCO + CETUX Arm vs Control Arm Per BICR
Aikaikkuna: Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
cORR as determined by Blinded (to treatment received) Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, was defined as the proportion of participants with a best overall response of either complete response (CR) or partial response (PR), where CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
|
Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Confirmed Objective Response Rate (cORR) in ENCO + CETUX Arm vs Control Arm Per Investigator
Aikaikkuna: Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
cORR as determined by investigator assessment per RECIST Version 1.1, was defined as the proportion of participants with a best overall response of either complete response (CR) or partial response (PR), where CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
|
Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Duration of Response (DOR) in ENCO + CETUX Arm vs Control Arm Per BICR
Aikaikkuna: From time of response to the earliest documented PD or death due to underlying disease, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
|
DOR was defined for confirmed responders (CR or PR) only, as the time from the date of the first documented response to the earliest date of disease progression (PD) as determined by BICR per RECIST Version 1.1, or death due to any cause.
PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
|
From time of response to the earliest documented PD or death due to underlying disease, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Duration of Response (DOR) in ENCO + CETUX Arm vs Control Arm Per Investigator
Aikaikkuna: From time of response to the earliest documented PD or death due to underlying disease, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
|
DOR was defined for confirmed responders (CR or PR) only, as the time from the date of the first documented response to the earliest date of disease progression (PD) as determined by investigator assessment per RECIST Version 1.1, or death due to any cause.
PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
|
From time of response to the earliest documented PD or death due to underlying disease, with a minimal participant's follow-up of 19 months and a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Confirmed Disease Control Rate (cDCR) in ENCO + CETUX Arm vs Control Arm Per BICR
Aikaikkuna: Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
cDCR was defined as the proportion of participants with a confirmed Best Overall Response (BOR) of CR, PR or Stable Disease (SD), as determined by BICR per RECIST Version 1.1.
CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Confirmed Disease Control Rate (cDCR) in ENCO + CETUX Arm vs Control Arm Per Investigator
Aikaikkuna: Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
cDCR was defined as the proportion of participants with a confirmed Best Overall Response (BOR) of CR, PR or Stable Disease (SD), as determined by investigator assesment per RECIST Version 1.1.
CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
Every 6 weeks (± 7 days) from first dose for the first 24 week, then every 12 weeks (± 7 days) until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Time to Response (TTR) in ENCO + CETUX Arm vs Control Arm Per BICR
Aikaikkuna: From day 1 until first documented response, with a maximum treatment exposure of 116 weeks
|
TTR for confirmed responses was defined for responders (CR or PR) as the time between the date of randomization until the first documented response of CR or PR as determined by BICR per RECIST Version 1.1.
CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
|
From day 1 until first documented response, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Time to Response (TTR) in ENCO + CETUX Arm vs Control Arm Per Investigator
Aikaikkuna: From day 1 until first documented response, with a maximum treatment exposure of 116 weeks
|
TTR for confirmed responses was defined for responders (CR or PR) as the time between the date of randomization until the first documented response of CR or PR as determined by investigator assessment per RECIST Version 1.1.
CR: disappearance of all target and and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
|
From day 1 until first documented response, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Overall Survival (OS)
Aikaikkuna: From randomization to death due to any cause, with a maximum treatment exposure of 116 weeks
|
OS was defined as time from randomization until date of death due to any cause.
|
From randomization to death due to any cause, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Overall Duration of Exposure to Study Treatment
Aikaikkuna: Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 116 weeks
|
Exposure to the study intervention was defined as the time interval between the actual date of first study intervention administration (included) and the actual date of last study intervention administration (included), i.e., as the quantity "date of last study intervention administration date of first study intervention administration + 1 day".
Duration of exposure by treatment arm was computed as the maximum of all durations of exposure for each drug of the assigned regimen.
|
Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Aikaikkuna: Day 1 until 30 days after study intervention discontinuation
|
A TEAE is any untoward medical occurrence in a participant temporally associated with the use of study drug, whether or not considered related to the study drug.
Number of participants reporting TEAEs were reported in this outcome measure.
|
Day 1 until 30 days after study intervention discontinuation
|
|
Randomized Phase 2: Number of Participants With Serious TEAEs
Aikaikkuna: Day 1 until 30 days after study intervention discontinuation
|
A serious TEAE is a TEAE that results in significant health consequences, such as death, hospitalization, or permanent disability.
Number of participants reporting serious TEAEs were reported in this outcome measure.
|
Day 1 until 30 days after study intervention discontinuation
|
|
Randomized Phase 2: Number of Participants With Clinically Notable Vital Sign Abnormalities
Aikaikkuna: Day 1 until 30 days after last dose of study treatment
|
Clinically notable changes were defined as participants meeting the elevated or low values criterion compared to baseline.
The criterion for clinically notable elevated values included: systolic blood pressure (BP): ≥ 160 millimeters of mercury (mmHg) and an increase ≥ 20 mmHg from baseline; diastolic BP: ≥ 100 mmHg and an increase ≥ 15 mmHg from baseline; heart rate : ≥ 120 beats/min (bpm) with increase from baseline of ≥ 15 bpm; weight (kg) increase from baseline of ≥ 10 percent; body temperature [degree Celsius (deg C)] ≥ 37.5 deg C. The criterion for clinically notable low values included: systolic BP: ≤ 90 mmHg with decrease from baseline of ≥ 20 mmHg; diastolic BP: ≤ 50 mmHg with decrease from baseline of ≥ 15 mmHg; heart rate: ≤ 50 bpm with decrease from baseline of ≥ 15 bpm; weight: ≥ 20 percent decrease from baseline; body temperature [deg C]: ≤ 36 °C.
|
Day 1 until 30 days after last dose of study treatment
|
|
Randomized Phase 2: Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Aikaikkuna: Day 1 until 30 days after last dose of study treatment
|
Clinically notable ECG changes were defined as participants meeting the criterion for QT interval, QT interval corrected for heart rate using Fridericia's formula (QTcF), and heart rate compared to baseline.
The criterion for QT interval and QTcF included: increase from baseline > 30 msec (ms); increase from baseline > 60 ms, new > 450 ms, new > 480 ms, new > 500 ms.
The criterion for heart rate included: increase from baseline > 25 percent to a value > 100 beats per minute (bpm), decrease from baseline > 25 percent and to a value < 50 bpm.
|
Day 1 until 30 days after last dose of study treatment
|
|
Randomized Phase 2: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters
Aikaikkuna: Day 1 until 30 days after last dose of study treatment
|
Clinically notable shift was defined as a worsening from baseline by at least 2 grades, or to grade 3 or above based on NCI-CTCAE version 4.03.
'Low' laboratory parameter thresholds are defined as values falling below the institutional Lower Limit of Normal (LLN) that meet the criteria for a Grade 1 or a higher decrease.
'High' laboratory parameter thresholds are defined as values exceeding the institutional Upper Limit of Normal (ULN) that meet the criteria for a Grade 1 or higher increase.
Where, Grade 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death.
|
Day 1 until 30 days after last dose of study treatment
|
|
Randomized Phase 2: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters
Aikaikkuna: Day 1 until 30 days after last dose of study treatment
|
Clinically notable shift was defined as a worsening from baseline by at least 2 grades, or to grade 3 or above based on NCI-CTCAE version 4.03.
'Low' laboratory parameter thresholds are defined as values falling below the institutional Lower Limit of Normal (LLN) that meet the criteria for a Grade 1 or a higher decrease.
'High' laboratory parameter thresholds are defined as values exceeding the institutional Upper Limit of Normal (ULN) that meet the criteria for a Grade 1 or higher increase.
Where, Grade 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death.
|
Day 1 until 30 days after last dose of study treatment
|
|
Randomized Phase 2: Number of Participants With Notable Dermatological Abnormalities
Aikaikkuna: From screening and every 8 weeks from Cycle 1 Day 1 (i.e. on Day 1 of Cycles 1, 3, 5, 7…), the end of treatment visit and the 30-day safety follow up visit, with a maximum treatment exposure of 116 weeks
|
Dermatological examination was performed to monitor for the possible development of keratoacanthoma and/or squamous cell carcinoma and primary melanoma, as these have been reported to occur with selective B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitor treatment.
[1] All other dermatological findings identified during examination (e.g.
rash acneiform, skin hyperpigmentation...).
|
From screening and every 8 weeks from Cycle 1 Day 1 (i.e. on Day 1 of Cycles 1, 3, 5, 7…), the end of treatment visit and the 30-day safety follow up visit, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Measurement of Performance Status Using the Eastern Co-operative Oncology Group (ECOG) Scale
Aikaikkuna: Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 116 weeks
|
The performance status of participants was assessed using the Eastern Co-operative Oncology Group (ECOG) scale.
The scale was defined with the range from 0 to 5 with lower score mean a lower functional impairment, and a higher score (e.g. 5) corresponding to death.
[1] Participants with no assessment of ECOG in the time frame.
|
Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Time to Definitive Deterioration in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30) Questionnaire Scores
Aikaikkuna: Day 1 until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30) questionnaire consisted of nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social); three symptom scales (fatigue, pain, nausea and vomiting); and a global health and Quality of Life (QoL) scale.
Each scale in the questionnaire was scored (0 to 100).
High scores represented a high health/quality of life.
Time to definitive deterioration (at least 10% worsening relative to Baseline with no later improvement) was assessed for both randomized phase treatment arms.
|
Day 1 until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Time to Definitive Deterioration in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire
Aikaikkuna: Day 1 until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
The European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) consisted of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).
The descriptive system consisted of five dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each was rated according to a five-point verbal rating scale (VRS): 1. no problems, 2. slight problems, 3. moderate problems, 4. severe problems and 5. extreme problems) and translated into a five-digit number that described the participant's health state.
Time to definitive deterioration (at least 10% worsening relative to Baseline with no later improvement) was assessed for both randomized phase treatment arms.
|
Day 1 until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Time to Definitive Deterioration in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) Questionnaire
Aikaikkuna: Day 1 until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
The Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) was a validated quality of life questionnaire for patient reported outcome assessment.
The Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) consisted of 36 items, presented on a five-point Likert scale, in four domains of well-being (physical, emotional, social and functional) and the Colorectal Cancer Subscale.
Higher score reflects a better quality of life.
Time to definitive deterioration (at least 10% worsening relative to Baseline with no later improvement) was assessed for both randomized phase treatment arms.
|
Day 1 until 30 days safety follow-up, with a maximum treatment exposure of 116 weeks
|
|
Randomized Phase 2: Evolution in the Patient Global Impression of Change (PGIC) Questionnaire
Aikaikkuna: Cycle 2 Day 1 until 30 days safety follow-up
|
The Patient Global Impression of Change (PGIC) questionnaire is a scale often used to anchor and characterize participant reported outcome (PRO) findings.
This consisted of questions that asked participants to evaluate their colorectal cancer symptoms since starting study intervention according to a seven-point verbal rating scale: 1. very much improved, 2. much improved, 3. minimally improved, 4. no change, 5. minimally worse, 6. much worse, 7. very much worse.
Completions of questionnaire are summarized per treatment group and study visits.
Number of participants analyzed correspond to the actual number of participants who completed the questionnaire at the corresponding visit.
|
Cycle 2 Day 1 until 30 days safety follow-up
|
|
Randomized Phase 2: Evaluation of the Plasma Concentrations of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Evaluation of the Serum Concentrations of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Evaluation of the Area Under the Curve (AUC) Derived From Plasma Concentration of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Evaluation of the Area Under the Curve (AUC) Derived From Serum Concentration of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Evaluation of the Minimum Concentration (Cmin) Derived From Plasma Concentration of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Evaluation of the Minimum Concentration (Cmin) Derived From Serum Concentration of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Evaluation of the Maximum Concentration (Cmax) Derived From Plasma Concentration of Encorafenib
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of encorafenib.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
|
Randomized Phase 2: Evaluation of the Maximum Concentration (Cmax) Derived From Serum Concentration of Cetuximab
Aikaikkuna: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of cetuximab.
|
First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle of 28 days.
|
Muut tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Satunnaistettu vaihe 2: muutokset lähtötasosta veren karsinoembryonisessa antigeenissä (CEA) ja syöpäantigeenissä 19-9 (CA19-9) kunkin syklin alussa ja hoidon lopussa
Aikaikkuna: Seulonta (päivä -28 - -1) tutkimuksen loppuun asti, noin 12 - 29 kuukautta
|
Seulonta (päivä -28 - -1) tutkimuksen loppuun asti, noin 12 - 29 kuukautta
|
|
Satunnaistettu vaihe 2: Mikrosatelliitin epävakauden (MSI) tila formaliinilla kiinnitetyissä ja parafiiniin upotetuissa (FFPE) näytteissä käyttäen vakiintuneita polymeraasiketjureaktiomäärityksiä (PCR) kasvainnäytteessä versus ituradan kontrolli seulonnassa
Aikaikkuna: Seulonta (päivä -28 - päivä -1)
|
Seulonta (päivä -28 - päivä -1)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Shen Lin, MD, Peking University Cancer Hospital & Institute
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Tiistai 14. syyskuuta 2021
Ensisijainen valmistuminen (Todellinen)
Tiistai 19. joulukuuta 2023
Opintojen valmistuminen (Todellinen)
Lauantai 7. joulukuuta 2024
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 30. huhtikuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 5. elokuuta 2021
Ensimmäinen Lähetetty (Todellinen)
Perjantai 13. elokuuta 2021
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 30. huhtikuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 8. huhtikuuta 2026
Viimeksi vahvistettu
Sunnuntai 1. helmikuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Suoliston sairaudet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Paksusuolen sairaudet
- Kolorektaaliset kasvaimet
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Camptothecin
- Alkaloidit
- Entsyymit ja koentsyymit
- Vasta -aineet, monoklonaalinen, humanisoitu
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Pyrimidiinit
- Formyyltetrahydrofolaatit
- Tetrahydrofolaatit
- Foolihappo
- Pterinit
- Pteridiinit
- Urasiili
- Pyrimidinonit
- Koentsyymit
- Irinotekaani
- Setuksimabi
- Fluorourasiili
- Leukovoriini
- encorafenibi
- IFL -protokolla
Muut tutkimustunnusnumerot
- W00090GE202
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
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