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Badanie oceniające połączenie enkorafenibu i cetuksymabu w porównaniu z irynotekanem/cetuksymabem lub podawanym we wlewie 5-fluorouracylem (5-FU)/kwasem foliowym (FA)/irynotekanem (FOLFIRI)/cetuksymabem u chińskich pacjentów z przerzutowym rakiem jelita grubego z mutacją BRAF V600E. (NAUTICALCRC)

8 kwietnia 2026 zaktualizowane przez: Pierre Fabre Medicament

Wieloośrodkowe, randomizowane, otwarte, dwuramienne badanie fazy II z fazą wstępną dotyczącą bezpieczeństwa oceniające połączenie enkorafenibu i cetuksymabu w porównaniu z irynotekanem/cetuksymabem lub 5-fluorouracylem (5-FU)/kwasem foliowym (FA) we wlewie dożylnym /Irynotekan (FOLFIRI)/Cetuksymab u chińskich pacjentów z przerzutowym rakiem jelita grubego z mutacją BRAF V600E.

Obecnie opracowywany jest enkorafenib (z binimetynibem lub bez), w skojarzeniu z cetuksymabem, do leczenia dorosłych pacjentów z protoonkogenem B-RAF, mutantem kinazy serynowo-treoninowej V600E (BRAF V600E) z przerzutowym rakiem jelita grubego (mCRC), u których stwierdzono otrzymał wcześniejszą terapię systemową.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

107

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100730
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Beijing, Beijing Municipality, Chiny, 100036
        • Beijing Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, Chiny, 350014
        • Fujian Medical University - Fujian Provincial Cancer Hospital
      • Xiamen, Fujian, Chiny, 361001
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Foshan, Guangdong, Chiny, 528010
        • The First People's Hospital of Foshan
      • Guangzhou, Guangdong, Chiny, 510095
        • Cancer Center of Guangzhou Medical University
      • Guangzhou, Guangdong, Chiny, 510655
        • The Sixth Affiliated Hospital Sun Yat-sen University
      • Shantou, Guangdong, Chiny, 515041
        • Cancer Hospital Affiliated to Shantou University Medical College
      • Shenzhen, Guangdong, Chiny, 518036
        • Peking University Shenzhen Hospital
    • Hebei
      • Baoding, Hebei, Chiny, 071000
        • The Affiliated Hospital of Hebei University
    • Heilongjiang
      • Harbin, Heilongjiang, Chiny, 150040
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, Chiny, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, Chiny, 450008
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, Chiny, 430071
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, Chiny, 430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Wuhan, Hubei, Chiny, 430030
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Chiny, 410008
        • Xiangya Hospital Central South University
    • Jiangsu
      • Changzhou, Jiangsu, Chiny, 213003
        • The First People's Hospital of Changzhou
    • Jiangxi
      • Ganzhou, Jiangxi, Chiny, 341001
        • First Affiliated Hospital of Gannan Medical University
      • Nanchang, Jiangxi, Chiny, 330006
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, Chiny, 330006
        • The Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, Chiny, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Jinzhou, Liaoning, Chiny, 121011
        • The First Affiliated Hospital of Jinzhou Medical University
      • Shenyang, Liaoning, Chiny, 110001
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, Chiny, 110042
        • Liaoning Cancer Hospital & Institute
    • Shaanxi
      • Xi'an, Shaanxi, Chiny, 710068
        • Shaanxi Provincial People's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chiny, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai Municipality, Chiny, 200040
        • Huashan Hospital Fudan University
      • Shanghai, Shanghai Municipality, Chiny, 200092
        • Xinhua Hospital Affilliated to Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai Municipality, Chiny, 200120
        • Shanghai East Hospital, Tongji University
    • Sichuan
      • Neijiang, Sichuan, Chiny, 641000
        • The Second People's Hospital of Neijiang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chiny, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Chiny, 310003
        • The First Affiliated Hospital - Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, Chiny, 310016
        • Sir Run Run Shaw Hospital - Zhejiang University School of Medicine

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria włączenia do wstępnego badania molekularnego:

Aby uczestnik mógł zostać zakwalifikowany do wstępnego badania przesiewowego w kierunku raka molekularnego, musi spełniać następujące kryteria włączenia:

  • Chiński uczestnik płci męskiej lub żeńskiej w wieku ≥18 lat w momencie wyrażenia świadomej zgody.
  • Potwierdzony histologicznie lub cytologicznie rak jelita grubego (CRC) z przerzutami.
  • Kwalifikuje się do otrzymywania cetuksymabu zgodnie z zatwierdzoną przez Chiny etykietą w odniesieniu do statusu mutacji nowotworu Mięsak szczura wirusowego homologu onkogenu (RAS) (tj. zatwierdzony dla statusu Homologu Homologu Wirusa Mięsaka Szczurów (RAS wt)).
  • Możliwość dostarczenia wystarczającej ilości reprezentatywnej próbki guza do centralnych prospektywnych badań laboratoryjnych statusu mutacji protoonkogenu B-RAF, kinazy serynowo-treoninowej (BRAF), a także retrospektywnego statusu RAS wt i niestabilności mikrosatelitarnej (MSI).

Kryteria włączenia do okresu leczenia:

Aby uczestnik mógł zostać zakwalifikowany do tego badania, muszą być spełnione następujące kryteria włączenia:

  • Chiński uczestnik płci męskiej lub żeńskiej w wieku ≥18 lat w momencie wyrażenia świadomej zgody.
  • Potwierdzony histologicznie lub cytologicznie CRC z przerzutami i nieoperacyjny w momencie włączenia do badania (tj. nie nadaje się do całkowitej resekcji chirurgicznej podczas badania przesiewowego).
  • Obecność mutacji BRAF V600E w tkance nowotworowej uprzednio stwierdzona za pomocą lokalnego testu w dowolnym momencie przed badaniem przesiewowym lub przez laboratorium centralne.

UWAGA: Mogą obowiązywać inne kryteria włączenia określone w protokole

Kryteria wyłączenia z wstępnego badania molekularnego:

Uczestnicy spełniający którekolwiek z poniższych kryteriów nie kwalifikują się do poddania się wstępnemu badaniu na obecność nowotworów molekularnych:

  • Wcześniejsze leczenie przeciw receptorowi naskórkowego czynnika wzrostu (anty-EGFR).
  • Więcej niż dwa wcześniejsze schematy leczenia w przypadku przerzutów.
  • Znane przeciwwskazanie do przyjmowania cetuksymabu lub irynotekanu w zaplanowanej dawce zgodnie z najnowszą lokalną etykietą cetuksymabu i irynotekanu.
  • Znana historia zespołu Gilberta lub jeden z następujących genotypów: 5'-difosfo-glukuronylotransferaza urydyny (UGT)1A1*6/*6, UGT1A1*28/*28 lub UGT1A1*6/*28.
  • Choroba leptomeningalna.

Kryteria wykluczenia z okresu leczenia:

  • Wcześniejsze leczenie jakimkolwiek inhibitorem kinazy białkowej protoonkogenu/treoniny (RAF), cetuksymabem, panitumumabem lub innymi inhibitorami EGFR.
  • Objawowe przerzuty do mózgu.
  • Choroba leptomeningalna.
  • Stosowanie jakichkolwiek leków/suplementów ziołowych lub jakichkolwiek leków lub pokarmów, które są umiarkowanymi lub silnymi inhibitorami lub induktorami cytochromu P450 (CYP)3A4/5 ≤1 tydzień przed rozpoczęciem interwencji w ramach badania.
  • Znana historia ostrego lub przewlekłego zapalenia trzustki w ciągu 6 miesięcy przed rozpoczęciem interwencji w ramach badania.

UWAGA: Mogą obowiązywać inne zdefiniowane w protokole kryteria wykluczenia

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Enkorafenib i cetuksymab

Faza wprowadzenia bezpieczeństwa (SLI):

28-dniowe cykle enkorafenibu raz dziennie (QD) 300 mg (4 kapsułki doustne x 75 mg) i cetuksymabu 400 mg/m² dawka początkowa (120-minutowy wlew), następnie 250 mg/m² (60-minutowy wlew) raz w tygodniu

Randomizowana (faza II) faza:

28-dniowe cykle enkorafenibu raz dziennie (QD) 300 mg (4 kapsułki doustne x 75 mg) i cetuksymabu 400 mg/m² dawka początkowa (120-minutowy wlew), następnie 250 mg/m² (60-minutowy wlew) raz w tygodniu
Lek: Enkorafenib
twarda kapsułka doustna
Inne nazwy:
  • LGX818
  • Braftovi®
  • PF-07263896
  • W0090
  • ONO-7702
Lek: Cetuksymab
infuzja dożylna
Inne nazwy:
  • C225
  • Erbitux®
Eksperymentalny: Irynotekan i cetuksymab lub FOLFIRI i cetuksymab

Randomizowana faza (faza II): Irynotekan i cetuksymab lub FOLFIRI i cetuksymab w 28-dniowych cyklach.

Irynotekan i cetuksymab:

  • irynotekan 180 mg/m² (90-minutowy wlew dożylny lub zgodnie z normami miejsca badania) co 2 tygodnie oraz
  • cetuksymab 400 mg/m² dawka początkowa (120-minutowy wlew dożylny), następnie 250 mg/m² (60-minutowy wlew) raz w tygodniu

LUB

FOLFIRI i cetuksymab:

  • irynotekan 180 mg/m² (90-minutowy wlew dożylny lub do standardów miejsca badania) co 2 tygodnie
  • Kwas folinowy 400 mg/m² (120-minutowy wlew lub zgodnie z normami miejsca badania) lub maksymalna dawka tolerowana w poprzednim schemacie co 2 tygodnie
  • 5-FU 400 mg/m² dawka początkowa bolus (nie dłużej niż 15 minut), następnie 1200 mg/m²/dzień × 2 dni (łącznie 2400 mg/m² w ciągu 46 do 48 godzin) ciągły wlew lub maksymalna dawka tolerowana w poprzednim schemacie co 2 tygodnie i
  • cetuksymab 400 mg/m² dawka początkowa (120-minutowy wlew dożylny), następnie 250 mg/m² (60-minutowy wlew) raz w tygodniu
Lek: Enkorafenib
twarda kapsułka doustna
Inne nazwy:
  • LGX818
  • Braftovi®
  • PF-07263896
  • W0090
  • ONO-7702
Lek: Cetuksymab
infuzja dożylna
Inne nazwy:
  • C225
  • Erbitux®
Lek: FOLFIRI

Kombinacja:

irynotekan (znany również jako: Kamptosar, Kamptotecyna-11 i CPT-11) we wlewie dożylnym, kwas folinowy (znany również jako: kwas 5-formylotetrahydrofoliowy i leukoworyna) we wlewie dożylnym oraz 5-FU (znany również jako; fluorouracyl) w bolusie dożylnym /wlew dożylny

Inne nazwy:
  • Kwas foliowy + Fluorouracyl + Irynotekan

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Safety Lead-in Phase (SLI): Incidence of Dose Limiting Toxicities (DLTs)
Ramy czasowe: Cycle 1 (up to 28 days)
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.
Cycle 1 (up to 28 days)
Randomized Phase 2: Progression-free Survival (PFS) by Blinded (to Treatment Received) Independent Central Review (BICR) at the Primary Completion Date
Ramy czasowe: 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
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.
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
Randomized Phase 2: Progression-free Survival (PFS) by Blinded (to Treatment Received) Independent Central Review (BICR) at the Final Analysis
Ramy czasowe: 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 disease progression as determined by BICR assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause.
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Safety Lead-in Phase: Confirmed Objective Response Rate (cORR) Per BICR
Ramy czasowe: 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 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 111 weeks
Safety Lead-in Phase: Confirmed Objective Response Rate (cORR) Per Investigator
Ramy czasowe: 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.
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
Safety Lead-in Phase: Duration of Response (DOR) Per BICR
Ramy czasowe: 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 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 maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Duration of Response (DOR) Per Investigator
Ramy czasowe: 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.
From time of response to the earliest documented PD or death due to underlying disease, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Overall Duration of Exposure to Study Treatment
Ramy czasowe: 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.
Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Ramy czasowe: Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
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, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Number of Participants With Serious TEAEs
Ramy czasowe: 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.
Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs)
Ramy czasowe: Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 68 weeks
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.
Day 1 until 30 days after study intervention discontinuation, with a maximum treatment exposure of 68 weeks
Safety Lead-in Phase: Number of Participants With Clinically Notable Vital Sign Abnormalities
Ramy czasowe: 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.
Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Ramy czasowe: 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.
Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters
Ramy czasowe: 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.
Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters
Ramy czasowe: 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.
Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 111 weeks
Safety Lead-in Phase: Number of Participants With Notable Dermatological Abnormalities
Ramy czasowe: 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...).
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
Safety Lead-in Phase: Measurement of Performance Status Using the Eastern Co-operative Oncology Group (ECOG) Scale
Ramy czasowe: 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.
Day 1 until 30 days after last dose of study treatment, with a maximum treatment exposure of 68 weeks
Safety Lead-in Phase: Evaluation of the Plasma Concentrations of Encorafenib
Ramy czasowe: 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.
Safety Lead-in Phase: Evaluation of the Serum Concentrations of Cetuximab
Ramy czasowe: 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 Area Under the Curve (AUC) Derived From Plasma Concentration of Encorafenib
Ramy czasowe: 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 Area Under the Curve (AUC) Derived From Serum Concentration of Cetuximab
Ramy czasowe: 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 Maximum Concentration (Cmax) Derived From Plasma Concentration of Encorafenib
Ramy czasowe: 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 Maximum Concentration (Cmax) Derived From Serum Concentration of Cetuximab
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Ramy czasowe
Randomizowana faza 2: zmiany w stosunku do wartości wyjściowych we krwi w odniesieniu do antygenu rakowo-płodowego (CEA) i antygenu nowotworowego 19-9 (CA19-9) na początku każdego cyklu i na końcu leczenia
Ramy czasowe: Badanie przesiewowe (dzień -28 do -1) do zakończenia badania, w przybliżeniu od 12 do 29 miesięcy
Badanie przesiewowe (dzień -28 do -1) do zakończenia badania, w przybliżeniu od 12 do 29 miesięcy
Randomizowana faza 2: Status niestabilności mikrosatelitarnej (MSI) w próbkach utrwalonych w formalinie i zatopionych w parafinie (FFPE) przy użyciu ustalonych testów reakcji łańcuchowej polimerazy (PCR) w próbce guza w porównaniu z kontrolą linii zarodkowej podczas badań przesiewowych
Ramy czasowe: Badanie przesiewowe (od dnia -28 do dnia -1)
Badanie przesiewowe (od dnia -28 do dnia -1)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pierre Fabre Medicament

Współpracownicy

Merck KGaA, Darmstadt, Germany

Śledczy

  • Główny śledczy: Shen Lin, MD, Peking University Cancer Hospital & Institute

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

14 września 2021

Zakończenie podstawowe (Rzeczywisty)

19 grudnia 2023

Ukończenie studiów (Rzeczywisty)

7 grudnia 2024

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 sierpnia 2021

Pierwszy wysłany (Rzeczywisty)

13 sierpnia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 kwietnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 kwietnia 2026

Ostatnia weryfikacja

1 lutego 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • W00090GE202

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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