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Studie hodnotící kombinaci enkorafenibu a cetuximabu versus irinotekan/cetuximab nebo infuzní 5-fluorouracil (5-FU)/kyselina folinová (FA)/irinotekan (FOLFIRI)/cetuximab u čínských pacientů s BRAF V600E mutantní kolorační rakovina. (NAUTICALCRC)

8. dubna 2026 aktualizováno: Pierre Fabre Medicament

Multicentrická, randomizovaná, otevřená, dvouramenná studie fáze II s bezpečnostní úvodní fází hodnotící kombinaci enkorafenibu a cetuximabu versus irinotekan/cetuximab nebo infuzní 5-fluorouracil (5-FU)/kyselina folinová (FA) /Irinotecan (FOLFIRI)/Cetuximab u čínských pacientů s BRAF V600E mutantním metastatickým kolorektálním karcinomem.

Enkorafenib je v současné době vyvíjen (s binimetinibem nebo bez něj), v kombinaci s cetuximabem, pro léčbu dospělých pacientů s B-RAF protoonkogenem, mutantem serin/threonin kinázy V600E (BRAF V600E) metastatickým kolorektálním karcinomem (mCRC), kteří mají dostávali předchozí systémovou léčbu.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

107

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria zahrnutí pro molekulární prescreening:

Aby byl účastník způsobilý podstoupit prescreening molekulárního nádoru, musí být splněna následující kritéria pro zařazení:

  • Čínský muž nebo žena ve věku ≥ 18 let v době informovaného souhlasu.
  • Histologicky nebo cytologicky potvrzený kolorektální karcinom (CRC), který je metastatický.
  • Způsobilý k podávání cetuximabu podle čínského schváleného štítku s ohledem na mutační stav nádorového sarkomu virového onkogenu (RAS) (tj. schváleno pro stav krysího sarkomu virového onkogenu divokého typu (RAS wt).
  • Schopnost poskytnout dostatečné množství reprezentativního vzorku nádoru pro centrální prospektivní laboratorní testování B-RAF protoonkogenu, mutačního stavu serin/threonin kinázy (BRAF) a také retrospektivního RAS wt statusu a mikrosatelitní nestability (MSI).

Kritéria pro zařazení do období léčby:

Aby byl účastník způsobilý pro tuto studii, musí splňovat následující kritéria pro zařazení:

  • Čínský muž nebo žena ve věku ≥ 18 let v době informovaného souhlasu.
  • Histologicky nebo cytologicky potvrzený CRC, který je metastatický a neresekovatelný v době vstupu do studie (tj. nevhodné pro kompletní chirurgickou resekci při screeningu).
  • Přítomnost mutace BRAF V600E v nádorové tkáni dříve stanovená lokálním testem kdykoli před screeningem nebo centrální laboratoří.

POZNÁMKA: Mohou platit jiná kritéria pro zařazení definovaná protokolem

Kritéria vyloučení pro molekulární prescreening:

Účastníci splňující kterékoli z následujících kritérií nejsou způsobilí podstoupit molekulární prescreening nádorů:

  • Předchozí léčba receptorem epidermálního růstového faktoru (anti-EGFR).
  • Více než dva předchozí režimy u metastatického onemocnění.
  • Známá kontraindikace podávání cetuximabu nebo irinotekanu v plánované dávce podle nejnovějšího místního označení cetuximabu a irinotekanu.
  • Známá anamnéza Gilbertova syndromu nebo je známo, že má některý z následujících genotypů: uridin 5'-difosfo-glukuronosyltransferáza (UGT)1A1*6/*6, UGT1A1*28/*28 nebo UGT1A1*6/*28.
  • Leptomeningeální onemocnění.

Kritéria vyloučení pro období léčby:

  • Předchozí léčba jakýmkoli inhibitorem proto onkogen serin/threonin-proteinkinázy (RAF), cetuximabem, panitumumabem nebo jinými inhibitory EGFR.
  • Symptomatická metastáza v mozku.
  • Leptomeningeální onemocnění.
  • Užívání jakýchkoli rostlinných léků/doplňků nebo jakýchkoli léků nebo potravin, které jsou středně silnými nebo silnými inhibitory nebo induktory cytochromu P450 (CYP)3A4/5 ≤1 týden před zahájením studijní intervence.
  • Známá anamnéza akutní nebo chronické pankreatitidy během 6 měsíců před zahájením studijní intervence.

POZNÁMKA: Mohou platit jiná kritéria pro vyloučení definovaná protokolem

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Enkorafenib a cetuximab

Fáze Safety Lead-in (SLI):

28denní cykly enkorafenibu jednou denně (QD) 300 mg (4 x 75 mg perorální tobolka) a cetuximabu 400 mg/m² počáteční dávka (120minutová infuze), poté 250 mg/m² (60minutová infuze) poté jednou týdně

Randomizovaná (fáze II) fáze:

28denní cykly enkorafenibu jednou denně (QD) 300 mg (4 x 75 mg perorální tobolka) a cetuximabu 400 mg/m² počáteční dávka (120minutová infuze), poté 250 mg/m² (60minutová infuze) poté jednou týdně
Lék: Encorafenib
perorální tvrdé tobolky
Ostatní jména:
  • LGX818
  • Braftovi®
  • PF-07263896
  • W0090
  • ONO-7702
Lék: Cetuximab
intravenózní infuze
Ostatní jména:
  • C225
  • Erbitux®
Experimentální: Irinotekan a cetuximab nebo FOLFIRI a cetuximab

Randomizovaná (fáze II) fáze: Buď irinotekan a cetuximab nebo FOLFIRI a cetuximab ve 28denních cyklech.

Irinotekan a cetuximab:

  • irinotekan 180 mg/m² (90minutová intravenózní infuze nebo podle standardů místa studie) každé 2 týdny a
  • cetuximab 400 mg/m² počáteční dávka (120minutová intravenózní infuze), poté 250 mg/m² (60minutová infuze) poté jednou týdně

NEBO

FOLFIRI a cetuximab:

  • irinotekan 180 mg/m² (90minutová intravenózní infuze nebo podle standardů místa studie) každé 2 týdny
  • Kyselina folinová 400 mg/m² (120minutová infuze nebo podle standardů místa studie) nebo maximální dávka tolerovaná v předchozím režimu každé 2 týdny
  • 5-FU 400 mg/m² počáteční dávka bolus (nepřekročit 15 minut), poté 1200 mg/m²/den × 2 dny (celkem 2400 mg/m² během 46 až 48 hodin) kontinuální infuze nebo maximální dávka tolerovaná v předchozím režimu každé 2 týdny a
  • cetuximab 400 mg/m² počáteční dávka (120minutová intravenózní infuze), poté 250 mg/m² (60minutová infuze) poté jednou týdně
Lék: Encorafenib
perorální tvrdé tobolky
Ostatní jména:
  • LGX818
  • Braftovi®
  • PF-07263896
  • W0090
  • ONO-7702
Lék: Cetuximab
intravenózní infuze
Ostatní jména:
  • C225
  • Erbitux®
Lék: FOLFIRI

Kombinace:

irinotekan (také známý jako: Camptosar, Camptothecin-11 a CPT-11) intravenózní infuze, kyselina folinová (také známá jako: kyselina 5-formyltetrahydrolistová a leukovorin) intravenózní infuze a 5-FU (také známý jako; fluorouracil) intravenózní bolus /nitrožilní infuze

Ostatní jména:
  • Kyselina folinová + fluorouracil + irinotekan

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Safety Lead-in Phase (SLI): Incidence of Dose Limiting Toxicities (DLTs)
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Safety Lead-in Phase: Confirmed Objective Response Rate (cORR) Per BICR
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Časové okno
Randomizovaná fáze 2: Změny od výchozí hodnoty v krvi karcinoembryonálního antigenu (CEA) a rakovinného antigenu 19-9 (CA19-9) na začátku každého cyklu a na konci léčby
Časové okno: Screening (den -28 až -1) až po dokončení studie, přibližně od 12 do 29 měsíců
Screening (den -28 až -1) až po dokončení studie, přibližně od 12 do 29 měsíců
Randomizovaná fáze 2: Stav mikrosatelitové nestability (MSI) ve vzorcích fixovaných ve formalínu a zalitých v parafínu (FFPE) pomocí zavedených testů polymerázové řetězové reakce (PCR) ve vzorku nádoru versus kontrola zárodečné linie při screeningu
Časové okno: Promítání (den -28 až den -1)
Promítání (den -28 až den -1)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pierre Fabre Medicament

Spolupracovníci

Merck KGaA, Darmstadt, Germany

Vyšetřovatelé

  • Vrchní vyšetřovatel: Shen Lin, MD, Peking University Cancer Hospital & Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

14. září 2021

Primární dokončení (Aktuální)

19. prosince 2023

Dokončení studie (Aktuální)

7. prosince 2024

Termíny zápisu do studia

První předloženo

30. dubna 2021

První předloženo, které splnilo kritéria kontroly kvality

5. srpna 2021

První zveřejněno (Aktuální)

13. srpna 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. dubna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. dubna 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • W00090GE202

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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