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BRAF V600E 変異転移性結​​腸直腸癌の中国人患者を対象に、エンコラフェニブとセツキシマブとイリノテカン/セツキシマブまたは注入 5-フルオロウラシル (5-FU)/フォリン酸 (FA)/イリノテカン (FOLFIRI)/セツキシマブの組み合わせを評価する研究。 (NAUTICALCRC)

2026年4月8日 更新者：Pierre Fabre Medicament

エンコラフェニブとセツキシマブの組み合わせとイリノテカン/セツキシマブまたは輸液 5-フルオロウラシル (5-FU)/フォリン酸 (FA) の組み合わせを評価する、安全性導入段階を伴う多施設共同、無作為化、非盲検、2 アーム、第 II 相試験/イリノテカン (FOLFIRI)/BRAF V600E 変異転移性結​​腸直腸癌の中国人患者におけるセツキシマブ。

Encorafenib は現在、B-RAF プロトオンコジーン、セリン/スレオニンキナーゼ V600E 変異体 (BRAF V600E) 転移性結腸直腸癌 (mCRC) を有する成人患者の治療のために、セツキシマブと併用して (ビニメチニブの有無にかかわらず) 開発されています。 -以前に全身療法を受けた。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

107

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

分子事前スクリーニングの包含基準:

参加者が分子腫瘍の事前スクリーニングを受ける資格を得るには、以下の選択基準を満たす必要があります。

  • -インフォームドコンセント時の年齢が18歳以上の中国人男性または女性参加者。
  • -転移性である組織学的または細胞学的に確認された結腸直腸癌（CRC）。
  • 腫瘍ラット肉腫ウイルスがん遺伝子ホモログ（RAS）変異状態（すなわち、 Rat Sarcoma Viral Oncogene Homologue Wild Type (RAS wt) status で承認されています)。
  • B-RAF プロトオンコジーン、セリン/スレオニンキナーゼ (BRAF) 変異状態、およびレトロスペクティブ RAS wt 状態およびマイクロサテライト不安定性 (MSI) テストの中心的な前向き検査に十分な量の代表的な腫瘍標本を提供することができます。

治療期間の包含基準:

参加者がこの研究に適格であるためには、以下の選択基準を満たす必要があります。

  • -インフォームドコンセント時の年齢が18歳以上の中国人男性または女性参加者。
  • -組織学的または細胞学的に確認されたCRCは、研究登録時に転移性で切除不能です（つまり、 スクリーニング時の完全な外科的切除には適していません)。
  • -スクリーニング前の任意の時点での局所アッセイまたは中央検査室によって以前に決定された腫瘍組織におけるBRAF V600E変異の存在。

注: 他のプロトコル定義の包含基準が適用される場合があります

分子事前スクリーニングの除外基準:

以下の基準のいずれかを満たす参加者は、分子腫瘍の事前スクリーニングを受ける資格がありません。

  • -以前の抗上皮成長因子受容体（抗EGFR）治療
  • -転移状況での2つ以上の以前のレジメン。
  • -最新のセツキシマブおよびイリノテカンのローカルラベルに従って、計画された用量でセツキシマブまたはイリノテカンを受ける既知の禁忌。
  • -ギルバート症候群の既知の病歴、または次の遺伝子型のいずれかを持つことが知られている：ウリジン5'-ジホスホ-グルクロノシルトランスフェラーゼ（UGT）1A1 * 6 / * 6、UGT1A1 * 28 / * 28またはUGT1A1 * 6 / * 28。
  • 軟髄膜疾患。

治療期間の除外基準:

  • -癌原遺伝子セリン/スレオニン-プロテインキナーゼ（RAF）阻害剤、セツキシマブ、パニツムマブまたは他のEGFR阻害剤による以前の治療。
  • 症候性脳転移。
  • 軟髄膜疾患。
  • -シトクロムP450（CYP）3A4 / 5の中等度または強力な阻害剤または誘導剤であるハーブ薬/サプリメント、または薬または食品の使用 研究介入開始の1週間前。
  • -研究介入開始前の6か月以内の急性または慢性膵炎の既知の病歴。

注: 他のプロトコル定義の除外基準が適用される場合があります

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：エンコラフェニブとセツキシマブ

安全導入 (SLI) フェーズ:

encorafenib の 28 日サイクル 1 日 1 回 (QD) 300 mg (4 x 75 mg 経口カプセル) およびセツキシマブ 400 mg/m² の初期用量 (120 分間の注入)、その後 250 mg/m² (60 分間の注入) を週 1 回

無作為化 (フェーズ II) フェーズ:

encorafenib の 28 日サイクル 1 日 1 回 (QD) 300 mg (4 x 75 mg 経口カプセル) およびセツキシマブ 400 mg/m² の初期用量 (120 分間の注入)、その後 250 mg/m² (60 分間の注入) を週 1 回
薬：エンコラフェニブ
経口ハードカプセル
他の名前：
  • LGX818
  • ブラフトビ®
  • PF-07263896
  • W0090
  • ONO-7702
薬：セツキシマブ
静脈内注入
他の名前：
  • C225
  • アービタックス®
実験的：イリノテカンとセツキシマブ、または FOLFIRI とセツキシマブ

無作為化 (第 II 相) フェーズ: 28 日サイクルのイリノテカンとセツキシマブ、または FOLFIRI とセツキシマブのいずれか。

イリノテカンとセツキシマブ:

  • イリノテカン 180 mg/m² (90 分間の静脈内注入または研究施設の基準に合わせて) 2 週間ごとおよび
  • セツキシマブ 400 mg/m² の初回用量 (120 分間の静脈内注入)、その後 250 mg/m² (60 分間の注入) を週 1 回

また

FOLFIRI とセツキシマブ:

  • イリノテカン 180 mg/m² (90 分間の静脈内注入または研究施設の基準に合わせて) 2 週間ごと
  • フォリン酸 400 mg/m² (120 分間の注入または試験施設の基準に合わせて) または 2 週間ごとに以前のレジメンで許容される最大用量
  • 5-FU 400 mg/m² 初回用量ボーラス (15 分を超えないこと)、その後 1200 mg/m²/日 × 2 日 (46 ～ 48 時間で合計 2400 mg/m²) 持続注入または以前のレジメンで許容される最大用量2週間ごとと
  • セツキシマブ 400 mg/m² の初回用量 (120 分間の静脈内注入)、その後 250 mg/m² (60 分間の注入) を週 1 回
薬：エンコラフェニブ
経口ハードカプセル
他の名前：
  • LGX818
  • ブラフトビ®
  • PF-07263896
  • W0090
  • ONO-7702
薬：セツキシマブ
静脈内注入
他の名前：
  • C225
  • アービタックス®
薬：フォルフィリ

組み合わせ:

イリノテカン (別名: カンプトサール、カンプトテシン-11、および CPT-11) 静脈内注入、フォリン酸 (別名: 5-ホルミル テトラヒドロ葉酸およびロイコボリン) 静脈内注入、および 5-FU (別名: フルオロウラシル) 静脈内ボーラス/点滴

他の名前：
  • フォリン酸＋フルオロウラシル＋イリノテカン

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Safety Lead-in Phase (SLI): Incidence of Dose Limiting Toxicities (DLTs)
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Safety Lead-in Phase: Confirmed Objective Response Rate (cORR) Per BICR
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

その他の成果指標

結果測定
時間枠
無作為化第 2 相：各サイクルの開始時および治療終了時の血中癌胎児性抗原（CEA）および癌抗原 19-9（CA19-9）のベースラインからの変化
時間枠：スクリーニング (-28 日目から -1 日目) から試験完了まで、約 12 ～ 29 か月
スクリーニング (-28 日目から -1 日目) から試験完了まで、約 12 ～ 29 か月
無作為化フェーズ 2: スクリーニング時の腫瘍サンプルと生殖細胞系コントロールで確立されたポリメラーゼ連鎖反応 (PCR) アッセイを使用したホルマリン固定およびパラフィン包埋 (FFPE) サンプルのマイクロサテライト不安定性 (MSI) ステータス
時間枠：スクリーニング（-28日目～-1日目）
スクリーニング（-28日目～-1日目）

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pierre Fabre Medicament

協力者

Merck KGaA, Darmstadt, Germany

捜査官

  • 主任研究者：Shen Lin, MD、Peking University Cancer Hospital & Institute

出版物と役立つリンク

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年9月14日

一次修了 (実際)

2023年12月19日

研究の完了 (実際)

2024年12月7日

試験登録日

最初に提出

2021年4月30日

QC基準を満たした最初の提出物

2021年8月5日

最初の投稿 (実際)

2021年8月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年4月30日

QC基準を満たした最後の更新が送信されました

2026年4月8日

最終確認日

2026年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • W00090GE202

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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