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Clinical Trials List

Protocol Number20190172
NCT Number(ClinicalTrials.gov Identfier)NCT05198934

2021-12-01 - 2025-07-31

Phase III

Recruiting6

ICD-10C18.8

Malignant neoplasm of overlapping sites of colon

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9153.8

Malignant neoplasm of other specified sites of large intestine

A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Amgen Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hao-Wei Teng Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHOU-CHEN CHEN Division of Colorectal Surgery
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jaw-Yuan Wang Division of Colorectal Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Sheng Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Colorectal Cancer (CRC)

Objectives

The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).

Test Drug

AMG 510；Panitumumab

Active Ingredient

AMG 510；Panitumumab

Dosage Form

Tablets；Concentrate for solution for infusion

Dosage

120 mg/Tablet；20 mg/mL, vial

Endpoints

Primary:
PFS
Secondary
OS
ORR

-反應持續時間 (DOR)
-開始反應時間 (TTR)
-疾病控制率 (DCR)
-試驗主持人評估 ORR 和 PFS
-評估 sotorasib 240 mg QD 和 panitumumab 相對於試驗主持人選用藥物 (trifluridine 和 tipiracil 或 regorafenib)，以及 sotorasib 960 mg QD 和 panitumumab 相對於試驗主持人選用藥物 (trifluridine 和 tipiracil 或 regorafenib) 的安全性及耐受性
評估 sotorasib 240 mg QD 和 panitumumab 相對於試驗主持人選用藥物 (trifluridine 和 tipiracil 或 regorafenib)，以及 sotorasib 960 mg QD 和 panitumumab 相對於試驗主持人選用藥物 (trifluridine 及 tipiracil 或 regorafenib) 對患者自評倦怠、疼痛、生理功能及整體健康狀態 (患者自評結果 [PRO]) 的影響
-評估並比較 sotorasib 240 mg 和 panitumumab 相對於試驗主持人選用藥物 (trifluridine 和 tipiracil 或 regorafenib) 治療，以及 sotorasib 960 mg QD 和 panitumumab 相對於試驗主持人選用藥物 (trifluridine 及 tipiracil 或 regorafenib) 治療，對其他治療和疾病相關症狀及健康相關生活品質相較於試驗主持人選用藥物 (trifluridine 和 tipiracil 或 regorafenib) 的影響
-探討 sotorasib 和 panitumumab 的藥物動力學 (PK)

Inclution Criteria

Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Age ≥18 years.
Pathologically documented metastatic colorectal adenocarcinoma with Kirsten rat sarcoma (KRAS) p.G12C mutation as determined by central testing.
Participants will have received at least 1 prior line of therapy for metastatic disease. Participants must have received and progressed or experienced disease recurrence on or after fluoropyrimidine, irinotecan, and oxaliplatin given for metastatic disease unless the participant, in the opinion of the investigator, is not a candidate for fluoropyrimidine, irinotecan, or oxaliplatin, in which case, the participant may be eligible after investigator discussion with Amgen medical monitor provided participant has received at least one prior line of therapy for metastatic disease and provided trifluridine and tipiracil or regorafenib is deemed the appropriate next line of therapy for the participant.
Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
Life expectancy of >3 months, in the opinion of the investigator.
Adequate hematologic and end-organ function, defined as the following within 10 days prior to randomization:

Absolute neutrophil count (ANC) ≥1.5 x 10^9/L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility).
Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility).
Platelet count ≥100 x 10^9/L (without transfusion within 2 weeks of laboratory test used to determine eligibility).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal (ULN).
Serum bilirubin ≤1.0 x ULN. For participants with Gilbert's disease, direct bilirubin ≤1.0 x ULN.
International normalized ratio (INR) and activated partial thromboplastin time (or partial thromboplastin time) ≤1.5 x ULN. Prothrombin time (PT) ≤1.5 x ULN may be used instead of INR for sites whose labs do not report INR.
Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥30 mL/min/1.73 m^2.
Fridericia's Correction Formula (QTcF) ≤470 msec.

Exclusion Criteria

Active brain metastases. Participants who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible if they meet all of the following criteria: a) residual neurological symptoms grade ≤2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up magnetic resonance imaging (MRI) performed within 28 days of day 1 shows no progression or new lesions appearing.
History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥2 years.
History of other malignancy within the past 3 years, with the following exceptions:

Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease.
Adequately treated breast ductal carcinoma in situ without evidence of disease.
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.
Leptomeningeal disease.
Significant gastrointestinal (GI) disorder that results in significant malabsorption, requirement for intravenous (IV) alimentation, or inability to take oral medication.
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to randomization, unstable arrhythmias or unstable angina.
Previous treatment with a KRAS G12C inhibitor.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    153 participants

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