A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal Cancer - 20060447

Active, not recruiting

Conditions: wild-type KRAS metastatic colorectal cancer
MedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

Registration Number: EUCTR2008-001751-21-IT

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 144

Inclusion Criteria

Man or woman ≥ 18 years of age A life expectancy estimate of ≥ 3 months ECOG 0 or 1 Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment Radiographic evidence of disease progression during or following prior treatment with irinotecan and/or oxaliplatin based chemotherapy for mCRC At least 1 uni-dimensionally measurable lesion ≥ 20 mm in one dimension per modified RECIST (CT or MRI) Adequate hematology, renal, and hepatic function Magnesium ≥ lower limit of normal Subjects with known diabetes (Type 1 or 2) must have adequate glycemic function, as follows: - Must be controlled with a glycosylated hemoglobin (HgbA1c) of < 8.0% - Documented fasting blood sugars < 160 mg/dL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Participation in a phase 3 randomized study of panitumumab in combination with chemotherapy, regardless of treatment assignment Prior treatment with anti-EGFr inhibitors (eg, panitumumab, cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant setting ≥ 6 months before enrollment Prior treatment with c-Met, IGF-IR, or IGF-IIR inhibitors Prior treatment with either AMG 102 or AMG 479 Use of experimental or approved systemic chemotherapy or radiotherapy ≤ 21 days before enrollment Use of experimental or approved targeted therapies ≤ 30 days before enrollment History of prior or concurrent central nervous system (CNS) metastases History of other primary cancer, unless: - Curatively resected non-melanomatous skin cancer - Curatively treated cervical carcinoma in situ - Other primary solid tumor treated with curative intent and no known active disease present for ≥ 5 years before enrollment History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as ≥ grade 2 per CTCAE version 3.0) Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion) Serious or non-healing wound ≤ 35 days before enrollment Major surgical procedure ≤ 35 days before enrollment or minor surgical procedure ≤ 14 days before enrollment. Subjects must have recovered from surgery related toxicities. Central venous catheter placement, fine needle aspiration, thoracentesis, or paracentesis is not considered a major or minor surgical procedure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy as assessed by the overall objective response rate (ORR) of AMG 102 (tolerable dose selected from part 1) in combination with panitumumab and AMG 479 in combination with panitumumab versus panitumumab alone;Secondary Objective: To evaluate the safety and efficacy of AMG 102 (tolerable dose selected from part 1) in combination with panitumumab and AMG 479 in combination with panitumumab versus panitumumab alone PK exposure of AMG 102 and panitumumab when given in combination PK exposure of AMG 479 and panitumumab when given in combination PK exposure of panitumumab when given alone;Primary end point(s): Overall ORR (objective response rate)

Secondary Outcome Measures

Name	Time	Method

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