A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer
Inclusion Criteria:
- metastatic adenocarcinoma of the colon or rectum
- wild-type KRAS tumor status
- radiographic evidence of disease progression during or following treatment with
irinotecan and/or oxaliplatin containing chemotherapy for mCRC
- measurable disease >/= 20 mm per RECIST
- ECOG 0 or 1
- adequate laboratory values
Exclusion Criteria:
- history of CNS metastases
- history of another 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
- prior treatment with an anti-EGFR, c-MET, and/or IGFR inhibitor
- prior treatment with AMG 102 or AMG 479
- prior treatment with chemotherapy or radiotherapy = 21 days
- prior treatment with targeted therapy = 30 days
- known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479
- history of interstitial lung disease
- clinically significant cardiovascular disease = 1 year
- active inflammatory bowel disease
- known HIV, hepatitis C, or hepatitis B infection
- any co-morbid disease or condition that could increase the risk of toxicity
- serious or non-healing wound = 35 days
- any uncontrolled concurrent illness or history of any medical condition that could
interfere with the interpretation of the study results
- major surgical procedure = 35 days or minor surgical procedure = 14 days
- other investigational procedures or drugs = 30 days