Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS status.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Panitumumab; Rilotumumab

Criteria

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 Response Evaluation Criteria In Solid Tumors (RECIST)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• adequate laboratory values

Exclusion Criteria:

• history of central nervous system (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-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor

• prior treatment with AMG 102 or AMG 479

• prior treatment with chemotherapy or radiotherapy
• prior treatment with targeted therapy
• known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479

• history of interstitial lung disease

• clinically significant cardiovascular disease
• active inflammatory bowel disease

• known human immunodeficiency virus (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
• any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results

• major surgical procedure
• other investigational procedures or drugs