Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over Pharmaceutical / Industry 20060447 NCT00788957

Trial Description

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 AMG 102 or AMG 479 in combination with panitumumab versus panitumumab alone in subjects with metastatic colorectal cancer whose tumors are wild-type KRAS status.

Eligibility 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen, Incorporated

MD

Study Director

Amgen Call Center

Ph: 866-572-6436

U.S.A.
South Carolina
	Greenville
	Research Site
Belgium
	Leuven
	Research Site
Spain
	Barcelona
	Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00788957
Information obtained from ClinicalTrials.gov on November 28, 2008