Status:
COMPLETED
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
Lead Sponsor:
Amgen
Conditions:
Metastatic Colorectal Cancer
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mF...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- Subjects with measurable or unmeasurable disease
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women at least 18 years of age
- Adequate hematologic, renal, hepatic and coagulation function
Exclusion
- History or known presence of central nervous system (CNS) metastases
- Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
- Any investigational agent or therapy for advanced or metastatic CRC
- Clinically significant cardiac disease
- Clinically significant peripheral neuropathy
- Active inflammatory bowel disease
- Recent gastrointestinal ulcer or hemorrhage
- Recent arterial thrombotic event or pulmonary embolus
- Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
- Recent major surgical procedure or not yet recovered from major surgery
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00625651
Start Date
October 1 2007
End Date
September 1 2011
Last Update
April 25 2014
Active Locations (61)
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1
Research Site
Hot Springs, Arkansas, United States, 71913
2
Research Site
Downey, California, United States, 90241
3
Research Site
La Jolla, California, United States, 92093-0957
4
Research Site
Loma Linda, California, United States, 92354