Status:
COMPLETED
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Colorectal Cancer (CRC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metas...
Eligibility Criteria
Inclusion
- ECOG Performance Status (PS) ≤1
- Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
- Measurable disease by RECIST guidelines
- Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
- Available paraffin embedded tumor tissue
- Willing to give a whole blood sample for the study of proteins and genetic polymorphisms
Exclusion
- Less than 28 days elapsed since major surgery at time of randomization
- Known CNS metastases
- Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
- Uncontrolled hypertension
- Clinically significant cardiovascular disease
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
- Known HIV Positive
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00851045
Start Date
October 1 2009
End Date
October 1 2011
Last Update
October 12 2015
Active Locations (15)
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1
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
2
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States, 92708
3
Compassionate Cancer Care Medical Group, Inc
Riverside, California, United States, 92501
4
Sharp Memorial Hospital
San Diego, California, United States, 92123