Status:
COMPLETED
A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a randomized, placebo-controlled, double-blind study of vismodegib (GDC-0449) added to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (CRC), with treatment until d...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologically confirmed metastatic colorectal cancer (CRC)
- Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, must be confirmed to be available and requested at any time prior to entry of study
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematopoetic capacity
- Adequate hepatic function
- Adequate renal function
- Use of an effective method of barrier contraception (for women of childbearing potential)
- Signed informed consent
Exclusion
- Prior chemotherapy for metastatic CRC or adjuvant chemotherapy for CRC within the prior 6 months
- Clinically suspected or confirmed CNS metastases or carcinomatous meningitis
- Major surgical procedure within 4 weeks prior to the first day of treatment in this study (Day 1)
- Pelvic radiation within 2 weeks prior to Day 1
- Wound dehiscence requiring intervention, gastrointestinal perforation, or bowel obstruction
- Pregnancy or lactation
- Uncontrolled medical illnesses including the following: Infection requiring intravenous (IV) antibiotics, congestive heart failure not controlled with medication, hypertension not controlled with medication
- Thromboembolic disease
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00636610
Start Date
May 1 2008
End Date
December 1 2010
Last Update
June 8 2017
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