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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00636610 |
Purpose
This is a randomized, placebo-controlled, double-blind study of GDC-0449 added to biochemotherapy standard-of-care regimens for metastatic CRC, with treatment until disease progression. Patients will receive either FOLFOX or FOLFIRI chemotherapy with bevacizumab. The decision of which regimen (FOLFOX or FOLFIRI) to use will be made by the treating physician and patient. Patients will be randomized to receive GDC-0449 or placebo and will be stratified based on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid Tumors (RECIST) measurable disease is present at baseline.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: bevacizumab Drug: chemotherapy Drug: GDC-0449 Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | A Randomized, Placebo-Controlled Phase II Study of GDC-0449 (Systemic Hedgehog Antagonist) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer |
| Enrollment: | 198 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Intravenous repeating dose
Drug: GDC-0449
Oral repeating dose
|
| 2: Placebo Comparator |
Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Intravenous repeating dose
Drug: placebo
Oral repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | SHH4429g |
| Study First Received: | March 5, 2008 |
| Last Updated: | September 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00636610 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hedgehog CRC Colorectal Cancer Hedgehog Pathway Inhibitor |
|
Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases Angiogenesis Inhibitors |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Colorectal Neoplasms |