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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00076024 |
Purpose
The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Placebo Drug: AG-013736 (axitinib) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination |
| Enrollment: | 168 |
| Study Start Date: | February 2004 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
B
Docetaxel + Placebo
|
Drug: Placebo
5 mg bid continuous dosing
|
|
A: Experimental
Docetaxel + AG-013736
|
Drug: AG-013736 (axitinib)
5mg bid continuous dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 56 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A4061010 |
| Study First Received: | January 12, 2004 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00076024 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
metastatic breast cancer |
|
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents |
Therapeutic Uses Breast Neoplasms Pharmacologic Actions Breast Diseases |