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Sponsors and Collaborators: |
Wilex U.S. Army Medical Research and Materiel Command |
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Information provided by: | Wilex |
ClinicalTrials.gov Identifier: | NCT00615940 |
This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: WX-671 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Two-Arm, Double-Blind, Multi-Center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-Line Her2-Negative Metastatic Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with WX-671 once daily by mouth, Days 1-21 inclusive.
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Drug: WX-671
capsules taken per os once daily until progression or toxicity
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2: Experimental
Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with placebo once daily by mouth, Days 1-21 inclusive.
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Drug: placebo
capsule taken per os once daily until progression or toxicity
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal organ and marrow function as defined by laboratory parameters (obtained within the screening period) within the following limits:
Exclusion Criteria:
Contact: Carola Mala, PhD | +49-89-413138-0 ext 50 | carola.mala@wilex.com |
Principal Investigator: | Lori Goldstein, MD | Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USA |
Principal Investigator: | Nadia Harbeck, MD | Department of Obstetrics and Gynecology, Technical University of Munich, Ismaninger Strasse 22, 81675 Munich, Germany |
Responsible Party: | Wilex ( Dr. Carola Mala ) |
Study ID Numbers: | WX/60-006 |
Study First Received: | February 1, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00615940 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Brazil: National Health Surveillance Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Ukraine: State Pharmacological Center - Ministry of Health; Israel: Ministry of Health |
HER2negative |
Capecitabine Skin Diseases Breast Neoplasms Breast Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |