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Clinical Trial DRUG M12-895

Title
A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Principal Investigator
William Gradishar
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG M12-895
Purpose
The main purpose of the study is to determine if patients with the BRCA1 or BRCA2 mutation and metastatic breast cancer do better with veliparib in combination with temozolomide or carboplatin and paclitaxel with or without veliparib.
Overview
This study is for breast cancer patients who may be carriers of the BRCA1 or BRCA2 mutation with metastatic breast cancer. BRCA 1 and BRCA 2 are human genes that belong to a class of genes known as tumor suppressors. Mutation of these genes has been linked to breast cancer. Temozolomide (TemodarĀ®), carboplatin and paclitaxel are Food and Drug Administration (FDA) approved chemotherapy drugs in both the United States and other countries and are widely used as a first treatment for advanced or metastatic (spread to/from other areas) cancer. Veliparib (also known as ABT-888) is a PARP inhibitor (blocker) that is not approved for use in the United States or any other countries, and is considered experimental. PARP is a naturally occurring protein made by the body that may help cancer cells overcome injury or damage caused by radiation and certain types of anti-cancer drugs, making these treatments less effective (don't work well). Veliparib inhibits (blocks) the activity of PARP. This blocking activity may prevent the cancer cell from repairing itself and resume growing. Veliparib when given together with certain chemotherapies such as temozolomide or carboplatin and paclitaxel may make the combination treatments work better by stopping the cancer cell from healing and growing.
Eligibility
Some of the eligibility criteria include:
  • Participants must have metastatic breast cancer (it has spread beyond the breast) and must have a BRCA1 or BRCA2 mutation.
  • Participants must be 18 or older.
  • Both men and women are eligible.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Study participants will be randomly assigned (like flipping a coin) to one of three treatment groups: veliparib plus temozolomide; veliparib plus carboplatin and paclitaxel; or placebo plus carboplatin and paclitaxel
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 22-Dec-14 03:11 AM

 

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