NCI/CTEP 8282: A Phase 1 Study of Chronically-Dosed, Single-Agent ABT-888 in Patients with Either BRCA 1/2 Mutated Cancer; Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; or Basal-Like Breast Cancer

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NCI/CTEP 8282: A Phase 1 Study of Chronically-Dosed, Single-Agent ABT-888 in Patients with Either BRCA 1/2 Mutated Cancer; Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; or Basal-Like Breast Cancer

The main goal of this research study is to find out the highest and safest dose of the study drug, ABT-888, that can be given on a daily basis to subjects with the following cancers: a cancer with a BRCA 1 or 2 (breast cancer 1 or 2 gene) associated cancer (most often breast and ovarian, but may include prostate and pancreatic); ovarian, fallopian tube, or primary peritoneal cancer that returns within 6 months after responding to a platinum-based chemotherapy, or breast cancer that does not express estrogen receptor, progesterone receptor, or human epidermal growth factor receptor (referred to as triple-negative breast cancer). This study will test different dosages of ABT-888. The study uses a well-established process of slowly increasing drug dosage to determine the highest dosage that can be given without causing serious side effects. Other purposes of this research study will be to examine what side effects occur when the drug is given to subjects, how much ABT-888 is in the blood at specific times after it is received, and whether or not ABT-888 is effective in treating these specific types of cancer.

Protocol Number050810
Principal InvestigatorAntoinette Tan
PhasePhase I
ScopeNational
Applicable Disease SitesPancreas
Prostate
Breast - Female
Ovary
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedABT-888
Participating InstitutionsThe Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.