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RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with gemcitabine hydrochloride may kill more tumor cells
PURPOSE: This phase I trial is studying the side effects and best dose of giving ABT-888 together with gemcitabine hydrochloride in treating patients with advanced solid tumors.
- Establish the maximum-tolerated dose and dose-limiting toxicities of the combination of ABT-888 and gemcitabine hydrochloride in patients with advanced solid tumors.
- Establish the safety and tolerability of this regimen in these patients.
- Determine the effects of ABT-888 treatment on the level of PARP inhibition in peripheral blood mononuclear cells (PBMCs).
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the generation of gemcitabine triphosphate in PBMCs.
- Document any evidence of anti-tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive oral ABT-888 twice daily on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Plasma and peripheral blood mononuclear cells are collected periodically for pharmacokinetic and other laboratory studies.
After completion of study therapy, patients are followed for at least 4 weeks.
Masking: Open Label, Primary Purpose: Treatment
brca1 Mutation Carrier
gemcitabine hydrochloride, veliparib, laboratory biomarker analysis, pharmacological study, mutation carrier screening
UPMC Cancer Centers
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:12:31-0400
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