Breast Carcinoma Clinical Trial
Official title:
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
This phase I trial studies the side effects and best dose of veliparib in treating patients with malignant solid tumors that do not respond to previous therapy. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and
recommended phase II dose of chronically dosed single-agent ABT-888 (veliparib) in patients
with either a refractory breast cancer (BRCA) 1/2- mutated solid cancer; platinum-refractory
ovarian, fallopian tube, or primary peritoneal cancer; or basal-like breast cancer.
SECONDARY OBJECTIVES:
I. To establish the safety and tolerability of single-agent ABT-888 in the above patient
population. A dose expansion at the recommended phase II dose will be performed in 6-12
evaluable patients with germline BRCA mutations.
II. To determine the effects of ABT-888 treatment on the level of poly ADP-ribose polymerase
(PARP) inhibition and deoxyribonucleic acid (DNA) damage in peripheral blood mononuclear
cells (PBMCs) and tumor samples or cells in malignant ascitic fluid.
III. To determine the pharmacokinetics (PK) of chronically dosed ABT-888. IV. To document any
evidence of anti-tumor response.
OUTLINE: This is a dose-escalation study.
Patients receive veliparib orally (PO) twice daily (BID)* on days 1-28. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive veliparib once on day 1 of course 1 for pharmacokinetic and
pharmacodynamic studies.
After completion of study therapy, patients are followed for 4 weeks.
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