Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
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.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
