NCT00892736

Veliparib in Treating Patients With Malignant Solid Tumors That Do Not Respond to Previous Therapy

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Basal-Like Breast Carcinoma
• BRCA1 Mutation Carrier
• BRCA2 Mutation Carrier
• Breast Carcinoma
• Estrogen Receptor Negative
• HER2/Neu Negative
• Hereditary Breast and Ovarian Cancer Syndrome
• Ovarian Carcinoma
• Pancreatic Carcinoma
• Progesterone Receptor Negative
• Prostate Carcinoma
• Recurrent Breast Carcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Solid Neoplasm
• Triple-Negative Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Veliparib	Given PO

Timeline

• Start date: 2009-04-20
• Primary completion: 2017-05-19
• Completion: 2017-05-19
• First posted: 2009-05-04
• Last updated: 2018-06-29

Locations

7 sites across 1 country: United States