NCT00535119

Veliparib, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer

A Phase 1 Study of ABT-888 in Combination With Carboplatin and Paclitaxel in Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of veliparib when given together with carboplatin and paclitaxel in treating patients with advanced solid cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with carboplatin and paclitaxel may help kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended dose for phase II studies of veliparib (ABT-888 ) that can be administered in combination with carboplatin and paclitaxel in patients with advanced solid malignancies. (Stratum I) II. To determine the recommended dose for phase II studies of veliparib that can be administered in combination with carboplatin and paclitaxel in patients with advanced solid malignancies that harbor a germline BRCA1/2 mutation. (Stratum II) (added 04/07/09) SECONDARY OBJECTIVES: I. To define the dose-limiting toxicity and other toxicities associated with the use of this combination. II. To obtain preliminary evidence of antitumor activity in patients treated with this combination. III. To evaluate the pharmacokinetic parameters of veliparib, carboplatin, and paclitaxel when administered as a combination. IV. To conduct correlative science studies. OUTLINE: This is a multicenter, dose-escalation study of veliparib. Patients are stratified according to BRCA status (no \[stratum I\] vs yes \[stratum II\]). Patients receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3 hours on day 3 and veliparib orally (PO) twice daily on days 1-7 until the recommended phase II dose is determined. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo peripheral blood mononuclear cell collection periodically for pharmacokinetic and biomarker studies. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Adult Solid Neoplasm
• BRCA1 Mutation Carrier
• BRCA2 Mutation Carrier
• Hereditary Breast and Ovarian Cancer Syndrome

Interventions

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

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-10-01
• First posted: 2007-09-26
• Last updated: 2015-05-22

Locations

7 sites across 1 country: United States