drugset / Trial / NCT01617928

A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors

NCT01617928

Phase 1 Completed 12 enrolled AbbVie
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.

Timeline

Start
2012-05
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Veliparib Small molecule 40 mg Oral
Subject Veliparib Small molecule 80 mg Oral
Subject Veliparib Small molecule 120 mg Oral
Background Carboplatin Small molecule Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous

Indications