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