NCT01617928

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

A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	veliparib (ABT-888)	Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort.
DRUG	carboplatin	Carboplatin will be administered on Day 3 of each cycle, intravenously.
DRUG	paclitaxel	Paclitaxel will be administered on Day 3 of each cycle, intravenously.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-06-13
• Last updated: 2017-11-20

Locations

1 site across 1 country: Japan