A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors

Summary

This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac repolarization in patients with solid tumors who's cancer has recurred or is no longer responding to current treatment.

Timeline

Start

2013-11

Primary completion

2014-12

Completion

2014-12

Outcome

Met primary endpoint

paper Maximum mean ∆∆QTcF of veliparib 400 mg was 6.4 ms, with a 95 % UCB of 8.9 ms PMID 27709282 ↗

paper Single-dose veliparib (200 mg or 400 mg) did not result in clinically significant QTc prolongation PMID 27709282 ↗

Publications

• Results Munasinghe W, Stodtmann S, Tolcher A, Calvo E, Gordon M, Jalving M, de Vos-Geelen J, Medina D, Bergau D, Nuthalapati S, Hoffman D, Shepherd S, Xiong H. Effect of veliparib (ABT-888) on cardiac repolarization in patients with advanced solid tumors: a randomized, placebo-controlled crossover study. Cancer Chemother Pharmacol. 2016 Nov;78(5):1003-1011. doi: 10.1007/s00280-016-3156-x. Epub 2016 Oct 5.

Drugs

Indications