Journal article
Randomized phase II study evaluating veliparib (ABT-888) with temozolomide in patients with metastatic melanoma
MR Middleton, P Friedlander, O Hamid, A Daud, R Plummer, N Falotico, B Chyla, F Jiang, E McKeegan, NM Mostafa, M Zhu, J Qian, M McKee, Y Luo, VL Giranda, GA McArthur
Annals of Oncology | OXFORD UNIV PRESS | Published : 2015
Abstract
Background: Veliparib (ABT-888) is a potent, orally bioavailable, small-molecule inhibitor of the DNA repair enzymes poly ADP-ribose polymerase-1 and -2. Veliparib enhances the efficacy of temozolomide (TMZ) and other cytotoxic agents in preclinical tumor models. Patients and methods: In this multicenter, double-blind trial, adults with unresectable stage III or IV metastatic melanoma were randomized 1:1:1 to TMZ plus veliparib 20 or 40 mg, or placebo twice daily. Efficacy end points included progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). Results: Patients (N = 346) were randomized between February 2009 and January 2010. Median [95% confidence inte..
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Funding Acknowledgements
This work was supported by AbbVie Inc. AbbVie provided financial support for this study and participated in the design, study conduct, analysis, and interpretation of the data, as well as the writing, review, and approval of this manuscript. No applicable grant numbers apply.