M13-695: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib Extended Release Formulations in Subjects with Solid Tumors

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M13-695: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib Extended Release Formulations in Subjects with Solid Tumors

Assess and compare the bioavailability of three test extended release (ER) formulations of veliparib with that of the current imemdiate release formulation of veliparib. Evaluate the potential effect of food on the oral bioavailability of three test extended release (ER) formulations of veliparib. Establish the maximum tolerated dose (MTD) and to establish the recommended Phase 2 dose (RPTD) and schedule for one or more of the ER formulations. Secondary objectives of the study are to assess the safety and tolerability of the ER formulations.

Protocol Number051207
Principal InvestigatorAntoinette Tan
PhasePhase I
ScopeNational
Applicable Disease SitesBreast - Female
Ovary
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedABT-888
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.