An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors

What is the purpose of this trial?

This is a two stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Specifically, a 300 mg niraparib tablet will be compared to 3 niraparib capsules (3 × 100 mg).The Extension Phase of this study is to enable patients enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.



TESARO, Inc

Start Date: 01/30/2019

End Date: 05/31/2019

Last Updated: 01/31/2019

Study HIC#: 2000024073