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
Anus | Colon | Esophagus | Kidney | Larynx | Lip, Oral Cavity and Pharynx | Liver | Lung | Melanoma, skin | Other Digestive Organ | Other Endocrine System | Other Female Genital | Other Male Genital | Other Respiratory and Intrathoracic Organs | Other Skin | Other Urinary | Ovary | Pancreas | Prostate | Rectum | Small Intestine | Soft Tissue | Stomach | Thyroid | Phase I | Unknown Sites | Breast | Urinary Bladder
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.
- Trial withTESARO, Inc
- Start Date05/09/2021
- End Date09/14/2021
- Last Updated07/30/2021
- Study HIC#2000024073