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Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Niraparib in Japanese patients with advanced solid tumors.


Clinical Trial Description

The drug being tested in this study is called Niraparib. Niraparib is being tested to treat Japanese patients with advanced solid tumors. This study will look at the safety, tolerability and pharmacokinetics of Niraparib administered once daily orally.

The study will enroll approximately 12 patients as a maximum. Participants will be assigned to Cohort 1 (21-day treatment cycle). After that, participants will be assigned to Cohort 2 when safety and tolerability of the 200 mg dose will be demonstrated.

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 16 months. Participants will make multiple visits to the clinic with final visit approximately 28 days after last dose of study drug for a follow-up assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03497429
Study type Interventional
Source Takeda
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 5, 2018
Completion date August 31, 2019

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