NCT03497429

A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors

A Phase 1, Open-label Study of Niraparib as Single Agent in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The drug being tested in this study is called Niraparib. Niraparib is being tested to treat Japanese participants 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 participants 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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib capsule

Timeline

• Start date: 2018-04-05
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2018-04-13
• Last updated: 2021-11-09
• Results posted: 2021-11-09

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study