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

Sponsor
Takeda
Study ID
NCT03497429
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Apr 5, 2018
Status verified
Oct 2021
Primary completion
Feb 10, 2020
Completion
Feb 10, 2020

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1: Niraparib 200 mg
    Niraparib 200 milligrams (mg), capsule, once orally on Days 1 - 21 of each 21-day treatment cycle.
  • Experimental: Cohort 2: Niraparib 300 mg
    Niraparib 300 mg, capsule, once orally on Days 1 - 21 of each 21-day treatment cycle.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline up to Day 21 in Cycle 1 (Cycle length=21 days) ]

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