A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

Sponsor
pharmaand GmbH
Study ID
NCT03499444
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • Rucaparib — DRUG
    Rucaparib will be administered twice daily

Study Details

This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.

Key Dates

Start date
Feb 6, 2018
Status verified
Jun 2023
Primary completion
Jun 18, 2019
Completion
Apr 13, 2022

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Rucaparib monotherapy
    Part I: Dose Escalation, Part II: Dose Expansion (Additional patients will be enrolled at the recommended dose as defined in Part I of the study.)

Primary Outcome Measure

Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability [ Time Frame: From enrollment to completion of Part I (up to 12 months) ]

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