Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor

Sponsor
pharmaand GmbH
Study ID
NCT03521037
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Rucaparib camsylate — DRUG
    In Part I, eligible patients will receive a single oral dose of 600 mg rucaparib followed by intensive plasma PK sampling up to Day 7 (hour 144). In Part II, patients may continue to receive continuous oral rucaparib in 28 day cycles.

Study Details

Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic impairment (Group 2, n = 8) according to the NCI-ODWG criteria. Patients in Group 1 and Group 2 may be enrolled in parallel, with preferential enrollment of Group 2 patients before Group 1 patients. The study will consist of 2 parts: a single-dose PK part (Part I) and a continuous rucaparib treatment part (Part II).

Key Dates

Start date
Feb 27, 2018
Status verified
Jun 2023
Primary completion
Sep 27, 2019
Completion
Feb 24, 2021

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: no name
    Group 1: patients with normal hepatic function Group 2: patients who have moderate hepatic impairment

Primary Outcome Measure

Maximum plasma rucaparib concentration (Cmax) [ Time Frame: day 1 to day 7 ]

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