Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor

• Status: Completed
• Trial end date: 2021-02-24
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Treatments: Rucaparib

Criteria

Inclusion Criteria:

All Patients:

• Patients ≥18 years of age at the time the ICF is signed;

• Patients with a histologically or cytologically confirmed advanced solid tumor who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib

• ECOG PS less than or equal to 2

• Adequate bone marrow and renal function

Hepatically Impaired Patients (in addition):

• Stable hepatic impairment as judged by the Investigator

• Moderate Hepatic Impairment (NCI-ODWG criteria) during Screening

Patients with Normal Hepatic Function (in addition):

• Normal Hepatic Function (NCI-ODWG criteria)

Exclusion Criteria:

All Patients:

• Prior treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or investigational drugs within 14 days prior to day 1

• Ongoing toxicity ≥ Grade 2 per Common Terminology Criteria for Adverse Events criteria (CTCAE version 4.03)

• Prior treatment with any poly adenosine diphosphate ribose polymerase inhibitor

• Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, stenting or poorly controlled hypertension within the last 3 months prior to Screening

• Pre-existing duodenal stent, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib

• Hospitalization for bowel obstruction within 3 months prior to Day 1

• Untreated or symptomatic central nervous system (CNS) metastases

• Evidence or history of bleeding disorder

• Acute illness within 14 days prior to Day 1

• Active second malignancy

Hepatically Impaired Patients (in addition):

• Severe hepatic encephalopathy (Grade >2);

• History of liver transplantation;

• Advanced ascites or ascites that require drainage and albumin supplementation, as judged by the Investigator;

• Acute damage of the liver with Grade 4 AST/ALT values