Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered [14C] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation

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

Details

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

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced solid tumor

• Part II only: Have a known deleterious BRCA1/2 mutation (germline or somatic) as determined by a local or central laboratory

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate bone marrow, renal, and liver function

Exclusion Criteria:

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

• Participation in a trial involving administration of [14C]-labeled compound(s) within the last 6 months prior to Day 1

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

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

• Untreated or symptomatic central nervous system (CNS) metastases

• Evidence or history of bleeding disorder

• Participation in another investigational drug trial within 14 days prior to Day 1 (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to Day 1

• Acute illness (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to Day 1, unless mild in severity and approved by the Investigator and Sponsor's/designated medical representative

• Active second malignancy