Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess pharmacokinetic concentrations of multiple probes alone followed by assessment of the same drug pharmacokinetic concentrations when the patient has steady-state exposure to 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: Caffeine; Digoxin; Midazolam; Omeprazole; Rucaparib; Vitamin K; Vitamins; Warfarin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced solid tumor

• Have evidence of measurable disease as defined by RECIST Version 1.1

• 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, angiogenesis inhibitors, or experimental drugs within 14 days prior to Day 1

• Prior treatment with any poly adenosine diphosphate ribose polymerase inhibitor (PARPi)

• 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, recent or existing bowel obstruction, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of study drugs

• Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents including acetylsalicylic acid),

• Current use of one of the probe drugs;

• Untreated or symptomatic central nervous system (CNS) metastases.

• Evidence or history of bleeding disorder

• Participation in another investigational drug trial within 30 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 within 14 days prior to Day 1 unless mild in severity and approved by the Investigator and Sponsor's medical representative

• Active second malignancy, i.e., patient known to have potentially fatal cancer present for which they may be (but not necessarily) currently receiving treatment.