Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

• Status: Completed
• Trial end date: 2021-06-09
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator.

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

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Ethinyl Estradiol; Levonorgestrel; Rosuvastatin Calcium; Rucaparib

Criteria

Inclusion Criteria (All patients):

• Willing to sign the ICF and to comply with the study restrictions

• Body mass index (BMI) 18.0 to 35.0 kg/m2

• Histologically or cytologically confirmed advanced solid tumor

• Patients who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib

• ECOG performance status less than or equal to 1

• Adequate organ function

Inclusion Criteria (Arm A):

• Male or female patients ≥ 18 years of age

Inclusion Criteria (Arm B):

• Female patients ≥ 18 years of age

Exclusion Criteria (All patients):

• Specific cancer treatments within 14 days prior to Day 1

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

• Pre-existing duodenal stent, recent or existing bowel obstruction

• Untreated or symptomatic central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible

• Known HIV or AIDS-related illness, acute or history of chronic hepatitis B or C

• Female patients who are pregnant or breastfeeding

• Participation in another investigational drug trial within 30 days prior to Day 1 or exposure to more than 3 new investigational agents within 12 months prior to Day 1

• Presence of active infection requiring antibiotics

• Active second malignancy

• History of drug abuse (including alcohol)

Exclusion Criteria (Arm A):

• Current use of rosuvastatin or any other statin

• History of hypersensitivity to rosuvastatin

• Current, or history of, clinically significant myopathy

Exclusion Criteria (Arm B):

• Current use of any 1 of the contraceptive drugs or previous contraceptive implants or depot injections, which may still be clinically effective

• History of hypersensitivity to ethinylestradiol or levonorgestrel