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

pharmaand

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: Oral Contraceptives

Drug: Rosuvastatin

Drug: Rucaparib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03954366

CO-338-095

Details and patient eligibility

About

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.

Full description

This is a Phase 1, open-label, drug-drug-interaction (DDI) study in patients with advanced solid tumor. In Part I, the effects of rucaparib (600 mg twice daily [BID]) on the PK of oral rosuvastatin (Arm A) and the combined oral contraceptives (ethinylestradiol and levonorgestrel; Arm B) will be assessed.

Part I: patients will receive single oral doses of rosuvastatin or oral contraceptives (according to assigned arm) on Day 1 and Day 19. Continuous treatment with rucaparib at 600 mg BID will commence on Day 5 and continue until the end of Part I (Day 23).

Part II (optional): treatment with rucaparib in 28-day cycles may continue (at the discretion of the Investigator) until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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