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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2021-06-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm A - rucaparib and oral rosuvastatin

Group Type OTHER

Rucaparib

Intervention Type DRUG

Rucaparib 600 mg BID commencing on Day 5 until Day 23.

Rosuvastatin

Intervention Type DRUG

Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.

Arm B - rucaparib and oral contraceptives

Group Type OTHER

Rucaparib

Intervention Type DRUG

Rucaparib 600 mg BID commencing on Day 5 until Day 23.

Oral Contraceptives

Intervention Type DRUG

Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.

Interventions

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Rucaparib

Rucaparib 600 mg BID commencing on Day 5 until Day 23.

Intervention Type DRUG

Rosuvastatin

Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.

Intervention Type DRUG

Oral Contraceptives

Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.

Intervention Type DRUG

Other Intervention Names

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Rubraca Crestor

Eligibility Criteria

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Inclusion Criteria

* 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

\- Male or female patients ≥ 18 years of age

\- Female patients ≥ 18 years of age

Exclusion Criteria

* 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)

* Current use of rosuvastatin or any other statin
* History of hypersensitivity to rosuvastatin
* Current, or history of, clinically significant myopathy

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No