Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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This is a Phase 1, open-label, sequential, drug-drug-interaction (DDI) study in patients with advanced solid tumors. The study will consist of 2 parts: a DDI part (Part I) and a rucaparib treatment part (Part II).

In Part I, the PK of cytochrome P450 (CYP) cocktail probes: caffeine, S-warfarin, omeprazole, and midazolam and a P-glycoprotein probe (digoxin) will be assessed with and without rucaparib treatment. Patients will receive single doses of CYP drug cocktail (caffeine, warfarin, omeprazole, and midazolam) on Day 1 and Day 12, and single doses of digoxin on Day 2 and Day 13. Continuous treatment with 600 mg rucaparib twice daily (BID) will start on Day 5 and will last until at least Day 16 of Part I.

In Part II, the treatment with rucaparib in 28-day cycles will continue 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Open Label

Study Groups

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single arm probe drugs and rucaparib

Caffeine Warfarin Vitamin K Omeprazole Midazolam Digoxin rucaparib

Group Type OTHER

Caffeine

Intervention Type DRUG

200 mg (4 x 50mg) Tablet

Warfarin

Intervention Type DRUG

10 mg (2 x 5mg) Tablet

Omeprazole

Intervention Type DRUG

40 mg Tablet

Midazolam

Intervention Type DRUG

5 mg/mL

digoxin

Intervention Type DRUG

.25 mg Tablet

Vitamin K

Intervention Type DRUG

10 mg Tablet

Rucaparib

Intervention Type DRUG

200 \& 300 mg tablet

Interventions

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Caffeine

200 mg (4 x 50mg) Tablet

Intervention Type DRUG

Warfarin

10 mg (2 x 5mg) Tablet

Intervention Type DRUG

Omeprazole

40 mg Tablet

Intervention Type DRUG

Midazolam

5 mg/mL

Intervention Type DRUG

digoxin

.25 mg Tablet

Intervention Type DRUG

Vitamin K

10 mg Tablet

Intervention Type DRUG

Rucaparib

200 \& 300 mg tablet

Intervention Type DRUG

Other Intervention Names

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Marevan® Losec®; MUPS® Midazolam Accord®; versed lanoxin® warfarin antagonist rucaparib camsylate Rubraca CO-338

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No