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Spots Global Cancer Trial Database for Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

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Trial Identification

Brief Title: Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

Official Title: A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin (Arm A) and Oral Contraceptives (Ethinylestradiol and Levonorgestrel) (Arm B) in Patients With Advanced Solid Tumors

Study ID: NCT03954366

Conditions

Neoplasms

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

PRA Magyarország Fázis I-es Klinikai Farmakológiai Vizsgálóhely FMC Dialízis Központ, II. em., Budapest, , Hungary

Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej, Biała Podlaska, , Poland

BioVirtus Centrum Medyczne, Józefów, , Poland

Ujastek Sp. z o.o. Centrum medyczne, Kraków, , Poland

Med Polonia Sp. z o.o., Poznań, , Poland

Zdrowie Kobiety Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy ATTIS Sp. z o.o., Zakład Onkologii Kobiecej, Warszawa, , Poland

Summit Clinical Research s.r.o., Bratislava, , Slovakia

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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