Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03954366 |
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Recruitment Status :
Active, not recruiting
First Posted : May 17, 2019
Last Update Posted : February 12, 2020
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Sponsor:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasms | Drug: Rucaparib Drug: Rosuvastatin Drug: Oral Contraceptives | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 32 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | May 8, 2019 |
| Actual Primary Completion Date : | December 6, 2019 |
| Estimated Study Completion Date : | November 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Drug Reactions
| Arm | Intervention/treatment |
|---|---|
| Arm A - rucaparib and oral rosuvastatin |
Drug: Rucaparib
Rucaparib 600 mg BID commencing on Day 5 until Day 23.
Other Name: Rubraca Drug: Rosuvastatin Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.
Other Name: Crestor |
| Arm B - rucaparib and oral contraceptives |
Drug: Rucaparib
Rucaparib 600 mg BID commencing on Day 5 until Day 23.
Other Name: Rubraca Drug: Oral Contraceptives Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only. |
Primary Outcome Measures :
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]Maximum plasma concentration (Cmax)
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]Area under the concentration-time curve (AUC) from time zero up to the last time point with a quantifiable concentration (AUC0-last)
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)
Secondary Outcome Measures :
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]Terminal half-life (t1/2)
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]Time to occurrence of Cmax (tmax)
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]Apparent total clearance of drug after oral administration (CL/F)
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]Apparent volume of distribution during terminal phase (Vz/F)
- The following secondary PK parameter will be calculated for rucaparib. [ Time Frame: Day 1 to Day 23 ]Trough plasma concentration (Cmin)
- Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years) ]
- Incidence of clinical laboratory abnormalities [Safety and Tolerability] [ Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years) ]
- Incidence of dose modifications [Safety and Tolerability] [ Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Both male and female patients are eligible for Arm A. Female patients only are eligible for Arm B. |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954366
Locations
| Hungary | |
| PRA Magyarország Fázis I-es Klinikai Farmakológiai Vizsgálóhely FMC Dialízis Központ, II. em. | |
| Budapest, Hungary, 1076 | |
| Poland | |
| Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej | |
| Biała Podlaska, Poland, 21-500 | |
| BioVirtus Centrum Medyczne | |
| Józefów, Poland, 05-410 | |
| Ujastek Sp. z o.o. Centrum medyczne | |
| Kraków, Poland, 31-752 | |
| Med Polonia Sp. z o.o. | |
| Poznań, Poland, 60-693 | |
| Zdrowie Kobiety Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy ATTIS Sp. z o.o., Zakład Onkologii Kobiecej | |
| Warszawa, Poland, 01-401 | |
| Slovakia | |
| Summit Clinical Research s.r.o. | |
| Bratislava, Slovakia, 831 01 | |
Sponsors and Collaborators
Clovis Oncology, Inc.
| Responsible Party: | Clovis Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT03954366 |
| Other Study ID Numbers: |
CO-338-095 |
| First Posted: | May 17, 2019 Key Record Dates |
| Last Update Posted: | February 12, 2020 |
| Last Verified: | May 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Clovis Oncology, Inc.:
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rucaparib CO-338 Clovis |
Clovis Oncology PARP Inhibitor Drug-drug Interaction |
Additional relevant MeSH terms:
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Rucaparib Rosuvastatin Calcium Contraceptive Agents Levonorgestrel Contraceptives, Oral Ethinyl Estradiol Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female Contraceptives, Oral, Synthetic Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Poly(ADP-ribose) Polymerase Inhibitors Antineoplastic Agents |