| 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 : | March 2021 |
| 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.
|
| 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 |
Inclusion Criteria (All patients):
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):
Exclusion Criteria (Arm A):
Exclusion Criteria (Arm B):
| 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 | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 2, 2019 | ||||||
| First Posted Date ICMJE | May 17, 2019 | ||||||
| Last Update Posted Date | February 10, 2021 | ||||||
| Actual Study Start Date ICMJE | May 8, 2019 | ||||||
| Actual Primary Completion Date | December 6, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives | ||||||
| Official Title ICMJE | 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 | ||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE | Neoplasms | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Estimated Enrollment ICMJE |
32 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | March 2021 | ||||||
| Actual Primary Completion Date | December 6, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria (All patients):
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):
Exclusion Criteria (Arm A):
Exclusion Criteria (Arm B):
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Hungary, Poland, Slovakia | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03954366 | ||||||
| Other Study ID Numbers ICMJE | CO-338-095 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Clovis Oncology, Inc. | ||||||
| Study Sponsor ICMJE | Clovis Oncology, Inc. | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Clovis Oncology, Inc. | ||||||
| Verification Date | January 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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