Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT03954366
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2019-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531549', 'term': 'rucaparib'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.', 'timeFrame': 'Day 1 to Day 23', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.', 'timeFrame': 'Day 1 to Day 23', 'description': 'Area under the concentration-time curve (AUC) from time zero up to the last time point with a quantifiable concentration (AUC0-last)'}, {'measure': 'PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.', 'timeFrame': 'Day 1 to Day 23', 'description': 'AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)'}], 'secondaryOutcomes': [{'measure': 'PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.', 'timeFrame': 'Day 1 to Day 23', 'description': 'Terminal half-life (t1/2)'}, {'measure': 'PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.', 'timeFrame': 'Day 1 to Day 23', 'description': 'Time to occurrence of Cmax (tmax)'}, {'measure': 'PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.', 'timeFrame': 'Day 1 to Day 23', 'description': 'Apparent total clearance of drug after oral administration (CL/F)'}, {'measure': 'PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.', 'timeFrame': 'Day 1 to Day 23', 'description': 'Apparent volume of distribution during terminal phase (Vz/F)'}, {'measure': 'The following secondary PK parameter will be calculated for rucaparib.', 'timeFrame': 'Day 1 to Day 23', 'description': 'Trough plasma concentration (Cmin)'}, {'measure': 'Incidence of Adverse Events [Safety and Tolerability]', 'timeFrame': 'From Day 1 to last patient visit in Part II (approximately 2 years)'}, {'measure': 'Incidence of clinical laboratory abnormalities [Safety and Tolerability]', 'timeFrame': 'From Day 1 to last patient visit in Part II (approximately 2 years)'}, {'measure': 'Incidence of dose modifications [Safety and Tolerability]', 'timeFrame': 'From Day 1 to last patient visit in Part II (approximately 2 years)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rucaparib', 'CO-338', 'Clovis', 'Clovis Oncology', 'PARP Inhibitor', 'Drug-drug Interaction'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '34370076', 'type': 'DERIVED', 'citation': 'Liao M, Jeziorski KG, Tomaszewska-Kiecana M, Lang I, Jasiowka M, Skarbova V, Centkowski P, Ramlau R, Gornas M, Lee J, Edwards S, Habeck J, Nash E, Grechko N, Xiao JJ. A phase 1, open-label, drug-drug interaction study of rucaparib with rosuvastatin and oral contraceptives in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2021 Nov;88(5):887-897. doi: 10.1007/s00280-021-04338-7. Epub 2021 Aug 9.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPart 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).\n\nPart 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Both male and female patients are eligible for Arm A. Female patients only are eligible for Arm B.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (All patients):\n\n* Willing to sign the ICF and to comply with the study restrictions\n* Body mass index (BMI) 18.0 to 35.0 kg/m2\n* Histologically or cytologically confirmed advanced solid tumor\n* Patients who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib\n* ECOG performance status less than or equal to 1\n* Adequate organ function\n\nInclusion Criteria (Arm A):\n\n\\- Male or female patients ≥ 18 years of age\n\nInclusion Criteria (Arm B):\n\n\\- Female patients ≥ 18 years of age\n\nExclusion Criteria (All patients):\n\n* Specific cancer treatments within 14 days prior to Day 1\n* 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\n* Pre-existing duodenal stent, recent or existing bowel obstruction\n* Untreated or symptomatic central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible\n* Known HIV or AIDS-related illness, acute or history of chronic hepatitis B or C\n* Female patients who are pregnant or breastfeeding\n* 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\n* Presence of active infection requiring antibiotics\n* Active second malignancy\n* History of drug abuse (including alcohol)\n\nExclusion Criteria (Arm A):\n\n* Current use of rosuvastatin or any other statin\n* History of hypersensitivity to rosuvastatin\n* Current, or history of, clinically significant myopathy\n\nExclusion Criteria (Arm B):\n\n* Current use of any 1 of the contraceptive drugs or previous contraceptive implants or depot injections, which may still be clinically effective\n* History of hypersensitivity to ethinylestradiol or levonorgestrel'}, 'identificationModule': {'nctId': 'NCT03954366', 'briefTitle': 'Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives', 'organization': {'class': 'INDUSTRY', 'fullName': 'pharmaand GmbH'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CO-338-095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm A - rucaparib and oral rosuvastatin', 'interventionNames': ['Drug: Rucaparib', 'Drug: Rosuvastatin']}, {'type': 'OTHER', 'label': 'Arm B - rucaparib and oral contraceptives', 'interventionNames': ['Drug: Rucaparib', 'Drug: Oral Contraceptives']}], 'interventions': [{'name': 'Rucaparib', 'type': 'DRUG', 'otherNames': ['Rubraca'], 'description': 'Rucaparib 600 mg BID commencing on Day 5 until Day 23.', 'armGroupLabels': ['Arm A - rucaparib and oral rosuvastatin', 'Arm B - rucaparib and oral contraceptives']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.', 'armGroupLabels': ['Arm A - rucaparib and oral rosuvastatin']}, {'name': 'Oral Contraceptives', 'type': 'DRUG', 'description': 'Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.', 'armGroupLabels': ['Arm B - rucaparib and oral contraceptives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1076', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'PRA Magyarország Fázis I-es Klinikai Farmakológiai Vizsgálóhely FMC Dialízis Központ, II. em.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '21-500', 'city': 'Biała Podlaska', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej', 'geoPoint': {'lat': 52.03238, 'lon': 23.11652}}, {'zip': '05-410', 'city': 'Józefów', 'country': 'Poland', 'facility': 'BioVirtus Centrum Medyczne', 'geoPoint': {'lat': 52.13707, 'lon': 21.23589}}, {'zip': '31-752', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Ujastek Sp. z o.o. Centrum medyczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '60-693', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Med Polonia Sp. z o.o.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '01-401', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Zdrowie Kobiety Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy ATTIS Sp. z o.o., Zakład Onkologii Kobiecej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '831 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Summit Clinical Research s.r.o.', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'pharmaand GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}