Clinical trial · Interventional
Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives
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
NCT03954366CI-TRIAL-00066996completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Contraceptives | Drug | — | UNRESOLVED |
| Rosuvastatin | Drug | — | UNRESOLVED |
| Rucaparib | Drug | Rucaparib | ALIAS |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (3)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLiao 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. PMID 34370076