Clinical trial · Interventional
Pharmacokinetic Drug-Drug Interaction Study of Rucaparib
A Phase 1, Open-label, Multiple-probe Drug-drug Interaction Study to Determine the Effect of Rucaparib on Pharmacokinetics of Caffeine, S-Warfarin, Omeprazole, Midazolam, and Digoxin in Patients With Advanced Solid Tumors
- 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)
The purpose of this study is to assess pharmacokinetic concentrations of multiple probes alone followed by assessment of the same drug pharmacokinetic concentrations when the patient has steady-state exposure to rucaparib followed by cycle-by-cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caffeine | Drug | — | UNRESOLVED |
| digoxin | Drug | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Omeprazole | Drug | — | UNRESOLVED |
| Rucaparib | Drug | Rucaparib | ALIAS |
| Vitamin K | Drug | — | UNRESOLVED |
| Warfarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single arm probe drugs and rucaparib
- description
- Caffeine Warfarin Vitamin K Omeprazole Midazolam Digoxin rucaparib
- interventionNames
- Drug: Caffeine
- Drug: Warfarin
- Drug: Omeprazole
- Drug: Midazolam
- Drug: digoxin
- Drug: Vitamin K
- Drug: Rucaparib
Primary outcomes (2)
- measure
- PK parameters for caffeine, S-warfarin, omeprazole, midazolam, and digoxin with and without rucaparib treatment to be calculated from the plasma concentration-time data
- timeFrame
- Days 1-5 and Days 12-16
- description
- Maximum plasma concentration \[Cmax\]
- measure
- PK parameters for caffeine, S-warfarin, omeprazole, midazolam, and digoxin with and without rucaparib treatment to be calculated from the plasma concentration-time data
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumor * Have evidence of measurable disease as defined by RECIST Version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate bone marrow, renal, and liver function Exclusion Criteria: * Prior treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs within 14 days prior to Day 1 * Prior treatment with any poly adenosine diphosphate ribose polymerase inhibitor (PARPi) * Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, stenting or poorly controlled hypertension within the last 3 months prior to Screening; * Pre-existing duodenal stent, recent or existing bowel obstruction, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of study drugs * Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents including acetylsalicylic acid), * Current use of one of the probe drugs; * Untreated or symptomatic central nervous system (CNS) metastases. * Evidence or history of bleeding disorder * Participation in another investigational drug trial within 30 days prior to Day 1 (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to Day 1; * Acute illness within 14 days prior to Day 1 unless mild in severity and approved by the Investigator and Sponsor's medical representative * Active second malignancy, i.e., patient known to have potentially fatal cancer present for which they may be (but not necessarily) currently receiving treatment.
References
Publications (1)
- DERIVEDXiao JJ, Nowak D, Ramlau R, Tomaszewska-Kiecana M, Wysocki PJ, Isaacson J, Beltman J, Nash E, Kaczanowski R, Arold G, Watkins S. Evaluation of Drug-Drug Interactions of Rucaparib and CYP1A2, CYP2C9, CYP2C19, CYP3A, and P-gp Substrates in Patients With an Advanced Solid Tumor. Clin Transl Sci. 2019 Jan;12(1):58-65. doi: 10.1111/cts.12600. Epub 2018 Dec 20. PMID 30427584