Clinical trial · Interventional
Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor
A Phase 1, Open-Label, Parallel Group Study to Determine the Pharmacokinetics, Safety and Tolerability of Rucaparib in Patients With an Advanced Solid Tumor and Either Moderate Hepatic Impairment or Normal Hepatic Function
- 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)
Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic impairment (Group 2, n = 8) according to the NCI-ODWG criteria. Patients in Group 1 and Group 2 may be enrolled in parallel, with preferential enrollment of Group 2 patients before Group 1 patients. The study will consist of 2 parts: a single-dose PK part (Part I) and a continuous rucaparib treatment part (Part II).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rucaparib camsylate | Drug | Rucaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- no name
- description
- Group 1: patients with normal hepatic function Group 2: patients who have moderate hepatic impairment
- interventionNames
- Drug: Rucaparib camsylate
Primary outcomes (2)
- measure
- Maximum plasma rucaparib concentration (Cmax)
- timeFrame
- day 1 to day 7
- description
- PK parameter of rucaparib to be calculated from the plasma concentration-time data
- measure
- Area under the plasma rucaparib concentration-time curve from time zero up to the last time point with quantifiable concentration (AUC0-last)
- timeFrame
- day 1 to day 7
- description
- PK parameter of rucaparib 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: All Patients: * Patients ≥18 years of age at the time the ICF is signed; * Patients with a histologically or cytologically confirmed advanced solid tumor who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib * ECOG PS less than or equal to 2 * Adequate bone marrow and renal function Hepatically Impaired Patients (in addition): * Stable hepatic impairment as judged by the Investigator * Moderate Hepatic Impairment (NCI-ODWG criteria) during Screening Patients with Normal Hepatic Function (in addition): • Normal Hepatic Function (NCI-ODWG criteria) Exclusion Criteria: All Patients: * Prior treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or investigational drugs within 14 days prior to day 1 * Ongoing toxicity ≥ Grade 2 per Common Terminology Criteria for Adverse Events criteria (CTCAE version 4.03) * Prior treatment with any poly adenosine diphosphate ribose polymerase inhibitor * 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, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib * Hospitalization for bowel obstruction within 3 months prior to Day 1 * Untreated or symptomatic central nervous system (CNS) metastases * Evidence or history of bleeding disorder * Acute illness within 14 days prior to Day 1 * Active second malignancy Hepatically Impaired Patients (in addition): * Severe hepatic encephalopathy (Grade \>2); * History of liver transplantation; * Advanced ascites or ascites that require drainage and albumin supplementation, as judged by the Investigator; * Acute damage of the liver with Grade 4 AST/ALT values
References
Publications (0)
Data not yet available