Clinical trial · Interventional
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to a change in development priorities.
Summary
Brief summary (as posted)
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rucaparib | Drug | Rucaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rucaparib
- description
- Eligible participants will be enrolled in either Cohort A or Cohort B. Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D. Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
- interventionNames
- Drug: Rucaparib
Primary outcomes (1)
- measure
- Best Overall Response Rate by Investigator
- timeFrame
- From first dose of study drug until disease progression (up to approximately 2 years)
- description
- Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
Secondary outcomes (7)
- measure
- Overall Response Rate by Independent Radiology Review
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease * Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate cancer) * Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are ineligible for this trial. * At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion criteria for previous treatments. * ECOG 0 or 1 * Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no archival tumor tissue available * Adequate organ function * Life expectancy of 4 months Key Exclusion Criteria: * Active central nervous system brain metastases, leptomeningeal disease or primary tumor of CNS origin * Active second malignancy (Exceptions: Successfully treated malignancy with no active disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving ongoing anticancer hormonal therapy for a previously treated cancer) * Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib * Prior treatment with a PARP inhibitor * More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting * History of myelodysplastic syndrome or acute myeloid leukemia
References
Publications (1)
- DERIVEDAnbil S, Seewald NJ, Chiorean EG, Hussein M, Kasi PM, Laux DE, Schwartz GK, Shapiro GI, Lin KK, Craib M, Maloney L, McLachlan K, Tukachinsky H, Schrock AB, Wang S, Sokol ES, Decker B, Nathanson KL, Domchek SM, Reiss KA. LODESTAR: A Single-Arm Phase II Study of Rucaparib in Solid Tumors With Pathogenic Germline or Somatic Variants in Homologous Recombination Repair Genes. JCO Precis Oncol. 2025 Jul;9:e2500090. doi: 10.1200/PO-25-00090. Epub 2025 Jul 9. PMID 40632975