LODESTAR: Study of Rucaparib as Treatment for SoliD Tumors Associated with DEleteriouS MuTations in Homologous RecombinAtion Repair Genes
Enrolling By Invitation
18 years - 99 years
All
Phase
2
30 participants needed
1 Location
Brief description of study
This is a Phase 2 multicenter, open-label study evaluating rucaparib as treatment for solid tumors associated with a deleterious mutation in Homologous Recombination Repair (HRR) genes. All patients will be required to have received prior treatment with at least 1 line of life-extending therapy (if available) or have a tumor not amenable to treatment with curative intent. Enrollment of at least 30 patients, and up to 220patients, is planned to allow for the inclusion of multiple rare tumor types that harbor deleterious mutations in various HRR genes.
All patients will be required to provide adequate tumor tissue for analysis. If archival tissue is not available, the patient must undergo a screening biopsy, unless the biopsy procedure is considered unsafe by the investigator or the biopsy site is considered inaccessible. Tumor samples will be analyzed using a central laboratory next-generation sequencing (NGS) test.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: solid tumors
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Age: 18 years - 99 years
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Gender: All
Updated on
04 Aug 2024.
Study ID: 834348
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