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Clinical Trial 20619

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04171700

Phase: Phase I
Principal Investigator: Sahebjam, Solmaz

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Study Title

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated with Deleterious Mutations in Homologous Recombination Repair Genes (LODESTAR)


A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in patients with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.


Primary Objective: To determine the objective response rate (ORR), as assessed by the investigator, by RECIST v1.1 (or by RECIST v1.1 and Prostate Cancer Working Group Guidelines Version 3 [PCWG3] criteria in patients with mCRPC). [Rucaparib (CO-338)] Clovis Oncology Clinical Study Protocol: CO-338-100 Amendment 2 27 February 2020 Confidential Page 14 of 118 Secondary Objectives: Objective response rate (ORR) as assessed by independent radiology review (IRR) by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in patients with mCRPC); DOR; Disease Control Rate (DCR), defined as the percentage of CRs, PRs, and SDs greater than 16 weeks; PFS; Overall survival (OS); To evaluate the safety and tolerability of rucaparib; To evaluate steady-state pharmacokinetics (PK) of rucaparib.



Therapy (NOS)


AG-014447 (Rucaparib); CO-338 (Rucaparib); Not Applicable (); PF-01367338-BW (Rucaparib); Rucaparib ()

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
  • Other criteria apply

  • 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
  • Other criteria apply

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