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Brief Title: A Study to Evaluate Rucaparib in Patients 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

INTRODUCTION

  • Org Study ID: CO-338-100
  • Secondary ID: N/A
  • NCT ID: NCT04171700
  • Sponsor: pharmaand GmbH

BRIEF SUMMARY

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.

  • Overall Status
    Terminated
  • Start Date
    January 16, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Solid Tumor

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Kim Reiss-Binder, MD

Role: Principal Investigator

Affiliation: University of Pennsylvania

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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