Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

Summary

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.

Official Title

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

Keywords

Solid Tumor rucaparib PARPi rare tumor CO-338 ovarian cancer prostate cancer pancreatic cancer breast cancer lung cancer colon cancer gastric cancer bladder cancer colorectal cancer PARP inhibitor homologous recombination DNA repair LODESTAR germline somatic BRCA1 BRCA2 PALB2 RAD51C RAD51D BARD1 BRIP1 FANCA RAD51 RAD51B sarcoma HRR HRD platinum sensitive platinum resistant primary peritoneal cancer fallopian tube cancer tumor agnostic basket study basket trial metastatic locally advanced esophageal cancer leiomyosarcoma ampullary carcinoma carcinosarcoma endometrial cancer cervical cancer Neoplasms

Eligibility

For people ages 18 years and up

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

Locations

  • UCLA Medicine Hematology and Oncology not yet accepting patients
    Los Angeles California 90024 United States
  • Innovative Clinical Research Institute accepting new patients
    Glendale California 91204 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT04171700
Phase
Phase 2
Study Type
Interventional
Last Updated