Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA,

Trial Details

NCT ID
NCT04633239
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Abemaciclib
  • Biopsy Procedure
  • Biospecimen Collection
  • Olaparib
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Irvine, California, United States|33.66946,-117.82311
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Patients must have histologically confirmed recurrent platinum-resistant epithelial ovarian carcinoma (EOC) of any histology, as defined by progres…
  • High-grade serous histology is required (for the dose expansion cohort only) (data on BRCA (e.g. germline BRCA, Somatic BRCA, Neither, Unknown) and…
  • Patients must have received 1-3 prior systemic therapies
  • Women age \>= 18 years. Because no dosing or adverse event data are currently available on the use of abemaciclib in combination with olaparib in p…

For full eligibility, visit ClinicalTrials.gov.

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