A Phase II Study of Olaparib in Patients with Previously Treated Advanced Solid Tumors with Certain Genetic Mutations

Full Title

A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

Purpose

The purpose of this study is to assess the safety and effectiveness of the anticancer drug olaparib in patients with advanced solid tumors that have continued to grow despite treatment and contain certain genetic mutations called homologous recombination repair mutations (HRRm). Researchers believe that the presence of these mutations may make olaparib more effective.

Olaparib is a PARP inhibitor, a drug which may slow down the process cancer cells use to repair their DNA. Cancer cells need to repair their DNA to survive and grow. Olaparib has been shown to be effective in ovarian and breast cancers that have BRCA1 or BRCA2 mutations, two of the homologous recombination repair (HRR) genes. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced solid tumor that contains an HRR mutation and cannot be cured with standard therapies. Patients with BRCA-positive breast or ovarian cancer may not participate because olaparib is already approved for use in these patients.
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • Prior treatment with olaparib is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Hyman at 646-888-4544.

Protocol

19-139

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators