A Phase II Study of Olaparib or Placebo in Patients with Surgically Removed Pancreatic Cancer Who Have a BRCA1, BRCA2 or PALB2 Mutation

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Full Title

APOLLO: A Randomized Phase II Double-Blind Study of Olaparib versus Placebo Following Adjuvant Chemotherapy in Patients with Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2, or PALB2 Mutation (EA2192) (CIRB)

Purpose

The purpose of this study is to see if one year of treatment with olaparib is better than observation alone in patients who had pancreatic cancer surgically removed and who have mutations in the BRCA1, BRCA2 or PALB2 genes. Olaparib is a type of anticancer medication called a PARP inhibitor, 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 is an oral medication (given by mouth) that is already used to treat several cancers, including metastatic BRCA-mutated pancreatic cancer; its use in this study is considered investigational. Patients in this study will be randomly assigned to receive olaparib or a placebo.

Eligibility

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

  • Patients must have pancreatic cancer that was (or will be) surgically removed, with no evidence of disease after surgery.
  • Patients must have a BRCA1, BRCA2 or PALB2 genetic mutation.
  • Patients must have had or be planning to have chemotherapy (before or after surgery) for at least 3 combined months.
  • At least 3 weeks must pass since the completion of chemotherapy or chemoradiation and receipt of the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Fiyinfolu Balogun at 646-888-6964.

Protocol

21-215

Phase

II

Disease Status

Relapsed or Refractory

Investigator