A Phase III Study of Olaparib versus Placebo as Maintenance Therapy in Patients with BRCA-Mutated Metastatic Pancreatic Cancer with Stable Disease after Platinum-Based Chemotherapy

Full Title

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

Purpose

BRCA is a gene that helps cells repair DNA damage. Cells with mutations in BRCA1 or BRCA2 are unable to repair their DNA effectively. Olaparib is a drug used to treat ovarian cancer that blocks PARP, a protein that cancer cells use to repair damaged DNA so they can keep growing. Because BRCA-mutated cancer cells are already less able to repair their DNA, they are especially sensitive to the anticancer effects of olaparib.

Olaparib is approved to treat women with BRCA-mutated ovarian cancer. BRCA may also be mutated in pancreatic cancer. In this study, researchers want to see if olaparib can be used to keep BRCA-mutated pancreatic cancer from growing when used in patients with metastatic pancreatic cancer that has shrunk or stopped growing with platinum-containing chemotherapy. This is called "maintenance therapy."

Patients in this study will be randomly assigned to receive olaparib (60 percent of patients) or a placebo (40 percent). Olaparib 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 BRCA-mutated pancreatic cancer which did not continue to grow with initial chemotherapy that included a platinum-containing drug.
  • At least 4 weeks must pass between the completion of prior treatments and entry into the study.
  • 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 and to inquire about eligibility for this study, please contact Dr. Maeve Lowery at 646-888-4543.

Protocol

15-293

Phase

III

Investigator