A Phase II Study of a New Tablet Formulation of Olaparib to Treat Women with Recurrent Ovarian Cancer

Full Title

Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects with Different HRD Tumor Status and with Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy

Purpose

Olaparib kills cancer cells by blocking the PARP protein, thereby preventing the repair of DNA or genetic damage in cancer cells, resulting in cell death. It is a capsule approved for treating some patients with ovarian cancer and breast cancer who have inherited BRCA mutations and whose cancer has continued to grow despite prior chemotherapy.

In this study, researchers are assessing a new tablet formulation of olaparib that is more convenient than the capsule because it requires patients to take fewer pills. This treatment will be assessed in four groups of patients with recurrent ovarian cancer:

  • Women who have an inherited mutation in the BRCA1 or BRCA2 genes
  • Women whose tumors have a mutation in BRCA1 or BRCA2
  • Women whose tumors have a change called “homologous recombination deficiency” (HRD), which will be found by a test done on the tumor
  • Women whose tumors have none of these features.

The purpose of this study is to see if olaparib is effective for treating these different groups of patients with high-grade epithelial ovarian, fallopian, or primary peritoneal cancer.

Eligibility

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

  • Patients must have recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer that has come back at least 6 months after previous platinum-based chemotherapy.
  • Patients must have received at least two prior regimens of platinum-based chemotherapy.
  • Patients may not have previously received a PARP inhibitor.
  • 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. Karen Cadoo at 646-888-4946.

Protocol

17-452

Phase

II

Investigator

Co-Investigators