Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer. Subjects should have received at least 1 prior line of platinum-based chemotherapy.

I'M INTERESTED

This research study is lead by Dr. Tashanna Myers.

Contact: Laura Sorci, 413-794-3188

Participation details:

December 22, 2016
BH17-106
Cancer, Cancer-Gynecologic

D’Amour Center for Cancer Care, 3350 Main Street, Springfield, MA

Inclusion Criteria:

  • Female subjects with histologically diagnosed relapsed high-grade serous or high-grade endometrioid ovarian cancer
  • At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment
  • Subjects must have received at least 1 prior platinum-based line of chemotherapy for ovarian cancer.
  • Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment
  • Subjects must have a life expectancy greater than or equal to 16 weeks
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations

Exclusion Criteria:

  • Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection
  • Breast feeding women
  • Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus
  • Subjects with known active hepatitis (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
Active
Interventional (Clinical Trial), Non-Randomized
2