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.
This research study is lead by Dr. Tashanna Myers.
Contact: Laura Sorci, 413-794-3188
December 22, 2016
D’Amour Center for Cancer Care, 3350 Main Street, Springfield, MA
- 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
- 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
Interventional (Clinical Trial), Non-Randomized