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

To determine the clinical effectiveness of olaparib treatment

Criteria

$25 for initial genetic testing and $50 / research visit; Travel expenses also available

At Least 18 years old

Female subjects with histologically diagnosed relapsed high-grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high-grade endometrioid cancer

At least 1 lesion (measurable) 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. Note: There is no limit on the number of lines of chemotherapy

Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum-sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy);

Can not:

Have any previous treatment with a PARP inhibitor, including olaparib

Subjects can’t have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;

No other malignancy within the last 5 years

Subjects can’t receive any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

No symptomatic uncontrolled brain metastases

Must not be unable to swallow orally administered medication, and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication

Details

Study treatment is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered olaparib orally at 300 mg (two 150 mg tablets), twice daily.

Subjects will continue with olaparib tablets 300 mg (two 150 mg tablets), twice daily, from enrollment (Visit 2) until objective radiological disease progression as assessed by the Investigator, or when they meet any discontinuation criteria

Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB: CGIRB
IRB Number:
Trial Type: Drug
Sponsor: Astra Zenca