Ovarian Cancer D6018C00004

A Phase II Randomized, Multi-Centre Study to Investigate the Efficacy and Tolerability of a Second Maintenance Treatment in Patients with Platinum-Sensitive Relapsed Epithelial Ovarian Cancer, who have Previously Received PARP Inhibitor Maintenance Treatment

To investigate the effectiveness and tolerability of a second maintenance treatment in participants with platinum-sensitivity relapsed (PSR) epithelial ovarian cancer, who have previously received PARPi maintenance treatment and who have benefit (complete response [CR] or partial response [PR]) or stable disease (SD) from further platinum based chemotherapy.

Eligibility Criteria:

• Patients with relapsed histologically confirmed diagnosis of high grade epithelial ovarian cancer (including primary peritoneal and/or fallopian tube cancer), with disease relapse on or after completion of PARPi maintenance therapy and who have not received any intervening systemic treatment since discontinuation of PARPi (this excludes the platinum-based chemotherapy received during screening Part 1 of this study)
• A minimum of 6 months of prior PARPi treatment received in the maintenance setting for PSROC (a minimum of 12 months is required if patient received PARPi maintenance following first-line chemotherapy). If the prior PARPi used was Olaparib then patients must have received treatment without significant toxicity or the need for a permanent dose reduction
• Disease relapse in the second-line (first relapse) or third-line (second relapse) setting
• No History of leptomeningeal carcinomatosis
• No Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen or during the period between completion of chemotherapy and first dose of study treatment

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut