AstraZeneca DUETTE

Clinical Trial Title A Phase II Randomised, 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
Trial Status Closed to Enrollment
Start Date 09/09/2020
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description 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

Inclusion 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 PSR ovarian cancer (a minimum of 12 months is required if the 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.
  • Platinum-sensitive disease at the time of disease relapse, ie, TFIp of greater than 6 months as defined by the Gynecological Cancer Intergroup (GCIG)
  • For the platinum-based chemotherapy course received following pre-screening (Part 1) and prior to entering the main screening (Part 2):
  •      Patient must be in response (CR or PR) or have SD as assessed by the investigator at the end of chemotherapy. The response should be assessed a minimum of 3 weeks after the last dose of chemotherapy and within 4 weeks from start of study drug. Measurable disease at the end of chemotherapy is not mandated.
  •     Patient must have received a minimum of 4 cycles of a platinum-containing doublet chemotherapy.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Principal Investigator Colleen McCormick, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail