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AstraZeneca DUETTE

Trial

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

September 9, 2020

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 Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Thursday, May 6, 2021 01:56:42 PM