NRG-GY029
Terminated
Protocol Information
Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants
A Randomized Phase II Trial Comparing the Combination of PI3K Inhibitor Copanlisib (BAY 80-6946) and PARP Inhibitor Olaparib (AZD2281) to Standard Chemotherapy in Patients with Recurrent Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Progressed Through Prior PARP Inhibitor Therapy
Principal Investigator
Status
Terminated
Open to Accrual
June 30, 2022
Temporarily Closed to Accrual
March 15, 2023
Terminated
March 17, 2023
Disease Site
Gynecologic [GY] Ovarian
Phase
II
Developmental Therapeutics
No
Primary Objective
To assess the clinical
efficacy of the combination of copanlisib/olaparib, as measured by
investigator-assessed progression free
survival (PFS), compared to standard chemotherapy in the setting of
recurrent platinum resistant ovarian cancer that has progressed through prior
PARP inhibitor therapy.
Patient Population
Patients with recurrent platinum resistant
ovarian, fallopian tube, or primary peritoneal cancer who have progressed
through prior PARP inhibitor therapy.
Target Accrual
96
Forms
Safety Reports
- Copanlisib-Dihydrochloride-BAY-80-6946-Dihydrochloride-July-19-2022.pdf
- Copanlisib-Dihydrochloride-Investigator-Notification-Bayer-AG-Manufacturer-Control-2022A143517-November-4-2022.pdf
- Copanlisib-Follow-up-to-an-Investigator-Notification-Bayer-AG-Manufacturer-Control-2022A071527-October-21-2022.pdf
- Copanlisib-Investigator-Notification-Bayer-AG-Manufacturer-Control-2022A119265-October-21-2022.pdf
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.
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