Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy
Public ClinicalTrials.gov record NCT05295589. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial compares copanlisib and olaparib to standard of care chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that did not respond to previous platinum-based chemotherapy (platinum resistant) and that has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib and olaparib may extend the time that the cancer does not progress compared to standard of care chemotherapy in patients with recurrent platinum resistant ovarian, fallopian tube, or primary peritoneal cancer.
Study identification
- NCT ID
- NCT05295589
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
- Platinum-Refractory Fallopian Tube Carcinoma
- Platinum-Refractory Ovarian Carcinoma
- Platinum-Refractory Primary Peritoneal Carcinoma
- Recurrent Fallopian Tube Endometrioid Adenocarcinoma
- Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
- Recurrent Ovarian Endometrioid Adenocarcinoma
- Recurrent Ovarian High Grade Serous Adenocarcinoma
- Recurrent Platinum-Resistant Fallopian Tube Carcinoma
- Recurrent Platinum-Resistant Ovarian Carcinoma
- Recurrent Platinum-Resistant Primary Peritoneal Carcinoma
- Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
- Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma
Interventions
- Computed Tomography Procedure
- Copanlisib Hydrochloride Drug
- Magnetic Resonance Imaging Procedure
- Olaparib Drug
- Paclitaxel Drug
- Pegylated Liposomal Doxorubicin Hydrochloride Drug
- Topotecan Hydrochloride Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 29, 2022
- Primary completion
- Mar 16, 2023
- Completion
- Mar 16, 2023
- Last update posted
- Sep 25, 2023
2022 – 2023
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05295589, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05295589 live on ClinicalTrials.gov.