Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib f… (NCT05295589) | Clinical Trial Compass
WithdrawnPhase 2
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
Stopped: Drug supply issues
United States0Started 2022-06-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients with recurrent ovarian cancer. Ovarian cancer = fallopian tube cancer, ovarian cancer, primary peritoneal cancer. The following histology types are eligible:
* High grade serous
* Endometrioid, grade 3
* Any histology with BRCA1 and/or BRCA2 deleterious mutation (germline or somatic)
* Histologic confirmation of the original primary tumor is required via the pathology report (upload of report required)
* Confirmation of BRCA1 and BRCA2 germline status is required for all entered patients (upload of report\[s\] required)
* Tumor/somatic genomic testing can be provided or entered as not done (upload of report\[s\] required)
* Homologous recombination deficiency (HRD) testing can be provided or entered as not done (upload of report\[s\] required)
* Genetic/genomic testing results and HRD testing results, initially entered as not done, should be uploaded if they become available anytime during conduct of the study
* Participants must have progressed by imaging while receiving PARP inhibitor therapy (irrespective of whether PARP inhibitor therapy was given as maintenance therapy or as primary recurrence therapy); rising CA125 only is not considered as evidence of progression
* Platinum-resistant disease, defined as progression within \< 6 months from completion of platinum-based therapy, and inclusive of platinum refractory disease. The date should be calculated from the last administered dose of platinum therapy
* Unlimi…
What they're measuring
1
Progression free survival (PFS)
Timeframe: Time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years