Recurrent Platinum-Resistant Ovarian Carcinoma Clinical Trial
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
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.
PRIMARY OBJECTIVE: I. 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. SECONDARY OBJECTIVES: I. To assess the clinical efficacy of the combination of copanlisib/olaparib, as measured by objective response rate (ORR), per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To assess the clinical efficacy of the combination of copanlisib/olaparib, as measured by overall survival (OS), compared to standard chemotherapy in the setting of recurrent platinum resistant ovarian cancer that has progressed through prior PARP inhibitor therapy. III. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 for each treatment arm. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive either paclitaxel intravenously (IV) OR pegylated liposomal doxorubicin hydrochloride IV, OR topotecan hydrochloride IV while on study. ARM II: Patients receive copanlisib hydrochloride IV and olaparib orally (PO) while on study. Patients undergo computed tomography (CT) scan while on study and may undergo magnetic resonance imaging (MRI) throughout the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05691504 -
Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT05026606 -
Etigilimab and Nivolumab for the Treatment of Platinum-Resistant Recurrent Clear Cell Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 2 | |
| Recruiting |
NCT05231122 -
Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02839707 -
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT06393751 -
Testing the Addition of ASTX660 (Tolinapant) to the Usual Chemotherapy Treatment (Paclitaxel With or Without Bevacizumab) in Patients With Recurrent Ovarian Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04739800 -
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
|
Phase 2 | |
| Recruiting |
NCT04633239 -
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
|
Phase 1 | |
| Recruiting |
NCT04840589 -
Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03113487 -
P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 2 |