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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma, Endometrioid
  • Carcinoma, Ovarian Epithelial
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Platinum-Refractory Fallopian Tube Carcinoma
  • Platinum-Refractory Ovarian Carcinoma
  • Platinum-Refractory Primary Peritoneal Carcinoma
  • Recurrence
  • Recurrent Fallopian Tube Endometrioid Adenocarcinoma
  • Recurrent Ovarian Endometrioid 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

NCT number NCT05295589
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Withdrawn
Phase Phase 2
Start date June 30, 2022
Completion date March 17, 2023

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