Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05295589

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

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

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREComputed TomographyUndergo CT scan
DRUGCopanlisib HydrochlorideGiven IV
PROCEDUREMagnetic Resonance ImagingUndergo MRI
DRUGOlaparibGiven PO
DRUGPaclitaxelGiven IV
DRUGPegylated Liposomal Doxorubicin HydrochlorideGiven IV
DRUGTopotecan HydrochlorideGiven IV

Timeline

Start date
2022-06-30
Primary completion
2023-03-17
Completion
2023-03-17
First posted
2022-03-25
Last updated
2023-09-26

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05295589. Inclusion in this directory is not an endorsement.