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PI3K Inhibitor
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
Philadelphia, PA
Phase 2
Waitlist Available
Led By Panagiotis A Konstantinopoulos
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination of drugs to treat ovarian, fallopian tube, or primary peritoneal cancer that has come back and did not respond to previous platinum-based chemotherapy.
See full description
Eligible Conditions
- Fallopian Tube Carcinoma
- Ovarian Adenocarcinoma
- Peritoneal Carcinoma
- Ovarian Cancer
- Peritoneal Adenocarcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Incidence of adverse events
Objective response rate (ORR)
Overall survival (OS)
Side effects data
From 2022 Phase 4 trial • 202 Patients • NCT0433004051%
Anaemia
22%
Thrombocytopenia
20%
Nausea
17%
Vomiting
16%
Fatigue
11%
Leukopenia
11%
Diarrhoea
11%
Decreased appetite
10%
Pyrexia
10%
Back pain
9%
Abdominal pain
8%
Neutropenia
8%
Asthenia
6%
Constipation
6%
Headache
6%
Cough
6%
Dyspnoea
5%
COVID-19
1%
Malaria
1%
Pericardial effusion
1%
Abdominal pain upper
1%
Death
1%
Dengue fever
1%
Ischaemic stroke
1%
Vaginal discharge
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ovarian Cancer
Breast Cancer
Both Ovarian Cancer and Breast Cancer
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (copanlisib, olaparib)Experimental Treatment4 Interventions
Patients receive copanlisib hydrochloride IV and olaparib PO while on study. Patients undergo CT scan while on study and may undergo MRI throughout the study.
Group II: Arm I (standard of care chemotherapy)Active Control5 Interventions
Patients receive either paclitaxel IV OR pegylated liposomal doxorubicin hydrochloride IV, OR topotecan hydrochloride IV while on study.
Patients undergo CT scan while on study and may undergo MRI throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2020
Completed Phase 3
~1180
Copanlisib Hydrochloride
2019
Completed Phase 2
~20
Computed Tomography
2017
Completed Phase 2
~2440
Olaparib
2017
Completed Phase 4
~2310
Find a Location
Closest Location:Cleveland Clinic Foundation· Cleveland, OH· 129 miles
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
14,057 Previous Clinical Trials
41,149,428 Total Patients Enrolled
NRG OncologyOTHER
241 Previous Clinical Trials
104,987 Total Patients Enrolled
Panagiotis A KonstantinopoulosPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
98 Total Patients Enrolled