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PI3K inhibitor
Copanlisib for Cancer
Phase 2
Waitlist Available
Led By Senthilkumar Damodaran
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
Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
Patients must have PIK3CA mutation as determined via the MATCH Master Protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights
Study Summary
This trial is testing the effects of copanlisib hydrochloride in patients with cancer that has a PIK3CA mutation. Copanlisib may stop the growth of cancer cells by blocking PIK3, a protein needed for cell growth.
Who is the study for?
This trial is for cancer patients with a specific genetic change called PIK3CA mutation. They must meet prior MATCH Protocol criteria, have certain blood cell counts and organ function levels, not use herbal medications or strong CYP3A4 inhibitors, and agree to contraception. It's not for those with hypersensitivity to copanlisib, previous PI3K inhibitor treatments, activating KRAS mutations, HER2 positive breast cancer, heart rhythm issues or non-healing wounds.Check my eligibility
What is being tested?
The trial tests the drug copanlisib hydrochloride on various cancers with the PIK3CA mutation. Copanlisib aims to halt cancer growth by inhibiting a protein essential for cell proliferation. The study involves biopsies and imaging like CT scans and MRIs to monitor effects.See study design
What are the potential side effects?
Potential side effects of copanlisib may include high blood sugar levels (especially in diabetics), liver enzyme changes indicating potential liver damage, digestive disturbances due to bilirubin fluctuations, fatigue from anemia (low hemoglobin), increased risk of infection from low neutrophil count (a type of white blood cell), bleeding risks associated with low platelets count.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent ECG showed no significant heart issues.
Select...
My cancer has a PIK3CA mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
6-month Progression-Free Survival (PFS) Rate
Progression Free Survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (copanlisib)Experimental Treatment4 Interventions
Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsies at screening and end of treatment and CT or MRI at baseline, every 2 cycles for the first 26 cycles, and then every 3 cycles thereafter until progressive disease or start of another MATCH treatment step.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~850
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,632 Total Patients Enrolled
Senthilkumar DamodaranPrincipal InvestigatorECOG-ACRIN Cancer Research Group
5 Previous Clinical Trials
1,152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is higher than 9 grams per deciliter.Your absolute neutrophil count is at least 1.5 billion per liter.I am not taking strong CYP3A4 inhibitors or inducers.I do not have slow-growing types of non-Hodgkin lymphoma or diffuse large B-cell lymphoma.I do not have a history of or current lung inflammation.I have never been treated with copanlisib or similar drugs.My recent ECG showed no significant heart issues.My liver enzymes are within the required range.I will stop taking herbal supplements like St. John's Wort 7 days before starting copanlisib.I agree to use birth control during and for 1 month after my treatment.My cancer has a PIK3CA mutation.Your platelet count is at least 100 billion per liter.I am not on any heart rhythm medications except for digoxin or beta-blockers.My latest HbA1c level is 8.5% or lower.You are allergic to copanlisib or similar drugs.My cancer does not have KRAS mutations.My breast cancer is not HER2 positive.I do not have any non-healing wounds, ulcers, or bone fractures.Your total serum bilirubin level is less than 2.0 mg/dL.Your kidney function, as measured by a blood test for creatinine, is within a certain normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (copanlisib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals being enrolled in this research endeavor at present?
"As the information held on clinicaltrials.gov indicates, this trial is not currently recruiting patients. Originally posted in June 2018 and edited as recently as August 2022, there are a multitude of other trials that are actively seeking enrolment at present - 4651 to be precise."
Answered by AI
What potential hazards come with utilizing Copanlisib Hydrochloride?
"The safety of Copanlisib Hydrochloride was rated a 2 by our team at Power, as this Phase 2 trial has some evidence supporting its safety but none confirming efficacy."
Answered by AI
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