Copanlisib for Cancer

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, Anti-arrhythmics

Disqualifiers: Diabetes, Hypertension, HER2 positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 31

Duration: Up to 3 years

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using herbal medications at least 7 days before starting copanlisib. You also cannot be on strong inhibitors or inducers of CYP3A4 within two weeks before and during the study. If you are on anti-arrhythmic therapy, only digoxin or beta-blockers are allowed.

How is the drug Copanlisib unique in treating cancer?

Copanlisib is unique because it is an intravenous drug that targets the PI3K pathway, which is involved in cancer cell growth, and it has shown effectiveness in treating certain types of lymphoma and solid tumors. Unlike some other treatments, it specifically inhibits PI3K-α/δ, which may help overcome resistance mechanisms in cancer cells. ^{1 2 3 4 5}

What is the purpose of this trial?

The phase II MATCH treatment trial tests how well copanlisib works to treat patients with cancer with PTEN loss. Copanlisib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth.

Research Team

Jordi Rodon Ahnert

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for cancer patients with a specific genetic change called PTEN loss. Participants must be willing to undergo procedures like biopsies, provide biospecimens, and have radiologic exams.

Inclusion Criteria

Hemoglobulin (Hgb) > 9 g/dl

Serum creatinine < 1.5 x ULN

Patients must have met applicable eligibility criteria in the Master MATCH Protocol EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 3 years

Visits every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3 months for 2 years and then every 6 months for 1 year.

3 years

Follow-up every 3 months for 2 years, then every 6 months for 1 year

Treatment Details

Interventions

• Copanlisib

Trial Overview The study is examining the effectiveness of Copanlisib in treating cancers with PTEN loss. It's a phase II trial aiming to see if this drug can halt tumor growth or kill cancer cells by blocking enzymes that are essential for cell growth.

Participant Groups

Group I: Subprotocol Z1G (PTEN loss) Experimental Treatment 4 Interventions

Patients receive copanlisib IV at a dose of 60 mg over 1 hour on day 18 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and radiologic evaluation and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

Copanlisib is effective in treating relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), with an overall response rate of 57% and a complete response rate of 13% based on a meta-analysis of 652 patients across 8 studies.

Combination therapy with copanlisib and rituximab showed significantly higher efficacy compared to copanlisib alone, with complete response rates of 34% versus 6%, while treatment-related adverse events were manageable, with common side effects including hyperglycemia and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of copanlisib in relapsed/refractory B-cell non-Hodgkin lymphoma: A meta-analysis of prospective clinical trials. Wang, J., Zhou, H., Mu, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

First-in-human phase I study of copanlisib (BAY 80-6946), an intravenous pan-class I phosphatidylinositol 3-kinase inhibitor, in patients with advanced solid tumors and non-Hodgkin's lymphomas. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation study of copanlisib in combination with gemcitabine or cisplatin plus gemcitabine in patients with advanced cancer. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of copanlisib in relapsed/refractory B-cell non-Hodgkin lymphoma: A meta-analysis of prospective clinical trials. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

A Phase I study of intravenous PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

On-Target Pharmacodynamic Activity of the PI3K Inhibitor Copanlisib in Paired Biopsies from Patients with Malignant Lymphoma and Advanced Solid Tumors. [2021]