Copanlisib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called copanlisib to determine its effectiveness in stopping tumor growth and potentially killing cancer cells. The focus is on patients whose cancer shows a specific loss of a protein called PTEN, crucial for controlling cell growth. Suitable candidates have cancer with confirmed PTEN loss and have not received similar treatments before. The study aims to provide insights into copanlisib's effectiveness for these cancer types. As a Phase 2 trial, researchers focus on measuring the treatment's efficacy in an initial, smaller group of participants.
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.
Is there any evidence suggesting that copanlisib is likely to be safe for humans?
Research has shown that copanlisib is generally well-tolerated by patients. In one study, researchers found no new safety concerns. Another study demonstrated that copanlisib, when combined with another treatment, remained well-tolerated and helped fight tumors. Common side effects include high blood sugar, high blood pressure, nausea, and a drop in certain white blood cells, but these were usually manageable. Overall, copanlisib appears safe for many patients.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for cancers with PTEN loss, which often involve chemotherapy or targeted therapies that can affect multiple pathways, Copanlisib is a targeted therapy that specifically inhibits the PI3K pathway. This pathway is crucial for cancer cell growth and survival, especially when PTEN is lost or mutated. Researchers are excited about Copanlisib because it offers a more precise mechanism of action, potentially leading to fewer side effects and improved effectiveness against tumors that have become resistant to other treatments. By directly targeting this specific pathway, Copanlisib may provide a new option for patients who have limited responses to existing therapies.
What evidence suggests that copanlisib might be an effective treatment for cancer with PTEN loss?
Studies have shown that copanlisib can help treat certain cancers. In patients with relapsed or hard-to-treat lymphoma, copanlisib led to a strong response, with 59% of patients improving and 12% experiencing complete remission. Research also suggests that copanlisib works quickly, providing faster results for patients. Although not all studies show longer survival, copanlisib has been linked to lasting responses in some types of cancer. In this trial, participants will receive copanlisib as part of Subprotocol Z1G, focusing on patients with PTEN loss.12367
Who Is on the Research Team?
Jordi Rodon Ahnert
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
What Are the Treatments Tested in This Trial?
Interventions
- Copanlisib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor