PI3K-beta Inhibitor for Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, GSK2636771 (a PI3K-beta inhibitor), designed to shrink or halt the growth of tumors with a specific genetic change called a PTEN mutation. The treatment blocks a protein called PI3K-beta, which may play a role in cancer cell growth. Eligible participants are those with cancer exhibiting PTEN mutations, confirmed by a test called immunohistochemistry. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain cancer treatments targeting the PI3K beta, AKT, or mTOR pathways before. If you are on anti-platelet drugs like clopidogrel, you cannot participate.
Is there any evidence suggesting that GSK2636771 is likely to be safe for humans?
Research has shown that GSK2636771, a drug targeting a specific protein, has undergone safety testing in people. Diarrhea, nausea, and vomiting were the most common side effects reported in earlier studies where patients took GSK2636771, sometimes with other treatments.
The drug is now in phase 2 trials, indicating it has already been tested for safety in humans. Although the FDA has not yet approved it, current information suggests the drug is generally well-tolerated. However, as with any new drug under study, there is always a risk of side effects. Participants should discuss these risks with their doctor.12345Why do researchers think this study treatment might be promising?
Researchers are excited about GSK2636771 because it targets the PI3K-beta pathway, which is often linked to tumor growth in certain cancers. Unlike standard treatments that may not specifically target this pathway, GSK2636771 aims to block the signals that allow cancer cells to multiply. This precise mechanism could lead to more effective management of the disease with potentially fewer side effects, offering hope for better outcomes in patients with tumors driven by this pathway.
What evidence suggests that GSK2636771 might be an effective treatment for tumors with PTEN mutations?
Research has shown that GSK2636771 targets a protein called PI3K-beta, which may aid cancer cell growth, particularly in tumors with PTEN mutations. In earlier studies, some patients with these mutations experienced disease stabilization, with about 32% achieving this stable state. Additionally, another study found that a small number of patients saw their tumors shrink by more than half, known as a partial response. These findings suggest that GSK2636771 might slow down or reduce cancer growth in certain patients.34567
Who Is on the Research Team?
Filip Janku
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for cancer patients with a specific genetic change called PTEN mutation or deletion. They must have some PTEN expression, normal hemoglobin levels, acceptable kidney function, and a stable heart rhythm on an ECG. Excluded are those allergic to GSK2636771, with certain other gene changes that affect cancer growth pathways, prior treatments targeting similar pathways, history of lung disease like pneumonitis, congenital platelet defects or current use of certain anti-platelet drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PI3K-beta inhibitor GSK2636771 orally once daily on days 1-28. 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. Follow-up occurs every 3 months if less than 2 years from study entry, and then every 6 months for year 3.
What Are the Treatments Tested in This Trial?
Interventions
- GSK2636771
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor