Study on GSK2636771 for Treating Cancers with PTEN Genetic Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04439149

Provider View

This clinical trial is testing a drug called GSK2636771 to see if it can help shrink or stop the growth of cancers that have a specific genetic change known as a PTEN mutation or deletion.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug GSK2636771 can effectively treat cancers that have a genetic change called a PTEN mutation or deletion. This drug may work by blocking a protein that cancer cells need to grow. Researchers hope to see if GSK2636771 can shrink these types of cancers or stop them from growing.

Description

The main goal of this study is to see how many patients experience a reduction in their cancer size after taking GSK2636771. Researchers also want to know how many patients are still alive and have not seen their cancer grow after six months of treatment. They will also look at how long it takes for the cancer to start growing again or for the patient to pass away. Additionally, the study will explore other factors that might predict how well the treatment works, using various tests and imaging techniques.

Patients in the study will take GSK2636771 as a pill once a day for 28 days. This cycle will repeat every 28 days as long as the cancer does not grow or the patient does not experience severe side effects. After finishing the treatment, patients will have follow-up visits every three months for up to two years, and then every six months in the third year.

This study is part of a larger research effort called the MATCH Screening Trial, which helps identify patients who might benefit from specific treatments based on their cancer's genetic makeup.

Eligibility Criteria

Inclusion Criteria

  • Must meet the eligibility criteria of the main MATCH Protocol before joining this study.
  • Must have a recent electrocardiogram (ECG) showing no major heart issues.
  • Must have a PTEN gene mutation or deletion, confirmed by specific tests.
  • Must have a hemoglobin level of at least 9 g/dL.
  • Must have normal kidney function, as shown by specific blood tests.

Exclusion Criteria

  • Cannot have an allergy to GSK2636771 or similar drugs.
  • Cannot have other genetic changes that affect certain cancer growth pathways.
  • Cannot have been treated before with drugs targeting the PI3K beta, AKT, or mTOR pathways.
  • Cannot have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Cannot have any platelet function disorders or be taking certain anti-platelet medications.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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