Testing GSK2636771 for Cancers with PTEN Loss of Expression

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04439188

Provider View

This study is exploring whether the drug GSK2636771 can help shrink or stop the growth of cancers that have lost PTEN expression. The drug may block a protein needed for cancer cell growth.

Patient Parameters

Program Overview

This phase II trial is testing the effects of GSK2636771 in patients whose cancer has lost PTEN expression. The drug may block a protein called PI3K-beta, which might be necessary for the growth of these cancer cells. Researchers want to see if GSK2636771 can shrink the cancer or stop it from growing.

Description

PRIMARY GOAL:

  • To see how many patients respond to the treatment with GSK2636771 in advanced cancers, lymphomas, or multiple myeloma.

SECONDARY GOALS:

  • To find out how many patients are alive and without disease progression after 6 months of treatment.
  • To measure the time until the cancer progresses or the patient passes away.
  • To identify other factors that might predict how well the treatment works or why it might not work, using various tests on genes, RNA, proteins, and imaging.
  • To see if imaging tests before and after treatment can predict how well the treatment works and how long patients stay free of disease.

TREATMENT PLAN:

Patients will take the drug GSK2636771 orally once a day for 28 days. This cycle repeats every 28 days unless the cancer progresses or side effects become unacceptable.

After finishing the treatment, patients will have follow-up visits every 3 months for up to 2 years, and then every 6 months in the third year.

MATCH SCREENING TRIAL:

For more information on the MATCH Screening Protocol, please refer to NCT02465060.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the Master MATCH Protocol before joining this study.
  • Must have a recent ECG with no significant heart issues.
  • Must have complete loss of PTEN expression as confirmed by specific tests.
  • Must have hemoglobin levels of at least 9 g/dL.
  • Must have normal kidney function as shown by specific tests.

Exclusion Criteria

  • Cannot have allergies to GSK2636771 or similar drugs.
  • Cannot have tumors with certain genetic changes that activate specific pathways.
  • Cannot have had previous treatments targeting PI3K beta, AKT, or mTOR, except for specific allowed drugs.
  • Cannot have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Cannot have congenital platelet function defects or be on certain anti-platelet medications.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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