Study on MLN0128 (TAK-228) for Cancers with TSC1 or TSC2 Genetic Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06390865

Provider View

This clinical trial is testing the effectiveness of MLN0128 (TAK-228) in treating cancers with specific genetic changes known as TSC1 or TSC2 mutations. The study aims to see if this drug can stop cancer cells from growing by blocking certain enzymes they need.

Patient Parameters

Program Overview

The purpose of this phase II study is to find out how well the drug MLN0128 (TAK-228) works in patients with cancers that have specific genetic changes called TSC1 or TSC2 mutations. The drug may help stop cancer cells from growing by blocking enzymes necessary for their growth. Patients will take the drug daily in 28-day cycles, and their progress will be monitored through scans and tests. The study will also collect blood samples and perform biopsies to better understand the drug's effects.

Description

The main goal of this study is to see how many patients experience a reduction in their cancer after taking MLN0128 (TAK-228). Researchers will also look at how long patients live without their cancer getting worse and identify any markers that might predict how well the treatment works. Patients will take the drug by mouth every day for 28 days, with cycles repeating as long as the treatment is effective and side effects are manageable. Regular scans and tests will be conducted to monitor the cancer's response. After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for one year.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the main MATCH study.
  • Must have a TSC1 or TSC2 genetic mutation.
  • Must have a recent ECG and no serious heart issues.
  • Cannot have uncontrolled high blood pressure.
  • Cannot have allergies to MLN0128 (TAK-228).
  • Cannot have active hepatitis B or C infections.
  • Cannot have had recent serious heart or blood vessel issues.
  • Cannot have conditions affecting drug absorption.
  • Brain metastases must be treated and stable.
  • Cannot use certain medications like proton pump inhibitors.
  • Cannot have uncontrolled diabetes or high triglycerides.
  • Cannot have used similar drugs before.
  • Must use effective birth control during and after the study.
  • Cannot be HIV-positive.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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