Study on MLN0128 (TAK-228) for Cancers with mTOR Genetic Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06385496

Provider View

This clinical trial is testing a new drug, MLN0128 (TAK-228), to see if it can help stop the growth of cancer cells in patients with specific genetic changes known as mTOR mutations.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug MLN0128 (TAK-228) can effectively treat cancers that have certain genetic changes called mTOR mutations. The drug works by blocking enzymes that cancer cells need to grow. This study is in Phase II, which means it is focused on understanding how well the drug works and its safety in patients with advanced cancers that have not responded to other treatments.

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 how long they live overall. They will study the cancer cells to find out if there are other factors that can predict how well the treatment works.

Patients will take MLN0128 (TAK-228) by mouth once a day for 28 days in each cycle. These cycles will continue as long as the cancer does not progress and the patient can tolerate the treatment. Patients will have CT or MRI scans to monitor their cancer and will provide blood samples and biopsies for further study. After finishing the treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 1 year.

Eligibility Criteria

Inclusion Criteria

  • Must meet the eligibility criteria of the MATCH Master Protocol.
  • Must have a specific genetic mutation in mTOR, KEAP1, or NFE2L2.
  • Must have a recent electrocardiogram (ECG) and no serious heart issues.
  • Must not have uncontrolled high blood pressure or known lung hypertension.
  • Must not be allergic to MLN0128 or similar drugs.
  • Must not have active hepatitis B or C infections.
  • Must not have had recent serious heart or blood vessel issues.
  • Must not have problems absorbing the drug due to past surgeries or diseases.
  • If there is a history of brain metastasis, it must be treated and stable.
  • Must not be taking certain medications that interfere with the study drug.
  • Must not have uncontrolled diabetes or high triglycerides.
  • Must not have been treated with similar drugs before.
  • Women of childbearing age and men must use effective birth control during the study and for 120 days after the last dose.
  • Must not be HIV-positive.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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