Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)

Running, not enrolling · Phase 2

Conditions studied: Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma

In brief

This phase II MATCH treatment trial tests how well MLN0128 (TAK-228) works in treating patients with cancer that has certain genetic changes called TSC1 or TSC2 mutations. MLN0128 (TAK-228) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT06390865

Run by

National Cancer Institute (NCI)

People needed

49

Starts

2017-03-12

Expected to finish

2026-12-31

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have met applicable eligibility criteria in the Master MATCH Protocol EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
• Patients must fulfill all eligibility criteria of MATCH Master Protocol at the time of registration to treatment step (Step 1, 3, 5, 7)
• Patients must have a TSC1 or TSC2 mutation as determined via the MATCH Master Protocol
• Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must NOT have any of the following cardiac criteria:
• Clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block, corrected QT interval (QTc) interval > 480 milliseconds)
• Uncontrolled hypertension (i.e. systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg) are not eligible. Use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed
• Known pulmonary hypertension
• Patients must not have known hypersensitivity to MLN0128 (TAK-228) or compounds of similar chemical or biologic composition
• Patients must not have known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection, but may have had previously treated and successfully eradicated hepatitis C virus (HCV)
• Patients must have none of the following within six months of receiving the first dose of MLN0128 (TAK-228): ischemic, myocardial or cerebrovascular event, class III or IV heart failure, placement of pacemaker, or pulmonary embolism
• Patients must have no manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228)
• Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:
• Brain metastases which have been treated
• No evidence of disease progression for >= 1 months before the first dose of study drug
• No hemorrhage after treatment
• Off-treatment with dexamethasone for 4 weeks before administration of the first dose of MLN0128 (TAK-228)
• No ongoing requirement for dexamethasone or anti-epileptic drugs
• Patients meeting the following criteria for concomitant medications prior to starting MLN0128 (TAK-228) are not eligible for the study:
• Patients who use a proton pump inhibitor (PPI) within 7 days before receiving the first dose of study drug
• Patients who would require treatment with PPIs throughout the trial
• Patients who would need to take H2 receptor antagonists within 24 hours of the first dose of study drug NOTE Strong CYP1A2 inhibitors and CYP inducers should be administered with caution, at the discretion of the investigator. Alternative treatments, if available, should be considered.
• Patients must not have known treatment with systemic corticosteroid within one week prior to the first administration of study drug
• Patients must not have uncontrolled diabetes mellitus. Controlled diabetes is defined as: Glycosylated hemoglobin (HbA1c) < 7.0%, or fasting serum glucose (=< 130 mg/dL)
• Patients must not have fasting triglycerides >= 300 mg/dL
• Patients must not have had prior treatment with other known TORC1/2 inhibitors, including:

Where it is running

• ECOG-ACRIN Cancer Research Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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