Trial Title:
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With mTOR Genetic Changes (MATCH - Subprotocol L)
NCT ID:
NCT06385496
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (sapanisertib [MLN0128 (TAK-228)])
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (sapanisertib [MLN0128 (TAK-228)])
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (sapanisertib [MLN0128 (TAK-228)])
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (sapanisertib [MLN0128 (TAK-228)])
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Drug
Intervention name:
Sapanisertib
Description:
Given PO
Arm group label:
Treatment (sapanisertib [MLN0128 (TAK-228)])
Other name:
INK-128
Other name:
INK128
Other name:
MLN-0128
Other name:
MLN0128
Other name:
TAK-228
Summary:
This phase II MATCH treatment trial tests how well MLN0128 (TAK-228) works in treating
patients with cancer that has certain genetic changes called mTOR mutations. MLN0128
(TAK-228) may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with objective response (OR) to targeted study
agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of
treatment with targeted study agent in patients with advanced refractory
cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential
predictive biomarkers beyond the genomic alteration by which treatment is assigned or
resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and
imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes
from pre- through post-therapy imaging can predict objective response and progression
free survival and to evaluate the association between pre-treatment radiomic phenotypes
and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive sapanisertib (MLN0128 [TAK-228]) orally (PO) once daily (QD) on days
1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or
magnetic resonance imaging (MRI) during screening and on study, as well as during
follow-up as clinically necessary. Patients also undergo biopsies and blood sample
collection on study.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 mutation in mTOR, KEAP1 or NFE2L2 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). 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 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:
- AZD8055
- XL765
- BEZ235
- GSK2126458
- XL388
- DS3078(a)
- PF-05212384
- SF1126
- Palomid-529
- GDC0980 (apitolisib)
- LY30223414
- BKM120
- OSI0127
- MLN0128 (TAK-228)
- AZD2014
- Patients must not have other clinically significant co-morbidities that, in the
opinion of the investigator, would limit compliance with study requirements
- Fertility and developmental studies with MLN0128 (TAK-228) have not been conducted.
On the basis of potential hazard of other mTOR inhibitors (i.e., rapamycin and other
rapalogs) on the developing fetus, women of childbearing age should avoid becoming
pregnant while taking MLN0128 (TAK-228). For this reason, women of child-bearing
potential and men must agree to practice 1 highly effective method of contraception
and 1 additional effective (barrier) method of contraception, at the same time, from
the time of signing the informed consent through 120 days after the last dose of
study drug, or agree to completely abstain from heterosexual intercourse. Men must
agree not to donate sperm during the course of this study or within 120 days after
receiving their last dose of study drug
- Patients who are known to be HIV-positive are not eligible for this study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
March 12, 2017
Completion date:
December 31, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385496
