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MATCH Treatment Subprotocol C1: Crizotinib in Patients With Tumors With MET Amplification
This phase II MATCH treatment trial tests how well crizotinib works in treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have MET gene amplification. Crizotinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow.
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 crizotinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation and collection of blood samples throughout the study. Patients may undergo biopsy at screening, on study, and/or at end of treatment. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 additional year. THE MATCH SCREENING TRIAL: Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States
Start Date
July 29, 2016
Primary Completion Date
November 15, 2022
Completion Date
December 31, 2026
Last Updated
March 19, 2026
44
ACTUAL participants
Biopsy Procedure
PROCEDURE
Biospecimen Collection
PROCEDURE
Crizotinib
DRUG
Radiologic Examination
PROCEDURE
Lead Sponsor
National Cancer Institute (NCI)
NCT04550494
NCT06311214
Data Source & Attribution
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