NCT06357975 · REGISTRY CONDITION SEARCH

Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-03-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

6-month Progression Free Survival (PFS)

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outcome · POSTED

Progression Free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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 * Patient must fulfill all eligibility criteria outlined in section 3.1 of MATCH Master protocol (excluding section 3.1.6) at the time of registration to treatment step (step 1, 3, 5, 7) * Patient must have MET amplification as defined via the MATCH Master Protocol and described. Amplified MET will be defined as \>= 7 copies/cell as identified by the Oncomine (Registered Trademark) Assay, or the Oncomine Assay equivalent of 7 or greater as identified by a designated laboratory assay which will be \>= 15 copies per cell for those designated laboratories that correct for tumor content * Patients must have an electrocardigram (ECG) within 8 weeks prior to treatment assignment and must not have clinically important abnormalities in rhythm, conduction or morphology of resting ECG, including complete left bundle branch block, third degree heart block * Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition * Patient must not have had any of the following prior therapies: AMG 337, BMS 777607, cabozantinib (XL184), crizotinib (PF02341066), EMD1214063, foretinib (GSK1363089) (XL880), golvatinib (E7050), IncB28060 (INC280), JNJ 8877605, MGCD265, MK2461, MSC2156119J, PF 04217903, SGX523, tivantinib (ARQ197) or any other novel MET tyrosine kinase inhibitor (TKI) with any MET inhibitory activity half-maximal inhibitory concentration (IC50) \< 1 uM. Prior anti-HGF or anti-MET antibodies are acceptable * Patients must not have a history of extensive disseminated/bilateral or known presence of grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis * Patients must not have had myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment. Clinically significant GI abnormalities that may alter absorption (e.g., malabsorption syndrome, major resection of stomach or small bowel) * Patients using drugs or foods that are known strong CYP3A4 inhibitors or inducers will be excluded. Patients must not require concurrent use of CYP3A substrates with narrow therapeutic indices * Patients must not have had major surgery or tumor embolization within 4 weeks and minor surgery within 2 weeks prior to the initiation of the study drug
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive crizotinib PO 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.
intervention Names
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Drug: Crizotinib
Procedure: Radiologic Examination
label
Subprotocol C1 (MET amplification)
type
EXPERIMENTAL

interventions

arm Group Labels
Subprotocol C1 (MET amplification)
description
Undergo biopsy
name
Biopsy Procedure
other Names
Biopsy
BIOPSY_TYPE
Bx
type
PROCEDURE
arm Group Labels
Subprotocol C1 (MET amplification)
description
Undergo collection of blood samples
name
Biospecimen Collection
other Names
Biological Sample Collection
Biospecimen Collected
Specimen Collection
type
PROCEDURE
arm Group Labels
Subprotocol C1 (MET amplification)
description
Given PO
name
Crizotinib
other Names
Alkixen
Crizocent
MET Tyrosine Kinase Inhibitor PF-02341066
PF 02341066
PF-02341066
PF-2341066
PF02341066
Xalkori
type
DRUG
arm Group Labels
Subprotocol C1 (MET amplification)
description
Undergo radiologic evaluation
name
Radiologic Examination
other Names
Radiologic Evaluation
Radiologic Exam
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 44
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
measure
Objective Response Rate (ORR)
time Frame
Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

secondary Outcomes

description
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
measure
6-month Progression Free Survival (PFS)
time Frame
Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
description
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.
measure
Progression Free Survival
time Frame
Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Full study description

brief Summary: 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.
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 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.

Source references

references

citation
Coleman N, Wei Z, Iafrate AJ, Zwiebel JA, Sharon E, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Takebe N, Williams T, Croley JJ, Onitilo AA, Tricoli JV, Cheng J, Karlovich C, Conley BA, Arteaga CL, Harris L, O'Dwyer PJ, Hong DS, Chen AP, Flaherty KT. Crizotinib in Patients with Tumors with MET Amplification or Exon 14 Deletion: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocols C1 and C2. Clin Cancer Res. 2026 Apr 1;32(7):1224-1233. doi: 10.1158/1078-0432.CCR-25-1247.
pmid
41556942
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice