Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01126 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EAY131-C1 | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EAY131-C1 | Other Identifier | CTEP | |
| U10CA180820 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subprotocol C1 (MET amplification) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy Procedure | Procedure | Undergo biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression Free Survival (PFS) | 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David S Hong | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41556942 | Result | 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. |
Not provided
Not provided
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Not provided
Not provided
Not provided
For subprotocol C1, patients were required to have MET amplification defined as ≥7 copies/cell as identified by the Oncomine® Assay, or the Oncomine® Assay equivalent of 7 or greater as identified by a Designated Laboratory.
Subprotocol C1 was activated on May 31, 2016. Forty-four patients were enrolled on EAY131-C1 between July 29, 2016, and November 12, 2021. Thirteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 31 on the basis of the outside assay results.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Crizotinib) | Patients receive crizotinib 250 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2020 | Mar 2, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
|
| Crizotinib | Drug | Given PO |
|
|
| Radiologic Examination | Procedure | Undergo radiologic evaluation |
|
|
| 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 |
| Progression Free Survival | 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. | 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 |
| Started Protocol Therapy |
|
| Eligible, Treated and Mutation Status Confirmed | Primary efficacy analysis set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients who were eligible, started protocol therapy, and had mutation status confirmed at the analysis time were the analyzable patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Crizotinib) | Patients receive crizotinib 250 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 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. | Eligible, treated and mutation status confirmed | Posted | Number | 90% Confidence Interval | percentage of participants | 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 | 6-month Progression Free Survival (PFS) | 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. | Eligible, treated and mutation status confirmed | Posted | Number | 90% Confidence Interval | percentage of participants | 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 |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival | 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. | Eligible, treated and mutation status confirmed | Posted | Median | 90% Confidence Interval | months | 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 |
|
|
Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding four who did not receive treatment).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Crizotinib) | Patients receive crizotinib 250 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. | 36 | 44 | 14 | 40 | 33 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Bone infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Edema limbs | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Flashing lights | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Cancer Research Group | 617-632-3012 | eatrials@jimmy.harvard.edu |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 19, 2020 | Mar 2, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D000077547 | Crizotinib |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|