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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03269 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EAY131-G | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EAY131-G | Other Identifier | CTEP | |
| U10CA180820 | U.S. NIH Grant/Contract | View source | |
| U24CA196172 | U.S. NIH Grant/Contract | View source |
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This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose cancer has a genetic change called ROS1 translocation. Crizotinib may block a protein called ROS1, which may be needed for cancer cell growth. Researchers hope to learn if crizotinib will shrink this type of cancer or stop its growth.
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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (crizotinib) | Experimental | Patients receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response 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 the detailed definitions of response criteria. The 90% two-sided binomial exact confidence interval was 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) Rate | 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 NeuroOncology 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron S Mansfield | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | Philadelphia | Pennsylvania | 19103 | United States |
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol G, patients had to have an ROS1 translocations (other than patients with non-small cell lung cancer).
Subprotocol G was activated on August 12, 2015. A total of 5 patients were assigned to this arm after screening, 2 from screening cohort and 3 from outside assay. Of the 5 patients, 4 patients were enrolled to arm G between August 2015, and September 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Crizotinib) | Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2019 | Jul 26, 2022 |
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| 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) | 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 |
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| COMPLETED | Treatment continued until disease progression or intolerability. |
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| NOT COMPLETED |
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Eligible and treated patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Crizotinib) | Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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) | Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response 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 the detailed definitions of response criteria. The 90% two-sided binomial exact confidence interval was calculated for ORR. | Patients who were eligible and received protocol treatment | 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 |
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| Secondary | 6-month Progression-free Survival (PFS) Rate | 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 NeuroOncology 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. | Patients who were eligible and received protocol treatment | 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) | 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. | Patients who were eligible and received protocol treatment | 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 |
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Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All 4 cases that received protocol treatment were monitored for adverse events.
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| 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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO | 4 | 4 | 2 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Weight gain | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE 4.0 | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Dry eye | Eye disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Statistical Office | 617-632-3012 | eatrials@jimmy.harvard.edu |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | 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 |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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