Trial Outcomes & Findings for Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F) (NCT NCT04439266)

Last Updated: 2026-05-07

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

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

Results posted on

2026-05-07

Participant Flow

Subprotocol F was activated on August 12, 2015. A total of 5 patients were assigned to this arm after screening, 1 from screening cohort and 4 from outside assay. Of the 5 patients, 5 patients were enrolled to arm F between August 12, 2015 and April 24, 2019.

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 F, patients had to have an ALK mutation.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	5
Overall Study Eligible	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Ineligible	1
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Disease progression	1
Overall Study Still on treatment	1

Baseline Characteristics

Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Crizotinib) n=4 Participants Patients receive crizotinib 250mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Crizotinib: Given PO
Age, Continuous	59 years n=54 Participants
Sex: Female, Male Female	3 Participants n=54 Participants
Sex: Female, Male Male	1 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	0 Participants n=54 Participants
Race (NIH/OMB) White	4 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants

PRIMARY outcome

Timeframe: 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

Population: Patients who were eligible and received protocol treatment

Outcome measures

Outcome measures
Measure	Treatment (Crizotinib) n=4 Participants 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
Objective Response Rate (ORR)	50 percentage of participants Interval 9.8 to 90.2

SECONDARY outcome

Timeframe: 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

Population: Patients who were eligible and received protocol treatment

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.

Outcome measures

Outcome measures
Measure	Treatment (Crizotinib) n=4 Participants 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
6-month Progression-free Survival (PFS) Rate	25 percentage of participants Interval 6.0 to 100.0

SECONDARY outcome

Timeframe: 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

Population: Patients who were eligible and received protocol treatment

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.

Outcome measures

Outcome measures
Measure	Treatment (Crizotinib) n=4 Participants 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
Progression Free Survival (PFS)	3.8 months Interval 1.7 to Median PFS 90% CI upper bound could not be determined due to insufficient number of participants with events

Adverse Events

Treatment (Crizotinib)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Crizotinib) n=5 participants at risk 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
Investigations Alanine aminotransferase increased	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Aspartate aminotransferase increased	40.0% 2/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Blood bilirubin increased	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hyponatremia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypophosphatemia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.

Other adverse events

Other adverse events
Measure	Treatment (Crizotinib) n=5 participants at risk 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
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Cardiac disorders Sinus bradycardia	40.0% 2/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
General disorders Edema limbs	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
General disorders Fatigue	40.0% 2/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
General disorders General disorders and administration site conditions - Other	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Skin and subcutaneous tissue disorders Rash acneiform	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Abdominal distension	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Constipation	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Diarrhea	60.0% 3/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Nausea	60.0% 3/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Alanine aminotransferase increased	60.0% 3/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Alkaline phosphatase increased	60.0% 3/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Aspartate aminotransferase increased	40.0% 2/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Blood bilirubin increased	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Lymphocyte count decreased	40.0% 2/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations White blood cell decreased	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Investigations Investigations - Other, specify	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Anorexia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hyperglycemia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 2/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypocalcemia	40.0% 2/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypoglycemia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Nervous system disorders Dysgeusia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Nervous system disorders Headache	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Eye disorders Flashing lights	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Eye disorders Photophobia	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Eye disorders Eye disorders - Other, specify	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.0% 1/5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 5 cases that received protocol treatment were monitored for adverse events.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60