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

NCT ID: NCT04439266

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-12
• Study Completion Date: 2026-03-17

Brief Summary

This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose cancer has a genetic change called ALK rearrangement. Crizotinib may stop the growth of cancer cells by blocking the ALK protein which may be needed for cell growth. Researchers hope to learn if crizotinib will shrink this type of cancer or stop its growth.

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. 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.

Conditions

Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (crizotinib)

Patients receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

Crizotinib

Intervention Type: DRUG

Given PO

Interventions

Crizotinib

Given PO

Intervention Type: DRUG

Other Intervention Names

Alkixen; Crizocent; MET Tyrosine Kinase Inhibitor PF-02341066; PF 02341066; PF-02341066; PF-2341066; PF02341066; Xalkori

Eligibility Criteria

Inclusion Criteria

• Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
• Patients must have an ALK rearrangement as defined via the MATCH Master Protocol
• Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)

Exclusion Criteria

• Patients must not have non small cell lung cancer or anaplastic large cell lymphoma (ALCL)
• Patients with a history of interstitial lung disease or pneumonitis are excluded
• Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition
• Patients must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922
• Patients must not have had brain metastases unless 1) treated and neurologically stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment
• Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will be excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice T Shaw

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NCI-2020-03270

Identifier Type: REGISTRY

Identifier Source: secondary_id

EAY131-F

Identifier Type: OTHER

Identifier Source: secondary_id

EAY131-F

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U24CA196172

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2020-03270

Identifier Type: -

Identifier Source: org_study_id