Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)

Trial Title: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)

NCT ID: NCT06360575

Condition: Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma

Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Crizotinib
Tyrosine Kinase Inhibitors

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biopsy
Description: Undergo tumor biopsy
Arm group label: Treatment (Crizotinib)

Other name: BIOPSY_TYPE

Other name: Bx

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: Treatment (Crizotinib)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Drug
Intervention name: Crizotinib
Description: Given PO
Arm group label: Treatment (Crizotinib)

Other name: MET Tyrosine Kinase Inhibitor PF-02341066

Other name: PF 02341066

Other name: PF-02341066

Other name: PF-2341066

Other name: PF02341066

Other name: Xalkori

Intervention type: Procedure
Intervention name: Radiologic Examination
Description: Undergo radiologic evaluation
Arm group label: Treatment (Crizotinib)

Other name: Radiologic Evaluation

Other name: Radiologic Exam

Summary: This phase II MATCH treatment trial tests how well crizotinib works to treat patients with cancers with MET exon 14 deletion genetic changes. Crizotinib is in a group of medications called tyrosine kinase inhibitors. It works by blocking 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 undergo tumor biopsy on study and undergo radiologic evaluation and blood sample collection throughout the study. After completion of study treatment, patients followed up every 3 months for 2 years then every 6 months for year 3.

Criteria for 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 exon 14 skipping as defined via the MATCH Master Protocol and described or other mutations that disrupt exon 14 that are approved as a dynamic aMOI - 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 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 gastrointestinal (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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: ECOG-ACRIN Cancer Research Group

Address:
City: Philadelphia
Zip: 19103
Country: United States

Start date: May 30, 2016

Completion date: November 15, 2025

Lead sponsor:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06360575