Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic… (NCT06360575) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)
United States20 participantsStarted 2016-07-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 inte…
What they're measuring
1
Objective Response Rate (ORR)
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