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Therapy Name	Belizatinib
Synonyms
Therapy Description	Belizatinib (TSR-011) binds to ALK and TRK kinases and inhibits downstream signaling, which may result in decreased proliferation of ALK/TRK expressing tumor cells (PMID: 26753004, PMID: 31217479).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Belizatinib		TSR-011	ALK Inhibitor 33 Trk Receptor Inhibitor (Pan) 33	Belizatinib (TSR-011) binds to ALK and TRK kinases and inhibits downstream signaling, which may result in decreased proliferation of ALK/TRK expressing tumor cells (PMID: 26753004, PMID: 31217479).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
ALK rearrange	Advanced Solid Tumor	sensitive	Belizatinib	Phase Ib/II	Actionable	In a Phase I trial, Belizatinib (TSR-011) treatment resulted in a response in 100% (3/3) of patients with ALK-rearranged advanced solid tumors when administered at higher doses, and stable disease for 7 months or longer in 56% (5/9) of patients at a lower dose (J Clin Oncol 33, 2015 (suppl; abstr 8063)).	detail...
ALK amp	lung non-small cell carcinoma	no benefit	Belizatinib	Phase I	Actionable	In a Phase I trial, treatment with Belizatinib (TSR-011) in ALK inhibitor-naive non-small cell lung cancer patients (n=14) harboring either an ALK mutation, ALK amplification, or an ALK rearrangement resulted in a partial response in 6 patients and stable disease in 8 patients, however, it was determined that the drug resulted in limited efficacy and development of the drug was discontinued (PMID: 31217479; NCT02048488).	31217479
ALK mutant	lung non-small cell carcinoma	no benefit	Belizatinib	Phase I	Actionable	In a Phase I trial, treatment with Belizatinib (TSR-011) in ALK inhibitor-naive non-small cell lung cancer patients (n=14) harboring either an ALK mutation, ALK amplification, or an ALK rearrangement resulted in a partial response in 6 patients and stable disease in 8 patients, however, it was determined that the drug resulted in limited efficacy and development of the drug was discontinued (PMID: 31217479; NCT02048488).	31217479
ALK rearrange	lung non-small cell carcinoma	no benefit	Belizatinib	Phase I	Actionable	In a Phase I trial, treatment with Belizatinib (TSR-011) in ALK inhibitor-naive non-small cell lung cancer patients (n=14) harboring either an ALK mutation, ALK amplification, or an ALK rearrangement resulted in a partial response in 6 patients and stable disease in 8 patients, however, it was determined that the drug resulted in limited efficacy and development of the drug was discontinued (PMID: 31217479; NCT02048488).	31217479
ALK R1275Q	neuroblastoma	no benefit	Belizatinib	Case Reports/Case Series	Actionable	In a Phase I trial, a neuroblastoma patient harboring ALK R1275Q did not respond to treatment with Belizatinib (TSR-011) (PMID: 31217479; NCT02048488).	31217479
EML4 - ALK ALK F1174L ALK G1269A	lung adenocarcinoma	predicted - resistant	Belizatinib	Case Reports/Case Series	Actionable	In a clinical case study, ALK F1174L and ALK G1269A were identified as newly acquired mutations in the pleural effusion from a patient with lung adenocarcinoma harboring an acquired EML4-ALK after his disease progressed on Belizatinib (TSR-011) treatment (PMID: 28434515).	28434515

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02048488	Phase Ib/II	Belizatinib	A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas	Completed	USA \| POL \| GBR \| ESP	1

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