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|Profile Name||ALK amp|
|Gene Variant Detail|
|Relevant Treatment Approaches|
|Molecular Profile||Indication/Tumor Type||Response Type||Relevant Treatment Approaches||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|ALK amp||neuroblastoma||sensitive||Crizotinib||Preclinical - Cell culture||Actionable||In a preclinical study, Xalkori (crizotinib) was less efficient than Lorlatinib (PF-06463922) to induced growth inhibition in ALK-amplified neuroblastoma cells in culture (PMID: 26554404).||26554404|
|ALK amp||neuroblastoma||sensitive||CEP-28122||Preclinical - Cell culture||Actionable||In a preclinical study, CEP-28122 inhibited growth of ALK-amplified neuroblastoma cells in culture (PMID: 22203728).||22203728|
|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 amp||neuroblastoma||sensitive||Lorlatinib||Preclinical - Cell culture||Actionable||In a preclinical study, Lorlatinib (PF-06463922) inhibited growth of ALK amplified neuroblastoma cells in culture (PMID: 26554404).||26554404|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT00939770||Phase Ib/II||Crizotinib||Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma||Completed|
|NCT03868423||Phase II||Brigatinib||Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers||Recruiting|
|NCT02091141||Phase II||Erlotinib Alectinib Cobimetinib + Vemurafenib Pertuzumab + Trastuzumab Vismodegib Atezolizumab||My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors||Active, not recruiting|
|NCT02186821||Phase II||Ceritinib||Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)||Terminated|
|NCT02422589||Phase I||Warfarin Midazolam Ceritinib||A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors||Completed|
|NCT01744652||Phase I||Crizotinib + Dasatinib||Dasatinib and Crizotinib in Advanced Cancer||Completed|
|NCT01121588||Phase I||Crizotinib||An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)||Active, not recruiting|
|NCT04094610||Phase Ib/II||Repotrectinib||A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations||Recruiting|
|NCT03107988||Phase I||Cyclophosphamide + Lorlatinib + Topotecan Lorlatinib||NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)||Recruiting|