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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 | Lorlatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Lorlatinib (PF-06463922) inhibited growth of 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 | no benefit | Crizotinib | Case Reports/Case Series | Actionable | In a Phase I/II trial (ADVL0912), Xalkori (crizotinib) treatment resulted in an objective response of 15% (3/20) in pediatric patients with relapsed/refractory neuroblastoma harboring ALK activating mutations or amplifications, although both patients harboring ALK amplification had disease progression after only 1 cycle of treatment (PMID: 33568345; NCT00939770). | 33568345 | |
ALK amp | neuroblastoma | no benefit | 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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04116541 | Phase II | Alectinib Cabozantinib Ribociclib + Siremadlin | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. (MegaMOST) | Recruiting | FRA | 0 |
NCT02186821 | Phase II | Ceritinib | Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) | Terminated | USA | 0 |
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 | USA | ITA | ESP | 1 |
NCT04094610 | Phase Ib/II | Repotrectinib | A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations | Recruiting | USA | CAN | 4 |
NCT01744652 | Phase I | Crizotinib + Dasatinib | Dasatinib and Crizotinib in Advanced Cancer | Completed | USA | 0 |
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 | USA | 0 |
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 | USA | ITA | 5 |
NCT00939770 | Phase Ib/II | Crizotinib | Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma | Completed | USA | CAN | 0 |
NCT05004116 | Phase Ib/II | Irinotecan + Repotrectinib + Temozolomide | A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer | Recruiting | USA | 0 |
NCT03107988 | Phase I | Cyclophosphamide + Lorlatinib + Topotecan Lorlatinib | NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) | Recruiting | USA | FRA | CAN | 1 |
NCT03868423 | Phase II | Brigatinib | Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers | Withdrawn | USA | 0 |