Molecular Profile Detail

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Profile Name ALK amp
Gene Variant Detail

ALK amp (no effect)

Relevant Treatment Approaches

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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