Brigatinib

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Information
Drug Name
Brigatinib
Description
Entry(CIViC)
6
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
lung non-small cell carcinoma ROS1 CD74-ROS1 G2032R D Predictive Supports Resistance Somatic 3 26372962 Detail
lung non-small cell carcinoma ALK EML4-ALK V1180L D Predictive Supports Sensitivity/Response Somatic 2 25228534 Detail
neuroblastoma ALK DEL4-11 ALK DEL4-11 D Predictive Supports Sensitivity/Response Somatic 3 27049722 Detail
cancer ALK p.Gly1202Arg (p.G1202R) ALK p.Gly1202Arg (p.G1202R) D Predictive Supports Resistance Somatic 3 25727400 Detail
cancer ALK p.Gly1269Ala (p.G1269A) ALK p.Gly1269Ala (p.G1269A) D Predictive Supports Sensitivity/Response Somatic 2 25727400 Detail
lung non-small cell carcinoma ALK ALK FUSIONS ALK ALK FUSIONS B Predictive Supports Sensitivity/Response Somatic 4 28475456 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
Preclinical study analyzing the efficacy of dual R... ROS1 ROS1 CD74-ROS1 G2032R Resitance or Non-Reponse true CIViC Evidence detail
ALK mutation V1180L was found in an H3122 derivati... ALK ALK EML4-ALK V1180L Sensitivity true CIViC Evidence detail
The MYCN amplification positive relapsed neuroblas... ALK ALK DEL4-11 ALK DEL4-11 Sensitivity true CIViC Evidence detail
This study compared drug responses in Ba/F3 cells ... ALK ALK p.Gly1202Arg (p.G1202R) ALK p.Gly1202Arg (p.G1202R) Resitance or Non-Reponse true CIViC Evidence detail
EML4-ALK with ALK G1269A has been seen in crizotin... ALK ALK p.Gly1269Ala (p.G1269A) ALK p.Gly1269Ala (p.G1269A) Sensitivity true CIViC Evidence detail
In a phase II randomized trial we evaluated two re... ALK ALK ALK FUSIONS ALK ALK FUSIONS Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT03596866 Active, not recruiting Phase 3 A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer April 19, 2019 September 30, 2024
NCT03707938 Active, not recruiting Phase 1 Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer December 18, 2018 January 28, 2026
NCT04227028 Active, not recruiting Phase 1 Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC March 9, 2020 November 1, 2024
NCT03737994 Active, not recruiting Phase 2 Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer July 25, 2019 September 21, 2024
NCT04223596 Active, not recruiting Phase 2 Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients May 4, 2020 April 15, 2025
NCT04074993 Active, not recruiting Phase 2 Brigatinib in ALK-positive NSCLC Identified Via Blood-based Assays May 15, 2020 March 31, 2025
NCT04318938 Active, not recruiting Phase 2 Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping March 30, 2020 December 31, 2025
NCT03535740 Active, not recruiting Phase 2 A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib January 31, 2019 June 28, 2024
NCT04591431 Active, not recruiting Phase 2 The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy October 7, 2020 June 2025
NCT06132867 Completed Phase 1 A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults January 17, 2024 February 14, 2024
NCT02094573 Completed Phase 2 A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib June 4, 2014 February 27, 2020
NCT02737501 Completed Phase 3 ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants May 26, 2016 January 29, 2021
NCT03410108 Completed Phase 2 Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) January 29, 2018 July 28, 2021
NCT03420742 Completed Phase 1 A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors June 26, 2019 April 29, 2021
NCT03546894 Completed A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors July 23, 2018 February 13, 2023
NCT04647110 Completed Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers. December 14, 2020 March 15, 2021
NCT01449461 Completed Phase 1/Phase 2 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113) September 20, 2011 February 18, 2020
NCT02784158 No longer available An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer
NCT05721950 Recruiting A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC) January 17, 2024 December 31, 2026
NCT05834348 Recruiting A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. June 26, 2023 February 3, 2025
NCT04925609 Recruiting Phase 1/Phase 2 Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors August 18, 2022 December 2030
NCT05100069 Recruiting Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer November 1, 2021 May 31, 2026
NCT05718297 Recruiting Phase 2 Brigatinib Post Definitive Chemo-radiotherapy in Patients With ALK-fusion Non-small Cell Lung Cancer June 7, 2024 April 2029
NCT04374305 Recruiting Phase 2 Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2) June 20, 2020 December 2030
NCT04005144 Terminated Phase 1 Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer February 25, 2020 October 1, 2022
NCT02706626 Terminated Phase 2 Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors March 9, 2017 April 1, 2021
NCT04634110 Terminated Phase 2 Brigatinib Before Brain Irradiation Trial (B3i Trial) November 17, 2020 April 14, 2022
NCT05361564 Unknown status Phase 2 A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Preoperative Brigatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Fusions. June 2022 June 2024
NCT03868423 Withdrawn Phase 2 Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers March 20, 2019 December 30, 2021
NCT04260009 Withdrawn Phase 1/Phase 2 Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors September 1, 2020 September 1, 2025
NCT03719898 Withdrawn Phase 2 Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma December 6, 2018 June 16, 2020