Entrectinib

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Information
Drug Name
Entrectinib
Description
Entry(CIViC)
17
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
lung non-small cell carcinoma NTRK1 SQSTM1-NTRK1 C Predictive Supports Sensitivity/Response Somatic 3 26565381 Detail
salivary gland carcinoma NTRK3 ETV6-NTRK3 C Predictive Supports Sensitivity/Response Somatic 3 26884591 Detail
breast cancer NTRK3 ETV6-NTRK3 G623R C Predictive Supports Resistance Somatic 4 26884591 Detail
lung non-small cell carcinoma NTRK1 NTRK1 FUSIONS NTRK1 NTRK1 FUSIONS C Predictive Supports Sensitivity/Response Somatic 3 26565381 Detail
cancer NTRK1 NTRK1 FUSIONS NTRK1 NTRK1 FUSIONS B Predictive Supports Sensitivity/Response Somatic 3 28183697 Detail
cancer NTRK3 NTRK3 FUSIONS NTRK3 NTRK3 FUSIONS B Predictive Supports Sensitivity/Response Somatic 3 28183697 Detail
lung non-small cell carcinoma NTRK1 SQSTM1-NTRK1 C Predictive Supports Sensitivity/Response Somatic 3 28183697 Detail
cancer ROS1 REARRANGEMENT ROS1 REARRANGEMENT B Predictive Supports Sensitivity/Response Somatic 3 28183697 Detail
cancer ALK ALK FUSIONS ALK ALK FUSIONS B Predictive Supports Sensitivity/Response Somatic 3 28183697 Detail
cancer NTRK1 AMPLIFICATION
( ENST00000524377.7 ) NTRK1 AMPLIFICATION
( ENST00000524377.7 ) 		B Predictive Supports Resistance Somatic 4 28183697 Detail
cancer NTRK3 AMPLIFICATION
( ENST00000394480.6 ) NTRK3 AMPLIFICATION
( ENST00000394480.6 ) 		B Predictive Supports Resistance Somatic 4 28183697 Detail
colorectal adenocarcinoma NTRK1 LMNA-NTRK1 C Predictive Supports Sensitivity/Response N/A 3 26546295 Detail
colorectal adenocarcinoma NTRK1 LMNA-NTRK1 G595R AND G667C C Predictive Supports Resistance Somatic 4 26546295 Detail
neuroblastoma ALK p.Phe1245Val (p.F1245V)
( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) ALK p.Phe1245Val (p.F1245V)
( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) 		C Predictive Supports Sensitivity/Response Somatic 3 28183697 Detail
mucosal melanoma ALK ALTERNATIVE TRANSCRIPT (ATI) ALK ALTERNATIVE TRANSCRIPT (ATI) C Predictive Does Not Support Sensitivity/Response 4 29054983 Detail
colorectal cancer ALK CAD-ALK C Predictive Supports Sensitivity/Response Somatic 3 26633560 Detail
acute myeloid leukemia NTRK3 ETV6-NTRK3 D Predictive Supports Sensitivity/Response Somatic 3 29237803 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
In 1378 cases of NSCLC screened for NTRK1 rearrang... NTRK1 NTRK1 SQSTM1-NTRK1 Sensitivity true CIViC Evidence detail
Case report of a patient with mammary analogue sec... NTRK3 NTRK3 ETV6-NTRK3 Sensitivity true CIViC Evidence detail
Case report of a patient with mammary analogue sec... NTRK3 NTRK3 ETV6-NTRK3 G623R Resitance or Non-Reponse true CIViC Evidence detail
1378 cases of NSCLC were screened. One patient (fr... NTRK1 NTRK1 NTRK1 FUSIONS NTRK1 NTRK1 FUSIONS Sensitivity true CIViC Evidence detail
in two phase I studies in patients with advanced o... NTRK1 NTRK1 NTRK1 FUSIONS NTRK1 NTRK1 FUSIONS Sensitivity true CIViC Evidence detail
in two phase I studies in patients with advanced o... NTRK3 NTRK3 NTRK3 FUSIONS NTRK3 NTRK3 FUSIONS Sensitivity true CIViC Evidence detail
Two phase I studies in patients with advanced or m... NTRK1 NTRK1 SQSTM1-NTRK1 Sensitivity true CIViC Evidence detail
Two phase I studies in patients with advanced or m... ROS1 ROS1 REARRANGEMENT ROS1 REARRANGEMENT Sensitivity true CIViC Evidence detail
Two phase I studies in patients with advanced or m... ALK ALK ALK FUSIONS ALK ALK FUSIONS Sensitivity true CIViC Evidence detail
Entrectinib, a potent oral inhibitor of the tyrosi... NTRK1 NTRK1 AMPLIFICATION
( ENST00000524377.7 ) NTRK1 AMPLIFICATION
( ENST00000524377.7 ) 		Resitance or Non-Reponse true CIViC Evidence detail
Entrectinib, a potent oral inhibitor of the tyrosi... NTRK3 NTRK3 AMPLIFICATION
( ENST00000394480.6 ) NTRK3 AMPLIFICATION
( ENST00000394480.6 ) 		Resitance or Non-Reponse true CIViC Evidence detail
A gene fusion between exon 10 of NTRK1 and exon 11... NTRK1 NTRK1 LMNA-NTRK1 Sensitivity true CIViC Evidence detail
A gene fusion between exon 10 of NTRK1 and exon 11... NTRK1 NTRK1 LMNA-NTRK1 G595R AND G667C Resitance or Non-Reponse true CIViC Evidence detail
Clinical trial of entrectinib in patients with ALK... ALK ALK p.Phe1245Val (p.F1245V)
( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) ALK p.Phe1245Val (p.F1245V)
( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) 		Sensitivity true CIViC Evidence detail
ALK expression was analyzed in 45 melanoma patient... ALK ALK ALTERNATIVE TRANSCRIPT (ATI) ALK ALTERNATIVE TRANSCRIPT (ATI) Sensitivity false CIViC Evidence detail
A patient with colorectal cancer harboring CAD-ALK... ALK ALK CAD-ALK Sensitivity true CIViC Evidence detail
Two AML cell lines, IMS-M2 and M0-91, with the ETV... NTRK3 NTRK3 ETV6-NTRK3 Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT03498521 Active, not recruiting Phase 2 A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site July 10, 2018 June 9, 2024
NCT02568267 Active, not recruiting Phase 2 Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) November 19, 2015 April 1, 2025
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
NCT02650401 Active, not recruiting Phase 1/Phase 2 Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options May 3, 2016 June 15, 2025
NCT04551495 Active, not recruiting Phase 2 Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE) January 14, 2021 October 2024
NCT02097810 Completed Phase 1 Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. July 28, 2014 June 2, 2020
NCT03330990 Completed Phase 1 Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients November 14, 2017 July 11, 2018
NCT04226833 Completed Phase 1 A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function February 11, 2020 September 27, 2021
NCT04632992 Completed Phase 2 A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response January 13, 2021 February 27, 2024
NCT03066661 No longer available Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions
NCT03994796 Recruiting Phase 2 Genetic Testing in Guiding Treatment for Patients With Brain Metastases August 15, 2019 June 2025
NCT05770544 Recruiting Phase 2/Phase 3 DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Teenage/Young Adults and Paediatric Patients With ROS1 Gene Fusion-positive Cancers. June 2024 October 2029
NCT04302025 Recruiting Phase 2 A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer November 6, 2020 March 6, 2029
NCT02693535 Recruiting Phase 2 TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer March 14, 2016 December 31, 2025
NCT05722886 Recruiting Phase 2/Phase 3 DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol March 1, 2023 October 2029
NCT05396859 Recruiting Phase 1 Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia October 28, 2022 June 30, 2025
NCT05525858 Recruiting KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II September 28, 2022 September 2025
NCT03178552 Recruiting Phase 2/Phase 3 A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) September 22, 2017 August 3, 2028
NCT02925234 Recruiting Phase 2 The Drug Rediscovery Protocol (DRUP Trial) August 2016 December 2027
NCT04589845 Recruiting Phase 2 Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study January 18, 2021 September 25, 2032
NCT04603807 Recruiting Phase 3 A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases September 30, 2021 December 1, 2027
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
NCT05159245 Recruiting Phase 2 The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs December 10, 2021 November 25, 2026
NCT05170204 Recruiting Phase 3 A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) November 1, 2022 April 14, 2035
NCT04589832 Terminated Phase 1/Phase 2 Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma January 11, 2021 June 24, 2022
NCT03878524 Terminated Phase 1 Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial April 1, 2020 December 10, 2020
NCT02587650 Terminated Phase 2 Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma March 26, 2015 July 12, 2018
NCT05238831 Withdrawn Early Phase 1 SMMART Adaptive Clinical Treatment (ACT) Trial January 30, 2023 May 31, 2026