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    DRUG:

    Rozlytrek (entrectinib)

    i
    Other names: RXDX-101, NMS-E628, RXDX101, RXDX 101, NMS E628, RG6268, RG 6268, NMSE628, RG-6268
    Company:
    Nerviano Medical Sciences, Roche
    Drug class:
    ALK inhibitor, TrkA receptor inhibitor, TrkB receptor inhibitor, TrkC kinase inhibitor, ROS1 inhibitor, JAK2 inhibitor, TNK2 inhibitor
    Related drugs:
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    A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer (NAUTIKA1) (NCT04302025)
    Phase 2
    Genentech, Inc.
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    11/06/2020
    Primary completion :
    12/30/2025
    Completion :
    03/06/2029
    PD-L1 • KRAS • BRAF • ALK • RET • ROS1 • NTRK1 • NTRK3 • NTRK2
    |
    PD-L1 expression • KRAS mutation • KRAS G12C • BRAF mutation • BRAF V600 • RET fusion • ALK fusion • RET mutation • ROS1 fusion • KRAS G12
    |
    Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Cotellic (cobimetinib) • Gavreto (pralsetinib) • divarasib (RG6330)
    Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study (NCT04589845)
    Phase 2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/18/2021
    Primary completion :
    09/25/2032
    Completion :
    09/25/2032
    BRAF
    |
    Tecentriq (atezolizumab) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Gavreto (pralsetinib) • ipatasertib (RG7440) • belvarafenib (RG6185) • idasanutlin (RG7388) • divarasib (RG6330) • Itovebi (inavolisib) • camonsertib (RP-3500)
    A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (BFAST) (NCT03178552)
    Phase 2/3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    02/12/2025
    Initiation :
    09/22/2017
    Primary completion :
    08/03/2028
    Completion :
    08/03/2028
    BRAF • TMB
    |
    Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • carboplatin • gemcitabine • Rozlytrek (entrectinib) • docetaxel • Alecensa (alectinib) • Cotellic (cobimetinib) • pemetrexed • divarasib (RG6330)
    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 (NCT02693535)
    Phase 2
    American Society of Clinical Oncology
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    03/14/2016
    Primary completion :
    06/30/2026
    Completion :
    06/30/2027
    BRAF
    |
    ER positive • HER-2 negative • PGR positive
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Xalkori (crizotinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Yervoy (ipilimumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • Imfinzi (durvalumab) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • sunitinib • tamoxifen • Perjeta (pertuzumab) • Cotellic (cobimetinib) • Bavencio (avelumab) • Talzenna (talazoparib) • Verzenio (abemaciclib) • albumin-bound paclitaxel • cyclophosphamide • Stivarga (regorafenib) • fulvestrant • Lytgobi (futibatinib) • Tukysa (tucatinib) • temsirolimus • letrozole • axitinib • epirubicin • anastrozole • exemestane • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • leuprolide acetate for depot suspension
    Genetic Testing in Guiding Treatment for Patients with Brain Metastases (NCT03994796)
    Phase 2
    Alliance for Clinical Trials in Oncology
    Recruiting
    Last update posted :
    01/15/2025
    Initiation :
    10/17/2019
    Primary completion :
    10/01/2026
    Completion :
    06/01/2028
    KRAS • BRAF • ER • PGR • ROS1 • NTRK
    |
    HER-2 positive • EGFR mutation • HER-2 negative
    |
    Rozlytrek (entrectinib) • Verzenio (abemaciclib) • Krazati (adagrasib) • paxalisib (GDC-0084)
    Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE) (NCT04551495)
    Phase 2
    Jules Bordet Institute
    Active, not recruiting
    Last update posted :
    06/13/2024
    Initiation :
    01/14/2021
    Primary completion :
    08/01/2024
    Completion :
    10/01/2024
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    Rozlytrek (entrectinib) • letrozole • goserelin acetate
    Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation (PIKACHU) (NCT04322890)
    Phase 2
    Hunan Province Tumor Hospital
    Recruiting
    Last update posted :
    06/04/2024
    Initiation :
    04/16/2020
    Primary completion :
    12/24/2026
    Completion :
    12/24/2027
    EGFR • BRAF • ALK • ROS1
    |
    EGFR mutation • ALK positive • ALK mutation • ROS1 positive • ROS1 mutation
    |
    cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • erlotinib • gefitinib • Rozlytrek (entrectinib) • Alecensa (alectinib) • Lorbrena (lorlatinib) • Zykadia (ceritinib) • pemetrexed • Alunbrig (brigatinib) • Gavreto (pralsetinib) • Ameile (aumolertinib) • Orpathys (savolitinib) • Ivesa (firmonertinib)
    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) (NCT05170204)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    06/04/2024
    Initiation :
    11/01/2022
    Primary completion :
    06/17/2029
    Completion :
    04/14/2035
    PD-L1 • RET • ROS1
    |
    RET fusion • ALK fusion • ROS1 fusion
    |
    Imfinzi (durvalumab) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Gavreto (pralsetinib)
    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 (STARTRK-NG) (NCT02650401)
    Phase 1/2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    03/29/2024
    Initiation :
    05/03/2016
    Primary completion :
    06/15/2025
    Completion :
    06/15/2025
    ROS1 • NTRK1 • NTRK3 • NTRK2
    |
    NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • ROS1 fusion
    |
    Rozlytrek (entrectinib)
    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) (STARTRK-2) (NCT02568267)
    Phase 2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    03/28/2024
    Initiation :
    11/19/2015
    Primary completion :
    12/31/2024
    Completion :
    04/01/2025
    ROS1 • NTRK1 • NTRK3 • NTRK2
    |
    ALK rearrangement • ROS1 rearrangement
    |
    Xalkori (crizotinib) • Rozlytrek (entrectinib)
    DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol (CRUKD/21/004) (NCT05722886)
    Phase 2/3
    Cancer Research UK
    Recruiting
    Last update posted :
    03/20/2024
    Initiation :
    03/01/2023
    Primary completion :
    10/01/2029
    Completion :
    10/01/2029
    BRAF
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Perjeta (pertuzumab) • Cotellic (cobimetinib)
    Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (NCT05396859)
    Phase 1
    OHSU Knight Cancer Institute
    Recruiting
    Last update posted :
    03/15/2024
    Initiation :
    10/28/2022
    Primary completion :
    12/31/2024
    Completion :
    06/30/2025
    TP53 • RUNX1 • MAPK1 • NTRK • MAPK3
    |
    TP53 mutation • NTRK expression
    |
    Rozlytrek (entrectinib) • Inqovi (decitabine/cedazuridine)