Entrectinib
- Generic Name
- Entrectinib
- Brand Names
- Rozlytrek
- Drug Type
- Small Molecule
- Chemical Formula
- C31H34F2N6O2
- CAS Number
- 1108743-60-7
- Unique Ingredient Identifier
- L5ORF0AN1I
- Background
Entrectinib is a tropomyosin receptor tyrosine kinase (TRK) TRKA, TRKB, TRKC, proto-oncogene tyrosine-protein kinase ROS1, and anaplastic lymphoma kinase (ALK) inhibitor. It was approved by the FDA in August 2019 for use in the treatment of ROS1-positive metastatic non-small cell lung cancer and NTRK gene fusion positive solid tumors. Entrectinib's approved use is meant as a last line of therapy due to its accelerated approval based on early trial data. This therapy offers benefit over similar ALK inhibitors such as alectinib, ceritinib, and lorlatinib due to a wider range of targets.
- Indication
Entrectinib is indicated for the treatment of metastatic ROS1-positive non-small cell lung cancer in adults. Entrectinib is also indicated in adults and children over 12 years old for the treatment of NTRK gene fusion-positive solid tumors which have metastasized or for which surgical resection is likely to result in severe morbidity and for which has progressed on previous therapies or for which no comparable alternative therapies are available.
FoundationOne®Liquid CDx is the only FDA-approved test for the detection of ROS1 rearrangement(s) in NSCLC for selecting patients for treatment with entrectinib.
- Associated Conditions
- Metastatic Non-Small Cell Lung Cancer, Metastatic Solid Neoplasm, Solid Tumors
Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
- Conditions
- Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2022-05-31
- Last Posted Date
- 2025-03-05
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 12
- Registration Number
- NCT05396859
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
SMMART Adaptive Clinical Treatment (ACT) Trial
- Conditions
- Advanced Breast CarcinomaAnatomic Stage IV Breast Cancer AJCC v8Stage II Pancreatic Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Advanced Prostate CarcinomaRecurrent Adult Soft Tissue SarcomaRecurrent Breast CarcinomaStage IV Ovarian Cancer AJCC v8Advanced Malignant Solid NeoplasmAdvanced Ovarian Carcinoma
- Interventions
- Biological: AtezolizumabBiological: BevacizumabProcedure: BiopsyProcedure: Biospecimen CollectionBiological: Hyaluronidase-zzxf/Pertuzumab/TrastuzumabBiological: PertuzumabOther: Quality-of-Life AssessmentBiological: TrastuzumabBiological: Trastuzumab Emtansine
- First Posted Date
- 2022-02-14
- Last Posted Date
- 2024-01-23
- Lead Sponsor
- OHSU Knight Cancer Institute
- Registration Number
- NCT05238831
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)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2021-12-27
- Last Posted Date
- 2025-05-22
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 121
- Registration Number
- NCT05170204
- Locations
- 🇨🇱
RedSalud Vitacura, Santiago, Chile
🇺🇸Southern California Kaiser Permanente, Los Angeles, California, United States
🇺🇸Rocky Mountain Cancer Centers - Lone Tree, Lone Tree, Colorado, United States
The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs
- Conditions
- Advanced CancerSolid TumorHaematological Malignancy
- Interventions
- Drug: Trastuzumab+PertuzumabDrug: Dabrafenib+Trametinib
- First Posted Date
- 2021-12-16
- Last Posted Date
- 2024-07-15
- Lead Sponsor
- Helsinki University Central Hospital
- Target Recruit Count
- 250
- Registration Number
- NCT05159245
- Locations
- 🇫🇮
Turku University Hospital Cancer Centre, Turku, Varsinais-Suomi, Finland
🇫🇮Kuopio University Hospital, Kuopio, Finland
🇫🇮Oulu University Hospital OYS Cancer Center, Oulu, Finland
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
- Conditions
- Advanced Unresectable or Metastatic Solid Malignancy
- Interventions
- Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxfDrug: Investigator's Choice of Chemotherapy
- First Posted Date
- 2020-11-17
- Last Posted Date
- 2025-01-08
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 252
- Registration Number
- NCT04632992
- Locations
- 🇺🇸
Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga, Tennessee, United States
🇺🇸SCRI Oncology Partners, Nashville, Tennessee, United States
🇺🇸Alaska Oncology and Hematology, Anchorage, Alaska, United States
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
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- First Posted Date
- 2020-10-27
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 220
- Registration Number
- NCT04603807
- Locations
- 🇧🇷
Hospital Sao Rafael - HSR, Salvador, Bahia, Brazil
🇧🇷Oncocentro Serviços Médicos e Hospitalares Ltda, Fortaleza, Ceará, Brazil
🇧🇷Hospitais Integrados da Gavea S/A, Brasilia, Distrito Federal, Brazil
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
- Conditions
- Other CancerBreast CancerGastrointestinal CancerNon Small Cell Lung Cancer
- Interventions
- Drug: Oncology DrugsDrug: Vismogedib
- First Posted Date
- 2020-10-19
- Last Posted Date
- 2023-10-03
- Lead Sponsor
- Fondazione per la Medicina Personalizzata
- Target Recruit Count
- 400
- Registration Number
- NCT04591431
- Locations
- 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy
Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma
- First Posted Date
- 2020-10-19
- Last Posted Date
- 2023-11-22
- Lead Sponsor
- Arkadiusz Z. Dudek, MD
- Target Recruit Count
- 6
- Registration Number
- NCT04589832
- Locations
- 🇺🇸
HealthPartners Institute Regions Cancer Care Center, Minneapolis, Minnesota, United States
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
- Conditions
- Solid Tumors
- Interventions
- First Posted Date
- 2020-10-19
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 920
- Registration Number
- NCT04589845
- Locations
- 🇧🇪
GHdC Site Les Viviers, Charleroi, Belgium
🇧🇪UZ Antwerpen, Edegem, Belgium
🇨🇳Jilin Cancer Hospital, Changchun, China
Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)
- Conditions
- Invasive Lobular Breast CarcinomaER+ Breast CancerHER2-negative Breast Cancer
- Interventions
- First Posted Date
- 2020-09-16
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Jules Bordet Institute
- Target Recruit Count
- 65
- Registration Number
- NCT04551495
- Locations
- 🇧🇪
Institut Jules Bordet, Bruxelles, Belgium
🇫🇷Institut Bergonié, Bordeaux, France
🇧🇪Grand Hôpital de Charleroi, Charleroi, Belgium
Drug Development Updates
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