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Larotrectinib

Generic Name
Larotrectinib
Brand Names
Vitrakvi
Drug Type
Small Molecule
Chemical Formula
C21H22F2N6O2
CAS Number
1223403-58-4
Unique Ingredient Identifier
PF9462I9HX
Background

Larotrectinib is an orally administered tropomyosin receptor kinase (Trk) inhibitor with demonstrated antineoplastic activity. Upon administration, larotrectinib binds to Trk, thereby preventing neurotrophin-Trk interaction and Trk activation, which results in both the induction of cellular apoptosis and the inhibition of cell growth in tumors that overexpress Trk. Trk, a receptor tyrosine kinase activated by neurotrophins, is mutated in a variety of cancer cell types and plays an important role in tumor cell growth and survival.

Originally discovered by Array BioPharma, the agent was ultimately licensed to Loxo Oncology in 2013. Larotrectinib is another example of innovative new cancer therapy medications that target key, specific genetic biomarker drivers of cancer rather than particular types of tumors .

Indication

用于治疗携带NTRK基因融合的局部晚期或转移性实体瘤的成人和儿童患者。包括肺癌、甲状腺癌、黑色素瘤、胃肠癌、结肠癌、软酿肉瘤、唾液腺、婴儿纤维肉瘤、阑尾癌、乳腺癌、胆管癌、胰腺癌等多种疾病。

Associated Conditions
NTRK1 Fusion Positive, NTRK2 Fusion Positive, NTRK3 Fusion Positive
Clinical Trials
Related News

Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

Phase 2
Active, not recruiting
Conditions
Advanced Malignant Solid Neoplasm
Recurrent Ependymoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Glioma
Recurrent Hepatoblastoma
Recurrent Kidney Wilms Tumor
Recurrent Langerhans Cell Histiocytosis
Recurrent Malignant Germ Cell Tumor
Recurrent Malignant Glioma
Recurrent Malignant Solid Neoplasm
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Radionuclide Imaging
Procedure: X-Ray Imaging
First Posted Date
2017-07-11
Last Posted Date
2025-05-14
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
9
Registration Number
NCT03213704
Locations
🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Providence Alaska Medical Center, Anchorage, Alaska, United States

🇺🇸

Banner Children's at Desert, Mesa, Arizona, United States

and more 121 locations

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Phase 2
Active, not recruiting
Conditions
Advanced Malignant Solid Neoplasm
Juvenile Xanthogranuloma
Langerhans Cell Histiocytosis
Malignant Glioma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Ewing Sarcoma
Recurrent Osteosarcoma
Recurrent Primary Central Nervous System Neoplasm
Refractory Hepatoblastoma
Refractory Medulloblastoma
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Other: Laboratory Biomarker Analysis
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Mutation Carrier Screening
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Other: Pharmacological Study
Procedure: Radionuclide Imaging
Procedure: Positron Emission Tomography
Procedure: X-Ray Imaging
First Posted Date
2017-05-16
Last Posted Date
2025-05-13
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
1376
Registration Number
NCT03155620
Locations
🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Providence Alaska Medical Center, Anchorage, Alaska, United States

🇺🇸

Banner Children's at Desert, Mesa, Arizona, United States

and more 169 locations

Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Conditions
Tumors Harboring NTRK Fusion
First Posted Date
2017-01-19
Last Posted Date
2019-12-19
Lead Sponsor
Bayer
Registration Number
NCT03025360

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

First Posted Date
2016-02-26
Last Posted Date
2025-05-06
Lead Sponsor
American Society of Clinical Oncology
Target Recruit Count
4200
Registration Number
NCT02693535
Locations
🇺🇸

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

🇺🇸

Cancer Treatment Centers of America-Phoenix, Phoenix, Arizona, United States

🇺🇸

Sutter Auburn, Auburn, California, United States

and more 129 locations

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

Phase 1
Active, not recruiting
Conditions
Solid Tumors Harboring NTRK Fusion
Interventions
First Posted Date
2015-12-22
Last Posted Date
2025-05-13
Lead Sponsor
Bayer
Target Recruit Count
154
Registration Number
NCT02637687
Locations
🇩🇰

Rigshospitalet - Børn og Unge, Copenhagen, Denmark

🇫🇷

Institut Curie - Ulm - Paris, PARIS cedex 5, France

🇳🇱

Prinses Maxima Centrum, Utrecht, Netherlands

and more 42 locations

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2
Active, not recruiting
Conditions
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Bladder Carcinoma
Breast Carcinoma
Cervical Carcinoma
Colon Carcinoma
Colorectal Carcinoma
Endometrial Carcinoma
Esophageal Carcinoma
Exocrine Pancreas Carcinoma
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Other: Cytology Specimen Collection Procedure
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Procedure: Echocardiography Test
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Procedure: Radionuclide Imaging
First Posted Date
2015-06-08
Last Posted Date
2025-05-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
6452
Registration Number
NCT02465060
Locations
🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

🇺🇸

Thomas Hospital, Fairhope, Alabama, United States

🇺🇸

Mobile Infirmary Medical Center, Mobile, Alabama, United States

and more 1406 locations

A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

Phase 1
Completed
Conditions
Solid Tumors Harboring NTRK Fusion
Interventions
First Posted Date
2014-04-25
Last Posted Date
2023-11-07
Lead Sponsor
Bayer
Target Recruit Count
75
Registration Number
NCT02122913
Locations
🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

and more 5 locations
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