Larotrectinib

Generic Name: Larotrectinib

Brand Names: Vitrakvi

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₂F_₂N_₆O_₂

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

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Phase 2

Recruiting

Conditions: Mutation
Lung Cancer Stage III

Interventions: Drug: Glecirasib
Drug: Dabrafenib+Trametinib
Drug: Larotrectinib
Drug: Crizotinib
Drug: Sunvozertinib
Drug: Pralsetinib
Drug: Savolitinib
Drug: Pyrotinib
Drug: Ensartinib

First Posted Date: 2024-08-21

Last Posted Date: 2024-12-10

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 120

Registration Number: NCT06563999

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Phase 2

Recruiting

Conditions: Locally Advanced Thyroid Gland Carcinoma

Interventions: Drug: Anlotinib
Drug: Lenvatinib
Drug: Sorafenib
Drug: Donafenib
Drug: Everolimus
Drug: Apatinib
Drug: Dabrafenib + Trametinib
Drug: Cabozantinib
Drug: Vandetanib
Drug: Entrectinib
Drug: Pralsetinib
Drug: Larotrectinib

First Posted Date: 2024-07-01

Last Posted Date: 2024-12-05

Lead Sponsor: West China Hospital

Target Recruit Count: 75

Registration Number: NCT06482086

Locations: 🇨🇳
West China hospital, Chengdu, Sichuan, China

Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Advanced Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Refractory Lymphoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Larotrectinib
Procedure: Magnetic Resonance Imaging

First Posted Date: 2024-04-30

Last Posted Date: 2025-05-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT06390852

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer

Phase 2

Recruiting

Conditions: Pediatric Cancer
Differentiated Thyroid Cancer
Cancer, Thyroid
Cancer

Interventions: Drug: Larotrectinib monotherapy
Radiation: 131I therapy

First Posted Date: 2023-03-24

Last Posted Date: 2025-04-10

Lead Sponsor: Children's Hospital of Philadelphia

Target Recruit Count: 13

Registration Number: NCT05783323

Locations: 🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Phase 2

Recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Alectinib
Drug: Cetuximab
Drug: Crizotinib
Drug: Dasatinib
Drug: Everolimus
Drug: Encorafenib
Drug: Gemcitabine
Drug: Idelalisib
Drug: Larotrectinib
Drug: Methotrexate
Drug: Palbociclib
Drug: Panobinostat
Drug: Pembrolizumab
Drug: Petrozumab
Drug: Trastuzumab
Drug: Talazoparib
Drug: Venetoclax

First Posted Date: 2023-02-13

Last Posted Date: 2023-02-21

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 40

Registration Number: NCT05725200

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway

A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database

Completed

Conditions: Locally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene Fusion
Infantile Fibrosarcoma

Interventions: Drug: Larotrectinib (Vitrakvi, BAY2757556)
Drug: Standard of Care

First Posted Date: 2022-02-11

Last Posted Date: 2024-12-10

Lead Sponsor: Bayer

Target Recruit Count: 93

Registration Number: NCT05236257

Locations: 🇫🇷
Multiple Locations, Multiple Locations, France

NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes

Recruiting

Conditions: Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

Interventions: Drug: Larotrectinib (Vitrakvi, BAY2757556)

First Posted Date: 2021-06-30

Last Posted Date: 2025-05-13

Lead Sponsor: Bayer

Target Recruit Count: 100

Registration Number: NCT04945330

Locations: 🇯🇵
Many locations, Multiple Locations, Japan

Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors

Phase 2

Recruiting

Conditions: Metastatic Malignant Solid Neoplasm
Locally Advanced Malignant Solid Neoplasm

Interventions: Drug: Larotrectinib Sulfate

First Posted Date: 2021-05-10

Last Posted Date: 2025-05-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 13

Registration Number: NCT04879121

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma with NTRK Fusion

Early Phase 1

Recruiting

Conditions: High Grade Glioma
Diffuse Intrinsic Pontine Glioma

Interventions: Drug: Larotrectinib
Procedure: Larotrectinib surgical

First Posted Date: 2020-12-07

Last Posted Date: 2025-02-18

Lead Sponsor: Nationwide Children's Hospital

Target Recruit Count: 15

Registration Number: NCT04655404

Locations: 🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States
🇺🇸
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

and more 13 locations

Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia

Phase 2

Active, not recruiting

Conditions: Central Nervous System Neoplasm
Infantile Fibrosarcoma
Recurrent Acute Leukemia
Refractory Acute Leukemia
Solid Neoplasm

Interventions: Drug: Larotrectinib Sulfate

First Posted Date: 2019-02-08

Last Posted Date: 2025-05-04

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 31

Registration Number: NCT03834961

Locations: 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Kaiser Permanente Downey Medical Center, Downey, California, United States

and more 77 locations

Drug Development Updates

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