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NCT03025360

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

APPROVED FOR MARKETING Last updated 19 December 2019
What this trial tests

trial testing Larotrectinib (Vitrakvi, BAY2757556) in Tumors Harboring NTRK Fusion. Approved for marketing.

Quick facts

Lead sponsorBayer
StatusAPPROVED FOR MARKETING
Study typeEXPANDED_ACCESS

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Eligibility, any sex, with Tumors Harboring NTRK Fusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib through an existing clinical trial. Gene fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion can lead to the development of solid tumors in a variety of tissue types. The study drug larotrectinib blocks the action of the NTRK gene fusion. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion who are unresponsive to current standard treatment for their condition and also are unable to participate in ongoing clinical trials.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeted fusion analysis can aid in the classification and treatment of pediatric glioma, ependymoma, and glioneuronal tumors.
    Lake JA, Donson AM, Prince E, Davies KD, et al · · 2020 · cited 49× · PMID 31595628 · DOI 10.1002/pbc.28028
  2. BDNF and its signaling in cancer.
    Malekan M, Nezamabadi SS, Samami E, Mohebalizadeh M, et al · · 2023 · cited 48× · PMID 36173463 · DOI 10.1007/s00432-022-04365-8
  3. Clinically relevant fusion oncogenes: detection and practical implications.
    Sorokin M, Rabushko E, Rozenberg JM, Mohammad T, et al · · 2022 · cited 25× · PMID 36601633 · DOI 10.1177/17588359221144108
  4. <i>BCR-NTRK2</i> fusion in a low-grade glioma with distinctive morphology and unexpected aggressive behavior.
    Jones KA, Bossler AD, Bellizzi AM, Snow AN. · · 2019 · cited 20× · PMID 30936198 · DOI 10.1101/mcs.a003855
  5. Larotrectinib in TRK fusion-positive pediatric B-cell acute lymphoblastic leukemia.
    Schewe DM, Lenk L, Vogiatzi F, Winterberg D, et al · · 2019 · cited 15× · PMID 31725893 · DOI 10.1182/bloodadvances.2019000700
  6. Abstracts from the 50th Congress of the International Society of Paediatric Oncology (SIOP) Kyoto, Japan November 16-19, 2018.
    · 2018 · cited 9× · PMID 30240102 · DOI 10.1002/pbc.27455
  7. Early access provision: Awareness, educational needs and opportunities to improve oncology patients' access to care.
    Krendyukov A, Singhvi S, Green-Morrison Y, Zabransky M. · · 2022 · cited 3× · PMID 36387084 · DOI 10.3389/fonc.2022.714516
  8. HGG-19. MOLECULAR ANALYSIS UNCOVERS 3 DISTINCT SUBGROUPS AND MULTIPLE TARGETABLE GENE FUSIONS IN INFANT GLIOMAS
    Stücklin A, Ryall S, Fukuoka K, Zapotocky M, et al · · 2019

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03025360.

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