A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumours

Titre officiel

A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumours

Sommaire:

This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

Description de l'essai

Primary Outcome:

  • Best overall response rate by IRC
Secondary Outcome:
  • Best overall response rate by investigator
  • Duration of response (DOR) by IRC
  • Duration of response (DOR) by investigator
  • Clinical benefit rate (CBR)
  • Progression-free survival (PFS) after Larotrectinib
  • Overall survival time
  • Progression-free survival (PFS) after past cancer therapy
  • Number of subjects with adverse events
  • Number of subjects with serious adverse events
  • Number of subjects with treatment-related adverse events
  • Severity of adverse events
  • Severity of serious adverse events
  • Severity of treatment-related adverse events
  • Duration of adverse events
  • Duration of serious adverse events
  • Duration of treatment-related adverse events
  • Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administration
  • Severity of safety-relevant changes in clinical parameters or vital signs after drug administration
  • Proportion of subjects that has any tumour regression as a best response
  • Concordance coefficient
The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumours harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults. Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumour types.

Voir cet essai sur ClinicalTrials.gov

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