Last updated on December 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Thyroid Adenoma | Colorectal Cancer | Lung Neoplasm | Ovarian Cancer | Invasive Ductal Breast Carcinoma | Head and Neck Squamous Cell Carcinoma | Biliary neoplasm | Pancreatic Cancer | salivary gland cancer | Thoracic Neoplasms | melanoma | Neoplasms | Renal Cell Carcinoma | Carcinoma | Bronchogenic Carcinoma | Respiratory Tract Neoplasm | Glioblastoma Multiforme | Bronchial Neoplasm | Solid Tumors Harboring NTRK Fusion | Solid Tumors Habouring NTRK Fusion | Solid Tumors | Nerve Tissue | Malignant neoplasm of brain | Astrocytoma | Nevi and Melanomas | Cholangiocarcinoma | gliomas pontine | Non-Small Cell Lung Cancer | Bile duct carcinoma | Sarcoma | skin cancer
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion identified through molecular assays
  • Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy
  • Subjects must have at least one measurable lesion as defined by RECIST v1.1

Exclusion Criteria:

  • Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. Subjects who received less than 28 days of treatment and discontinued because of intolerance or toxicity are eligible.
  • Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain metastases are eligible to participate in the study.) Subjects with primary CNS tumors are eligible.
  • Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures.
  • Pregnancy or lactation.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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