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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    203
  • sponsor
    Bayer
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Updated on 17 January 2021
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cancer
measurable disease
NTRK

Summary

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

The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors 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-tumor types.

Details
Treatment LOXO-101, Larotrectinib LOXO-101, BAY2757556 (Larotrectinib, Vitrakvi)
Clinical Study IdentifierNCT02576431
SponsorBayer
Last Modified on17 January 2021

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have any of these conditions: Bronchial Neoplasm or Solid Tumors Habouring NTRK Fusion or Vulvar Dysplasia and Carcinoma or Pancreatic Cancer or Metastatic Melanoma or Bile duct ca...?
Do you have any of these conditions: gliomas pontine or Thyroid Cancer or Ovarian Cancer or skin cancer or salivary gland cancer or Colon cancer; rectal cancer or Invasive Ductal Breast C...?
Do you have any of these conditions: Bronchogenic Carcinoma or Colon Cancer Screening or Islet Ce417ll Cancer or Malignant neoplasm of brain or Carcinoma or Nevi and Melanomas or Sarcoma ...?
Do you have any of these conditions: Soft Tissue Sarcoma or Bronchial Neoplasm or Lung Neoplasm or Recurrent Ovarian Cancer or Vulvar Dysplasia and Carcinoma or Solid Tumors Harboring NTR...?
Do you have any of these conditions: Cholangiocarcinoma or gliomas pontine or Thyroid Cancer or Bronchial Neoplasm or Solid Tumors Habouring NTRK Fusion or Astrocytoma or Sarcoma (Pediatr...?
Do you have any of these conditions: melanoma or Neoplasms, Nerve Tissue or Malignant neoplasm of brain or Non-Small Cell Lung Cancer or salivary gland cancer or Astrocytoma or gliomas po...?
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
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