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
    200
  • sponsor
    Bayer
Updated on 3 June 2021
cancer
tyrosine
measurable disease
breast cancer
lung cancer
NTRK
lung carcinoma

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
Condition Pancreatic Cancer, Bronchogenic Carcinoma, Non-Small Cell Lung Cancer, Bile duct carcinoma, Colorectal Cancer, Cholangiocarcinoma, Astrocytoma, Invasive Ductal Breast Carcinoma, Thyroid Adenoma, Respiratory Tract Neoplasm, Thoracic Neoplasms, Biliary neoplasm, Carcinoma, Ovarian Cancer, Glioblastoma Multiforme, Nevi and Melanomas, melanoma, Renal Cell Carcinoma, gliomas pontine, Lung Neoplasm, skin cancer, Malignant neoplasm of brain, Sarcoma, Bronchial Neoplasm, salivary gland cancer, Neoplasms, Nerve Tissue, Metastatic Melanoma, Vulvar Dysplasia and Carcinoma, Colon Cancer Screening, Brain Tumor (Pediatric), Solid Tumors, Colon cancer; rectal cancer, Head and Neck Squamous Cell Carcinoma, Advanced Malignancies, Recurrent Ovarian Cancer, Urothelial Tract Cancer, Sarcoma (Pediatric), Islet Ce417ll Cancer, Lung Cancer, Solid Tumors Habouring NTRK Fusion, Brain Cancer, Malignant Melanoma, Biliary Tract Cancer, Brain Tumor, Thyroid Cancer, Renal Cell Cancer, Soft Tissue Sarcoma, Solid Tumors Harboring NTRK Fusion
Treatment LOXO-101, Larotrectinib LOXO-101, BAY2757556 (Larotrectinib, Vitrakvi)
Clinical Study IdentifierNCT02576431
SponsorBayer
Last Modified on3 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Locally advanced or metastatic non-secretory breast cancer, lung cancer, melanoma, and colorectal cancer with unknown human neurotrophic tyrosine receptor kinase 1 (NTRK1), NTRK2, or NTRK3 fusion status
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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Exclusion Criteria

Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting tropomyosin receptor kinase (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 central nervous system (CNS) tumors are eligible
Pregnancy or lactation
Active uncontrolled systemic bacterial, viral, or fungal infection Common Terminology Criteria for Adverse Events(CTCAE) grade 2; unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures
Unstable cardiovascular disease is defined as
In adults, persistently uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg and/or diastolic BP > 100 mmHg despite antihypertensive therapy
Myocardial infarction within 3 months of screening
Stroke within 3 months of screening
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