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

Send

Updated on 3 June 2021

See if I qualify

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 Identifier	NCT02576431
Sponsor	Bayer
Last Modified on	3 June 2021

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