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
Updated on 23 March 2021
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
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 on23 March 2021

Eligibility

Yes No Not Sure

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...?
Do you have any of these conditions: Non-Small Cell Lung Cancer or Brain Tumor (Pediatric) or gliomas pontine or Invasive Ductal Breast Carcinoma or Biliary Tract Cancer or Glioblastoma M...?
Do you have any of these conditions: Renal Cell Cancer or Colon Cancer Screening or Soft Tissue Sarcoma or Renal Cell Carcinoma or Solid Tumors or Advanced Malignancies or Brain Tumor or ...?
Do you have any of these conditions: Solid Tumors or melanoma or Vulvar Dysplasia and Carcinoma or Urothelial Tract Cancer or Metastatic Melanoma or Brain Tumor (Pediatric) or Sarcoma or ...?
Do you have any of these conditions: Pancreatic Cancer or melanoma or Non-Small Cell Lung Cancer or Colon Cancer Screening or Invasive Ductal Breast Carcinoma or Ovarian Cancer or Thyroid...?
Do you have any of these conditions: Solid Tumors or Carcinoma or Urothelial Tract Cancer or Bronchogenic Carcinoma or Sarcoma (Pediatric) or Lung Cancer or Thyroid Cancer or Recurrent Ov...?
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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