A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer

  • End date
    Jul 26, 2024
  • participants needed
  • sponsor
Updated on 19 September 2021
kidney function tests
experimental drug
primary tumor
brain metastases
solid tumor
renal function tests
kidney function test


This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.


The trial will be conducted in 2 parts: dose escalation and expansion (Phase 1) and Phase 2.

The primary objective of Phase 1 is to establish the recommended dose of selitrectinib to treat neurotrophic tyrosine kinase (NTRK) fusion cancers in patients a) aged 12 years and older and b) younger than 12 years. Secondary objectives of Phase 1 are to characterize the pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the objective response rate (ORR) of NTRK-tumors.

The primary objective of Phase 2 is to assess the overall response rate in NTRK fusion cancer patients as determined by an independent radiology committee (IRR). Secondary objectives of Phase 2 comprise the safety and efficacy of selitrectinib at the recommended dose.

Condition Pancreatic Cancer, Fibrosarcoma, Bronchogenic Carcinoma, Non-Small Cell Lung Cancer, Bile duct carcinoma, Intestinal Cancer, Colorectal Cancer, Mesoblastic Nephroma, Cholangiocarcinoma, Astrocytoma, Invasive Ductal Breast Carcinoma, Thyroid Adenoma, Uterine Cancer, Central Nervous System Neoplasms, Respiratory Tract Neoplasm, Thoracic Neoplasms, Biliary neoplasm, Ovarian Cancer, Nerve Sheath Tumors, Glioblastoma Multiforme, Nevi and Melanomas, melanoma, Renal Cell Carcinoma, gliomas pontine, Lung Neoplasm, skin cancer, Malignant neoplasm of brain, Sarcoma, Bronchial Neoplasm, gastrointestinal stromal tumor, salivary gland cancer, Neoplasms, Nerve Tissue, Metastatic Melanoma, Colon Cancer Screening, Brain Tumor (Pediatric), Colon cancer; rectal cancer, Head and Neck Squamous Cell Carcinoma, Skin Carcinoma, Recurrent Ovarian Cancer, Urothelial Tract Cancer, Sarcoma (Pediatric), Islet Ce417ll Cancer, Infantile Fibrosarcoma, Breast Secretory Carcinoma, Lung Cancer, Brain Cancer, Malignant Melanoma, Biliary Tract Cancer, Brain Tumor, Thyroid Cancer, Renal Cell Cancer, Soft Tissue Sarcoma, Solid Tumors Harboring NTRK Fusion
Treatment LOXO-195, BAY2731954, Selitrectinib (BAY2731954)
Clinical Study IdentifierNCT03215511
Last Modified on19 September 2021

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