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 27 July 2021
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Prince of Wales Hospital (0.0 mi away) Contact
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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 on27 July 2021


Yes No Not Sure

Inclusion Criteria

Advanced solid tumor for which, in the opinion of the investigator, no other standard therapy offers greater benefit
A solid tumor diagnosis in the setting of
a) a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
b) a documented NTRK fusion unresponsive to a prior TRK inhibitor
c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
NTRK gene fusions will be identified in a CLIA-certified (or equivalently-accredited diagnostic) laboratory. If such a report cannot be provided, other available certifications/accreditations are required and need to be documented. Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on an ETV6+ FISH test without identifying NTRK3
Performance Status: Eastern Cooperative Oncology Group (ECOG) score 2 in adults or Karnofsky Performance Score (KPS) Score50% (age 16 years) or Lansky Performance Score (LPS) 40% (age < 16 years)
Life expectancy of at least 3 months
Adequate hematologic, hepatic and renal function
Patients with stable central nervous system (CNS) primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of selitrectinib
Ability to receive study drug orally or by enteral administration

Exclusion Criteria

Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib (TPX-0005)), taletrectinib (DS-6501b/AB-106)). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed
Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville oranges, or drugs associated with QT prolongation
Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, or prolongation of QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6 months
Major surgery within 7 days of enrollment
Uncontrolled systemic bacterial, fungal or viral infection
Pregnancy or lactation
Known hypersensitivity to selitrectinib or Ora-Sweet SF and OraPlus for patients receiving liquid formulation
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