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

Completed · Phase 1

Conditions studied: Solid Tumors Harboring NTRK Fusion

In brief

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.

Key facts

Study ID

NCT03215511

Run by

Bayer

People needed

81

Starts

2017-07-03

Expected to finish

2023-01-30

Last updated by the study team

2024-10-30

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Status (KPS) Score≥50% (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

You may not qualify if…

• 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.

Where it is running

• Univ.of California-San Diego Moores Cancer Center — La Jolla, California, United States
• UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Stanford Cancer Center — Palo Alto, California, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Midwestern Regional Medical Center — Zion, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Sydney Children's Hospital — Sydney, New South Wales, Australia
• Royal Children's Hospital Melbourne — Parkville, Victoria, Australia
• UZ Antwerpen — Edegem, Belgium
• Rigshospitalet - Kræftbehandling — Copenhagen, Denmark
• Institut Curie - Ulm - Paris — Paris, France
• Institut Gustave Roussy - Département de Médecine Oncologique — Villejuif, France
• Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
• Tallaght Hospital — Dublin, Ireland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.