An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer
Trial Status: complete
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.
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 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
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.
Additional locations may be listed on ClinicalTrials.gov for NCT03215511.
