Trial Search Results
A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer
This research study is being done to determine the safety and benefit of an investigational treatment called LOXO-195 on cancers that have genetic changes in NTRK genes. LOXO-195 may treat cancer by interfering with the effect of the NTRK genes on how cancer grows and is specifically for patients who have already tried other treatments.
Stanford is currently accepting patients for this trial.
- Drug: Selitrectinib (BAY2731954)
Phase 1/Phase 2
- 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
- NTRK gene fusions will be identified in a CLIA-certified (or equivalent) laboratory.
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 ≤ 3 (age ≥ 16
years) or Lansky Performance Score (LPS) ≥ 40% (age < 16 years). If enrolled with
primary CNS tumor to be assessed by RANO, Karnofsky Performance Score (KPS) (age ≥ 16
years) or LPS (age < 16 years) ≥ 50%.
- Life expectancy > 4 weeks.
- Adequate hematologic, hepatic and renal function.
- Patients with stable 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
- Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, TPX-0005).
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
- 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.
Ages Eligible for Study
1 Month - N/A
Genders Eligible for Study