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 not accepting patients for this trial.

Lead Sponsor:

Bayer

Stanford Investigator(s):

Intervention(s):

  • Drug: Selitrectinib (BAY2731954)

Phase:

Phase 1/Phase 2

Eligibility


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) 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.

Ages Eligible for Study

1 Month - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Aja Macias
650-497-7499
Not Recruiting