Trial Search Results

A Study to Test the Safety of the Investigational Drug Loxo-195 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.

Lead Sponsor:

Bayer

Intervention(s):

  • Drug: 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 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 LOXO-195

   - Ability to receive study drug orally or by enteral administration

Exclusion Criteria:

   - Concurrent treatment with a strong CYP3A4 inhibitor or inducer or drugs associated
   with QT prolongation.

   - Clinically significant active cardiovascular disease or history of myocardial
   infarction within 3 months prior to planned start of LOXO-195, 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 LOXO-195 or Ora-Sweet® SF and OraPlus® for patients
   receiving liquid formulation.

Ages Eligible for Study

1 Month - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Anastasia Harper
650-721-4070
Recruiting