LOXO-EXT-17005 : A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

0+Age Over 0

Advanced CancersCancer LocationMulti-Cancer

Systemic therapy | Bowel (colorectum),Brain and spinal cord,Head and neck,Lung,SarcomaBrain,Colon,Colorectum,Head and neck,Lung,Sarcoma,Soft Tissue Sarcoma,Thyroid

Trial Overview Read MoreRead more

This phase I/II trial is testing the safety of a new oral drug (Loxo-195) in children and adults with cancer that express a particular gene (NTRK1, NTRK2 or NTRK3).

This trial is treating patients with cancers with NTRK gene fusion.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers

Commercial Sponsor

Bayer Inc


This trial will be conducted across two phases: dose escalation (Phase I) and dose expansion (Phase II). Eligible participants will be grouped according to their age (under 12, or 12 years and older) and assigned to either the dose escalation or dose expansion phase. Patients who are less than 12 years of age will either receive an escalating dose (commencing at 43mg/m2) or the recommended dose of Loxo-195 twice daily (once daily for children under 3). Patients equal to or greater than 12 years will receive either an escalating dose (starting at 100mg) or escalating dose of Loxo-195 twice daily. Loxo-195 will either be administered as a capsule or in liquid form.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Trial Coordinator

Not Recruiting Hospitals Read MoreRead more


Austin Health
Ms Samantha Chakar
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.