A Phase 1 / 2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers
1 Months and older, Male and Female
This research study is done to test the safety of the new drug Loxo-195 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 Loxo-195 in humans with cancer, for whom no other effective therapy exists.
The trial will be conducted in 2 parts: dose escalation (Phase I ) and dose expansion (Phase
The primary objective of Phase 1 is to establish the recommended dose of Loxo-195 to treat
neurotrophic tyrosine kinase (NTRK) fusion cancers in patients a) aged 12 years and older and
b) younger than 12 years. Secondary objectives of Phase 1 are to characterize the
pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the
objective response rate (ORR) of NTRK-tumors.
The primary objective of Phase 2 is to assess the overall response rate in NTRK fusion cancer
patients as determined by an independent review committee (IRC). Secondary objectives of
Phase 2 comprise the safety and efficacy of Loxo-195 at the recommended dose.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials