A Phase 1/2 Study of LOXO-195 in Patients with NTRK Fusion Cancers
Research type
Research Study
Full title
A Phase 1/ 2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers
IRAS ID
258819
Contact name
Hendrik-Tobias Arkenau
Contact email
Sponsor organisation
Loxo Oncology Inc
Eudract number
2017-004246-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, days
Research summary
Summary of Research
This Phase 1/2, multi-centre, open-label study assessing the safety and benefit of the oral inhibitor, LOXO-195, in adults with neurotrophic tyrosine kinase (NTRK) fusion cancers previously treated with a TRK inhibitor.
LOXO-195 may treat cancer by interfering with the effect of the NTRK genes on how the cancer grows and is specifically for patients who have already tried other treatments. There may be no medical benefit for the participants. The information gained from this study may help doctors learn more about LOXO-195 as a potential treatment for certain types of cancers. This information may also help future patients.
Neither the FDA or any other health or regulatory authority in other countries have approved LOXO-195. The main purposes of this research study include the following:
• To determine whether LOXO-195 is safe;
• To identify which dose of LOXO-195 should be used in future clinical studies (Phase 1);
• To evaluate how the body absorbs and processes different doses of LOXO-195(i.e. pharmacokinetics (PK) testing);
• To determine how well the cancer responds to treatment with LOXO-195;
• To determine how long any benefits from treatment with LOXO-195 last.This study will be conducted in two parts: Phase 1 and Phase 2:
Phase 1 will enroll at least the minimum number of patients to clear a dose level cohort estimated at up to 6 patients each, with an upper limit total of 36 patients.
Phase 2 will enroll up to 57 patients.The study is planned to take 3 years to finish. Participants may continue study participation for as long as they do not experience any serious side effects related to LOXO-195, the cancer does not get worse while they are taking LOXO-195, and their study doctor feels that it is in their best interest to continue taking LOXO-195.
Summary of Results
Not available yet. Due 1 year after end of trial.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/0603
Date of REC Opinion
10 Jul 2019
REC opinion
Further Information Favourable Opinion