Loxo NTRK Tumours - LOXO-TRK-15002
Research type
Research Study
Full title
LOXO-TRK-15002: A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors
IRAS ID
199447
Contact name
David Propper
Contact email
Sponsor organisation
Loxo Oncology Inc
Eudract number
2015-003582-28
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
121211, IND #
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
LOXO-101 is an oral investigational (or experimental) medicine that blocks the actions of the NTRK genes in cancer cells and may be useful to treat cancer. The Medicines and Healthcare products Regulatory Agency (MHRA) or any other health or regulatory authorities in other countries have not approved LOXO-101 but it can be used in this type of research study (clinical trial).
In this study, LOXO-101 will be studied at a dose level of 100 mg twice a day in 8 different groups of patients (called cohorts) determined by cancer type. LOXO-101 is contained in a hard gelatin capsule that comes in two strengths, 25 mg or 100 mg. The study plan is that the patient will take the same LOXO-101 dose for as long as they are on the study. However, if the patient has a side effect that is too toxic, their doctor may reduce the dose and change the number of capsules they receive so that they can continue with study participation. Their doctor may also decide that the dose could be increased, if that increased dose has been tested and determined to be safe.REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1124
Date of REC Opinion
28 Oct 2016
REC opinion
Further Information Favourable Opinion