Loxo15003 - Paediatric CNS
Research type
Research Study
Full title
A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors
IRAS ID
215888
Contact name
Seema Ahmed
Contact email
Sponsor organisation
Bayer Consumer Care AG
Eudract number
2016-003498-16
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
128453, IND #
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
LOXO-101 (now named “Larotrectinib”) is an oral investigational (or experimental) medicine that blocks the actions of the NTRK genes in cancer cells and may treat cancer. The Medicines and Healthcare Products Regulatory Agency (MHRA) or any other health or regulatory authorities in other countries have not approved Larotrectinib but it can be used in this type of research study (clinical trial).
In this study, there are 2 phases:
• Phase 1 dose escalation, where Larotrectinib was studied at different dose levels to determine a safe dose to be given in the dose expansion portion of the study (see protocol Table 6). 24 patients were enrolled in this Phase 1 dose escalation portion of the study and enrolment is now complete.
The recommended phase 2 dose for the phase 1 expansion and phase 2 expansion portions of the study has been determined: 100mg/m2 BID (with 100mg BID as cap).
The Phase 1 dose expansion enrolment is ongoing and will be conducted to confirm the safety and drug exposure of Larotrectinib Up to 18 patients may be enrolled in this expansion cohort. To date, no patients have enrolled in this portion of the study.
• Phase 2 dose expansion enrolment (which includes only specified patients with infantile fibrosarcoma or identified NTRK gene fusions) is ongoing and will study Larotrectinib at the recommended phase 2 dose that was determined in the phase 1 dose escalation portion of the study (100 mg/m2 BID); Phase 2 will involve the enrolment of up to 30 patients in 3 cohorts with different tumour types (see protocol section 3.2.1). To date, one patient has enrolled in this portion of the study.
Larotrectinib is contained in a hard gelatin capsule that comes in two strengths, 25 mg and 100 mg, or an oral solution (20mg/ml). Dosing is based on patient's height and weight. The dose may be adjusted during the study if patient’s height and/or weight changes. In addition, if the patient has a side effect as a result of the Larotrectinib, the patient’s dose may be reduced. Doses may also be increased based on the response of other patients on the trial; each study doctor will decide whether it is safe for a given patient to have their dose increased.
Loxo Oncology, Inc. is the sponsor for this study; up to 72 patients (aged ≥1 months to ≤21 years) will be recruited into the study at locations in the United States, France, Germany, Italy, Spain and the United Kingdom.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1086
Date of REC Opinion
28 Sep 2017
REC opinion
Further Information Favourable Opinion