Phase 2 study of INCB054828 for FGFR1-rearranged neoplasms
Research type
Research Study
Full title
A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
IRAS ID
217953
Contact name
Claire Harrison
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2016-002596-10
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Abnormal Fibroblast Growth Factor Receptor (FGFR) signalling in the cells of human body can lead to the establishment and progression of cancer. Therefore, suppressing FGFR signalling could present a targeted approach to treating cancers with FGFR alterations. In early clinical studies FGFR inhibitor drugs have demonstrated acceptable safety and signs of clinical benefit in FGFR-dependent cancers. The drug INCB054828 is a potent inhibitor of FGFR1, FGFR2, and FGFR3 subtypes of Fibroblast Growth Factor Receptor. In this study it is proposed as a treatment for myeloid/lymphoid neoplasms (bone marrow and lymphatic system cancers) with FGFR1 abnormalities. INCB054828 will be evaluated for effectiveness and safety. Pharmacokinetics and biomarker data will also be collected and analysed.
The study will enrol approximately 46 patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement who are not candidates for other disease-modifying therapies including stem cell transplantation.
Upon successful screening, all patients will start on a daily 13.5 mg dose of INCB054828 by mouth on a 2-week-on–therapy and 1-week-off–therapy schedule. The dose may be reduced or stopped if the patient experiences drug-related toxicities. Dosing will continue until the occurrence of disease progression, unacceptable toxicity, pregnancy, initiation of other anticancer therapy, withdrawal of consent, non-compliance with study procedures or study termination. Patients will return for an end of treatment visit and will be followed up for safety, disease status and survival.
Study assessments include physical examinations, eye examinations, vital signs, ECG, blood and urine tests, bone marrow biopsies, questionnaires. CT or MRI scans, or X-ray assessments as well as optional biopsies of the tumours outside the bone marrow will be performed.
The study will run at 2 UK centres, and around 30 centres located in Europe and the US will participate.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0513
Date of REC Opinion
30 Jan 2017
REC opinion
Further Information Favourable Opinion