A Phase 1 Study of INCB057643 in Patients With Myeloid Neoplasms
Research type
Research Study
Full title
A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
IRAS ID
308812
Contact name
Aaron Packman
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2020-003532-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Study INCB 57643-103 is an open-label, 2-part study evaluating INCB057643 as monotherapy and in combination with ruxolitinib. Monotherapy participants will have relapsed or refractory myelofibrosis, myelodysplastic syndrome, or myelodysplastic syndrome/myeloproliferative neoplasm, and have received at least 1 line of prior therapy (participants with myelofibrosis must have received Janus kinase inhibitor[s] such as ruxolitinib) and have no further available therapy known to provide clinical benefit according to the investigator. Combination therapy participants will have advanced myelofibrosis and are currently receiving ruxolitinib monotherapy but are having a suboptimal response.
Part 1 of the study will examine the safety and tolerability of INCB057643 as monotherapy in participants with myelofibrosis, myelodysplastic syndrome, or myelodysplastic syndrome/myeloproliferative neoplasm. Part 2 will have 2 treatment groups: Treatment Group A will further evaluateINCB057643 as monotherapy in participants with myelofibrosis, and Treatment Group B will evaluate INCB057643 in combination with ruxolitinib in participants with myelofibrosis. The purpose of Part 2 will be to further characterize the safety and tolerability of INCB057643 as monotherapy and in combination with ruxolitinib and to evaluate preliminary efficacy.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0040
Date of REC Opinion
11 Apr 2022
REC opinion
Further Information Favourable Opinion