Phase 1/2 Study of INCB000928 in Participants With Anemia Due to Myeloproliferative Disorders
Research type
Research Study
Full title
A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
IRAS ID
1004187
Contact name
Michael McGraw
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2020-004029-21
Research summary
INCB000928 is an investigational drug that is being studied by Incyte Corporation (“Sponsor”) alone or in combination with ruxolitinib for use in the treatment of anaemia due to myeloproliferative disorders.
It consists of a dose-escalation stage for each of 3 treatment groups (TGA, TGB and TGC), and an expansion stage for each treatment group (TGA, TGB and TGC); approximately 206 evaluable participants will be included.
Dose escalation will proceed first with INCB000928 as monotherapy in Treatment Group A ((TGA) (participants previously treated with JAK inhibitors for at least 12 weeks and are resistant, refractory, or lost response to a JAK inhibitor, OR are intolerant, OR are not eligible to receive a JAK inhibitor treatment)).
Once the monotherapy dose has been evaluated in at least 3 participants, combination therapy with ruxolitinib will start in Treatment Group B ((TGB) (participants who have been on a stable dose of ruxolitinib for at least 12 weeks)). Dose escalation in will start at 100 mg (50% of the safe and tolerated tested dose in Study INCB 00928-102) and will not exceed the monotherapy maximum tolerated dose if identified in this current study.
After the TGB starting dose (combination of INCB00928 with ruxolitinib) is cleared, combination therapy of INCB000928 with ruxolitinib in Treatment Group C ((TGC) (participants who are JAK inhibitor treatment naïve)) may start at the highest dose of INCB000928 that has been shown to be safe and tolerable in the TGB treatment group.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0466
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion