Myeloproliferative Neoplasms Clinical Trial
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.
Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
Anemia: An Hgb value < 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: RBC transfusion must be at least 2 weeks before the Hgb measurement during screening).
Transfusion-dependent: Participant has received at least 4 units of RBC transfusions during the 28 days immediately preceding Cycle 1 Day 1 OR has received an average of at least 4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of < 8.5 g/dL, in the absence of bleeding or treatment-induced anemia. In addition, the most recent transfusion episode must have occurred in the 28 days before Cycle 1 Day 1.
ECOG performance status score of the following:
0 or 1 for the dose-escalation stages.
0, 1, or 2 for the dose-expansion stage.
Life expectancy is greater than 6 months
Agreement to avoid pregnancy or fathering children.
Ineligible to receive or have not responded to available therapies for anemia such as ESAs.
Participants previously treated with JAK inhibitors for at least 12 weeks.
Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.
Participants must have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks immediately preceding the first dose of study treatment.
Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.
Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
Laboratory Values outside of protocol defined range at screening.
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There are 26 Locations for this study
Duarte California, 91010, United States
Irvine California, 92618, United States
Los Angeles California, 90089, United States
Palo Alto California, 94304, United States
Atlanta Georgia, 30322, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Durham North Carolina, 27705, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Toronto Ontario, MG5 2, Canada
Angers Cedex 01 , 49033, France
Marseille Cedex 9 , 13273, France
Paris , 75010, France
Bergamo , 24127, Italy
Bologna , 40138, Italy
Firenze , 50134, Italy
Pavia , 27100, Italy
Bunkyo-ku , 113-8, Japan
Chiba , 260-8, Japan
Gifu , 500-8, Japan
Hirakata , 573-1, Japan
Kumamoto , 862-8, Japan
Osaka-shi , 541-8, Japan
Boston , PE21 , United Kingdom
Oxford , OX3 7, United Kingdom
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