Last updated: October 23, 2023
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting
Phase
1/2
Condition
Post-essential Thrombocythemia Myelofibrosis
Anemia
Post-polycythemia Vera Myelofibrosis
Treatment
Ruxolitinib
INCB000928
Clinical Study ID
NCT04455841
INCB 00928-104
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- For TGA:
- Participants previously treated with JAK inhibitors for at least 12 weeks.
- Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.
- For TGB:
- 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.
Exclusion
Exclusion 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.
Study Design
Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Ruxolitinib
Phase: 1/2
Study Start date:
March 19, 2021
Estimated Completion Date:
April 30, 2024
Study Description
Connect with a study center
Chiba Cancer Center
Chiba, 260-8717
JapanActive - Recruiting
Osaka International Cancer Institute
Osaka-Shi, 541-8567
JapanActive - Recruiting
Royal Cornwall Hospital Truro Sunrise Centre
Truro, TR1 3LQ
United KingdomActive - Recruiting
City of Hope National Medical Center
Duarte, California 91010
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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