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

  • STATUS
    Recruiting
Updated on 25 August 2021
anemia

Summary

This is an open-label, nonrandomized, Phase 1/2 study to evaluate the safety and tolerability, the PK, the PD, and the efficacy (antianemic activity) of INCB000928 administered alone or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia.

INCB000928 tablets will be administered orally at a starting dose of 50 mg QD in the TGA participant population (monotherapy). The starting dose in combination with ruxolitinib will be determined based on the data from the monotherapy dose escalation. One cycle will be defined as 28 consecutive days; treatment will consist of repeating 28-day cycles. The dose-escalation stages will use a BOIN design to determine the MTD.

For TGB only, the recommended dose for expansion of INCB000928 when administered in combination with ruxolitinib will be determined based on the dose-escalation stage results; efficacy will also be explored. The INCB000928 dose will be escalated using an open-label BOIN design in each defined population, and a safe and tolerable dose (RDE) will be determined in the dose-escalation stages. This RDE will be further explored in the expansion stages for TGB only. Dose escalation and de-escalation will follow the BOIN design algorithm.

For TGB only (Part 2), the expansion stages will aim at further assessing the safety and tolerability of INCB000928, the PK and PD, and determining its antianemic activity when combined with ruxolitinib in participants with transfusion-dependent or symptomatic anemia due to myeloproliferative disorders.

Details
Condition leukemia, Anemia, Leukemia (Pediatric), Anemia; Non-Hodgkin’s Lymphoma, Myelofibrosis
Clinical Study IdentifierTX251101
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

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
or 1 for the dose-escalation stages
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 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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