Anemia, Myelofibrosis(MF), Polycythemia Vera (PV)
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Incyte Study ID:
INCB 00928-104
CT.gov ID:
Eudra ID:
EU CT Number:
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Mar 2021 - Nov 2027
TYPE
Interventional
PHASE
Phase 1/Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
SAINT LOUIS, MO, US, 63110
Name
MD ANDERSON CANCER CENTER
HOUSTON, TX, US, 77030
Name
CITY OF HOPE NATIONAL MEDICAL CENTER
DUARTE, CA, US, 91010
Name
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN, US, 37232
Name
STANFORD CANCER CENTER
PALO ALTO, CA, US, 94304
Name
WEILL CORNELL MEDICAL CENTERS
NEW YORK, NY, US, 10065
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Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
- a. 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).
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.
Requirements information
Inclusion Criteria
- Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
- a. 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).
- b. 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:
- a. 0 or 1 for the dose-escalation stages.
- b. 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.
- For TGC:
- Participants must be JAK inhibitor treatment naive (no prior treatment with any JAK inhibitor) and have an indication for initiation of ruxolitinib 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.
Protocol Summary
Incyte Study ID:
INCB 00928-104
Primary Purpose:
Treatment
Allocation:
Non-randomized
Study Design:
Sequential Assignment
Masking:
None (Open Label)
Interventions:
Enrollment:
84
Primary Outcome
Open
Number of treatment-related adverse events
Timeframe: Approximately up to 13 months
Secondary Outcome
Open
Anemia Response
Timeframe: Approximately up to 13 months
Duration of Anemia Response
Timeframe: Approximately up to 13 months
Mean Change of Hemoglobin
Timeframe: Approximately up to 13 months
Rate of RBC transfusion
Timeframe: Approximately up to 13 months
TGB and TGC only -Splenic Volume
Timeframe: Approximately up to 13 months
TGB and TGC Only - Splenic Length
Timeframe: Approximately Up to 13 months
TGB and TGC only - Objective Response Rate
Timeframe: Approximately up to 13 months
TGB and TGC only - Progression Free Survival
Timeframe: Approximately up to 13 months
TGB and TGC only - Leukemia Free Survival
Timeframe: Approximately upto 13 months
AUC
Timeframe: Approximately up to 13 months
Tmax
Timeframe: Approximately up to 13 months
AUC0-t
Timeframe: Approximately up to 13 months
Hepcidin levels
Timeframe: Approximately up to 13 months
Iron Homeostasis
Timeframe: Approximately up to 13 months
Erythropoesis
Timeframe: Approximately up to 13 months