Myeloproliferative Neoplasms Clinical Trial

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 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 is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04455841

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 26 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
City of Hope Orange County
Irvine California, 92618, United States
Usc Norris Comprehensive Cancer Center
Los Angeles California, 90089, United States
Stanford Cancer Center
Palo Alto California, 94304, United States
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Weill Cornell Medical Centers
New York New York, 10065, United States
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy
Durham North Carolina, 27705, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Md Anderson Cancer Center
Houston Texas, 77030, United States
Princess Margaret Cancer Center
Toronto Ontario, MG5 2, Canada
Centre Hospitalier D'Angers
Angers Cedex 01 , 49033, France
Institut Paoli-Calmettes
Marseille Cedex 9 , 13273, France
Hospital Saint Louis
Paris , 75010, France
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo , 24127, Italy
S Orsolas University Hospital Seragnoli Institute of Hematology
Bologna , 40138, Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Firenze , 50134, Italy
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia , 27100, Italy
Tokyo Medical and Dental University Hospital
Bunkyo-ku , 113-8, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
Gifu Municipal Hospital
Gifu , 500-8, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Kumamoto Shinto General Hospital
Kumamoto , 862-8, Japan
Osaka International Cancer Institute
Osaka-shi , 541-8, Japan
United Lincolnshire Hospitals
Boston , PE21 , United Kingdom
Churchill Hospital
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04455841

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

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