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

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows: 1.

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). 2. 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: 1.

0 or 1 for the dose-escalation stages. 2. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04455841
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Incyte Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Amanda McBride, MD
Principal Investigator Affiliation	Incyte Corporation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, France, Italy, Japan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Treatment Group A (TGA)

INCB000928 will be administered once daily (QD).

Experimental: Treatment Group B (TGB)

INCB000928 will be administered in combination with ruxolitinib.

Experimental: Treatment Group C (TGC)

INCB000928 will be administered in combination with ruxolitinib.

Interventions

Drug: - INCB000928

INCB000928 will be administered at protocol defined dose.

Drug: - ruxolitinib

Ruxolitinib will be administered at protocol defined dose.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope National Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope National Medical Center

Duarte, California, 91010

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