Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows: 1.
- - ECOG performance status score of the following: 1.
- - 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.
- - 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.
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.
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|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ekatarine Asantiani, MD|
|Principal Investigator Affiliation||Incyte Corporation|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||France, Italy, Japan, United States|
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|
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.
Drug: - INCB000928
INCB000928 Dose Escalation
Drug: - ruxolitinib
INCB000928 +ruxolitinib Dose Expansion
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.