Actively Recruiting
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
Led by Incyte Corporation · Updated on 2026-05-04
186
Participants Needed
30
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with intermediate-1 or higher risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis with splenomegaly
- For monotherapy group, previously treated with at least 1 JAK inhibitor for 12 weeks or more and resistant, refractory, intolerant, or lost response to it
- For MF SubOpt R group, on a therapeutic regimen unlikely to benefit from further monotherapy as judged by the investigator
- Confirmed diagnosis of polycythemia vera with prior treatment using standard cytoreductive therapy and resistant, refractory, intolerant, or lost response to treatment
- Confirmed diagnosis of high-risk essential thrombocythemia with prior treatment using standard cytoreductive therapy and resistant, refractory, intolerant, or lost response to treatment
- Life expectancy greater than 6 months
- Willingness to undergo pretreatment and regular on-study bone marrow biopsies and aspirations as appropriate
- Existing documentation of JAK2V617F mutation from a qualified local laboratory
You will not qualify if you...
- Presence of another hematological malignancy requiring treatment other than specified myeloproliferative neoplasms
- History of major bleeding or thrombosis within 3 months before enrollment
- Abnormal blood, liver, or kidney function based on lab tests
- Previous allogenic or autologous stem-cell transplantation or planned allogenic stem-cell transplantation
- Active invasive cancer
- Significant uncontrolled medical conditions
- Acute or chronic hepatitis B virus, active hepatitis C virus, or known HIV infection
- Use of any prior MPN-directed therapy within 5 half-lives or 28 days before first study dose
- Treatment with G-CSF, GM-CSF, romiplostim, or eltrombopag within 4 weeks before first study dose
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
The University of Alabama At Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109-5008
Actively Recruiting
7
Cornell Medical Center
New York, New York, United States, 10021
Actively Recruiting
8
Icahn School of Medicine At Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
Sloan Kettering Institute For Cancer Research
New York, New York, United States, 10065
Actively Recruiting
10
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
11
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
15
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
16
McGill University Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
17
Hospital Saint Louis
Paris, France, 75010
Actively Recruiting
18
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
19
University Medical Center Rwth Aachen
Aachen, Germany, D-52074
Actively Recruiting
20
Universitatsklinikum Essen
Essen, Germany, 45147
Not Yet Recruiting
21
Universitatsklinikum Halle (Saale)
Halle, Germany, 06120
Actively Recruiting
22
Aou Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Not Yet Recruiting
23
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, Italy, 50134
Not Yet Recruiting
24
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, Italy, 20122
Not Yet Recruiting
25
Haukeland University Hospital
Bergen, Norway, N-5021
Actively Recruiting
26
Oslo University Hospital
Oslo, Norway, 00379
Actively Recruiting
27
Inselspital - Universitaetsspital Bern
Bern, Switzerland, 03010
Actively Recruiting
28
Universitatsspital Zurich
Zurich, Switzerland, 08091
Actively Recruiting
29
Guys and St Thomas Nhs Foundation Trust
London, United Kingdom, SE1 9RT
Not Yet Recruiting
30
Genesiscare Oxford
Oxford, United Kingdom, OX4 6LB
Not Yet Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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