Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
NCT ID: NCT01317875
Last Updated: 2025-08-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2011-03-31
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
NCT01340651
Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF
NCT01392443
Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
NCT01558739
Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis
NCT01433445
Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
NCT04279847
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stratum -1
Participants with baseline Platelet counts of 75-99 x10\^9/L
Ruxolitinib
Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID)
Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count
Stratum -2
Participants with baseline Platelet counts of 50-74 x10\^9/L
Ruxolitinib
Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID)
Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ruxolitinib
Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID)
Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Platelet count \< 100x10 \^9/L at screening or at Study Day 1.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Jones, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Winter Park, Florida, United States
Baltimore, Maryland, United States
Houston, Texas, United States
Vienna, , Austria
Nanjing, Jiangsu, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Beijing, , China
Angers, , France
Paris, , France
Pierre-Bénite, , France
Leipzig, , Germany
Florence, , Italy
Milan, , Italy
Terni, , Italy
Rotterdam, , Netherlands
Belfast, , United Kingdom
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Guglielmelli P, Kiladjian JJ, Vannucchi AM, Duan M, Meng H, Pan L, He G, Verstovsek S, Boyer F, Barraco F, Niederwieser D, Pungolino E, Liberati AM, Harrison C, Roussou P, Wroclawska M, Karumanchi D, Sinclair K, Te Boekhorst PAW, Gisslinger H. Efficacy and safety of ruxolitinib in patients with myelofibrosis and low platelet count (50 x 109/L to <100 x 109/L) at baseline: the final analysis of EXPAND. Ther Adv Hematol. 2022 Sep 10;13:20406207221118429. doi: 10.1177/20406207221118429. eCollection 2022.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-023055-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CINC424A2201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.