Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.
NCT ID: NCT02598297
Last Updated: 2019-08-16
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.
TERMINATED
PHASE3
49 participants
INTERVENTIONAL
2016-02-03
2017-10-23
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.
Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
NCT01969838
A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
NCT02718300
Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis
NCT04472598
Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
NCT04097821
Ruxolitinib in Patients With Myelofibrosis
NCT05762874
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
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ruxolitinib
Two tablets of ruxolitinib 5 mg were administered orally twice per day.
Ruxolitinib
5 mg tablet for oral use
Ruxolitinib Placebo
Two tablets of 5mg placebo were administered orally twice per day.
Ruxolitinib Placebo
5 mg placebo tablet for oral use
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ruxolitinib
5 mg tablet for oral use
Ruxolitinib Placebo
5 mg placebo tablet for oral use
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
* Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2 and IDH1/2)
* Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal margin to the point of greatest splenic protrusion
* Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
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.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Concord NSW, New South Wales, Australia
Novartis Investigative Site
Liverpool, New South Wales, Australia
Novartis Investigative Site
Wooloongabba, Queensland, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Salzburg, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Antwerp, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, , Brazil
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Aalborg, , Denmark
Novartis Investigative Site
Herlev, , Denmark
Novartis Investigative Site
Bayonne, Bayonne Cedex, France
Novartis Investigative Site
Angers, , France
Novartis Investigative Site
Brest, , France
Novartis Investigative Site
Chambéry, , France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Vandœuvre-lès-Nancy, , France
Novartis Investigative Site
Lübeck, Schleswig-Holstein, Germany
Novartis Investigative Site
Aachen, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Chemnitz, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Halle S, , Germany
Novartis Investigative Site
Heilbronn, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Nordhorn, , Germany
Novartis Investigative Site
Rostock, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Athens, GR, Greece
Novartis Investigative Site
Thessaloniki, GR, Greece
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Pátrai, , Greece
Novartis Investigative Site
Hong Kong, , Hong Kong
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Kaposvár, , Hungary
Novartis Investigative Site
Afula, , Israel
Novartis Investigative Site
Haifa, , Israel
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Zrifin, , Israel
Novartis Investigative Site
Bari, BA, Italy
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Catania, CT, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Rome, Lazio, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Reggio Emilia, RE, Italy
Novartis Investigative Site
Orbassano, TO, Italy
Novartis Investigative Site
Terni, TR, Italy
Novartis Investigative Site
Varese, VA, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Maebashi, Gunma, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Isehara, Kanagawa, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Chūō, Yamanashi, Japan
Novartis Investigative Site
Osaka, , Japan
Novartis Investigative Site
Bergen, , Norway
Novartis Investigative Site
Loerenskog, , Norway
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Torun, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Faro, , Portugal
Novartis Investigative Site
Porto, , Portugal
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Cadiz, Andalusia, Spain
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Gothenburg, , Sweden
Novartis Investigative Site
Huddinge, , Sweden
Novartis Investigative Site
Lund, , Sweden
Novartis Investigative Site
Uddevalla, , Sweden
Novartis Investigative Site
Basel, , Switzerland
Novartis Investigative Site
Sankt Gallen, , Switzerland
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigative Site
Putzu City, Chiayi Hsien, Taiwan
Novartis Investigative Site
Kaohsiung City, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taoyuan District, , Taiwan
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Samsun, , Turkey (Türkiye)
Novartis Investigative Site
Talas / Kayseri, , Turkey (Türkiye)
Novartis Investigative Site
Edgbaston, Birmingham, United Kingdom
Novartis Investigative Site
Westbruy on Trym, Bristol, United Kingdom
Novartis Investigative Site
Leeds, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
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.
2014-004928-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CINC424A2353
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.