Spots Global Cancer Trial Database for An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
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Trial Identification
Brief Title: An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
Official Title: A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib
Study ID: NCT03952039
Study Description
Brief Summary: A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.
Detailed Description: This Phase 3, multicenter, randomized, two-arm, open-label study will include subjects with intermediate or high-risk (as per the DIPSS score) primary myelofibrosis (PMF), postpolycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). This study will be conducted in compliance with International Council for Harmonisation (ICH) Good Clinical Practices (GCPs). Study design includes: * A 28-day Screening Period * 2:1 Randomization to fedratinib or best available therapy (BAT) * Stratification at Randomization according to: * Spleen size by palpation: \< 15 cm below left costal margin (LCM) versus ≥ 15 cm below LCM * Platelets ≥ 50 to \< 100 x 109/L versus platelets ≥ 100 x 109/L * Refractory or relapsed to ruxolitinib treatment versus intolerant to ruxolitinib treatment * Study Treatment Period (time on study drug plus 30 days after last dose) * Subjects are allowed to crossover from BAT to the fedratinib arm after the Cycle 6 response assessment or before the Cycle 6 response assessment in the event of a confirmed progression of splenomegaly by MRI/CT scan * A Survival Follow-up Period for progression and survival
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 103, Darlinghurst, New South Wales, Australia
Local Institution - 101, Adelaide, South Australia, Australia
Local Institution - 105, Box Hill, Victoria, Australia
Local Institution - 102, Frankston, Victoria, Australia
Local Institution - 100, Melbourne, , Australia
Local Institution - 156, Graz, , Austria
Local Institution - 154, Innsbruck, , Austria
Local Institution - 155, Linz, , Austria
Local Institution - 151, Salzburg, , Austria
Local Institution - 150, Vienna, , Austria
Local Institution - 153, Wels, , Austria
Local Institution - 152, Wien, , Austria
Local Institution - 200, Brugge, , Belgium
Local Institution - 202, Bruxelles, , Belgium
Local Institution - 205, La Louvière-(Haine St-Paul), , Belgium
Local Institution - 201, Leuven, , Belgium
Local Institution - 204, Liege, , Belgium
Local Institution - 203, Yvoir, , Belgium
Local Institution - 555, Beijing, , China
Local Institution - 550, Guangzhou, Guangdong, , China
Local Institution - 553, Tianjin, , China
Local Institution - 557, Zhengzhou, , China
Local Institution - 700, Brno, , Czechia
Local Institution - 702, Ostrava-Poruba, , Czechia
Local Institution - 701, Prague 2, , Czechia
Local Institution - 255, Angers, , France
Local Institution - 256, Brest, , France
Local Institution - 254, Lens Cedex, , France
Local Institution - 259, Lille, , France
Local Institution - 260, Nice Cedex 3, , France
Local Institution - 250, Nimes Cedex 9, , France
Local Institution - 252, Paris, , France
Local Institution - 258, Pessac, , France
Local Institution - 257, Pierre-Benite, , France
Local Institution - 261, Poitiers Cedex, , France
Local Institution - 251, Strasbourg, , France
Local Institution - 253, Toulouse Cedex 9, , France
Local Institution - 302, Aachen, , Germany
Local Institution - 308, Frankfurt am Main, , Germany
Local Institution - 306, Halle, , Germany
Local Institution - 303, Jena, , Germany
Local Institution - 307, Magdeburg, , Germany
Local Institution - 301, Mannheim, , Germany
Local Institution - 304, Minden, , Germany
Local Institution - 305, Ulm, , Germany
Local Institution - 600, Budapest, , Hungary
Local Institution - 601, Györ, , Hungary
Local Institution - 602, Kaposvar, , Hungary
Local Institution - 604, Nyiregyhaza, , Hungary
Local Institution - 603, Szeged, , Hungary
Local Institution - 751, Cork, , Ireland
Local Institution - 752, Dublin, , Ireland
Local Institution - 750, Dublin, , Ireland
Local Institution - 353, Bologna, , Italy
Local Institution - 363, Brescia, , Italy
Local Institution - 354, Catania, , Italy
Local Institution - 350, Firenze, , Italy
Local Institution - 358, Milano, , Italy
Local Institution - 362, Naples, , Italy
Local Institution - 357, Pavia, , Italy
Local Institution - 356, Roma, , Italy
Local Institution - 361, Roma, , Italy
Local Institution - 359, Roma, , Italy
Local Institution - 355, Torino, , Italy
Local Institution - 360, Udine, , Italy
Local Institution - 352, Varese, , Italy
Local Institution - 364, Verona, , Italy
Local Institution - 900, Seongnam-si, , Korea, Republic of
Local Institution - 905, Seoul, , Korea, Republic of
Local Institution - 901, Seoul, , Korea, Republic of
Local Institution - 903, Seoul, , Korea, Republic of
Local Institution - 904, Seoul, , Korea, Republic of
Local Institution - 902, Seoul, , Korea, Republic of
Local Institution - 402, Maastricht, , Netherlands
Local Institution - 400, Nijmegen, , Netherlands
Local Institution - 803, Poznan, , Poland
Local Institution - 801, Warszawa, , Poland
Local Institution - 802, Wroclaw, , Poland
Local Institution - 855, Moscow, , Russian Federation
Local Institution - 851, Moscow, , Russian Federation
Local Institution - 853, Moscow, , Russian Federation
Local Institution - 857, Novosibirsk, , Russian Federation
Local Institution - 852, Saint Petersburg, , Russian Federation
Local Institution - 854, Saint-Petersburg, , Russian Federation
Local Institution - 850, St Petersburg, , Russian Federation
Local Institution - 859, Vladikavkaz, , Russian Federation
Local Institution - 451, Alicante, , Spain
Local Institution - 452, Badalona (Barcelona), , Spain
Local Institution - 458, Barakaldo, , Spain
Local Institution - 450, Barcelona, , Spain
Local Institution - 462, Gerona, , Spain
Local Institution - 461, Las Palmas de Gran Canaria, , Spain
Local Institution - 453, Madrid, , Spain
Local Institution - 459, Madrid, , Spain
Local Institution - 457, Malaga, , Spain
Local Institution - 454, Murcia, , Spain
Local Institution - 455, Salamanca, , Spain
Local Institution - 463, Santa Cruz de Tenerife, , Spain
Local Institution - 460, Santiago de Compostela, , Spain
Local Institution - 456, Valencia, , Spain
Local Institution - 504, Manchester, Lancashire, United Kingdom
Local Institution - 506, Nottingham, Nottinghamshire, United Kingdom
Local Institution - 502, Birmingham, , United Kingdom
Local Institution - 503, Boston, , United Kingdom
Local Institution - 501, London, , United Kingdom
Local Institution - 505, London, , United Kingdom
Local Institution - 500, Oxford, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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