Spots Global Cancer Trial Database for Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
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Trial Identification
Brief Title: Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
Official Title: A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 Versus Best Available Therapy in Subjects With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)
Study ID: NCT04854096
Study Description
Brief Summary: This study will enroll male and female subjects who are 18 years of age or older with Primary Myelofibrosis, post-polycythemia Vera Myelofibrosis, or post-essential Thrombocythemia Myelofibrosis with severe thrombocytopenia (platelet count \<50,000/µL) including subjects with intermediate-2 or high-risk MF according to the Dynamic International Prognostic Scoring System (DIPSS).
Detailed Description: NS-018 will be self-administered orally at a dose of 300 mg BID. The BAT will be administered according to manufacturer's instructions and Investigator discretion. Subjects will complete study visits at Screening, Day 1 and Day 15 of Cycle 1, 2, 3, 4, 5, 6 and Day 1 of every cycle thereafter. At these visits, blood/urine sampling, spleen measurements, bone marrow assessments, patient-reported outcome (PRO) assessments, and safety assessments may be performed.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States
Houston Methodist Hospital, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Hamatologisch-onkologische Praxis Heinric/Bangerter Ausgsburg GbR, Augsburg, , Germany
Universitaetsklinikum Halle (Saale), Halle, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Universitätsmedizin Rostock, Rostock, , Germany
AO SS Antonio, Alessandria, , Italy
Azienda Ospedaliera SS. Antonio, Alessandria, , Italy
ASST Spedali Civili di Brescia, Brescia, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, , Italy
AOU "Policlinico - San Marco", Catania, , Italy
ASST Fatebenefratelli Sacco, Milano, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milano, , Italy
AO di Rilievo Ntl A Cardarelli, Naples, , Italy
Azienda Ospedaliera di Rilievo Nazionale, Naples, , Italy
AO di Rilievo Nazionale, Napoli, , Italy
Azienda Ospedaliera di Padova, Padova, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, , Italy
Istituto Nazionale Tumori Regina Elena IRCCS, Roma, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I, Roma, , Italy
AO Uni Policlinico Umberto I, Rome, , Italy
The Catholic University of Korea, Seoul St. Mary's Hospital, Banpo-dong, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Gyeongsang National University Hospital, Jinju-si, , Korea, Republic of
CHA Bundang Medical Center, CHA University, Seongnam, , Korea, Republic of
Soon Chun Hyang Central Medical Center, Seoul, , Korea, Republic of
Hospital Raja Permaisuri Bainun, Ipoh, Perak, Malaysia
Hospital Ampang, Ampang, , Malaysia
Hospital Sultanah Aminah, Johor Bahru, , Malaysia
Hospital Raja Perempuan Zainab II, Kota Bahru, , Malaysia
Hospital Queen Elizabeth, Kota Kinabalu, , Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Sunway Medical Centre, Petaling Jaya, , Malaysia
Hospital Pulau Pinang, Pulau Pinang, , Malaysia
Szpital Uniwersytecki nr 2 im. dr J. Biziela, Bydgoszcz, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
Dolnośląskie Centrum Onkologii we Wrocławiu, Oddział Hematologiczny, Wrocław, , Poland
Srinagarind Hospital, Khon Kaen, , Thailand
Songklanagarind Hospital, Songkla, , Thailand
Istanbul Medipol University, Bagcilar, Istanbul, Turkey
Ege Universitesi Tip Fak,, İzmir, , Turkey
Namik Kemal University Medicine School, Tekirdağ, , Turkey
Karadeniz Teknik Universitesi Tip Fak,, Trabzon, , Turkey
Royal United Hospitals - Bath, Bath, England, United Kingdom
Guys Hospital, London, England, United Kingdom
University College London Hospitals, London, England, United Kingdom
The Christie NHS Foundation Trust, Manchester, England, United Kingdom
Derriford Hospital, Plymouth, England, United Kingdom
Sandwell & West Birmingham Hospital, West Bromwich, England, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Contact Details
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