Spots Global Cancer Trial Database for Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
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Trial Identification
Brief Title: Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Official Title: A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis
Study ID: NCT04562389
Conditions
Study Description
Brief Summary: This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-naïve MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Division of Hematology/Oncology, Birmingham, Alabama, United States
UCLA - Satellite Site, Beverly Hills, California, United States
City of Hope, Duarte, California, United States
UCLA - Satellite Site, Encino, California, United States
City of Hope - Irvine Lennar - Satellite, Irvine, California, United States
UCLA, Los Angeles, California, United States
The Oncology Institute of Hope & Innovation, Pasadena, California, United States
Maryland Oncology Hematology-Satellite, Annapolis, Maryland, United States
Maryland Oncology Hematology-Satellite, Brandywine, Maryland, United States
Maryland Oncology Hematology, Columbia, Maryland, United States
Maryland Oncology Hematology-Satellite, Rockville, Maryland, United States
Maryland Oncology Hematology-Satellite, Silver Spring, Maryland, United States
The Cancer & Hematology Centers -Satellite Site, Grand Rapids, Michigan, United States
The Cancer & Hematology Centers of Muskegon, Norton Shores, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke Cancer Institue, Durham, North Carolina, United States
OhioHealth, Columbus, Ohio, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology, Dallas, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
VCU Massey Cancer Center, Richmond, Virginia, United States
University Multiprofile Hospital for Active Treatment Sveti George - Base 1, Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich, Stara Zagora, , Bulgaria
Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada
Fakultní Nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultní Nemocnice Olomouc, Olomouc, , Czechia
Institut Bergonié, Bordeaux, Aquitaine, France
Hôpital Emile Muller, Mulhouse, Grand Est, France
Hôpital Bretonneau, Tours Cedex, Indre-et-Loire, France
Centre Hospitalier Universitaire d'Angers, Angers, Pays De La Loire, France
Hôpital Saint-Louis, Paris, , France
Universitätsklinikum Halle, Halle, Sachsen-Anhalt, Germany
Universitätsklinikum Jena, Jena, Thuringen, Germany
Shamir Medical Center (Assaf Harofeh), Be'er Ya'akov, Central District, Israel
Hadassah University Hospital - Mount Scopus - Satellite Site, Jerusalem, Jerusalem District, Israel
Hadassah University Hospital Ein Kerem, Jerusalem, Jerusalem District, Israel
Western Galilee Hospital-Nahariya, Nahariya, Northern District, Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST, Meldola, Forli-Cesena, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata, Rionero In Vulture, Potenza, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, , Italy
Pusan National University Hospital, Busan Gwang'yeogsi [Pusan-Kwangyokshi], , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si Gyeonggido [Kyonggi-do], , Korea, Republic of
Samsung Medical Center, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń, Toruń, Kujawsko-Pomorskie, Poland
Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza, Brzozów, Podkarpackie, Poland
Pratia Onkologia Katowice, Katowice, Slaskie, Poland
Institutul Regional De Oncologie Iasi, Moldova, Iasi, Romania
Coltea - Spital Clinic, Bucuresti, , Romania
Spitalul Clinic Colentina, Bucuresti, , Romania
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, , Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca, , Spain
Contact Details
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