Spots Global Cancer Trial Database for Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
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Trial Identification
Brief Title: Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
Official Title: A Phase 2, International, Multicenter, Randomized, Open-label, Parallel Group to Evaluate the Efficacy and Safety of Cc-486 (Oral Azacitidine) Alone in Combination With Durvalumab (MEDI4736) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment With Azacitidine for Injection or Decitabine
Study ID: NCT02281084
Conditions
Study Description
Brief Summary: Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment. Extension: An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 113, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Chicago Medicine, Chicago, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Local Institution - 101, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Hillman Cancer Institute at UPMC, Pittsburgh, Pennsylvania, United States
University of Texas- MD Anderson, Houston, Texas, United States
Cancer Care Centers of South Texas - HOAST, San Antonio, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Westmead Hospital, Westmead, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Local Institution - 400, Clayton, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Cabrini Hospital, Malvern, Victoria, Australia
Local Institution - 405, Malvern, Victoria, Australia
Royal Brisbane and Women's Hospital, Herston, , Australia
Royal Perth Hospital, Perth, , Australia
Local Institution - 801, Brussel, , Belgium
Universitair Ziekenhuis Brussel, Brussel, , Belgium
Hopital Erasme, Bruxelles, , Belgium
Centre Hospitalier Universitaire de Liege, Liège, , Belgium
Clinique Saint-Pierre, Ottignies, , Belgium
Local Institution - UNK-004, Hamilton, Ontario, Canada
Institut Paoli Calmettes, Marseille Cedex 9, , France
Hopital Saint-Louis, Paris, , France
Local Institution - 201, Paris, , France
CHU Purpan, Toulouse, , France
Local Institution - 500, Dresden, , Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Local Institution - 502, Dusseldorf, , Germany
Marien Hospital, Dusseldorf, , Germany
Universitatsklinikum Freiburg, Freiburg, , Germany
Universitatsklinikum Halle Saale, Halle, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
Medizinische Klinik III Klinikum der Universität München-Großhadern, München, , Germany
Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo, Allessandria, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Local Institution - 601, Firenze, , Italy
Ospedale San Raffaele S.r.l., Milano, , Italy
Azienda Ospedaliera Sant Andrea, Roma, , Italy
Local Institution - 603, Roma, , Italy
Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii, Olsztyn, , Poland
MTZ Clinical Research Sp. z o.o., Warszawa, , Poland
Uniwersytecki Szpital Kliniczny, Wroclaw, , Poland
Institut Calatà d'Oncologia, L'Hospitalet, Barcelona, , Spain
Local Institution - 306, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Virgenes de las Nieves, Granada, , Spain
Hospital General Gregorio Maranon, Madrid, , Spain
Hospital Universitario Virgen De La Victoria, Malaga, , Spain
Hospital Central de Asturias, Oviedo, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
CEIC Hospital Universitario La Fe, Valencia, , Spain
United Lincolnshire Hospitals NHS Trust, Boston, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, , United Kingdom
Broomfield Hospital, Chelmsford, , United Kingdom
Saint James University Hospital, Leeds, , United Kingdom
King's College HospitalSchool of Medicine, London, , United Kingdom
Local Institution - 700, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
University College London, London, , United Kingdom
Northwick Park Hospital, Middlesex, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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