The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell... | NCT01566695 | Trialant

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell... | NCT01566695 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

18 years or older

Have a documented diagnosis of MDS

Anemia that requires red blood cell transfusions

Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Must agree to follow pregnancy precautions as required by protocol.

Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted

Exclusion Criteria:

Secondary or hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy

Prior treatment with azacitidine, decitabine, other hypomethylating agents and lenalidomide (for lenalidomide : unless the last dose received is >= 8 weeks prior to inclusion into the study).

Prior allogeneic or autologous stem cell transplant

Eligible for allogenic or autologous stem cell transplant

History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect

Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s), or microvascular disorder(s)

Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomization

Ongoing medically significant adverse events from previous treatment, regardless of the time period

Concurrent use of iron-chelating agents, (except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid (except for subjects on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS)

Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 3 years. (Basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and incidental histologic finding of prostate cancer) (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system is allowed)

Significant active cardiac disease within the previous 6 months

Uncontrolled systemic fungal, bacterial, or viral infection

Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection

Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding

Abnormal coagulation parameters

Abnormal liver function test results

Abnormal kidney function test results

Known or suspected hypersensitivity to azacitidine or mannitol

Any significant medical condition, laboratory abnormality, or psychiatric illness

Alta Bates Comprehensive Cancer Center

Berkeley, California 94704, United States

Tower Hematology/Oncology Medical Group and Tower Cancer Research Found

Beverly Hills, California 90211, United States

City Of Hope

Duarte, California 91010-301, United States

California Cancer Associates for Research and Excellence cCARE

Escondido, California 92025, United States

Marin Oncology Associates

Greenbrae, California 94904-2007, United States

UCSD-Thornton Hospital

La Jolla, California 92093-0943, United States

University of Southern California Norris Cancer Center

Los Angeles, California 90033, United States

Local Institution - 942

New Haven, Connecticut 06519, United States

University of Florida Health Cancer Center at Orlando Health

Orlando, Florida 32806, United States

Phoebe Cancer Center of Phoebe Putney Memorial Hospital

Albany, Georgia 31701, United States

Robert H Lurie Comprehensive Cancer Center NW Univ

Chicago, Illinois 60611, United States

University Of Illinois At Chicago

Chicago, Illinois 60612, United States

University Of Chicago Medical Center

Chicago, Illinois 60637, United States

Loyola University Chicago

Maywood, Illinois 60153, United States

University Of Kansas Medical Center

Kansas City, Kansas 66160-7233, United States

University of Louisville, J.G. Brown Cancer Center

Louisville, Kentucky 40202, United States

Hematology And Oncology Specialists, Llc

Metairie, Louisiana 70006, United States

Johns Hopkins Medicine

Baltimore, Maryland 21231, United States

UMASS Memorial Hospital

Worcester, Massachusetts 01655, United States

Mayo Clinic

Rochester, Minnesota 55905, United States

Jackson Oncology Associates PLLC

Jackson, Mississippi 39202, United States

Saint Luke's Cancer Institute

Kansas City, Missouri 64111, United States

Kansas City VA Medical Center University of Kansas Medical Center

Kansas City, Missouri 64128, United States

University Of Nebraska Medical Center

Omaha, Nebraska 68198-6805, United States

Weill Cornell Medical College - New York - Presbyterian Hospital

New York, New York 10021, United States

Icahn School of Medicine at Mount Sinai Medical Center

New York, New York 10029, United States

Levine Cancer Institute

Charlotte, North Carolina 28204, United States

Eastern Institute of Medical Sciences

Greenville, North Carolina 27834, United States

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio 44106-5000, United States

Ohio State University Medical Center

Columbus, Ohio 43210, United States

Local Institution - 917

Portland, Oregon 97227, United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania 19104, United States

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania 15224, United States

Brooke Army Medical Center Francis Street Medical Center

Fort Sam Houston, Texas 78235-8200, United States

Local Institution - 900

Houston, Texas 77030, United States

Local Institution - 924

Houston, Texas 77030, United States

Millennium Physicians - Oncology

Houston, Texas 77090, United States

VA Commonwealth University - Massey Cancer Center

Richmond, Virginia 23298-0037, United States

Local Institution - 904

Seattle, Washington 98109-4417, United States

Waukesha Memorial Hospital

Waukesha, Wisconsin 53188-5099, United States

Local Institution - 137

Garran, Australian Capital Territory 2605, Australia

Local Institution - 129

Adelaide, South Australia SA 5000, Australia

Local Institution - 134

Clayton, Victoria 3168, Australia

Local Institution - 132

Frankston, Victoria 3199, Australia

Local Institution - 131

Camperdown, 2050, Australia

Local Institution - 127

Epping, VIC, 3076, Australia

Local Institution - 133

Fitzroy, 3065, Australia

Local Institution - 135

Kogarah, 2217, Australia

Local Institution - 130

Malvern, 3144, Australia

Local Institution - 126

Milton, Brisbane, 4064, Australia

Local Institution - 138

Waratah, NSW, Australia

Local Institution - 136

Woolloongabba, QLD 4102, Australia

Local Institution - 203

Brasschaat, 2930, Belgium

Local Institution - 200

Bruges, 8000, Belgium

Local Institution - 202

Charleroi, 6000, Belgium

Local Institution - 201

Leuven, 3000, Belgium

Local Institution - 154

Fortaleza, Ceará 60430370, Brazil

Local Institution - 155

Curitiba, Paraná 81520-060, Brazil

Local Institution - 152

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Local Institution - 153

Rio de Janeiro, 20231-130, Brazil

Local Institution - 151

São Paulo, 05651-901, Brazil

Local Institution - 182

Edmonton, Alberta T6G 2B7, Canada

Local Institution - 178

Vancouver, British Columbia V5Z 1M9, Canada

Local Institution - 183

Barrie, Ontario LYM6M2, Canada

Local Institution - 180

Hamilton, Ontario L8V 5C2, Canada

Local Institution - 179

Toronto, Ontario M4N 3M5, Canada

Local Institution - 176

Toronto, Ontario M5G 2M9, Canada

Local Institution - 181

Montreal, Quebec H2W 1S6, Canada

Local Institution - 177

Montreal, Quebec H4J 1C5, Canada

Local Institution - 226

Brno, South Moravian 625 00, Czechia

Local Institution - 230

Hradec Králové, 500 05, Czechia

Local Institution - 229

Olomouc, 77520, Czechia

Local Institution - 228

Prague, 128 08, Czechia

Local Institution - 227

Prague, 128 20, Czechia

Local Institution - 253

Aarhus, 8000, Denmark

Local Institution - 252

Odense C, 5000, Denmark

Local Institution - 251

Roskilde, DK-4000, Denmark

Local Institution - 276

Helsinki, 00029 HUS, Finland

Local Institution - 277

Turku, 20521, Finland

Local Institution - 305

Lille, 59037, France

Local Institution - 304

Marseille, 13009, France

Local Institution - 301

Nantes, 44093, France

Local Institution - 308

Paris, 7575, France

Local Institution - 307

Pierre-Bénite, 69495, France

Local Institution - 302

Rennes, 35033, France

Local Institution - 303

Rouen, 76038, France

Local Institution - 306

Strasbourg, 67091, France

Local Institution - 300

Toulouse, 31059, France

Local Institution - 309

Tours, 37044, France

Local Institution - 350

Dresden, 01307, Germany

Local Institution - 361

Dresden, 01307, Germany

Local Institution - 355

Düsseldorf, 40225, Germany

Local Institution - 359

Düsseldorf, 40479, Germany

Local Institution - 356

Hamburg, D-20099, Germany

Local Institution - 353

Keil, 24105, Germany

Local Institution - 351

Leipzig, 04103, Germany

Local Institution - 352

München, 81675, Germany

Local Institution - 357

Tübingen, 72076, Germany

Local Institution - 360

Ulm, 89081, Germany

Local Institution - 853

Heraklion, Irakleio 71110, Greece

Local Institution - 851

Alexandroupoli, 68100, Greece

Local Institution - 852

Athens, 10676, Greece

Local Institution - 855

Athens, 115 27, Greece

Local Institution - 850

Athens, 124 62, Greece

Local Institution - 854

Pátrai, 26500, Greece

Local Institution - 452

Tel Aviv, Tel Aviv 64239, Israel

Local Institution - 453

Haifa, 31096, Israel

Local Institution - 451

Petah Tikva, 49100, Israel

Local Institution - 454

Tel Litwinsky, 52621, Israel

Local Institution - 482

Alessandria, 15121, Italy

Local Institution - 492

Bari, 70124, Italy

Local Institution - 489

Bologna, 40138, Italy

Local Institution - 494

Cagliari, 09121, Italy

Local Institution - 486

Florence, 50129, Italy

Local Institution - 479

Lecce, 73100, Italy

Local Institution - 498

Milan, 20089, Italy

Local Institution - 488

Milan, 20122, Italy

Local Institution - 497

Novara, 28100, Italy

Local Institution - 480

Palermo, 90146, Italy

Local Institution - 495

Pavia, 27100, Italy

Local Institution - 496

Pisa, 56126, Italy

Local Institution - 485

Reggio Calabria, 89133, Italy

Local Institution - 484

Rionero in Vulture, 85028, Italy

Local Institution - 487

Roma, 00133, Italy

Local Institution - 490

Roma, 00161, Italy

Local Institution - 481

Roma, 00168, Italy

Local Institution - 499

Terni, 05100, Italy

Local Institution - 477

Torino, 10126, Italy

Local Institution - 493

Torrette Di Ancona, 60020, Italy

Local Institution - 478

Udine, 33100, Italy

Local Institution - 476

Venezia - Mestre, 30174, Italy

Local Institution - 830

Huixquilucan de Degollado, 52763, Mexico

Local Institution - 828

Monterrey, 64460, Mexico

Local Institution - 829

Monterrey, 64710, Mexico

Local Institution - 827

Tlalpan, 14080, Mexico

Local Institution - 528

Amsterdam, 1081 HV, Netherlands

Local Institution - 527

Groningen, 9713 GZ, Netherlands

Local Institution - 526

Nijmegen, 6500 HB, Netherlands

Local Institution - 529

Rotterdam, 3075 EA, Netherlands

Local Institution - 552

Førde, 6807, Norway

Local Institution - 551

Oslo, N-0027, Norway

Local Institution - 582

Bydgoszcz, 85-168, Poland

Local Institution - 576

Gdansk, 80-952, Poland

Local Institution - 579

Krakow, 31-501, Poland

Local Institution - 581

Lodz, 93-510, Poland

Local Institution - 580

Torun, 87-100, Poland

Local Institution - 583

Warsaw, 02-097, Poland

Local Institution - 577

Warsaw, 02-776, Poland

Local Institution - 578

Wroclaw, 50-367, Poland

Local Institution - 604

Beja, 7801-849, Portugal

Local Institution - 600

Coimbra, 3000-075, Portugal

Local Institution - 601

Lisbon, 1099-023, Portugal

Local Institution - 603

Lisbon, 1150-314, Portugal

Local Institution - 602

Porto, 4200-072, Portugal

Local Institution - 704

Busan, 614-735, South Korea

Local Institution - 703

Daegu, 700-721, South Korea

Local Institution - 701

Seoul, 06591, South Korea

Local Institution - 702

Seoul, 120-752, South Korea

Local Institution - 700

Seoul, 135-710, South Korea

Local Institution - 626

Badalona (Barcelona), 8916, Spain

Local Institution - 635

Barcelona, 08025, Spain

Local Institution - 625

Barcelona, 8035, Spain

Local Institution - 636

Granada, 18014, Spain

Local Institution - 629

Madrid, 28009, Spain

Local Institution - 634

Madrid, 28034, Spain

Local Institution - 631

Madrid, 28046, Spain

Local Institution - 632

Málaga, 29010, Spain

Local Institution - 628

Oviedo, 33006, Spain

Local Institution - 630

Salamanca, 37007, Spain

Local Institution - 627

Seville, 41013, Spain

Local Institution - 633

Vitoria-Gasteiz, Álava, 1009, Spain

Local Institution - 653

Gothenburg, 413 45, Sweden

Local Institution - 652

Lund, 222 41, Sweden

Local Institution - 651

Stockholm, 14186, Sweden

Local Institution - 401

Adana, 01250, Turkey (Türkiye)

Local Institution - 405

Antalya, 07100, Turkey (Türkiye)

Local Institution - 403

Istanbul, 34098, Turkey (Türkiye)

Local Institution - 400

Istanbul, 34390, Turkey (Türkiye)

Local Institution - 404

Mersin, 33343, Turkey (Türkiye)

Local Institution - 402

Trabzon, 61080, Turkey (Türkiye)

Local Institution - 685

Oxford, Oxfordshire OX3 9DU, United Kingdom

Local Institution - 687

Aberdeen, AB25 2ZN, United Kingdom

Local Institution - 691

Birmingham, B9 5SS, United Kingdom

Local Institution - 686

Bristol, BS2 8ED, United Kingdom

Local Institution - 689

Cambridge, CB2 0QQ, United Kingdom

Local Institution - 678

Cardiff, CF14 4XW, United Kingdom

Local Institution - 688

Harrow Middlesex, HA1 3UJ, United Kingdom

Local Institution - 692

Hull, HU16 5JQ, United Kingdom

Local Institution - 677

Leicester, LE1 5WW, United Kingdom

Local Institution - 683

Liverpool, L7 8XP, United Kingdom

Local Institution - 676

London, EC1A 7BE, United Kingdom

Local Institution - 684

London, SE1 9RT, United Kingdom

Local Institution - 679

Manchester, M13 9WL, United Kingdom

Local Institution - 681

Nottingham, NG5 1PB, United Kingdom

Local Institution - 690

Sutton in Ashfield, NG17 4JL, United Kingdom

Local Institution - 680

Wolverhampton, WV10 0QP, United Kingdom