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Spots Global Cancer Trial Database for A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

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Trial Identification

Brief Title: A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Official Title: A Randomized, Double-blind, Placebo-controlled, Phase III, Multi-centre Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With IPSS Intermediate-1, Intermediate 2 and High-risk Myelodysplastic Syndromes (MDS) SUPPORT: A StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine

Study ID: NCT02158936

Study Description

Brief Summary: Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura \[ITP\], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of \<75 Giga (10\^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Novartis Investigative Site, Hartford, Connecticut, United States

Novartis Investigative Site, Atlanta, Georgia, United States

Novartis Investigative Site, Chicago, Illinois, United States

Novartis Investigative Site, Anderson, Indiana, United States

Novartis Investigative Site, Kansas City, Missouri, United States

Novartis Investigative Site, San Luis, Missouri, United States

Novartis Investigative Site, Bronx, New York, United States

Novartis Investigative Site, Winston-Salem, North Carolina, United States

Novartis Investigative Site, Seattle, Washington, United States

Novartis Investigative Site, Milwaukee, Wisconsin, United States

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina

Novartis Investigative Site, Santa Fe, , Argentina

Novartis Investigative Site, Kogarah, New South Wales, Australia

Novartis Investigative Site, Adelaide, South Australia, Australia

Novartis Investigative Site, Clayton, Victoria, Australia

Novartis Investigative Site, East Melbourne, Victoria, Australia

Novartis Investigative Site, Melbourne, Victoria, Australia

Novartis Investigative Site, Graz, , Austria

Novartis Investigative Site, Innsbruck, , Austria

Novartis Investigative Site, Linz, , Austria

Novartis Investigative Site, Rankweil, , Austria

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Steyr, , Austria

Novartis Investigative Site, Vienna, , Austria

Novartis Investigative Site, Brasschaat, , Belgium

Novartis Investigative Site, Brugge, , Belgium

Novartis Investigative Site, Leuven, , Belgium

Novartis Investigative Site, Lodelinsart, , Belgium

Novartis Investigative Site, Turnhout, , Belgium

Novartis Investigative Site, Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site, Curitiba, Paraná, Brazil

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Florianopolis, Santa Catarina, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Rio de Janeiro, , Brazil

Novartis Investigative Site, Sao Paulo - SP, , Brazil

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Sherbrooke, Quebec, Canada

Novartis Investigative Site, Quebec, , Canada

Novartis Investigative Site, Québec, , Canada

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Ostrava, , Czechia

Novartis Investigative Site, Praha 10, , Czechia

Novartis Investigative Site, Praha 2, , Czechia

Novartis Investigative Site, Praha, , Czechia

Novartis Investigative Site, Aarhus, , Denmark

Novartis Investigative Site, Koebenhavn Oe, , Denmark

Novartis Investigative Site, Angers Cedex 9, , France

Novartis Investigative Site, Caen Cedex 9, , France

Novartis Investigative Site, Le Mans, , France

Novartis Investigative Site, Paris Cedex 12, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Pringy Cedex, , France

Novartis Investigative Site, Stuttgart, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Muenchen, Bayern, Germany

Novartis Investigative Site, Goettingen, Niedersachsen, Germany

Novartis Investigative Site, Duesseldorf, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Duesseldorf, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Duisburg, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Dresden, Sachsen, Germany

Novartis Investigative Site, Athens,, , Greece

Novartis Investigative Site, Larisa, , Greece

Novartis Investigative Site, Patra, , Greece

Novartis Investigative Site, Thessaloniki, , Greece

Novartis Investigative Site, Thessaloniki, , Greece

Novartis Investigative Site, Chai Wan, , Hong Kong

Novartis Investigative Site, Hong Kong, , Hong Kong

Novartis Investigative Site, Shatin, New Territories, , Hong Kong

Novartis Investigative Site, Tuen Mun, , Hong Kong

Novartis Investigative Site, Debrecen, , Hungary

Novartis Investigative Site, Szeged, , Hungary

Novartis Investigative Site, Dublin, , Ireland

Novartis Investigative Site, Galway, , Ireland

Novartis Investigative Site, James Street, , Ireland

Novartis Investigative Site, Limerick, , Ireland

Novartis Investigative Site, Tallaght, Dublin, , Ireland

Novartis Investigative Site, Haifa, , Israel

Novartis Investigative Site, Holon, , Israel

Novartis Investigative Site, Jerusalem, , Israel

Novartis Investigative Site, Jerusalem, , Israel

Novartis Investigative Site, Kfar Saba, , Israel

Novartis Investigative Site, Petach-Tikva, , Israel

Novartis Investigative Site, Tel Aviv, , Israel

Novartis Investigative Site, Reggio Calabria, Calabria, Italy

Novartis Investigative Site, Modena, Emilia-Romagna, Italy

Novartis Investigative Site, Genova, Liguria, Italy

Novartis Investigative Site, Novara, Piemonte, Italy

Novartis Investigative Site, Firenze, Toscana, Italy

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Monterrey, Nuevo León, Mexico

Novartis Investigative Site, Oaxaca, , Mexico

Novartis Investigative Site, Bergen, , Norway

Novartis Investigative Site, Oslo, , Norway

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Krakow, , Poland

Novartis Investigative Site, Legnica, , Poland

Novartis Investigative Site, Lublin, , Poland

Novartis Investigative Site, Opole, , Poland

Novartis Investigative Site, Slupsk, , Poland

Novartis Investigative Site, Torun, , Poland

Novartis Investigative Site, San Juan, , Puerto Rico

Novartis Investigative Site, Kaluga, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Penza, , Russian Federation

Novartis Investigative Site, St Petersburg, , Russian Federation

Novartis Investigative Site, St'Petersburg, , Russian Federation

Novartis Investigative Site, Oviedo, Asturias, Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Gerona, , Spain

Novartis Investigative Site, La Laguna (Santa Cruz De Tenerife), , Spain

Novartis Investigative Site, Leon, , Spain

Novartis Investigative Site, León, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Majadahonda (Madrid), , Spain

Novartis Investigative Site, Malaga, , Spain

Novartis Investigative Site, Málaga, , Spain

Novartis Investigative Site, Oviedo, , Spain

Novartis Investigative Site, Palma de Mallorca, , Spain

Novartis Investigative Site, Palma de Mallorca, , Spain

Novartis Investigative Site, Pozuelo De Alarcon/Madrid, , Spain

Novartis Investigative Site, Pozuelo De Alarcón/Madrid, , Spain

Novartis Investigative Site, Salamanca, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Goteborg, , Sweden

Novartis Investigative Site, Göteborg, , Sweden

Novartis Investigative Site, Stockholm, , Sweden

Novartis Investigative Site, Uppsala, , Sweden

Novartis Investigative Site, Aarau, , Switzerland

Novartis Investigative Site, Bellinzona, , Switzerland

Novartis Investigative Site, Bern, , Switzerland

Novartis Investigative Site, Zuerich, , Switzerland

Novartis Investigative Site, Changhua, , Taiwan

Novartis Investigative Site, Kaohsiung, , Taiwan

Novartis Investigative Site, Kaohsiung, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, ChiangMai, , Thailand

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Izmir, , Turkey

Novartis Investigative Site, Izmir, , Turkey

Novartis Investigative Site, Samsun, , Turkey

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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