Spots Global Cancer Trial Database for Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
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Trial Identification
Brief Title: Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Official Title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Study ID: NCT03173248
Study Description
Brief Summary: Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Norton Cancer Institute - Suburban, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford park, South Australia, Australia
Salzburger Landeskliniken, Salzburg, , Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Wien, , Austria
Unicamp Universidade Estadual de Campinas, Campinas, Sao Paulo, Brazil
Hospital Amaral Carvalho, Jau, Sao Paulo, Brazil
Instituto Nacional de Cancer, Rio De Janeiro, , Brazil
Hospital Sirio Libanes, Sao Paulo, , Brazil
Hospital Sao Jose, Sao Paulo, , Brazil
Hospital Santa Marcelina, Sao Paulo, , Brazil
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
University Health Network, Toronto, Ontario, Canada
Henan Cancer Hospital, Zhengzhou, Henan, China
West China Hospital Sichuan University, Chengdu, Sichuan, China
Peking Union Medical College Hospital, Beijing, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, , China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, , China
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Hopital Haut Leveque, Pessac, Gironde, France
Hopital Bretonneau, Tours, Indre-et-Loire, France
Hotel Dieu - Nantes, Nantes, Loire-Atlantique, France
Centre Hospitalier Lyon Sud, Pierre-benite, Rhone, France
Centre Hospitalier Le Mans, Le Mans, Sarthe, France
CHRU de Brest - Hopital Morvan, Brest, , France
Institut dHematologie de Basse Normandie, Caen, , France
CHU de Grenoble, Grenoble, , France
Centre Hospitalier de Versailles CHV Hopital Andre Mignot, Le Chesnay, , France
Groupe Hospitalier Necker Enfants Malades, Paris, , France
CHRU de Poitiers La Miletrie, Poitiers, , France
Hopital de Hautepierre, Strasbourg, , France
EDOG - Institut Claudius Regaud - PPDS, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Klinikum Chemnitz gGmbH, Chemnitz, Sachsen, Germany
Charite - Universitatsmedizin Berlin, Berlin, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
LMU Klinikum der Universitat Munchen, Munchen, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Rabin Medical Center - PPDS, Petah Tikva, , Israel
Kaplan Medical Center, Rehovot, , Israel
ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi, Varese, Lombardia, Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola, , Italy
Ospedale San Raffaele S.r.l. - PPDS, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda, Milano, , Italy
Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia, , Italy
Ospedale Infermi di Rimini, Rimini, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, , Italy
Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan
University of Fukui Hospital, Fukui, , Japan
Japanese Red Cross Society Himeji Hospital, Himeji, , Japan
Kobe City Medical Center General Hospital, Kobe, , Japan
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Ajou University Hospital, Suwon-si, Gyeonggido, Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
SINACOR, Culiacan, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, , Mexico
VU Medisch Centrum, Amsterdam, Noord-Holland, Netherlands
Universitair Medisch Centrum Groningen, Nijmegen, , Netherlands
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw, Dolnoslaskie, Poland
Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Kaluga Regional Clinical Hospital, Kaluga, , Russian Federation
City Clinical Hospital # 40, Moscow, , Russian Federation
CHUS H. Clinico U. de Santiago, Santiago de Compostela, A Coruna, Spain
Hospital Universitario Son Espases, Palma de Mallorca, Baleares, Spain
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen del Rocio - PPDS, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Changhua Christian Medical Foundation Changhua Christian Hospital, Changhua City, , Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
Chi Mei Medical Center, Liouying, Tainan City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Birmingham Heartlands Hospital, Birmingham, West Midlands, United Kingdom
Contact Details
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