Spots Global Cancer Trial Database for Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]
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Trial Identification
Brief Title: Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]
Official Title: A Randomized, Double-Blind, Phase 3 Trial of Maintenance With Selinexor/ Placebo After Combination Chemotherapy for Patients With Advanced or Recurrent Endometrial Cancer
Study ID: NCT03555422
Conditions
Study Description
Brief Summary: This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Arizona Oncology, Tucson, Arizona, United States
Stanford University, Palo Alto, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Florida Cancer Specialists (Sarah Cannon Research Institute), West Palm Beach, Florida, United States
Gynecological Cancer Institute of Chicago, Oak Lawn, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
HCA Midwest Health - Kansas City (Sarah Cannon Research Institute), Kansas City, Missouri, United States
NYU Langone, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Oklahoma Health Sciences Center - Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon, Eugene, Oregon, United States
Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Tennessee Oncology Nashville (Sarah Cannon Research Institute), Nashville, Tennessee, United States
Texas Oncology, Austin, Austin, Texas, United States
Texas Oncology, Dallas, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Oncology Forth Worth, Fort Worth, Texas, United States
VCU Massey Cancer Center, Richmond, Virginia, United States
UZ Gent, Gent, , Belgium
Jan Yperman Ziekenhuis, Ieper, , Belgium
Universitaire Ziekenhuizen K.U. Leuven, Leuven, , Belgium
CHU UCL Namur, Site Sainte-Elisabeth, Namur, , Belgium
AZ Turnhout, Turnhout, , Belgium
CHR Verviers, Verviers, , Belgium
London Health Sciences Centre (London Regional Cancer Centre), London, Ontario, Canada
University Health Network (PMCC), Toronto, Ontario, Canada
McGill University Health Centre (MUHC), Montréal, Quebec, Canada
Peking Union Medical College Hospital, Beijing, Beijing, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangxi Maternal and Child Health Hospital, Nanchang, Jiangxi, China
Liaoning Cancer Hospital, Shenyang, Liaoning, China
Chongqing University Cancer Hospital, Chongqing, Shapingba District, China
Wenzhou Medical University - The First Affiliated Hospital, Wenzhou, Zhejiang, China
University Hospital Brno, Brno, , Czechia
University Hospital Ostrava, Ostrava, , Czechia
UH Královské Vinohrady, Prague, , Czechia
General University Hospital in Prague, Prague, , Czechia
Hospital Na Bulovce, Prague, , Czechia
Charite Berlin Universitatsmedizin, Berlin, , Germany
University Hospital Dresden, Dresden, , Germany
DIAKOVERE KH gGmbH, Henriettenstift Hannover, Hannover, , Germany
Universitatsklinikum Schleswig-Holstein, Kiel, , Germany
Universitätsfrauenklinik Mainz, Mainz, , Germany
Klinikum der Universitat Munchen, Munich, , Germany
Cartitas Klinikum Saarbrücken, Saarbrücken, , Germany
Universitätsfrauenklinik Ulm, Ulm, , Germany
Iaso Hospital, Maroussi, Athens, Greece
Euromedica General Clinic, Thessaloniki, Macedonia, Greece
ALEXANDRA Hospital, Athens, , Greece
Hillel Yaffe Medical Center, Hadera, , Israel
Wolfson Medical Center, Holon, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Sheba Medical Center, Ramat -Gan, , Israel
Istituto di Candiolo, FPO, IRCCS, Candiolo, , Italy
Romagnolo Scientific Institute for the Study and Treatment of Tumors, Meldola, , Italy
San Raffaele Hospital, Milan, , Italy
Istituto Nazionale dei Tumori IRCCS - MILANO S.C. Ginecologia Oncologica, Milan, , Italy
ULSS 3 SERENISSIMA UOC Oncologia Ed Ematologia Oncologica, Mirano, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica, Naples, , Italy
Agostino Gemelli University Polyclinic Foundation, Rome, , Italy
Hospital Universitario Donostia, San Sebastián, Gipuzkoa, Spain
Hospital Universitari Vall d' Hebrón, Barcelona, , Spain
Hospital Universitari Clínic de Barcelona, Barcelona, , Spain
Consorci Sanitari de Terrassa, Barcelona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Madrid, , Spain
Hospital Universitario Infanta Sofía, Madrid, , Spain
Virgen de la Arrixaca University Clinical Hospital, Murcia, , Spain
Hospital Son Llàtzer, Palma, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Universitario y Politécnico de La Fe, Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Contact Details
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