Spots Global Cancer Trial Database for Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
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Trial Identification
Brief Title: Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Official Title: A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
Study ID: NCT05797831
Conditions
Study Description
Brief Summary: This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Kaiser Permanente Center, Vallejo, California, United States
Northside Hospital, Atlanta, Georgia, United States
St. Joseph, Savannah, Georgia, United States
Dr. Sudarshan K. Sharma, Ltd., Hinsdale, Illinois, United States
Parkview Research Center, Fort Wayne, Indiana, United States
Indiana University, Indianapolis, Indiana, United States
Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Good Samaritan Hospital Medical Center, West Islip, New York, United States
FirstHealth Carolinas, Pinehurst, North Carolina, United States
OhioHealth Institute, Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
Oncology Associates of Oregon, Eugene, Oregon, United States
Northwest Cancer Specialists, Portland, Oregon, United States
Texas Oncology-Austin Central, Austin, Texas, United States
Texas Oncology-Fort Worth Cancer Center, Fort Worth, Texas, United States
Texas Oncology-San Antonio Medical Center, San Antonio, Texas, United States
University Hospital Graz, Department of Gynecology and Obstetrics, Graz, , Austria
Medizinische Universität Innsbruck, Innsbruck, , Austria
Medizinische Universität Wien, Vienna, , Austria
Cross Cancer Institute, Edmonton, , Canada
CHUM - University of Montreal Hospital Centre, Montreal, , Canada
Odense University Hospital, Odense, , Denmark
Tartu University Hospital, Tartu, , Estonia
Kuopio University Hospital, Kuopio, , Finland
Turku University Hospital, Turku, , Finland
LTD High Technology hospital Medcenter, Batumi, , Georgia
American Hospital Network LLC, Tbilisi, , Georgia
Caucasus Medical Centre, Tbilisi, , Georgia
National Institute of Oncology, Budapest, , Hungary
University of Debrecen Clinical Center, Debrecen, , Hungary
Rambam Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Sourasky Medical Center, Tel-Aviv, , Israel
A.O. Cannizzaro, Catania, , Italy
IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori", Forli, , Italy
Ospedale Policlinico San Martino, Genoa, , Italy
ASST di Lecco-Ospedale Alessandro Manzoni, Lecco, , Italy
Ospedale San Luca, Lucca, , Italy
Osp. Niguarda, Milan, , Italy
University Hospital of Parma, Parma, , Italy
Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Ospedale di Prato S. Stefano, Prato, , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department", Rimini, , Italy
Policlinico Umberto, Rome, , Italy
Ospedale Filippo Del Ponte, Varese, , Italy
Health Sciences Kaunas Clinics, Kaunas, , Lithuania
Nation Cancer Institute of Lithuania, Vilnius, Vilnius, , Lithuania
Southern Hospital Sorlandet, Kristiansand, , Norway
Oslo University Hospital HF, Oslo, , Norway
Sykehusapotek Nord Tromsø, Tromsø, , Norway
Białostockie Centrum Onkologii, Bialystok, , Poland
Szpitale Pomorskie, Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
NIO-PIB Oddzial w Gliwicach, Gliwice, , Poland
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji, Kraków, , Poland
Siedleckie Centrum Onkologii, Olsztyn, , Poland
Uniwersytecki Szpital, Poznan, , Poland
NIO-PIB Klinika Gine-Onk, Warsaw, , Poland
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology, Wroclaw, , Poland
Bucharest CF2 Hospital, Bucharest, , Romania
Ovidius Clinical Hospital SRL, Constanta, , Romania
Onco Clinic Consult S.A., Craiova, , Romania
Oncology Center "Sf. Nectarie", Craiova, , Romania
Gral Medical S.R.L. - Oncofort Hospital, Piteşti, , Romania
Oncocenter, Oncology Clinic SRL, Timisoara, , Romania
SC Oncomed SRL, Timisoara, , Romania
Institute of Oncology Ljubljana, Ljubljana, , Slovenia
University Clinical Center Maribor, Maribor, , Slovenia
CHUAC (Hospital de Coruña), A Coruna, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Galdakao-Usansolo, Galdakao, , Spain
Hospital Universitario de Jaen, Jaen, , Spain
H.G.U. Jerez de la Frontera, Jerez de la Frontera, , Spain
Hospital U Insular de GC, Las Palmas, , Spain
Hospital de Leon, Leon, , Spain
HCU Santiago de Compostela, Santiago de Compostela, , Spain
Hospital Universitario de Valme, Seville, , Spain
Linkoping University Hospital, Linköping, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Contact Details
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