Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Start Date
7/17/2023
Completion Date
7/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Navtemadlin
Navtemadlin Placebo
Conditions
Locations
Kaiser Permanente Center
Vallejo, California 94589
United States
Northside Hospital
Atlanta, Georgia 30342
United States
St. Joseph
Savannah, Georgia 31405
United States
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois 60521
United States
Parkview Research Center
Fort Wayne, Indiana 46845
United States
Indiana University
Indianapolis, Indiana 46202
United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland 20904
United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota 55404
United States
Washington University School of Medicine
St Louis, Missouri 63108
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
United States
Good Samaritan Hospital Medical Center
West Islip, New York 11795
United States
FirstHealth Carolinas
Pinehurst, North Carolina 28374
United States
OhioHealth Institute
Columbus, Ohio 43214
United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma 74146
United States
Oncology Associates of Oregon
Eugene, Oregon 97401
United States
Northwest Cancer Specialists
Portland, Oregon 97227
United States
Texas Oncology-Austin Central
Austin, Texas 78745
United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas 76104
United States
Texas Oncology-San Antonio Medical Center
San Antonio, Texas 78130
United States
University Hospital Graz, Department of Gynecology and Obstetrics
Graz, 8036
Austria
Medizinische Universität Innsbruck
Innsbruck, 6020
Austria
Medizinische Universität Wien
Vienna, 1090
Austria
Cross Cancer Institute
Edmonton, T6G 1Z2
Canada
CHUM - University of Montreal Hospital Centre
Montreal, H2X 3E4
Canada
Odense University Hospital
Odense, DK-5000
Denmark
Tartu University Hospital
Tartu, 50406
Estonia
Kuopio University Hospital
Kuopio, 70200
Finland
Turku University Hospital
Turku, 20520
Finland
LTD High Technology hospital Medcenter
Batumi, 6000
Georgia
American Hospital Network LLC
Tbilisi, 0102
Georgia
Caucasus Medical Centre
Tbilisi, 0186
Georgia
National Institute of Oncology
Budapest, H-1122
Hungary
University of Debrecen Clinical Center
Debrecen, 4032
Hungary
Rambam Medical Center
Haifa, Rambam Medical Center
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
Sourasky Medical Center
Tel Aviv, 6423906
Israel
A.O. Cannizzaro
Catania, 95126
Italy
IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"
Forlì, 47014
Italy
Ospedale Policlinico San Martino
Genoa, 16132
Italy
ASST di Lecco-Ospedale Alessandro Manzoni
Lecco, 23900
Italy
Ospedale San Luca
Lucca, 55100
Italy
Osp. Niguarda
Milan, 20162
Italy
University Hospital of Parma
Parma, 43126
Italy
Ospedale Guglielmo da Saliceto
Piacenza, 29121
Italy
Ospedale di Prato S. Stefano
Prato, 59100
Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121
Italy
"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"
Rimini, 47923
Italy
Policlinico Umberto
Rome, 00161
Italy
Ospedale Filippo Del Ponte
Varese, 21110
Italy
Health Sciences Kaunas Clinics
Kaunas, LT-45434
Lithuania
Nation Cancer Institute of Lithuania, Vilnius
Vilnius, LT-08660
Lithuania
Southern Hospital Sorlandet
Kristiansand, 4604
Norway
Oslo University Hospital HF
Oslo, 0379
Norway
Sykehusapotek Nord Tromsø
Tromsø, 9038
Norway
Białostockie Centrum Onkologii
Bialystok, 15-027
Poland
Szpitale Pomorskie
Gdansk, 80-210
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Poland
NIO-PIB Oddzial w Gliwicach
Gliwice, 44-102
Poland
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
Krakow, 31-115
Poland
Siedleckie Centrum Onkologii
Olsztyn, 10-228
Poland
Uniwersytecki Szpital
Poznan, 60-569
Poland
NIO-PIB Klinika Gine-Onk
Warsaw, 02-781
Poland
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology
Wroclaw, 53-413
Poland
Bucharest CF2 Hospital
Bucharest, 012244
Romania
Ovidius Clinical Hospital SRL
Constanța, 905900
Romania
Onco Clinic Consult S.A.
Craiova, 200094
Romania
Oncology Center "Sf. Nectarie"
Craiova, 200542
Romania
Gral Medical S.R.L. - Oncofort Hospital
Piteşti, 110283
Romania
Oncocenter, Oncology Clinic SRL
Timișoara, 300166
Romania
SC Oncomed SRL
Timișoara, 300239
Romania
Institute of Oncology Ljubljana
Ljubljana, 1000
Slovenia
University Clinical Center Maribor
Maribor, 2000
Slovenia
CHUAC (Hospital de Coruña)
A Coruña, 15006
Spain
Hospital del Mar
Barcelona, 08003
Spain
Hospital Galdakao-Usansolo
Galdakao, 48960
Spain
Hospital Universitario de Jaen
Jaén, 23007
Spain
H.G.U. Jerez de la Frontera
Jerez de la Frontera, 11407
Spain
Hospital U Insular de GC
Las Palmas, 35016
Spain
Hospital de Leon
León, 24008
Spain
HCU Santiago de Compostela
Santiago de Compostela, 15706
Spain
Hospital Universitario de Valme
Seville, 41014
Spain
Linkoping University Hospital
Linköping, 581 85
Sweden
Karolinska University Hospital
Stockholm, SE-171 76
Sweden