A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• ECOG 0-1
• Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
• Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1
• Adequate hematologic, hepatic and renal function (within 14 days)
Locations
United States
California
Kaiser Permanente Center
RECRUITING
Vallejo
Georgia
Northside Hospital
RECRUITING
Atlanta
St. Joseph
RECRUITING
Savannah
Illinois
Dr. Sudarshan K. Sharma, Ltd.
RECRUITING
Hinsdale
Indiana
Parkview Research Center
RECRUITING
Fort Wayne
Indiana University
RECRUITING
Indianapolis
Maryland
Maryland Oncology Hematology, P.A.
RECRUITING
Silver Spring
Minnesota
Minnesota Oncology Hematology, P.A.
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
FirstHealth Carolinas
RECRUITING
Pinehurst
Nevada
Women's Cancer Center of Nevada
RECRUITING
Las Vegas
New York
Good Samaritan Hospital Medical Center
RECRUITING
West Islip
Ohio
OhioHealth Institute
RECRUITING
Columbus
Oklahoma
Oklahoma Cancer Specialists and Research Institute
RECRUITING
Tulsa
Oregon
Oncology Associates of Oregon
RECRUITING
Eugene
Northwest Cancer Specialists
RECRUITING
Portland
Texas
Texas Oncology-Austin Central
RECRUITING
Austin
Texas Oncology-Fort Worth Cancer Center
RECRUITING
Fort Worth
Texas Oncology-San Antonio Medical Center
RECRUITING
San Antonio
Other Locations
Austria
University Hospital Graz, Department of Gynecology and Obstetrics
RECRUITING
Graz
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Medizinische Universität Wien
RECRUITING
Vienna
Canada
Cross Cancer Institute
RECRUITING
Edmonton
CHUM - University of Montreal Hospital Centre
RECRUITING
Montreal
Denmark
Odense University Hospital
RECRUITING
Odense
Estonia
Tartu University Hospital
RECRUITING
Tartu
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Turku University Hospital
RECRUITING
Turku
Georgia
LTD High Technology hospital Medcenter
RECRUITING
Batumi
American Hospital Network LLC
RECRUITING
Tbilisi
Caucasus Medical Centre
RECRUITING
Tbilisi
Hungary
National Institute of Oncology
RECRUITING
Budapest
University of Debrecen Clinical Center
RECRUITING
Debrecen
Israel
Rambam Medical Center
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
A.O. Cannizzaro
RECRUITING
Catania
IRCCS Istituto Romangolo per lo Studio dei Tumori Dino Amadori
RECRUITING
Forlì
Ospedale Policlinico San Martino
RECRUITING
Genoa
ASST di Lecco-Ospedale Alessandro Manzoni
RECRUITING
Lecco
Ospedale San Luca
RECRUITING
Lucca
Osp. Niguarda
RECRUITING
Milan
University Hospital of Parma
RECRUITING
Parma
Ospedale Guglielmo da Saliceto
RECRUITING
Piacenza
Ospedale di Prato S. Stefano
RECRUITING
Prato
Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Azienda Unità Sanitaria Locale della Romagna - Hospital Infermi of Rimini Oncology Department
RECRUITING
Rimini
Policlinico Umberto
RECRUITING
Rome
Ospedale Filippo Del Ponte
RECRUITING
Varese
Lithuania
Health Sciences Kaunas Clinics
RECRUITING
Kaunas
Nation Cancer Institute of Lithuania, Vilnius
RECRUITING
Vilnius
Norway
Southern Hospital Sorlandet
RECRUITING
Kristiansand
Oslo University Hospital HF
RECRUITING
Oslo
Sykehusapotek Nord Tromsø
RECRUITING
Tromsø
Poland
Białostockie Centrum Onkologii
RECRUITING
Bialystok
Szpitale Pomorskie
RECRUITING
Gdansk
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
NIO-PIB Oddzial w Gliwicach
RECRUITING
Gliwice
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
RECRUITING
Krakow
Siedleckie Centrum Onkologii
RECRUITING
Olsztyn
Uniwersytecki Szpital
RECRUITING
Poznan
NIO-PIB Klinika Gine-Onk
RECRUITING
Warsaw
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology
RECRUITING
Wroclaw
Romania
Bucharest CF2 Hospital
RECRUITING
Bucharest
Ovidius Clinical Hospital SRL
RECRUITING
Constanța
Onco Clinic Consult S.A.
RECRUITING
Craiova
Oncology Center Sf. Nectarie
RECRUITING
Craiova
Gral Medical S.R.L. - Oncofort Hospital
RECRUITING
Piteşti
Oncocenter, Oncology Clinic SRL
RECRUITING
Timișoara
SC Oncomed SRL
RECRUITING
Timișoara
Slovenia
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
University Clinical Center Maribor
RECRUITING
Maribor
Spain
CHUAC (Hospital de Coruña)
RECRUITING
A Coruña
Hospital del Mar
RECRUITING
Barcelona
Hospital Galdakao-Usansolo
RECRUITING
Galdakao
Hospital Universitario de Jaen
RECRUITING
Jaén
H.G.U. Jerez de la Frontera
RECRUITING
Jerez De La Frontera
Hospital U Insular de GC
RECRUITING
Las Palmas
Hospital de Leon
RECRUITING
León
HCU Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario de Valme
RECRUITING
Seville
Sweden
Linkoping University Hospital
RECRUITING
Linköping
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
John Mei
jmei@kartosthera.com
650-542-0136
Time Frame
Start Date: 2023-07-17
Estimated Completion Date: 2027-07
Participants
Target number of participants: 268
Treatments
Experimental: Part 1 Arm 1
Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Experimental: Part 1 Arm 2
Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
No_intervention: Part 1 Arm 3
Observational control (watch and wait) on a 28-day cycle.
Experimental: Part 2 Arm A
Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Experimental: Part 2 Arm B
Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Placebo_comparator: Part 2 Arm C
Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Placebo_comparator: Part 2 Arm D
Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Related Therapeutic Areas
Sponsors
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Leads: Kartos Therapeutics, Inc.