Trial Title:
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
NCT ID:
NCT05797831
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
navtemadlin
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Navtemadlin
Description:
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
Arm group label:
Part 1 Arm 1
Arm group label:
Part 1 Arm 2
Arm group label:
Part 2 Arm A
Arm group label:
Part 2 Arm B
Other name:
KRT-232
Intervention type:
Drug
Intervention name:
Navtemadlin Placebo
Description:
Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken
by mouth
Arm group label:
Part 2 Arm C
Arm group label:
Part 2 Arm D
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
- Prior immune therapy, cytokine therapy, or any investigational therapy (within 28
days)
- Indwelling surgical drains
- Grade 2 or higher QTc prolongation
- History of major organ transplant
- History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within
24 weeks)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaiser Permanente Center
Address:
City:
Vallejo
Zip:
94589
Country:
United States
Status:
Recruiting
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Joseph
Address:
City:
Savannah
Zip:
31405
Country:
United States
Status:
Recruiting
Facility:
Name:
Dr. Sudarshan K. Sharma, Ltd.
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
Parkview Research Center
Address:
City:
Fort Wayne
Zip:
46845
Country:
United States
Status:
Recruiting
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Facility:
Name:
Maryland Oncology Hematology, P.A.
Address:
City:
Silver Spring
Zip:
20904
Country:
United States
Status:
Recruiting
Facility:
Name:
Minnesota Oncology Hematology, P.A.
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63108
Country:
United States
Status:
Recruiting
Facility:
Name:
Women's Cancer Center of Nevada
Address:
City:
Las Vegas
Zip:
89106
Country:
United States
Status:
Recruiting
Facility:
Name:
Good Samaritan Hospital Medical Center
Address:
City:
West Islip
Zip:
11795
Country:
United States
Status:
Recruiting
Facility:
Name:
FirstHealth Carolinas
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Facility:
Name:
OhioHealth Institute
Address:
City:
Columbus
Zip:
43214
Country:
United States
Status:
Recruiting
Facility:
Name:
Oklahoma Cancer Specialists and Research Institute
Address:
City:
Tulsa
Zip:
74146
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Associates of Oregon
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Cancer Specialists
Address:
City:
Portland
Zip:
97227
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology-Austin Central
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology-Fort Worth Cancer Center
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology-San Antonio Medical Center
Address:
City:
San Antonio
Zip:
78130
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospital Graz, Department of Gynecology and Obstetrics
Address:
City:
Graz
Zip:
8036
Country:
Austria
Status:
Recruiting
Facility:
Name:
Medizinische Universität Innsbruck
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Medizinische Universität Wien
Address:
City:
Vienna
Zip:
1090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Facility:
Name:
CHUM - University of Montreal Hospital Centre
Address:
City:
Montreal
Zip:
H2X 3E4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
DK-5000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Tartu University Hospital
Address:
City:
Tartu
Zip:
50406
Country:
Estonia
Status:
Recruiting
Facility:
Name:
Kuopio University Hospital
Address:
City:
Kuopio
Zip:
70200
Country:
Finland
Status:
Recruiting
Facility:
Name:
Turku University Hospital
Address:
City:
Turku
Zip:
20520
Country:
Finland
Status:
Recruiting
Facility:
Name:
LTD High Technology hospital Medcenter
Address:
City:
Batumi
Zip:
6000
Country:
Georgia
Status:
Recruiting
Facility:
Name:
American Hospital Network LLC
Address:
City:
Tbilisi
Zip:
0102
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Caucasus Medical Centre
Address:
City:
Tbilisi
Zip:
0186
Country:
Georgia
Status:
Recruiting
Facility:
Name:
National Institute of Oncology
Address:
City:
Budapest
Zip:
H-1122
Country:
Hungary
Status:
Recruiting
Facility:
Name:
University of Debrecen Clinical Center
Address:
City:
Debrecen
Zip:
4032
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Rambam Medical Center
Address:
City:
Haifa
Zip:
Rambam Medical Center
Country:
Israel
Status:
Recruiting
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sourasky Medical Center
Address:
City:
Tel-Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
A.O. Cannizzaro
Address:
City:
Catania
Zip:
95126
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"
Address:
City:
Forli
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Policlinico San Martino
Address:
City:
Genoa
Zip:
16132
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST di Lecco-Ospedale Alessandro Manzoni
Address:
City:
Lecco
Zip:
23900
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Luca
Address:
City:
Lucca
Zip:
55100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Osp. Niguarda
Address:
City:
Milan
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
University Hospital of Parma
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Guglielmo da Saliceto
Address:
City:
Piacenza
Zip:
29121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale di Prato S. Stefano
Address:
City:
Prato
Zip:
59100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Maria delle Croci
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Facility:
Name:
"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"
Address:
City:
Rimini
Zip:
47923
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Umberto
Address:
City:
Rome
Zip:
00161
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Filippo Del Ponte
Address:
City:
Varese
Zip:
21110
Country:
Italy
Status:
Recruiting
Facility:
Name:
Health Sciences Kaunas Clinics
Address:
City:
Kaunas
Zip:
LT-45434
Country:
Lithuania
Status:
Recruiting
Facility:
Name:
Nation Cancer Institute of Lithuania, Vilnius
Address:
City:
Vilnius
Zip:
LT-08660
Country:
Lithuania
Status:
Recruiting
Facility:
Name:
Southern Hospital Sorlandet
Address:
City:
Kristiansand
Zip:
4604
Country:
Norway
Status:
Recruiting
Facility:
Name:
Oslo University Hospital HF
Address:
City:
Oslo
Zip:
0379
Country:
Norway
Status:
Recruiting
Facility:
Name:
Sykehusapotek Nord Tromsø
Address:
City:
Tromsø
Zip:
9038
Country:
Norway
Status:
Recruiting
Facility:
Name:
Białostockie Centrum Onkologii
Address:
City:
Bialystok
Zip:
15-027
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpitale Pomorskie
Address:
City:
Gdansk
Zip:
80-210
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
NIO-PIB Oddzial w Gliwicach
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
Address:
City:
Kraków
Zip:
31-115
Country:
Poland
Status:
Recruiting
Facility:
Name:
Siedleckie Centrum Onkologii
Address:
City:
Olsztyn
Zip:
10-228
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersytecki Szpital
Address:
City:
Poznan
Zip:
60-569
Country:
Poland
Status:
Recruiting
Facility:
Name:
NIO-PIB Klinika Gine-Onk
Address:
City:
Warsaw
Zip:
02-781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology
Address:
City:
Wroclaw
Zip:
53-413
Country:
Poland
Status:
Recruiting
Facility:
Name:
Bucharest CF2 Hospital
Address:
City:
Bucharest
Zip:
012244
Country:
Romania
Status:
Recruiting
Facility:
Name:
Ovidius Clinical Hospital SRL
Address:
City:
Constanta
Zip:
905900
Country:
Romania
Status:
Recruiting
Facility:
Name:
Onco Clinic Consult S.A.
Address:
City:
Craiova
Zip:
200094
Country:
Romania
Status:
Recruiting
Facility:
Name:
Oncology Center "Sf. Nectarie"
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Recruiting
Facility:
Name:
Gral Medical S.R.L. - Oncofort Hospital
Address:
City:
Piteşti
Zip:
110283
Country:
Romania
Status:
Recruiting
Facility:
Name:
Oncocenter, Oncology Clinic SRL
Address:
City:
Timisoara
Zip:
300166
Country:
Romania
Status:
Recruiting
Facility:
Name:
SC Oncomed SRL
Address:
City:
Timisoara
Zip:
300239
Country:
Romania
Status:
Recruiting
Facility:
Name:
Institute of Oncology Ljubljana
Address:
City:
Ljubljana
Zip:
1000
Country:
Slovenia
Status:
Recruiting
Facility:
Name:
University Clinical Center Maribor
Address:
City:
Maribor
Zip:
2000
Country:
Slovenia
Status:
Recruiting
Facility:
Name:
CHUAC (Hospital de Coruña)
Address:
City:
A Coruna
Zip:
15006
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Galdakao-Usansolo
Address:
City:
Galdakao
Zip:
48960
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Jaen
Address:
City:
Jaen
Zip:
23007
Country:
Spain
Status:
Recruiting
Facility:
Name:
H.G.U. Jerez de la Frontera
Address:
City:
Jerez de la Frontera
Zip:
11407
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital U Insular de GC
Address:
City:
Las Palmas
Zip:
35016
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital de Leon
Address:
City:
Leon
Zip:
24008
Country:
Spain
Status:
Recruiting
Facility:
Name:
HCU Santiago de Compostela
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Valme
Address:
City:
Seville
Zip:
41014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Linkoping University Hospital
Address:
City:
Linköping
Zip:
581 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
SE-171 76
Country:
Sweden
Status:
Recruiting
Start date:
July 17, 2023
Completion date:
July 2027
Lead sponsor:
Agency:
Kartos Therapeutics, Inc.
Agency class:
Industry
Collaborator:
Agency:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Agency class:
Other
Collaborator:
Agency:
GOG Foundation
Agency class:
Other
Source:
Kartos Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797831
