Actively Recruiting
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Led by Kartos Therapeutics, Inc. · Updated on 2024-05-02
268
Participants Needed
83
Research Sites
206 weeks
Total Duration
On this page
Sponsors
K
Kartos Therapeutics, Inc.
Lead Sponsor
E
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status 0-1
- Confirmed diagnosis of endometrial cancer with normal TP53 gene (TP53WT)
- Advanced or recurrent disease treated with a single line of up to 6 cycles of taxane-platinum chemotherapy
- Achieved complete response (CR) or partial response (PR) according to RECIST V1.1
- Adequate blood, liver, and kidney function within 14 days before enrollment
You will not qualify if you...
- Sarcomas or small-cell carcinomas with neuroendocrine features
- Received immune therapy, cytokine therapy, or any investigational treatment within 28 days
- Presence of indwelling surgical drains
- QTc prolongation of grade 2 or higher
- History of major organ transplant
- History of bleeding disorders, major hemorrhage, or intracranial hemorrhage within the past 24 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 83 locations
1
Kaiser Permanente Center
Vallejo, California, United States, 94589
Actively Recruiting
2
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
3
St. Joseph
Savannah, Georgia, United States, 31405
Actively Recruiting
4
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois, United States, 60521
Actively Recruiting
5
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States, 20904
Actively Recruiting
8
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
9
Washington University School of Medicine
St Louis, Missouri, United States, 63108
Actively Recruiting
10
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Actively Recruiting
11
Good Samaritan Hospital Medical Center
West Islip, New York, United States, 11795
Actively Recruiting
12
FirstHealth Carolinas
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
13
OhioHealth Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
14
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
15
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Actively Recruiting
16
Northwest Cancer Specialists
Portland, Oregon, United States, 97227
Actively Recruiting
17
Texas Oncology-Austin Central
Austin, Texas, United States, 78745
Actively Recruiting
18
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
19
Texas Oncology-San Antonio Medical Center
San Antonio, Texas, United States, 78130
Actively Recruiting
20
University Hospital Graz, Department of Gynecology and Obstetrics
Graz, Austria, 8036
Actively Recruiting
21
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
22
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
23
Cross Cancer Institute
Edmonton, Canada, T6G 1Z2
Actively Recruiting
24
CHUM - University of Montreal Hospital Centre
Montreal, Canada, H2X 3E4
Actively Recruiting
25
Odense University Hospital
Odense, Denmark, DK-5000
Actively Recruiting
26
Tartu University Hospital
Tartu, Estonia, 50406
Actively Recruiting
27
Kuopio University Hospital
Kuopio, Finland, 70200
Actively Recruiting
28
Turku University Hospital
Turku, Finland, 20520
Actively Recruiting
29
LTD High Technology hospital Medcenter
Batumi, Georgia, 6000
Actively Recruiting
30
American Hospital Network LLC
Tbilisi, Georgia, 0102
Actively Recruiting
31
Caucasus Medical Centre
Tbilisi, Georgia, 0186
Actively Recruiting
32
National Institute of Oncology
Budapest, Hungary, H-1122
Actively Recruiting
33
University of Debrecen Clinical Center
Debrecen, Hungary, 4032
Actively Recruiting
34
Rambam Medical Center
Haifa, Israel, Rambam Medical Center
Actively Recruiting
35
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
36
Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
37
A.O. Cannizzaro
Catania, Italy, 95126
Actively Recruiting
38
IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"
Forlì, Italy, 47014
Actively Recruiting
39
Ospedale Policlinico San Martino
Genoa, Italy, 16132
Actively Recruiting
40
ASST di Lecco-Ospedale Alessandro Manzoni
Lecco, Italy, 23900
Actively Recruiting
41
Ospedale San Luca
Lucca, Italy, 55100
Actively Recruiting
42
Osp. Niguarda
Milan, Italy, 20162
Actively Recruiting
43
University Hospital of Parma
Parma, Italy, 43126
Actively Recruiting
44
Ospedale Guglielmo da Saliceto
Piacenza, Italy, 29121
Actively Recruiting
45
Ospedale di Prato S. Stefano
Prato, Italy, 59100
Actively Recruiting
46
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
47
"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"
Rimini, Italy, 47923
Actively Recruiting
48
Policlinico Umberto
Rome, Italy, 00161
Actively Recruiting
49
Ospedale Filippo Del Ponte
Varese, Italy, 21110
Actively Recruiting
50
Health Sciences Kaunas Clinics
Kaunas, Lithuania, LT-45434
Actively Recruiting
51
Nation Cancer Institute of Lithuania, Vilnius
Vilnius, Lithuania, LT-08660
Actively Recruiting
52
Southern Hospital Sorlandet
Kristiansand, Norway, 4604
Actively Recruiting
53
Oslo University Hospital HF
Oslo, Norway, 0379
Actively Recruiting
54
Sykehusapotek Nord Tromsø
Tromsø, Norway, 9038
Actively Recruiting
55
Białostockie Centrum Onkologii
Bialystok, Poland, 15-027
Actively Recruiting
56
Szpitale Pomorskie
Gdansk, Poland, 80-210
Actively Recruiting
57
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
58
NIO-PIB Oddzial w Gliwicach
Gliwice, Poland, 44-102
Actively Recruiting
59
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
Krakow, Poland, 31-115
Actively Recruiting
60
Siedleckie Centrum Onkologii
Olsztyn, Poland, 10-228
Actively Recruiting
61
Uniwersytecki Szpital
Poznan, Poland, 60-569
Actively Recruiting
62
NIO-PIB Klinika Gine-Onk
Warsaw, Poland, 02-781
Actively Recruiting
63
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology
Wroclaw, Poland, 53-413
Actively Recruiting
64
Bucharest CF2 Hospital
Bucharest, Romania, 012244
Actively Recruiting
65
Ovidius Clinical Hospital SRL
Constanța, Romania, 905900
Actively Recruiting
66
Onco Clinic Consult S.A.
Craiova, Romania, 200094
Actively Recruiting
67
Oncology Center "Sf. Nectarie"
Craiova, Romania, 200542
Actively Recruiting
68
Gral Medical S.R.L. - Oncofort Hospital
Piteşti, Romania, 110283
Actively Recruiting
69
Oncocenter, Oncology Clinic SRL
Timișoara, Romania, 300166
Actively Recruiting
70
SC Oncomed SRL
Timișoara, Romania, 300239
Actively Recruiting
71
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
72
University Clinical Center Maribor
Maribor, Slovenia, 2000
Actively Recruiting
73
CHUAC (Hospital de Coruña)
A Coruña, Spain, 15006
Actively Recruiting
74
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
75
Hospital Galdakao-Usansolo
Galdakao, Spain, 48960
Actively Recruiting
76
Hospital Universitario de Jaen
Jaén, Spain, 23007
Actively Recruiting
77
H.G.U. Jerez de la Frontera
Jerez de la Frontera, Spain, 11407
Actively Recruiting
78
Hospital U Insular de GC
Las Palmas, Spain, 35016
Actively Recruiting
79
Hospital de Leon
León, Spain, 24008
Actively Recruiting
80
HCU Santiago de Compostela
Santiago de Compostela, Spain, 15706
Actively Recruiting
81
Hospital Universitario de Valme
Seville, Spain, 41014
Actively Recruiting
82
Linkoping University Hospital
Linköping, Sweden, 581 85
Actively Recruiting
83
Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Actively Recruiting
Research Team
J
John Mei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here