Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
3 other identifiers
interventional
268
16 countries
82
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2023
Typical duration for phase_2
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedStudy Start
First participant enrolled
July 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedMay 2, 2024
April 1, 2024
2 years
March 7, 2023
April 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part 1: To determine the navtemadlin Phase 3 dose
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
12 months
Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo
PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first
50 months
Secondary Outcomes (6)
Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment
50 months
Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST)
50 months
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
1 day
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
1 day
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
1 day
- +1 more secondary outcomes
Study Arms (7)
Part 1 Arm 1
EXPERIMENTALNavtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Part 1 Arm 2
EXPERIMENTALNavtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Part 1 Arm 3
NO INTERVENTIONObservational control ("watch and wait") on a 28-day cycle.
Part 2 Arm A
EXPERIMENTALNavtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Part 2 Arm B
EXPERIMENTALNavtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Part 2 Arm C
PLACEBO COMPARATORPlacebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Part 2 Arm D
PLACEBO COMPARATORPlacebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Interventions
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kartos Therapeutics, Inc.lead
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
- GOG Foundationcollaborator
Study Sites (83)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
April 4, 2023
Study Start
July 17, 2023
Primary Completion
August 1, 2025
Study Completion (Estimated)
July 1, 2027
Last Updated
May 2, 2024
Record last verified: 2024-04