Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
- Conditions
- Endometrial Cancer
- Interventions
- Registration Number
- NCT05797831
- Lead Sponsor
- Kartos Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 268
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2 Arm D Navtemadlin Placebo Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle. Part 2 Arm C Navtemadlin Placebo Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle. Part 2 Arm A Navtemadlin Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles. Part 1 Arm 2 Navtemadlin Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles. Part 1 Arm 1 Navtemadlin Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles. Part 2 Arm B Navtemadlin Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
- Primary Outcome Measures
Name Time Method Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo 50 months PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first
Part 1: To determine the navtemadlin Phase 3 dose 12 months Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
- Secondary Outcome Measures
Name Time Method Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST) 50 months TFST defined as the time from randomization to initiation of first subsequent anticancer therapy or death, whichever occurs first
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin 1 day Will determine the time of maximum plasma concentration (Tmax)
Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR) 50 months Best response of complete response (CR), partial response (PR) or stable disease (SD) by IRC/investigator assessment among subjects with PR as best response from prior chemotherapy
Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment 50 months PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first
Related Research Topics
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Trial Locations
- Locations (83)
Indiana University
🇺🇸Indianapolis, Indiana, United States
Texas Oncology-San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
Kaiser Permanente Center
🇺🇸Vallejo, California, United States
St. Joseph
🇺🇸Savannah, Georgia, United States
Cross Cancer Institute
🇨🇦Edmonton, Canada
Kuopio University Hospital
🇫🇮Kuopio, Finland
National Institute of Oncology
🇭🇺Budapest, Hungary
A.O. Cannizzaro
🇮🇹Catania, Italy
University of Debrecen Clinical Center
🇭🇺Debrecen, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"
🇮🇹Forli, Italy
Ospedale Policlinico San Martino
🇮🇹Genoa, Italy
Ospedale di Prato S. Stefano
🇮🇹Prato, Italy
Southern Hospital Sorlandet
🇳🇴Kristiansand, Norway
Sykehusapotek Nord Tromsø
🇳🇴Tromsø, Norway
NIO-PIB Oddzial w Gliwicach
🇵🇱Gliwice, Poland
Uniwersytecki Szpital
🇵🇱Poznan, Poland
Siedleckie Centrum Onkologii
🇵🇱Olsztyn, Poland
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology
🇵🇱Wroclaw, Poland
Bucharest CF2 Hospital
🇷🇴Bucharest, Romania
Onco Clinic Consult S.A.
🇷🇴Craiova, Romania
Institute of Oncology Ljubljana
🇸🇮Ljubljana, Slovenia
CHUAC (Hospital de Coruña)
🇪🇸A Coruna, Spain
Hospital Universitario de Jaen
🇪🇸Jaen, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Galdakao-Usansolo
🇪🇸Galdakao, Spain
H.G.U. Jerez de la Frontera
🇪🇸Jerez de la Frontera, Spain
Hospital de Leon
🇪🇸Leon, Spain
HCU Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Hospital Universitario de Valme
🇪🇸Seville, Spain
Hospital U Insular de GC
🇪🇸Las Palmas, Spain
Linkoping University Hospital
🇸🇪Linköping, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Poland
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
CHUM - University of Montreal Hospital Centre
🇨🇦Montreal, Canada
American Hospital Network LLC
🇬🇪Tbilisi, Georgia
Policlinico Umberto
🇮🇹Rome, Italy
Health Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
NIO-PIB Klinika Gine-Onk
🇵🇱Warsaw, Poland
Oncocenter, Oncology Clinic SRL
🇷🇴Timisoara, Romania
Osp. Niguarda
🇮🇹Milan, Italy
ASST di Lecco-Ospedale Alessandro Manzoni
🇮🇹Lecco, Italy
Northwest Cancer Specialists
🇺🇸Portland, Oregon, United States
University Hospital of Parma
🇮🇹Parma, Italy
Oncology Associates of Oregon
🇺🇸Eugene, Oregon, United States
University Hospital Graz, Department of Gynecology and Obstetrics
🇦🇹Graz, Austria
Medizinische Universität Wien
🇦🇹Vienna, Austria
Maryland Oncology Hematology, P.A.
🇺🇸Silver Spring, Maryland, United States
Ospedale Filippo Del Ponte
🇮🇹Varese, Italy
LTD High Technology hospital Medcenter
🇬🇪Batumi, Georgia
Tartu University Hospital
🇪🇪Tartu, Estonia
Turku University Hospital
🇫🇮Turku, Finland
Caucasus Medical Centre
🇬🇪Tbilisi, Georgia
"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"
🇮🇹Rimini, Italy
Nation Cancer Institute of Lithuania, Vilnius
🇱🇹Vilnius, Lithuania
Szpitale Pomorskie
🇵🇱Gdansk, Poland
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
🇵🇱Kraków, Poland
Ovidius Clinical Hospital SRL
🇷🇴Constanta, Romania
University Clinical Center Maribor
🇸🇮Maribor, Slovenia
Oslo University Hospital HF
🇳🇴Oslo, Norway
Białostockie Centrum Onkologii
🇵🇱Bialystok, Poland
Oncology Center "Sf. Nectarie"
🇷🇴Craiova, Romania
Ospedale San Luca
🇮🇹Lucca, Italy
Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
Gral Medical S.R.L. - Oncofort Hospital
🇷🇴Piteşti, Romania
SC Oncomed SRL
🇷🇴Timisoara, Romania
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Dr. Sudarshan K. Sharma, Ltd.
🇺🇸Hinsdale, Illinois, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Good Samaritan Hospital Medical Center
🇺🇸West Islip, New York, United States
FirstHealth Carolinas
🇺🇸Pinehurst, North Carolina, United States
Texas Oncology-Austin Central
🇺🇸Austin, Texas, United States
Texas Oncology-Fort Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
Oklahoma Cancer Specialists and Research Institute
🇺🇸Tulsa, Oklahoma, United States
OhioHealth Institute
🇺🇸Columbus, Ohio, United States
Odense University Hospital
🇩🇰Odense, Denmark
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria