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NCT05797831RecruitingPhase 2/3

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

Source: ClinicalTrials.gov · Last updated 2 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
268 (estimated)
First submitted
7 Mar 2023
Start date
17 Jul 2023
Primary completion date
Aug 2025
Lead sponsor
Kartos Therapeutics, Inc.
NCT number
NCT05797831

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 268
  • From 17 Jul 2023 to the primary completion date, Aug 2025
  • 83 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
  • Indwelling surgical drains

Other illness

  • History of major organ transplant
  • History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)

Lab values

  • Grade 2 or higher QTc prolongation

Other

  • Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (83)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Graz, Department of Gynecology and Obstetrics
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GrazAustriaRecruiting
Medizinische Universität Innsbruck
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InnsbruckAustriaRecruiting
Medizinische Universität Wien
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ViennaAustriaRecruiting
Cross Cancer Institute
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EdmontonCanadaRecruiting
CHUM - University of Montreal Hospital Centre
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MontrealCanadaRecruiting
Odense University Hospital
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OdenseDenmarkRecruiting
Tartu University Hospital
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TartuEstoniaRecruiting
CHUAC (Hospital de Coruña)
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A CoruñaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Galdakao-Usansolo
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GaldakaoSpainRecruiting
Hospital Universitario de Jaén
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JaénSpainRecruiting
H.G.U. Jerez de la Frontera
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Jerez de la FronteraSpainRecruiting
Hospital U Insular de GC
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Las PalmasSpainRecruiting
Hospital de León
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LeónSpainRecruiting
HCU Santiago de Compostela
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Santiago de CompostelaSpainRecruiting
Hospital Universitario de Valme
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SevilleSpainRecruiting
Kuopio University Hospital
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KuopioFinlandRecruiting
Turku University Hospital
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TurkuFinlandRecruiting
LTD High Technology Hospital Medcenter
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BatumiGeorgiaRecruiting
Caucasus Medical Centre
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TbilisiGeorgiaRecruiting
American Hospital Network LLC
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TbilisiGeorgiaRecruiting
National Institute of Oncology
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BudapestHungaryRecruiting
University of Debrecen Clinical Center
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DebrecenHungaryRecruiting
Rambam Medical Center
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HaifaIsraelRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Sourasky Medical Center
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Tel AvivIsraelRecruiting
A.O. Cannizzaro
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CataniaItalyRecruiting
IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"
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ForlìItalyRecruiting
Ospedale Policlinico San Martino
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GenoaItalyRecruiting
ASST di Lecco-Ospedale Alessandro Manzoni
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LeccoItalyRecruiting
Ospedale San Luca
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LuccaItalyRecruiting
Osp. Niguarda
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MilanItalyRecruiting
University Hospital Of Parma
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ParmaItalyRecruiting
Ospedale Guglielmo da Saliceto
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PiacenzaItalyRecruiting
Ospedale di Prato S. Stefano
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PratoItalyRecruiting
Ospedale Santa Maria delle Croci
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RavennaItalyRecruiting
"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"
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RiminiItalyRecruiting
Policlinico Umberto
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RomeItalyRecruiting
Ospedale Filippo del Ponte
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VareseItalyRecruiting
Health Sciences Kaunas Clinics
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KaunasLithuaniaRecruiting
Nation Cancer Institute of Lithuania, Vilnius
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VilniusLithuaniaRecruiting
Southern Hospital Sorlandet
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KristiansandNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Sykehusapotek Nord Tromsø
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TromsøNorwayRecruiting
Białostockie Centrum Onkologii
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BialystokPolandRecruiting
Szpitale Pomorskie
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GdanskPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
NIO-PIB Oddzial w Gliwicach
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GliwicePolandRecruiting
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
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KrakowPolandRecruiting
Siedleckie Centrum Onkologii
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OlsztynPolandRecruiting
Uniwersytecki Szpital
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PoznanPolandRecruiting
NIO-PIB Klinika Gine-Onk
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WarsawPolandRecruiting
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology
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WroclawPolandRecruiting
Bucharest CF2 Hospital
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BucharestRomaniaRecruiting
Ovidius Clinical Hospital SRL
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ConstanțaRomaniaRecruiting
Onco Clinic Consult S.A.
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CraiovaRomaniaRecruiting
Oncology Center Sf. Nectarie
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CraiovaRomaniaRecruiting
Gral Medical S.R.L. - Oncofort Hospital
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PiteştiRomaniaRecruiting
Oncocenter, Oncology Clinic SRL
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TimișoaraRomaniaRecruiting
SC Oncomed SRL
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TimișoaraRomaniaRecruiting
Linkoping University Hospital
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LinköpingSwedenRecruiting
Karolinska University Hospital
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StockholmSwedenRecruiting
Institute of Oncology Ljubljana
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LjubljanaSloveniaRecruiting
University Clinical Center Maribor
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MariborSloveniaRecruiting
Northside Hospital
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AtlantaUnited StatesRecruiting
Texas Oncology - Austin Central
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AustinUnited StatesRecruiting
OhioHealth Institute
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ColumbusUnited StatesRecruiting
Oncology Associates of Oregon
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EugeneUnited StatesRecruiting
Parkview Research Center
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Fort WayneUnited StatesRecruiting
Texas Oncology - Fort Worth Cancer Center
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Fort WorthUnited StatesRecruiting
Dr. Sudarshan K. Sharma, Ltd.
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HinsdaleUnited StatesRecruiting
Indiana University
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IndianapolisUnited StatesRecruiting
Women's Cancer Center of Nevada
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Las VegasUnited StatesRecruiting
Minnesota Oncology Hematology, P.A.
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MinneapolisUnited StatesRecruiting
FirstHealth Carolinas
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PinehurstUnited StatesRecruiting
Northwest Cancer Specialists
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PortlandUnited StatesRecruiting
Texas Oncology - San Antonio Medical Center
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San AntonioUnited StatesRecruiting
St. Joseph
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SavannahUnited StatesRecruiting
Maryland Oncology Hematology P.A.
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Silver SpringUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Oklahoma Cancer Specialists and Research Institute
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TulsaUnited StatesRecruiting
Kaiser Permanente Center
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VallejoUnited StatesRecruiting
Good Samaritan Hospital Medical Center
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West IslipUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.