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.
- Diseases
- Endometrial cancer
- 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
Sites (83)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Graz, Department of Gynecology and Obstetrics Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universität Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Medizinische Universität Wien Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| CHUM - University of Montreal Hospital Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu | Estonia | Recruiting |
| CHUAC (Hospital de Coruña) Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Galdakao-Usansolo Coordinator of this site? Confirm its status | Galdakao | Spain | Recruiting |
| Hospital Universitario de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Recruiting |
| H.G.U. Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Recruiting |
| Hospital U Insular de GC Coordinator of this site? Confirm its status | Las Palmas | Spain | Recruiting |
| Hospital de León Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| HCU Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario de Valme Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| LTD High Technology Hospital Medcenter Coordinator of this site? Confirm its status | Batumi | Georgia | Recruiting |
| Caucasus Medical Centre Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| American Hospital Network LLC Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| National Institute of Oncology Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| University of Debrecen Clinical Center Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| A.O. Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori" Coordinator of this site? Confirm its status | Forlì | Italy | Recruiting |
| Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| ASST di Lecco-Ospedale Alessandro Manzoni Coordinator of this site? Confirm its status | Lecco | Italy | Recruiting |
| Ospedale San Luca Coordinator of this site? Confirm its status | Lucca | Italy | Recruiting |
| Osp. Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| University Hospital Of Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Ospedale Guglielmo da Saliceto Coordinator of this site? Confirm its status | Piacenza | Italy | Recruiting |
| Ospedale di Prato S. Stefano Coordinator of this site? Confirm its status | Prato | Italy | Recruiting |
| Ospedale Santa Maria delle Croci Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| "Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department" Coordinator of this site? Confirm its status | Rimini | Italy | Recruiting |
| Policlinico Umberto Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Ospedale Filippo del Ponte Coordinator of this site? Confirm its status | Varese | Italy | Recruiting |
| Health Sciences Kaunas Clinics Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Nation Cancer Institute of Lithuania, Vilnius Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Southern Hospital Sorlandet Coordinator of this site? Confirm its status | Kristiansand | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Sykehusapotek Nord Tromsø Coordinator of this site? Confirm its status | Tromsø | Norway | Recruiting |
| Białostockie Centrum Onkologii Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Szpitale Pomorskie Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| NIO-PIB Oddzial w Gliwicach Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
| Centrum Badań klinicznych Jagiellońskie Centrum Innowacji Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Siedleckie Centrum Onkologii Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Uniwersytecki Szpital Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| NIO-PIB Klinika Gine-Onk Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Bucharest CF2 Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Ovidius Clinical Hospital SRL Coordinator of this site? Confirm its status | Constanța | Romania | Recruiting |
| Onco Clinic Consult S.A. Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Oncology Center Sf. Nectarie Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Gral Medical S.R.L. - Oncofort Hospital Coordinator of this site? Confirm its status | Piteşti | Romania | Recruiting |
| Oncocenter, Oncology Clinic SRL Coordinator of this site? Confirm its status | Timișoara | Romania | Recruiting |
| SC Oncomed SRL Coordinator of this site? Confirm its status | Timișoara | Romania | Recruiting |
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| University Clinical Center Maribor Coordinator of this site? Confirm its status | Maribor | Slovenia | Recruiting |
| Northside Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Texas Oncology - Austin Central Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| OhioHealth Institute Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Oncology Associates of Oregon Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Parkview Research Center Coordinator of this site? Confirm its status | Fort Wayne | United States | Recruiting |
| Texas Oncology - Fort Worth Cancer Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Dr. Sudarshan K. Sharma, Ltd. Coordinator of this site? Confirm its status | Hinsdale | United States | Recruiting |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Women's Cancer Center of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Minnesota Oncology Hematology, P.A. Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| FirstHealth Carolinas Coordinator of this site? Confirm its status | Pinehurst | United States | Recruiting |
| Northwest Cancer Specialists Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Texas Oncology - San Antonio Medical Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| St. Joseph Coordinator of this site? Confirm its status | Savannah | United States | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Silver Spring | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Oklahoma Cancer Specialists and Research Institute Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
| Kaiser Permanente Center Coordinator of this site? Confirm its status | Vallejo | United States | Recruiting |
| Good Samaritan Hospital Medical Center Coordinator of this site? Confirm its status | West Islip | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.