Recruiting NCT05797831
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Navtemadlin, Navtemadlin Placebo.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Canada, Denmark, Estonia +12
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
Overview
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.
Interventions
- Drug Navtemadlin
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth - Drug Navtemadlin Placebo
Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth
Primary outcome measures
- Part 1: To determine the navtemadlin Phase 3 dose [Time frame: 12 months]
- Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo [Time frame: 50 months]
Secondary outcome measures (6)
- Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment [Time frame: 50 months]
- Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST) [Time frame: 50 months]
- Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin [Time frame: 1 day]
- Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin [Time frame: 1 day]
- Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin [Time frame: 1 day]
- Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR) [Time frame: 50 months]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- Kaiser Permanente Center — Vallejo
- Northside Hospital — Atlanta
- St. Joseph — Savannah
- Dr. Sudarshan K. Sharma, Ltd. — Hinsdale
- Parkview Research Center — Fort Wayne
- Indiana University — Indianapolis
- Maryland Oncology Hematology, P.A. — Silver Spring
- Minnesota Oncology Hematology, P.A. — Minneapolis
- … and 11 more centers
Italy · 13 centers
- A.O. Cannizzaro — Catania
- IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori" — Forlì
- Ospedale Policlinico San Martino — Genoa
- ASST di Lecco-Ospedale Alessandro Manzoni — Lecco
- Ospedale San Luca — Lucca
- Osp. Niguarda — Milan
- University Hospital of Parma — Parma
- Ospedale Guglielmo da Saliceto — Piacenza
- … and 5 more centers
Poland · 9 centers
- Białostockie Centrum Onkologii — Bialystok
- Szpitale Pomorskie — Gdansk
- Uniwersyteckie Centrum Kliniczne — Gdansk
- NIO-PIB Oddzial w Gliwicach — Gliwice
- Centrum Badań klinicznych Jagiellońskie Centrum Innowacji — Krakow
- Siedleckie Centrum Onkologii — Olsztyn
- Uniwersytecki Szpital — Poznan
- NIO-PIB Klinika Gine-Onk — Warsaw
- … and 1 more center
Spain · 9 centers
- CHUAC (Hospital de Coruña) — A Coruña
- Hospital del Mar — Barcelona
- Hospital Galdakao-Usansolo — Galdakao
- Hospital Universitario de Jaen — Jaén
- H.G.U. Jerez de la Frontera — Jerez de la Frontera
- Hospital U Insular de GC — Las Palmas
- Hospital de Leon — León
- HCU Santiago de Compostela — Santiago de Compostela
- … and 1 more center
Romania · 7 centers
- Bucharest CF2 Hospital — Bucharest
- Ovidius Clinical Hospital SRL — Constanța
- Onco Clinic Consult S.A. — Craiova
- Oncology Center "Sf. Nectarie" — Craiova
- Gral Medical S.R.L. - Oncofort Hospital — Piteşti
- Oncocenter, Oncology Clinic SRL — Timișoara
- SC Oncomed SRL — Timișoara
Austria · 3 centers
- University Hospital Graz, Department of Gynecology and Obstetrics — Graz
- Medizinische Universität Innsbruck — Innsbruck
- Medizinische Universität Wien — Vienna
Georgia · 3 centers
- LTD High Technology hospital Medcenter — Batumi
- American Hospital Network LLC — Tbilisi
- Caucasus Medical Centre — Tbilisi
Israel · 3 centers
- Rambam Medical Center — Haifa
- Shaare Zedek Medical Center — Jerusalem
- Sourasky Medical Center — Tel Aviv
Norway · 3 centers
- Southern Hospital Sorlandet — Kristiansand
- Oslo University Hospital HF — Oslo
- Sykehusapotek Nord Tromsø — Tromsø
Canada · 2 centers
- Cross Cancer Institute — Edmonton
- CHUM - University of Montreal Hospital Centre — Montreal
Finland · 2 centers
- Kuopio University Hospital — Kuopio
- Turku University Hospital — Turku
Hungary · 2 centers
- National Institute of Oncology — Budapest
- University of Debrecen Clinical Center — Debrecen
Lithuania · 2 centers
- Health Sciences Kaunas Clinics — Kaunas
- Nation Cancer Institute of Lithuania, Vilnius — Vilnius
Slovenia · 2 centers
- Institute of Oncology Ljubljana — Ljubljana
- University Clinical Center Maribor — Maribor
Sweden · 2 centers
Center list to be confirmed — check the primary protocol.
Denmark · 1 center
- Odense University Hospital — Odense
Estonia · 1 center
- Tartu University Hospital — Tartu
Identifiers
NCT: NCT05797831 · KRT-232-118 · ENGOT en-21 · GOG-3089