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ENGOT-EN20/GOG-3083/XPORT-EC-042 - A phase III, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced, or recurrent endometrial carcinoma: rationale, methods, and trial design
I. Vergote, A. Perez Fidalgo, G. Valabrega, BJ. Monk, T. Herzog, D. Cibula, N. Colombo, B. Pothuri, J. Sehouli, J. Korach, J. Barlin, CA. Papadimitriou, T. van Gorp, D. Richardson, M. McCarthy, Y. Antill, MR. Mirza, K. Li, P. Kalyanapu, B....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, protokol klinické studie, klinické zkoušky, fáze III, randomizované kontrolované studie, multicentrická studie
NLK
ProQuest Central
od 2018-01-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 2018-01-01 do Před 6 měsíci
PubMed
38627035
DOI
10.1136/ijgc-2024-005412
Knihovny.cz E-zdroje
- MeSH
- dvojitá slepá metoda MeSH
- hydraziny * aplikace a dávkování terapeutické užití MeSH
- klinické zkoušky, fáze III jako téma MeSH
- lidé MeSH
- lokální recidiva nádoru * farmakoterapie patologie MeSH
- nádorový supresorový protein p53 genetika MeSH
- nádory endometria * farmakoterapie patologie MeSH
- triazoly * aplikace a dávkování MeSH
- udržovací chemoterapie metody MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- protokol klinické studie MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Patients with advanced/recurrent endometrial cancer have a poor prognosis and limited treatment options. Biomarkers such as tumor protein 53 (TP53) in endometrial cancer can integrate novel strategies for improved and individualized treatment that could impact patient outcomes. In an exploratory analysis of the phase III ENGOT-EN5/GOG-3055/SIENDO study of selinexor maintenance monotherapy 80 mg in advanced/recurrent endometrial cancer, a pre-specified subgroup of patients with TP53 wild type (wt) endometrial cancer showed preliminary activity at long-term follow-up with a generally manageable safety profile (median progression-free survival 27.4 months vs 5.2 months placebo, HR=0.41). PRIMARY OBJECTIVE: To evaluate the efficacy of selinexor compared with placebo as maintenance therapy in patients with advanced or recurrent TP53wt endometrial cancer. STUDY HYPOTHESIS: Selinexor administered at 60 mg weekly as maintenance therapy will show manageable safety and maintain efficacy in patients with TP53wt advanced/recurrent endometrial cancer after systemic therapy versus placebo. TRIAL DESIGN: This is a prospective, multicenter, double-blind, placebo-controlled, randomized phase III study designed to evaluate the efficacy and safety of selinexor as a maintenance therapy in patients with advanced or recurrent TP53wt endometrial cancer. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have histologically confirmed endometrial cancer, TP53wt confirmed by next-generation sequencing, completed at least 12 weeks of platinum-based therapy with or without immunotherapy, with confirmed partial response or complete response, and primary Stage IV disease or at first relapse. PRIMARY ENDPOINT: The primary endpoint is investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the intent-to-treat population. SAMPLE SIZE: A total of 220 patients will be enrolled. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual is expected to be completed in 2024 with presentation of results in 2025. TRIAL REGISTRATION: NCT05611931.
Central and Eastern European Gynecologic Oncology Group Prague Czech Republic
Charles University and General University Hospital Prague Prague Czech Republic
Copenhagen University Hospital Copenhagen Denmark
Department of Clinical Therapeutics University of Athens School of Medicine Athens Greece
Department of Medicine and Surgery University of Milan Bicocca Milan Italy
Department of Obstetrics and Gynecology University of Cincinnati Cincinnati Ohio USA
Department of Oncology Rigshospitalet
Department of Oncology University of Turin Turin Italy
Florida Cancer Specialists and Research Institute West Palm Beach Florida USA
Frankston Hospital Frankston and Monash University Frankston Victoria Australia
Galway University Hospitals Galway Ireland
Grupo Espanol de Investigacion en Cancer Ginecologico Madrid Spain
Gynaecological Oncology KU Leuven University Hospitals Leuven Leuven Belgium
Gynecologic Oncology Group Foundation Philadelphia Pennsylvania USA
Gynecologic Oncology Group Foundation Prague Czech Republic
Gynecologic Oncology Mount Sinai Medical Center New York New York USA
Gynecologic Oncology Program European Institute of Oncology IRCCS Milan Italy
Karyopharm Therapeutics Inc Newton Massachusetts USA
Medical Oncology Hospital Clinico Universitario Valencia Spain
Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies Naples Italy
NYU Langone Health Perlmutter Cancer Center New York New York USA
Sheba Medical Center Tel Hashomer Israel
Stephenson Cancer Center University of Oklahoma Health Sciences Center Oklahoma City Oklahoma USA
Tel Aviv University Tel Aviv Israel
Texas Oncology Shenandoah Texas USA
University Hospitals Leuven Leuven Belgium
Vlaams Instituut voor Biotechnologie KU Leuven Center for Cancer Biology Leuven Belgium
Citace poskytuje Crossref.org
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