drugset / Trial / NCT05611931
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Phase 3
Active not recruiting
257 enrolled
Karyopharm Therapeutics Inc
Australia New Zealand Gynaecological Oncology Group · collabBelgian Gynaecological Oncology Group · collabCancer Trials Ireland (CTI) · collabEuropean Network of Gynaecological Oncological Trial Groups (ENGOT) · collabGOG Foundation · collabGrupo Español de Investigación en Cáncer de Ovario · collabHellenic Cooperative Oncology Group · collabIsraeli Society of Gynecologic Oncology · collabMario Negri Gynecologic Oncology group (MaNGO) · collabMulticenter Italian Trials in Ovarian Cancer (MITO) · collabNorth Eastern German Society of Gynaecological Oncology · collabThe Central and Eastern European Gynecologic Oncology Group · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v 1.1\]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
Timeline
- Start
- 2023-04-18
- Primary completion
- 2026-08
- Completion
- 2028-01
Publications
- Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.
- Makker V, Perez-Fidalgo JA, Valabrega G, Hamilton E, Van Gorp T, Sehouli J, Reginacova K, Richardson DL, Perri T, Oza AM, Miller DS, Alia EMG, De Giorgi U, Henry S, Spitz DL, Wimberger P, Bednarikova M, Chon HS, Martinez-Garcia J, Pisano C, Berek JS, Romero I, Scambia G, Farinas-Madrid L, Buscema J, Schochter F, Li K, Kalyanapu P, Walker CJ, Vergote I. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study. Gynecol Oncol. 2024 Jun;185:202-211. doi: 10.1016/j.ygyno.2024.05.016. Epub 2024 Jun 3.
- Vergote I, Perez Fidalgo A, Valabrega G, Monk BJ, Herzog T, Cibula D, Colombo N, Pothuri B, Sehouli J, Korach J, Barlin J, Papadimitriou CA, van Gorp T, Richardson D, McCarthy M, Antill Y, Mirza MR, Li K, Kalyanapu P, Slomovitz B, Coleman RL. 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. Int J Gynecol Cancer. 2024 Aug 5;34(8):1283-1289. doi: 10.1136/ijgc-2024-005412.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |