Endometrial Cancer
Conditions
Keywords
Selinexor, KPT-330, Advanced or Recurrent Endometrial Carcinoma, XPORT-EC, ENGOT-EN20, GOG-3083, XPORT-EC-042, p53 wild-type, Tumor protein 53 wild-type
Brief 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.
Interventions
DRUGSelinexor
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Sponsors
Karyopharm Therapeutics Inc
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Belgian Gynaecological Oncology Group
North Eastern German Society of Gynaecological Oncology
The Central and Eastern European Gynecologic Oncology Group
Israeli Society of Gynecologic Oncology
Australia New Zealand Gynaecological Oncology Group
Multicenter Italian Trials in Ovarian Cancer (MITO)
Grupo Español de Investigación en Cáncer de Ovario
Hellenic Cooperative Oncology Group
Cancer Trials Ireland (CTI)
Mario Negri Gynecologic Oncology group (MaNGO)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study: * Adults (Aged ≥ 18 years) * Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGS * Must have completed at least 12 weeks of platinum-based chemotherapy (with or without immune checkpoint inhibitors), with a confirmed partial or complete response according to RECIST v1.1 * Must be able to initiate C1D1 within 3-8 weeks after last platinum dose * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate bone marrow function and organ function
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator assessed Progression Free Survival (PFS) per RECIST v1.1 | From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 34 months | Time from randomization to death due to any cause |
| Safety and tolerability of study drug (selinexor and placebo) | From start of study drug administration up to 34 months | The safety and tolerability of study drug (selinexor and placebo) will be evaluated based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results, by means of the occurrence, nature, and severity of AEs via Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. |
| Time to First Subsequent Therapy (TFST) | From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months) | Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first |
| Time to Second Subsequent Therapy (TSST) | From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months) | Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first |
| Progression-free survival after initiating a next-line treatment (PFS2) | From randomization until the next-line progression event or death due to any cause, up to 34 months | Time from randomization until the progression event after initiating a next-line treatment or death due to any cause, whichever occurs first |
| Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1 | From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months) | — |
| EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L) | From baseline and at specified timepoints up to 34 months | EQ-5D-5L is a generic questionnaire that assesses health status as perceived by the patient across 5 categories (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and overall. |
Countries
Australia, Belgium, Canada, Czechia, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Outcome results
None listed