Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Conditions

• Endometrial Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
• Matching Placebo for selinexor — DRUG
  Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Study Details

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.

Key Dates

Start date

Apr 18, 2023

Status verified

May 2026

Primary completion

Aug 31, 2026

Completion

Jan 31, 2028

Study Design

Enrollment

257 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Selinexor
  Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.
• Placebo Comparator: Placebo
  Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Primary Outcome Measure

Investigator assessed Progression Free Survival (PFS) per RECIST v1.1 [ Time Frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months) ]

Locations (73)

Find similar trials in Birmingham, AL

Related Studies

• Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
  Recruiting · Northwestern University · Chicago, Illinois
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
  Recruiting · Massive Bio, Inc. · Birmingham, Alabama
• The DETECT Study: Discovery and Evaluation of Testing for Endometrial and Ovarian Cancer in Tampons
  Recruiting · University of Alabama at Birmingham · Birmingham, Alabama