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ACTIVE NOT RECRUITING Phase 3

Maintenance with Selinexor/Placebo After Combination Chemotherapy in Participants with Endometrial Cancer [SIENDO]

NCT03555422 · View on ClinicalTrials.gov ↗

Study Summary

This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.

Conditions Studied

Interventions

  • DRUG Selinexor
  • DRUG Matching placebo for selinexor

Study Locations (20)

Texas

  • Texas Oncology, Austin — Austin
  • Texas Oncology DFW — Dallas
  • University of Texas Southwestern Medical Center — Dallas
  • Texas Oncology DFW — Fort Worth

Florida

  • Moffitt Cancer Center — Tampa
  • Florida Cancer Specialists (Sarah Cannon Research Institute) — West Palm Beach

Indiana

  • Parkview Research Center — Fort Wayne
  • Indiana University Simon Cancer Center — Indianapolis

New York

  • NYU Langone — New York
  • Memorial Sloan Kettering Cancer Center — New York

Arizona

  • Arizona Oncology — Tucson

California

  • Stanford University — Palo Alto

Illinois

  • Gynecological Cancer Institute of Chicago — Oak Lawn

Missouri

  • HCA Midwest Health - Kansas City (Sarah Cannon Research Institute) — Kansas City

Trial Details

FieldValue
Enrollment Target 263 participants
Start Date 2018-01-05
Est. Completion 2025-12
Phase Phase 3

Sponsor

Karyopharm Therapeutics

36 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03555422

The ClinicalTrials.gov registry entry for NCT03555422 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions — of which Selinexor is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03555422 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03555422 about?

NCT03555422 is a clinical study titled "Maintenance with Selinexor/Placebo After Combination Chemotherapy in Participants with Endometrial Cancer [SIENDO]". This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease ...

What is the current status of trial NCT03555422?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 263 participants. The study started on 2018-01-05. Estimated completion is 2025-12.

What conditions does trial NCT03555422 study?

This clinical trial studies the following conditions: Endometrial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03555422?

The interventions under investigation include: Selinexor (DRUG), Matching placebo for selinexor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03555422?

This trial is sponsored by Karyopharm Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03555422 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial