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NCT03555422 · ClinicalTrials.gov registry record · Phase 3
Maintenance with Selinexor/Placebo After Combination Chemotherapy in Participants with Endometrial Cancer [SIENDO]
A Phase 3 study of Endometrial Cancer, sponsored by Karyopharm Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 263
- Enrollment target
- 20
- Study locations
NCT03555422 is a Phase 3 study of Endometrial Cancer that is active but no longer recruiting, run by Karyopharm Therapeutics. The registered enrollment target is 263 participants, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT03555422, a Phase 3 study of Endometrial Cancer, is active but no longer recruiting, sponsored by Karyopharm Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 263 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2018-01-05 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (50% lower). The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
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.
NCT03555422 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, Florida, Indiana.
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.
What interventions are being tested in trial NCT03555422?
The interventions under investigation include: Selinexor (DRUG), Matching placebo for selinexor (DRUG).
Who is sponsoring clinical trial NCT03555422?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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