Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma (XPORT-EC-042)

August 26, 2026 updated by: Karyopharm Therapeutics Inc

A Phase 3, 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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Southport, Australia, 5000
        • The Royal Adelaide Hospital
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Border Medical Oncology & Haematology
      • Campbelltown, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Centre
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Gosford, New South Wales, Australia, 2250
        • Central Coast LHD - Gosford & Wyong Hospitals
      • New Lambton Heights, New South Wales, Australia, 2305
        • Newcastle Private Hospital
      • Saint Leonards, New South Wales, Australia
        • Royal North Shore Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Southport, Queensland, Australia, 4215
        • ICON Cancer Centre Southport
      • Toowoomba, Queensland, Australia, 4350
        • Toowoomba Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital - Eastern Health (Oncology)
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Malvern, Victoria, Australia, 3144
        • Cabrini Health
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St. Luc
      • Ghent, Belgium, 9000
        • AZ Sint Lucas
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Mons, Belgium, 7000
        • CHU Ambroise Pare
      • Namur, Belgium, 5000
        • CHU UCL Namur, Site Sainte-Elisabeth
    • Alberta
      • Calgary, Alberta, Canada, T3H2G5
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret
      • Toronto, Ontario, Canada, M9L 2H9
        • Sunnybrook Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l'Universite de Montreal
      • Montreal, Quebec, Canada
        • Hospital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H4A3J1
        • McGill University Health Centre (MUHC)
      • Brno, Czechia, 60200
        • University Hospital Brno
      • Ostrava, Czechia, 70852
        • University Hospital Ostrava
      • Prague, Czechia, 10034
        • UH Královské Vinohrady
      • Prague, Czechia, 12851
        • General University Hospital in Prague
      • Prague, Czechia, 18100
        • Hospital Na Bulovce
      • Batumi, Georgia, 6000
        • High Technology Hospital Medcenter
      • Tbilisi, Georgia, 0114
        • Ltd New Hospitals
      • Tbilisi, Georgia, 0186
        • Caucasus Medical Centre
      • Tbilisi, Georgia, 0112
        • Todua Clinic
      • Tbilisi, Georgia, 0156
        • Tbilisi Cancer Center
      • Tbilisi, Georgia, 0159
        • JSC - K.Eristavi National Center of Experimental and Clinical Surgery
      • Tbilisi, Georgia, 0186
        • LTD Innova Medical Center
      • Tbilisi, Georgia, 0186
        • Multiprofile Clinic "Consilium Medulla"
      • Berlin, Germany, 13353
        • Charite Berlin Universitatsmedizin
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Kiel, Germany, 01307
        • University Hospital Dresden
      • Krefeld, Germany, 47805
        • Helios Klinikum Krefeld
      • Leipzig, Germany, 04103
        • Universitätsklinik Leipzig
      • Mainz, Germany, 55131
        • Universitätsfrauenklinik Mainz
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim
      • Munich, Germany, 80337
        • Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern
      • Rostock, Germany, 18059
        • Klinikum Südstadt Rostock
      • Ulm, Germany, 89075
        • Universitätsfrauenklinik Ulm
      • Athens, Greece, 15123
        • Hygeia Hospital
      • Athens, Greece, 11528
        • Alexandra Hospital
      • Thessaloniki, Greece, 54645
        • Euromedica General Clinic
    • Athens
      • Marousi, Athens, Greece, 151 23
        • IASO Hospital
      • Debrecen, Hungary, 4032
        • Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen
      • Győr, Hungary, 9024
        • Petz Aladár University Teaching Hospital
      • Cork, Ireland, T12 DC4A
        • Cork University Hospital
      • Dublin, Ireland, D08 NHY1
        • St. James Hospital
      • Galway, Ireland, H91 YR71
        • Galway University
      • Waterford, Ireland, X91 ER8E
        • University Hospital Waterford
    • Elm Park
      • Dublin, Elm Park, Ireland, D04 T6F4
        • St. Vincent's University Hospital
      • Hadera, Israel, 38100
        • Hillel-Yaffe Medical Center
      • Holon, Israel
        • Wolfson Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero Universitaria di Bologna
      • Brescia, Italy, 25123
        • ASST Spedali Civili di Brescia
      • Meldola, Italy, 47014
        • IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L.
      • Milan, Italy, 20132
        • San Raffaele Hospital
      • Milan, Italy, 20141
        • Instituto Europeo di Oncologia
      • Milan, Italy, 20133
        • Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica
      • Milan, Italy, 20159
        • Humanitas San Pio X Hospital
      • Monza, Italy, 20900
        • Ospedale San Gerardo - Asst Monza
      • Naples, Italy, 20133
        • "Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica"
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
      • Pisa, Italy, 56127
        • Universita di Pisa
      • Prato, Italy, 59100
        • Nuovo Ospedale di Prato
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli - ROMA
      • Torino, Italy, 10128
        • AO Ordine Mauriziano
      • Torino, Italy, 10124
        • Ospedale Ostetrico Ginecologico Sant'Anna
      • Bratislava, Slovakia, 83310
        • National Cancer Institute
      • Bratislava, Slovakia, 81250
        • St. Elisabeth Cancer Institute
      • Bratislava, Slovakia, 82606
        • UH Bratislava
      • Trenčín, Slovakia, 91101
        • UH Trenčín
      • Changwon, South Korea, 51353
        • Samsung Changwon Hospital
      • Goyang-si, South Korea, 323
        • National Cancer Center (NCC)
      • Seongnam-si, South Korea, 59
        • CHA University/Bundang CHA General Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 101
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 73
        • Korea University Anam Hospital
      • Seoul, South Korea, 88
        • Asan Medical Center
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, South Korea, 31151
        • Soon Chun Hyang University Hospital Cheonan
    • Seongbuk
      • Seoul, Seongbuk, South Korea, 50-1
        • Severance Hospital (Yonsei University Health System)
      • Badalona, Spain, 08916
        • ICO Badalona
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d' Hebrón
      • Barcelona, Spain, 08908
        • Institut Catala d'Oncologia Hospitalet
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Girona, Spain, 17007
        • Institut Catala d'Oncologia de Girona
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Madrid
      • Madrid, Spain, 28041
        • H 12 de Octubre
      • Murcia, Spain, 30120
        • Virgen de la Arrixaca University Clinical Hospital
      • Málaga, Spain, 29010
        • Hospital Universitatrio Virgen de la Victoria
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
      • Valencia, Spain, 46026
        • Hospital LaFe Uacenlia
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Hospital Universitario Donostia
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
      • Kaohsiung City, Taiwan, 833401
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 407219
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 71004
        • Chi Mei Medical Center
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 104217
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 23561
        • Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital
      • Adana, Turkey (Türkiye), 01330
        • Cukurova University
      • Adana, Turkey (Türkiye), 34920
        • Adana Baskent Hospital
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hospital
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe University Oncology Hospital
      • Istanbul, Turkey (Türkiye), 34303
        • Acibadem Atakent Hospital
      • Istanbul, Turkey (Türkiye), 34098
        • Cerrahpasa University
    • Ankara
      • Çankaya, Ankara, Turkey (Türkiye), 34093
        • Ankara Baskent Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • The University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Honor Health
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Davis, California, United States, 95616
        • UC Davis
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Irvine, California, United States, 92618
        • City of Hope at Irvine Lennar
      • Los Alamitos, California, United States, 90720
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA - Women's Health Clinical Research Unit
      • Palo Alto, California, United States, 94304
        • Stanford University
      • San Francisco, California, United States, 94109
        • California Pacific Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32804
        • Advent Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30303
        • Grady Hospital
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
    • Indiana
      • Dyer, Indiana, United States, 46311
        • Northwest Cancer Center
      • Goshen, Indiana, United States, 46526
        • Goshen Health
      • Indianapolis, Indiana, United States, 46260
        • St Vincent Hospital
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Hospital, Inc.
      • New Orleans, Louisiana, United States, 70119
        • LSU Health Sciences Center New Orleans
      • Shreveport, Louisiana, United States, 71133
        • Trials365, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • USON - Minnesota Oncology Hematology
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • St. Dominic's Gynecologic Oncology
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Midwest Ventures Group HCA MId America Division
    • Montana
      • Billings, Montana, United States, 59101
        • Intermountain Health St. Vincent Regional Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Women's Cancer Center of Nevada
      • Reno, Nevada, United States, 89511
        • Center Of Hope
    • New York
      • Albany, New York, United States, 12208
        • Women's Cancer Care Associates, LLC
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital-Long Island
      • New Hyde Park, New York, United States, 11042
        • Northwell Health - Zuckerberg Cancer Center
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10016
        • Perlmutter Cancer Center at NYU Langone Health
      • Rego Park, New York, United States, 11374
        • Northwell Health - Queens Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Atrium Health Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth
      • Columbus, Ohio, United States, 43219
        • Zangmeister Cancer Center
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute, LLC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • Alliance Cancer Specialists
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee - Women's Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • Allegheny Health Network - West Penn Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee Health Science Center
    • Texas
      • Austin, Texas, United States, 78731
        • USON - Texas Oncology, Austin Central
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75235
        • Parkland Health & Hospital System
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Dallas
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - The Woodlands
      • Tyler, Texas, United States, 75702
        • Texas Oncology, PC, Tyler
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 exclusion criteria are not eligible to participate in this study:

  • Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
  • Palliative radiotherapy administered within 14 days of intended C1D1
  • Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy
  • Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous
  • Previous treatment with an XPO1 inhibitor
  • Stable disease or disease progression after platinum-based chemotherapy
  • Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
  • Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Other Names:
  • KPT-330
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.
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 34 months
Time from randomization to death due to any cause
Up to 34 months
Safety and tolerability of study drug (selinexor and placebo)
Time Frame: 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.
From start of study drug administration up to 34 months
Time to First Subsequent Therapy (TFST)
Time Frame: 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
From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
Time to Second Subsequent Therapy (TSST)
Time Frame: 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
From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
Progression-free survival after initiating a next-line treatment (PFS2)
Time Frame: 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
From randomization until the next-line progression event or death due to any cause, up to 34 months
Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1
Time Frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
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)
Time Frame: 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.
From baseline and at specified timepoints up to 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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