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Oral TGF-beta Receptor I Inhibitor Vactosertib in SOC Chemoradiotherapy for Esophageal Adenocarcinoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 31, 2026 → Mar 2027
Enrollment reduced 17% 30 → 25 participants
See other at-risk trials from Melissa Lumish

Record History

  1. Recruitment resumed after suspension Primary completion pushed from Dec 31, 2026 to Mar 2027 · Enrollment reduced: 30 → 25 participants · Completion pushed from Jun 1, 2027 to Sep 2027 · 3 more Show 6 more changesShow less
    • Primary completion pushed from Dec 31, 2026 to Mar 2027
    • Enrollment reduced: 30 → 25 participants
    • Completion pushed from Jun 1, 2027 to Sep 2027
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
  2. Trial status: Recruiting to Suspended Sponsor's reason: Major revisions due Lead sponsor: Sakti Chakrabarti to Melissa Lumish · Enrollment target: 25 to 30 · Interventions: Concurrent Radiation (Radiation), Standard of Care Chemotherapy (Drug), Vactosertib (Drug) to Standard of Care Preoperative Therapy (Drug), Vactosertib (Drug) · 3 morev8 Show 6 more changesShow less
    • Lead sponsor: Sakti Chakrabarti to Melissa Lumish
    • Enrollment target: 25 to 30
    • Interventions: Concurrent Radiation (Radiation), Standard of Care Chemotherapy (Drug), Vactosertib (Drug) to Standard of Care Preoperative Therapy (Drug), Vactosertib (Drug)
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints revised (3)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  3. Lead sponsor: Jennifer Eva Selfridge, MD to Sakti Chakrabartiv7
  4. Start date changed from estimate of Jan 1, 2025 to Sep 30, 2024v6
  5. Lead sponsor: Jennifer Eva Selfridge to Jennifer Eva Selfridge, MD Trial status: Not Yet Recruiting to Recruiting · Start date: Oct 1, 2024 to Jan 1, 2025 · Study sites: 0 to 1v5 Show 3 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 1, 2024 to Jan 1, 2025
    • Study sites: 0 to 1
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Apr 1, 2024 to Oct 1, 2024v4
  2. Study title expanded, about 1 wordv3 See this version in full on ClinicalTrials.gov ↗
  3. Start date: Nov 1, 2023 to Apr 1, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This interventional clinical trial aims to find ways of improving treatments for individuals with esophageal cancer. Laboratory-based studies show that using medicines that affect a protein called TGF-beta (TGFβ) can kill esophageal cancer cells in individuals who have localized esophageal adenocarcinoma and are being considered for standard-of-care chemoradiation prior to surgery. Participants of this study will take a pill called vactosertib for two weeks before starting standard of care therapy. At the end of the two weeks of taking vactosertib, participants will have a Positron Emission Tomography Computer Assisted Tomography (PET CT) scan and undergo an endoscopy with a biopsy to determine if the vactosertib is working. After standard of care therapy, participants will take vactosertib again for two weeks and then be considered for surgery.
Trial Details
NCT Number NCT06044311
Lead Sponsor Melissa Lumish
Conditions Adenocarcinoma Esophagus, Locally Advanced Adenocarcinoma, Siewert Type I Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov