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Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 11 months later May 2027 → May 2030
See other at-risk trials from University of Nebraska

Record History

  1. Notable Primary completion pushed from May 2027 to May 2030 Completion pushed from Jun 2029 to Jun 2034 · Eligibility criteria expanded, about 22 words · Site contacts updated at 1 of 3 sites · 1 more Show 4 more changesShow less
    • Completion pushed from Jun 2029 to Jun 2034
    • Eligibility criteria expanded, about 22 words
    • Site contacts updated at 1 of 3 sites
    • Publications: details revised at 1 of 1 entry
  2. Minor Re-verified, no change to tracked fieldsv12
  3. Minor Study sites: 1 to 3 Eligibility criteria shortened, about 45 wordsv11 Show 1 more changeShow less
    • Eligibility criteria shortened, about 45 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Re-verified, no change to tracked fieldsv10
  5. Minor Primary completion date: Jan 2028 to May 2027 Completion date: Feb 2028 to Jun 2029v9 Show 1 more changeShow less
    • Completion date: Feb 2028 to Jun 2029
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Primary completion date: May 2028 to Jan 2028 Completion date: Dec 2033 to Feb 2028v8 Show 1 more changeShow less
    • Completion date: Dec 2033 to Feb 2028
  2. Notable Primary completion date: May 2027 to May 2028 Completion date: Dec 2032 to Dec 2033v7 Show 1 more changeShow less
    • Completion date: Dec 2032 to Dec 2033
  3. Minor Completion date: Jun 2029 to Dec 2032v6
  4. Minor Site contact updatedv5
  5. Notable Lead sponsor: Chi Lin, MD, PhD to University of Nebraska Trial status: Active, Not Recruiting to Recruiting · Site details revised · Collaborators: 2 to 1v4 Show 3 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Re-verified, no change to tracked fieldsv3
  7. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting Start date changed from estimate of Jun 2022 to Aug 15, 2022 · Site contact updatedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2022 to Aug 15, 2022
    • Site contact updated
  1. Minor 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.
In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.
Trial Details
NCT Number NCT05254327
Lead Sponsor University of Nebraska
Collaborators: BioMimetix JV, LLC
Conditions Rectal Cancer
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov