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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
University of Nebraska
Study ID
NCT05254327
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMX-001 — DRUG
    Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.

Study Details

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.

Key Dates

Start date
Aug 15, 2022
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Short Chemo-Radiation Therapy (SCRT) + BMX-001
  • No Intervention: Arm B
    Short Chemo-Radiation Therapy (SCRT)
  • Experimental: Arm C
    Long Course Chemo-Radiation Therapy (LCCRT) + BMX-001
  • No Intervention: Arm D
    Long Course Chemo-Radiation Therapy (LCCRT)

Primary Outcome Measure

Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities [ Time Frame: Three weeks (During and 2 weeks after RT) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Markey Cancer CenterLexingtonKentucky40536
Samantha F Stokely, BSN, RN
[email protected]
859-323-4128
Cynthia A Leedham, Ph.D
[email protected]
859-257-4470
Mark E Bernard, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Jessi E Delaney, RN, BSN
[email protected]
402-559-8711
Samuel P Anderson, BS
[email protected]
402-559-1250
Chi Lin, MD, Ph.D (PRINCIPAL_INVESTIGATOR)
UT Health San Antonio MD Anderson Cancer CenterSan AntonioTexas78229
Vanessa N Collazo Velez, RN, MS
[email protected]
210-450-7382
James J Denno
[email protected]
210-450-5887
Neil B Newman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By condition
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By specialty
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By research site
Markey Cancer Center· Lexington, KYUniversity of Nebraska Medical Center· Omaha, NEUT Health San Antonio MD Anderson Cancer Center· San Antonio, TX

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