RecruitingPhase 2NCT05254327

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

A Randomized Phase 2 Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With and Without BMX-001 as Part of Total Neoadjuvant Therapy in Patients With Newly Diagnosed Locally Advanced Rectal Adenocarcinoma


Sponsor

University of Nebraska

Enrollment

118 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called BMX-001 to standard radiation therapy improves treatment for patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiation before surgery). BMX-001 is a drug that may protect healthy tissue from radiation damage while potentially making cancer cells more vulnerable. **You may be eligible if...** - You are 18 or older (19 or older in Nebraska) - You have confirmed stage II or III rectal adenocarcinoma (rectal cancer, not yet spread to other organs) - You are scheduled for total neoadjuvant therapy (chemotherapy and radiation before surgery) with curative intent - Your blood counts and organ function meet required levels - You are in reasonably good physical condition (ECOG 0-2) **You may NOT be eligible if...** - Your cancer has already spread to other organs - You have severe blood, liver, or kidney problems - You are pregnant or planning to become pregnant during the study period - You have had prior pelvic radiation Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGBMX-001

Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.


Locations(3)

UT Health San Antonio MD Anderson Cancer Center

San Antonio, Texas, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Markey Cancer Center

Lexington, Kentucky, United States

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NCT05254327


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