Phase 2 Trial of BMX-001 for Rectal Cancer
This study is testing a drug called BMX-001 along with radiation therapy for people with newly diagnosed, locally advanced rectal cancer. The goal is to see if BMX-001 can reduce side effects (toxicities) like severe gastrointestinal, genitourinary, and skin problems that can happen during and after radiation. You might receive a short course or a long course of radiation, with or without BMX-001. To join, you must be an adult (18 or older, or 19 in Nebraska) with stage II or III rectal cancer that requires total neoadjuvant therapy (treatment given before surgery). The study plans to enroll 118 participants, but its current status is unclear.
- Study design
- This is a Phase 2 interventional study. It involves two groups: one for long-course radiation and another for short-course radiation, with some participants randomized to receive BMX-001 or not.
- What's involved
- You would receive BMX-001 (a loading dose then maintenance doses twice a week) with either short-course or long-course radiation therapy. You would also receive chemotherapy (FOLFOX or CAPOX) before radiation.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main side effects are measured up to three weeks after radiation therapy ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Chi Lin, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Nebraska
Who to contact
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What this trial measures
- Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal ToxicitiesThree weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
- Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary ToxicitiesThree weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
- Efficacy of BMX-001 as measured by Grade 3 and above associated with skin ToxicitiesThree weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
- Efficacy of BMX-001 as measured by Grade 3 and above associated with hematologic ToxicitiesThree weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia