Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nebraska
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent.
AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy.
Adult, age > or equal to 18 years (for Nebraska, age of consent is ≥19 years old)
ECOG Performance Status 0-2
Disqualifiers
Breast-feeding or pregnant
Active infection requiring IV antibiotics 7 days before enrollment
Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell or carcinoma of the skin, invasive cancers with a 5-year disease-free interval, resected cancer of the bladder or low-grade (Gleason 6 or less) prostate cancer
Prior history of rectal adenocarcinoma (RAC)
Trial design
Design model
Parallel
Treatments tested in this trial
BMX-001
DrugLoading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.
Treatment groups
118 Participants
are divided into 4 treatment groupsGroup A: Arm AExperimental treatment 1 intervention
Group B: Arm BNo intervention 0 interventions
Group C: Arm CExperimental treatment 1 intervention
Group D: Arm DNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities
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
Time frame
Three weeks (During and 2 weeks after RT)2
Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary Toxicities
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
Time frame
Three weeks (During and 2 weeks after RT)3
Efficacy of BMX-001 as measured by Grade 3 and above associated with skin Toxicities
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
Time frame
Three weeks (During and 2 weeks after RT)4
Efficacy of BMX-001 as measured by Grade 3 and above associated with hematologic Toxicities
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
Time frame
Three weeks (During and 2 weeks after RT)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nebraska
Lead sponsor
BioMimetix JV, LLC
Collaborator
Source ClinicalTrials.gov