University of Nebraska
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.
In this trial, we will enroll patients in two cohorts: Cohort 1: A 6 patient safety lead-in for patients receiving capecitabine prior to beginning a randomized trial for the Long Course Chemo-radiation (LCCRT) cohort. There will be trial stopping rules to review safety and PK data prior to initiating the randomized trial of patients receiving LCCRT. Cohort 2: The Randomized Short Course Radiation (SCRT) cohort. Cohort 1 and 2 will begin enrolling concurrently. Cohort 1 will have a safety lead-in of patients receiving LCCRT (with capecitabine). Cohort 2 will begin with the randomized study o…
Inclusion Criteria: 1. Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent. 2. AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy. 3. Adult, age \> or equal to 18 years (for Nebraska, age of consent is ≥19 years old) 4. ECOG Performance Status 0-2 5. Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 /dl, platelets ≥ 100,000 /dl (The use of transfusion or other intervention to achieve Hgb \> 9.0 g/dl is acceptable) 6. Serum SGOT and bilirubin ≤ 1.5 times upper limit of no…
Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.
Arctuva estimate
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