RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective the study drug BMX-001 is when added to short-course radiation or longer-course radiation with chemotherapy. It is for adults with newly diagnosed stage II or III rectal cancer who will get treatment before surgery with the goal of curing the cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage II or III rectal adenocarcinoma, a type of rectal cancer, confirmed by a tissue test. Plan to get treatment before surgery with the goal of a cure.
  • Be at least 18 years old, or at least 19 in Nebraska.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Meet study limits for red blood cells, infection-fighting white blood cells, and platelets, which help blood clot. Blood transfusions to raise red blood cells are allowed.
  • Meet the study’s liver and kidney test limits. Kidney tests must be done within 2 weeks before joining.
  • Sign a written consent form before any study-only procedures.
  • If able to become pregnant, have a negative pregnancy test. These participants and male participants must use two effective forms of birth control during treatment and for 12 months after the last study treatment.
  • Have CT scans of the chest, belly, and pelvis and an MRI of the pelvis within 8 weeks before being assigned to a study group.

Who can't join

  • Are pregnant or breastfeeding, or have an active infection needing antibiotics through a vein in the 7 days before joining.
  • Have had rectal cancer before or radiation to the pelvis for another cancer. Another cancer needing active treatment may also exclude you, though the study allows certain exceptions.
  • Have an allergy or another medical reason you cannot receive BMX-001 or any drug in the FOLFOX or CAPOX chemotherapy plans.
  • Take corticosteroids, medicines that reduce swelling, unless your dose is stable or decreasing when assigned to a study group.
  • Have blood pressure above 150 for the top number or 100 for the bottom number. Certain problems with blood pressure dropping when standing or automatic body functions within the past year also exclude you.
  • Have serious active heart or brain blood vessel disease, including a heart attack or stroke within 6 months, certain heart failure, unstable chest pain, or serious heart rhythm problems.
  • Have certain brain or spinal cord problems not caused by cancer, such as seizures, unless well controlled with medicine. Serious blood vessel disease within 6 months may also exclude you.
  • Have a prolonged QT interval, a problem with the heart’s electrical timing, or added risk factors for a dangerous heart rhythm, such as low potassium, heart failure, or a family history of long QT syndrome.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 normal 7. Adequate renal function defined as follows: 1)Serum creatinine \< 1.5 mg/dl within 2 weeks prior to enrollment or 2)Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to enrollment determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\]/\[(Serum Cr mg/dl) x (72)\], CCr female = 0.85 x (CrCl male) 8. Signed, written informed consent prior to completing any study specific procedures 9. Negative pregnancy test for women of child-bearing potential at the time of screening 10. Women of childbearing potential and male participants must agree to use two forms of a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment 11. Chest/Abdominal/Pelvic (CAP) CT/ pelvic MRI done within 8 weeks prior to randomization. Exclusion Criteria: 1. Breast-feeding or pregnant 2. Active infection requiring IV antibiotics 7 days before enrollment 3. 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 4. Prior history of rectal adenocarcinoma (RAC) 5. Prior history of pelvic radiotherapy for any other type of malignancy 6. Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen. 7. Because corticosteroids are anti-inflammatory and could interrupt oxidative stress, patients will be excluded unless they are on stable or decreasing corticosteroids dose at the time of randomization. BMX-001 Specific Exclusion Criteria (Subjects meeting any of the following criteria are ineligible for study entry) 8. Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg) 9. Active or history of postural hypotension and autonomic dysfunction within the past year 10. Known hypersensitivity to BMX-001 11. Clinically significant (i.e. active) cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment 12. History or evidence upon physical/neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer unless adequately controlled by medication or potentially interfering with protocol treatment 13. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment 14. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms) (CTCAE grade 1) using the specific/usual choice by clinical center for correction factor. 15. A history of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome). Note: Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.

Study sites (3)

KY

NE

TX