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Tests treatment safety and results for Rectal Cancer
Official title Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
ClinicalTrials.gov ID: NCT05254327
What this study is testing
What is BMX-001?
BMX-001 is an investigational medicine, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative...
- 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
- 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...
You likely can't join if
- 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...
- Prior history of rectal adenocarcinoma (RAC)
- Prior history of pelvic radiotherapy for any other type of malignancy
- Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen.
See the full eligibility criteria
- 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
- 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)
- Serum SGOT and bilirubin ≤ 1.5 times upper limit of normal
- 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...
- 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...
- Prior history of rectal adenocarcinoma (RAC)
- Prior history of pelvic radiotherapy for any other type of malignancy
- Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen.
- 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...
- Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg)
- Active or history of postural hypotension and autonomic dysfunction within the past year
- Known hypersensitivity to BMX-001
- 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...
- 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...
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- Omaha, Nebraska, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; Omaha, Nebraska, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.