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Status:

ACTIVE_NOT_RECRUITING

Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer

Lead Sponsor:

University of Nebraska

Collaborating Sponsors:

BioMimetix JV, LLC

Conditions:

Anal Cancer, Squamous Cell Carcinoma

Radiation Exposure

Eligibility:

All Genders

19+ years

Phase:

PHASE1

PHASE2

Brief Summary

Over 80% of anal cancers are squamous cell carcinoma (SCC). Current standard treatment for locally advanced squamous cell carcinoma of the anal canal is a combination of radiation therapy (RT) and con...

Detailed Description

Over 80% of anal cancers are squamous cell carcinoma (SCC). Current standard treatment for locally advanced squamous cell carcinoma of the anal canal is a combination of radiation therapy (RT) and con...

Eligibility Criteria

Inclusion

  • Pathologically confirmed locally advanced anal squamous cell carcinoma (including oligometastatic disease) with concurrent chemoradiation with standard Fluorouracil (5FU)/mitomycin regimen with curative intent
  • Any cancer stage requiring a dose of 59.4 cGy
  • 19 years of age or older
  • Karnofsky Performance Status (KPS) ≥ 60%
  • Hemoglobin ≥ 9.0 g/dl (a transfusion or other intervention to achieve Hgb \> 9.0 g/dl is acceptable)
  • Absolute neutrophil count (ANC) ≥ 1,500 /dl
  • Platelets ≥ 100,000 /dl
  • Serum creatinine ≤ 1.5 mg/dl, serum SGOT and bilirubin ≤ 1.5 times upper limit of normal
  • Negative pregnancy test for women of child-bearing potential within 48 hours prior to first dose of BMX-001
  • Use of a medically effective means of birth control until 12 months following the last study treatment for women of childbearing potential and male participants
  • Positron Emission Tomography (PET)/ Computed Tomography (CT)/pelvic magnetic resonance imaging (MRI) done within 8 weeks of trial initiation

Exclusion

  • Breast-feeding
  • Active infection requiring IV antibiotics within 7 days before enrollment
  • Prior, unrelated malignancy requiring current active treatment, exception: 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 prostate cancer (Gleason 6 or less)
  • Prior history of Acantholytic squamous cell carcinoma (ASCC)
  • Prior history of pelvic radiotherapy for any other type of malignancy
  • Known hypersensitivity to Fluorouracil (5FU) and/or mitomycin
  • Current corticosteroid use unless dose is stable or decreasing at study enrollment (anti-inflammatory properties could interrupt oxidative stress)
  • Inadequately controlled hypertension (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 (active) cardiovascular disease or cerebrovascular disease, (e.g., 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
  • History or evidence from physical/neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer, potentially interfering with protocol treatment unless adequately controlled by medication
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment
  • Marked baseline prolongation of QT/QTc interval \[e.g., repeated demonstration of a QTc interval \>480 milliseconds (ms), CTCAE grade 1, using the specific/usual choice by clinical center for correction factor
  • History of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome)

Key Trial Info

Start Date :

November 28 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2029

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT03386500

Start Date

November 28 2017

End Date

December 1 2029

Last Update

June 11 2025

Active Locations (1)

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1

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198