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NCT03386500 · ClinicalTrials.gov registry record · Phase 1
Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer
A Phase 1 study of Radiation Exposure and Anal Cancer, Squamous Cell Carcinoma, sponsored by University of Nebraska.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03386500: Active Phase 1 study of Radiation Exposure and Anal Cancer, Squamous Cell Carcinoma, sponsored by University of Nebraska.
NCT03386500 is a Phase 1 study of Radiation Exposure and Anal Cancer, Squamous Cell Carcinoma that is active but no longer recruiting, run by University of Nebraska. The registered enrollment target is 24 participants, below the 47-participant average among 7 other Radiation Exposure trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386500, a Phase 1 study of Radiation Exposure and Anal Cancer, Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by University of Nebraska.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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 concurrent chemotherapy. This allows for organ preservation in approximately 75% of patients. The use of concurrent radiation and chemotherapy with infusional 5-fluorouracil (5-FU) and mitomycin results in locoregional relapse rates of 20-32 and 5-year overall survival rates of 58-78%. However, while mitomycin significantly increases the rate of grade 4 toxicities, it improves local outcomes and has been considered a necessary agent in the care of anal cancer. Oxidative stress induced by radiotherapy and chemotherapy tends to protect tumor cells and promote normal tissue damage. A recently developed compound, BMX-001 (MnTnBuOE-2- PyP5+), is among the most highly potent metalloporphyrin compounds which reduce oxidative stress, thereby protecting normal tissues and augmenting tumor killing. In this Phase 1/2 study, the investigators will conduct a safety and efficacy study of the combination of BMX-001 with standard radiation therapy and concurrent (5FU)/mitomycin in newly diagnosed Anal Squamous Cell Carcinoma (ASCC) patients. The primary Phase 1 objective is to determine the maximum tolerated dose (MTD) of BMX-001 in ASCC patients receiving RT and concurrent 5FU/mitomycin chemotherapy. Three participants will be treated at Dose Level 1 and three at Dose Level 2, then three at Dose Level 3. Dose Limiting Toxicities (DLT) experienced by any participant will be used to determine the MTD. The Phase II objective is to examine the impact of BMX-001 on the overall acute ≥ grade 3 toxicity rate of the normal tissue including rectum, bladder, and skin in combination with RT and concurrent 5FU/mitomycin in treatment of newly diagnosed ASCC patients. These will be determined by participant reports, biological materials (blood, tissue, urine) sampling and imaging. Participant health-
Primary Outcome
Maximum tolerated dose (MTD) of BMX-001 will be determined by the highest dose level at which at least 1 out of 6 participants experienced a Dose-Limiting Toxicity (DLT).
Conditions Studied
Interventions
- DRUG BMX-001
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
What the registry record for NCT03386500 still lists
NCT03386500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 47-participant average among 7 other Radiation Exposure trials with a reported enrollment target (49% lower).
The record links to 2 conditions, with Radiation Exposure appearing as the primary indexed condition, and to 1 intervention - of which BMX-001 is the first listed.
NCT03386500 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT03386500 about?
NCT03386500 is a clinical study titled "Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer". 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 concurrent chemotherapy. This allows for organ preservation in approximately 75% of patients. The use o...
What is the current status of trial NCT03386500?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-11-28. Estimated completion is 2029-12.
What conditions does trial NCT03386500 study?
This clinical trial studies the following conditions: Radiation Exposure, Anal Cancer, Squamous Cell Carcinoma.
What interventions are being tested in trial NCT03386500?
The interventions under investigation include: BMX-001 (DRUG).
Who is sponsoring clinical trial NCT03386500?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03386500 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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