Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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-

Conditions Studied

Radiation Exposure Anal Cancer, Squamous Cell Carcinoma

Interventions

  • DRUG BMX-001

Study Locations (1)

Nebraska

  • University of Nebraska Medical Center - Omaha

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2017-11-28
Est. Completion 2029-12
Phase Phase 1

Sponsor

University of Nebraska

407 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03386500

The ClinicalTrials.gov registry entry for NCT03386500 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 7 other Radiation Exposure trials with a reported enrollment target (49% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Learn More About Clinical Trials

Similar trials for Radiation Exposure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Radiation Exposure

All registered trials for this condition

Anal Cancer, Squamous Cell Carcinoma

All registered trials for this condition

Nebraska

All trials with a study site in Nebraska

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.