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Radio-protector

BMX-001 for Anal Cancer

Phase 1 & 2
Recruiting
Led By Chi Lin, MD
Research Sponsored by Chi Lin, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with pathologically confirmed locally advanced anal squamous cell carcinoma (including oligometastatic disease) who will be receiving concurrent chemoradiation with standard 5FU/Mitomycin regimen with curative intent
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)
Must not have
Prior history of ASCC
A 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within year 1 of the two year study
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs for anal cancer. The first part is to see what dose is safe, and the second part is to see if it has fewer side effects than the standard treatment.

Who is the study for?
This trial is for adults over 19 with newly diagnosed anal squamous cell carcinoma who need chemoradiation. They must have a good performance status, normal organ function tests, and agree to use birth control. Excluded are those breastfeeding, with active infections or other cancers needing treatment, prior pelvic radiation, certain heart conditions, uncontrolled hypertension, known allergies to the drugs involved or BMX-001.
What is being tested?
The study is testing the safety and effectiveness of BMX-001 as a radio-protector when combined with standard radiation therapy and chemotherapy (5FU/mitomycin) in treating anal cancer. Phase 1 will find the highest dose patients can take without severe side effects; Phase 2 will assess how well it reduces serious toxicity in tissues like rectum and skin.
What are the potential side effects?
Potential side effects of BMX-001 may include reactions at the infusion site, increased risk of infection due to immune system suppression by chemotherapy agents used alongside it (5FU/mitomycin), fatigue from radiation therapy combination, digestive issues such as nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced anal cancer and will be treated with chemoradiation aimed at curing it.
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My blood counts meet the required levels for hemoglobin, ANC, and platelets.
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I am 19 years old or older.
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My cancer treatment plan includes a specific radiation dose.
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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of anal squamous cell carcinoma.
Select...
My heart's electrical cycle is longer than normal.
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I have not needed IV antibiotics for an infection in the last 7 days.
Select...
I have had pelvic radiotherapy for another type of cancer.
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I have had issues with low blood pressure when standing or autonomic dysfunction in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within year 1 of the two year study
This trial's timeline: 3 weeks for screening, Varies for treatment, and within year 1 of the two year study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Count of Adverse events, serious adverse events and dose limiting toxicities
Maximum tolerated dose (MTD) of BMX-001
Secondary study objectives
Effect of study treatment on local control survival (PFS).
Effect of study treatment on locoreginal progression free survival survival (PFS).
Effect of study treatment on overall survival (OS) survival (PFS).
+9 more
Other study objectives
Effect of study treatment on blood cells level of 8-OHdG
Effect of study treatment on patient-reported outcomes of health-related quality of life (HRQoL)
Effect of study treatment on plasma levels of 4-hydroxynonenal (4-HNE)
+6 more

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT02990468
100%
Injection site reaction
100%
Nausea
100%
Dry Mouth
100%
Dysgeusia
100%
Constipation
100%
Dehydration
100%
Fatigue
100%
Oropharyngeal pain
100%
Stomatitis
100%
Vomiting
100%
Radiation skin injury
100%
Salivary duct inflammation
67%
Haemoptysis
67%
Neck pain
67%
Pain
67%
Peripheral sensory neuropathy
67%
Weight decreased
67%
Chills
67%
Cough
67%
Mucosal infection
33%
Hyponatraemia
33%
Anal incontinence
33%
Sepsis
33%
Dysphonia
33%
Ear pain
33%
Hypoacusis
33%
Confusional State
33%
Diarrhoea
33%
Dizziness
33%
Early satiety
33%
Lip infection
33%
Lymphoedema
33%
Pain in extremity
33%
Skin mass
33%
Toothache
33%
Urinary tract infection
33%
Skin infection
33%
Dyspepsia
33%
Acute kidney injury
33%
Conduction Disorder
33%
Malaise
33%
Sinus tachycardia
33%
Tinnitus
33%
Dermatitis acneiform
33%
Localised oedema
33%
Hypothyroidism
33%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Group I
Phase 1: Group II
Phase 2: Group III

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Concurrent Radiation Therapy, 5FU, Mitomycin and BMX-001Experimental Treatment1 Intervention
One arm includes all enrolled patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMX-001
2017
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Chi Lin, MD, PhDLead Sponsor
2 Previous Clinical Trials
162 Total Patients Enrolled
BioMimetix JV, LLCIndustry Sponsor
10 Previous Clinical Trials
673 Total Patients Enrolled
University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,360 Total Patients Enrolled

Media Library

BMX-001 (Radio-protector) Clinical Trial Eligibility Overview. Trial Name: NCT03386500 — Phase 1 & 2
Nuclear Radiation Emergency Research Study Groups: Concurrent Radiation Therapy, 5FU, Mitomycin and BMX-001
BMX-001 (Radio-protector) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03386500 — Phase 1 & 2
~3 spots leftby Dec 2025
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