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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within year 1 of the two year study

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within year 1 of the two year study

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Count of Adverse events, serious adverse events and dose limiting toxicities

Maximum tolerated dose (MTD) of BMX-001

Secondary outcome measures

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 outcome measures

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%

Dysgeusia

100%

Nausea

100%

Injection site reaction

100%

Dry Mouth

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%

Ear pain

33%

Hypoacusis

33%

Dysphonia

33%

Anal incontinence

33%

Confusional State

33%

Hyponatraemia

33%

Sepsis

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%

Study treatment Arm

Phase 1: Group I

Phase 1: Group II

Phase 2: Group III

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

0 / 5Eligibility criteria met

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

9 Previous Clinical Trials

646 Total Patients Enrolled

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,710 Total Patients Enrolled

Media Library

BMX-001 (Radio-protector) Clinical Trial Eligibility Overview. Trial Name: NCT03386500 — Phase 1 & 2

Anal Squamous Cell Carcinoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we looking for more test subjects at the moment?

"The listed clinical trial on clinicaltrials.gov is looking for more participants as of 2/14/2022. This study was first posted on 11/28/2017."

Answered by AI

How many participants are allowed in this clinical trial?

"That is accurate. According to the information available on clinicaltrials.gov, this trial posted on November 28th, 2017 is still seeking participants. There have been 24 patients recruited so far from 1 site."

Answered by AI

What are the primary conditions that this medication is designed to improve?

"This proposed treatment is effective for patients with cervical cancer, low-grade upper tract urothelial cancer (lg-utuc), and glaucoma."

Answered by AI

What goals does this experiment aim to achieve?

"The primary objective of this study, as measured over a 10-month post RT timeframe, is to establish the maximum tolerated dose (MTD) of BMX-001. In addition to the primary outcome, secondary outcomes being monitored include the impact of study treatment on acute grade 3 hematuria and rectal pain (as defined by CTCAE 4.0), overall survival rate, and progression-free survival."

Answered by AI

Are there any other examples in medical literature of this treatment's effectiveness?

"At the current moment, there are 47 active clinical trials researching this treatment. Of those, 12 have advanced to Phase 3 testing. The majority of these studies are based out of Bethesda, Maryland; however, 2080 locations across the globe are running trials for this treatment."

Answered by AI

Recent research and studies

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

clinicaltrials.govStudy

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

Chi Lin, MD, PhD 2017. "Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03386500.

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