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Head and Neck CancerPhase 2NCT04607642

Trial of BMX-001 or Placebo in Head and Neck Cancer Patients

A Phase 2 study testing BMX-001, Radiation Therapy and Cisplatin in people with Head and Neck Cancer, run by BioMimetix JV, LLC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

There are an estimated 65,000 newly diagnosed cases of head and neck cancer each year in the United States. The most common treatment for head and neck cancers is radiotherapy in combination with cisplatin chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
BMX-001, Radiation Therapy and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2021to Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed (histologically or cytologically) diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity with clinical or pathologic high-risk features who will be receiving radiation and concurrent cisplatin chemotherapy.
  • Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.1 Gy with a cumulative radiation dose between 60 Gy and 70 Gy depending on whether patients are receiving post-operative or definitive intent therapy respectively.
  • For patients undergoing curative intent resection, Patients must have undergone gross total surgical resection within 56 days prior to registration and beginning of therapy under the clinical trial.
  • General history and physical examination by a qualified head and neck cancer specialist and physician within 8 weeks prior to enrollment (including fiberoptic endoscopy).
  • Axial imaging of the neck and chest- CT, MRI and/or PET/CT is acceptable, within 8 weeks prior to date of consent.
  • Age ≥ 18 years.
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  • Zubrod Performance Status 0-2 within 4 weeks prior to enrollment.
  • CBC/differential obtained within 2 weeks prior to starting the study drug with adequate bone marrow function
  • Adequate hepatic function
  • Adequate renal function defined as follows:
  • Patient must be willing and able to follow study procedures and instructions.
  • Patient must provide study-specific informed consent within 28 days prior to starting the study drug.
  • Negative pregnancy test for women of child-bearing potential within 48 hours prior to first dose of BMX-001.
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment.

Who cannot join

  • Distant metastasis
  • Hypertension
  • Grade ≥2 hypotension at screening
  • Concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
  • History of syncope within the last 6 months
  • Patients receiving, or unable to stop use of prohibited medications
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  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Women who are breast feeding are not eligible
  • Known hypersensitivity to compounds of similar chemical composition to BMX-001
  • Grade 3-4 electrolyte abnormalities (CTCAE v 5.0)
  • Prior unrelated malignancy requiring current active treatment with exceptions
  • Prior history of HNSCC receiving radiation or chemo-radiation.
  • Prior systemic chemotherapy for the study cancer (including neoadjuvant chemotherapy); note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer.
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) using the specific/usual choice by clinical center for correction factor.
  • A history of additional risk factors for TdP
  • Severe, active co-morbidity as defined in the protocol

About this study

Official title: A Randomized, Blinded, Placebo Controlled Phase 2 Trial of Concurrent Radiation Therapy and Cisplatin With and Without BMX-001 in Patients With Locally Advanced Head and Neck Cancer

There are an estimated 65,000 newly diagnosed cases of head and neck cancer each year in the United States. The most common treatment for head and neck cancers is radiotherapy in combination with cisplatin chemotherapy. This treatment regimen is effective in killing the tumor; however, the normal tissues that line the mouth and throat can sustain severe injury from the radiation. Side-effects incurred during irradiation include: mucositis, xerostomia, swelling, trouble swallowing, pain, infections, cavities, hair loss and reddening of the skin. Some of these side effects can be so severe that patients require feeding tubes and management of severe pain can lead to the premature halt of radiotherapy. There are currently no effective radio-protectors used to ameliorate these severe side-effects.

BioMimetix has developed small molecular weight superoxide dismutase (SOD) mimetic, BMX-001, that is a very potent radio-protector of head and neck tissues. In our first clinical trial in a head and neck cancer patient cohort using this drug, we have early evidence that BMX-001 may protect against radiation-induced mucositis and xerostomia.

This will be a randomized, placebo-controlled Phase 2 clinical trial to study the effects of BMX-001 (14 mg/subject biw) + radiation therapy + cisplatin against placebo + radiation therapy + cisplatin in prevention of acute and chronic mucositis and xerostomia.

Read the detailed description

This study will seek to confirm protection of normal tissues by assessing the incidence, severity and duration of mucositis in a randomized, placebo controlled, Phase 2 clinical trial of BMX-001 in combination with standard RT and chemotherapy in newly diagnosed head and neck cancer patients (162 subjects, 1:1 randomization study drug: placebo).

The study will also confirm protection of normal tissues by assessing the acute and chronic extent of xerostomia in the same trial.

Being tested
BMX-001, Radiation Therapy, Cisplatin, Placebo
Keywords
head and neck squamous cell carcinoma
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMX-001Drug

    Also called manganese butoxyethyl pyridyl porphyrin, MnTnBuOE-2-PyP5+

    BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates.

  • Radiation TherapyRadiation

    Treatment plan should include a continuous course of treatment delivered as single daily fractions of 2.0 to 2.1 Gy with a cumulative radiation dose between 60 Gy and 70 Gy. Planned radiation treatment volumes must include at least two oral mucosal sub-sites (buccal mucosa, retromolar trigone, floor of mouth, tongue, soft palate, hard palate) with a portion of each site receiving at least 50 Gy.

  • CisplatinDrug

    Cisplatin is an IV chemotherapeutic agent approved to treat head and neck cancers. Cisplatin will be administered per institution's standard of care practice. Common standard of care practice includes dosing cisplatin at 100mg/m2 IV q21 days starting on Day 1 of RT for 2-3 doses or dosing cisplatin at 40 mg/m2 IV each week of RT for 6-7 total doses. Cisplatin will be infused per institutional guidelines.

  • PlaceboOther

    The placebo to be used in this study is 0.9% Sodium Chloride Injection, USP.

Study groups in NCT04607642
Study groupRoleWhat they receive
A BMX-001ExperimentalPatients will receive standard of care radiation therapy plus Cisplatin. BMX-001 will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks.
Receives: Drug: BMX-001; Radiation: Radiation Therapy; Drug: Cisplatin
B PlaceboPlacebo comparatorPatients will receive standard of care radiation therapy plus Cisplatin. Placebo will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks.
Receives: Radiation: Radiation Therapy; Drug: Cisplatin; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mucositis Incidence

    The primary outcome measure used for each study subject is a dichotomous measure of whether they experienced severe oral mucositis (OM, defined as grade 3 or 4 according to WHO criteria) at any time between the first IMRT fraction until 30 days after the completion of RT. The primary analysis will thus test the difference in the proportion of subjects from each treatment group who experience severe OM.

    Measured: 12 weeks

Secondary outcomes (7)

  1. Mucositis Duration

    The interval (measured in days) from the date of first determination of severe OM to the date of the first determination of not having severe OM, without a subsequent instance of severe OM.

    Measured: 12 weeks

  2. Mucositis Severity

    Days it takes for patients in each arm to develop severe oral mucositis.

    Measured: 12 weeks

  3. Xerostomia Incidence

    The dichotomous measure of whether the study subject had grade 2 (or greater) Xerostomia (as defined by CTCAE v 5.0). This will be assessed at 1, 6, 12, and 24 months after completion of RT.

    Measured: 1, 6, 12, and 24 months

  4. Saliva Production Measurements

    The continuous measure of saliva production (g/min), measured at baseline and 1, 6, 12, and 24 months after completion of RT. Both stimulated and unstimulated saliva production will be measured.

    Measured: 1, 6, 12, and 24 months

  5. Radiation Dermatitis Duration

    The continuous endpoint of duration of radiation dermatitis, where duration is defined as the interval (measured in days) from the date of first determination of radiation dermatitis to the date of the first determination of not having radiation dermatitis, without a subsequent instance of radiation dermatitis. For any subject whose radiation dermatitis persists, the final date will be 30 days after the completion of RT.

    Measured: 12 weeks

  6. Overall Survival

    Overall survival (OS), defined as the interval (measured in days) from the date of randomization until the date of death from any cause.

    Measured: 2 years

  7. Disease Free Survival

    Disease-free survival (DFS), defined as the interval (measured in days) from the date of randomization until the date of CT scan showing tumor progression.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study startJul 2021 (estimated)
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2025 (estimated)

Why it stopped: Will be conducted as a different study with different sponsorship

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607642
Sponsor's protocol ID
BMX-HN-201
Status last verified
Oct 2021
First submitted
23 Oct 2020
Last updated
11 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Myers MS, Kosmacek EA, Liew CS, Lushnikov AJ, Chatterjee A, Marky LA, Riethoven JM, Oberley-Deegan RE. BMX-001, a clinically relevant radioprotector, can reverse radiation-induced fibrosis when given three weeks after radiation, in part, by restoring methylation. Redox Biol. 2026 Mar;90:104020. doi: 10.1016/j.redox.2026.104020. Epub 2026 Jan 10.

    PubMed 41544350

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMX-001, Radiation Therapy and Cisplatin in people with Head and Neck Cancer, run by BioMimetix JV, LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mucositis Incidence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.

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