AzTrials
AzTrials

Multiple Brain MetastasesPhase 1/2NCT03608020

A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy

A Phase 1/2 study testing BMX-001 and Whole Brain Radiation Therapy in people with Multiple Brain Metastases, run by BioMimetix JV, LLC at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This protocol is for a lead-in safety study of 5 patients followed by a randomized Phase 2 clinical trial of BMX-001, a new class of pharmaceutical, in 64 patients with multiple brain metastases (MBM) undergoing whole brain radiation therapy (WBRT). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Brain Metastases
What is being tested?
BMX-001 and Whole Brain Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
4 sitesUnited States
Study dates
4 Oct 2018to 15 Apr 2024
Phase
Phase 1/2
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

  • Subjects must have histologically confirmed diagnosis of a non-small cell lung cancer, breast cancer, melanoma or renal cell cancer primary
  • Subjects must have >5 contrast-enhancing lesions, never previously treated with SRS and/or surgical resection, on a contrast-enhanced T1-weighted brain MRI performed within two weeks of enrollment, with at least one lesion >0.5cm in greatest dimension
  • Physical examination by a radiation oncologist or medical oncologist within 14 days of the start of WBRT
  • Plan to be treated with WBRT to a dose of 30 Gy in 10 fractions
  • Age * 18 years
  • Karnofsky Performance Status (KPS) ≥ 70
Show all 13Show fewer
  • Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 cells/*l, platelets ≥ 125,000 cells/*l
  • Serum creatinine ≤ 1.5 mg/dl, serum SGOT and bilirubin ≤ 1.5 times upper limit of normal
  • Signed informed consent approved by the Institutional Review Board
  • If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 6 months afterwards as stated in the informed consent
  • Able to provide study specific informed consent
  • Willing to follow study procedures, complete QOL questionnaires and neurocognitive testing as described in the protocol
  • Negative serum pregnancy test for women of child bearing potential within 48 hours of first dose of BMX

Who cannot join

  • Active infection requiring IV antibiotics 7 days before enrollment
  • Hypertension requiring 3 or more anti-hypertensive medications to control
  • Requirement for 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
  • Subjects receiving prohibited medications listed in Section 6.4.2 of this protocol are not eligible. Subjects who can safely stop taking a prohibited medication at least 7 days prior to the first dose of BMX may participate at the discretion of the treating physician.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Show all 13Show fewer
  • Women who are breast feeding
  • Known hypersensitivity to compounds of similar chemical composition to BMX-001
  • Prior surgical resection for brain metastases and/or stereotactic radiosurgery for up to 5 brain metastases in total are permitted if performed at least 1 month prior to planned WBRT under this protocol.
  • Prior whole brain radiation therapy
  • Patients with diffuse leptomeningeal disease (carcinomatous meningitis)
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1)
  • A history of additional risk factors for TdP (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • University of Kentucky

    Lexington, Kentucky, 40506

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Safety Lead-In/Randomized Phase 2 Study of BMX-001 as a Therapeutic Agent for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy

This protocol is for a lead-in safety study of 5 patients followed by a randomized Phase 2 clinical trial of BMX-001, a new class of pharmaceutical, in 64 patients with multiple brain metastases (MBM) undergoing whole brain radiation therapy (WBRT). Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition.

Read the detailed description

This protocol is for a Phase 1 safety lead-in clinical trial of BMX-001 in combination with WBRT in 5 patients with MBM. Demonstrating safety of the selected MTD of BMX-001 in patients with MBM undergoing standard protocol WBRT will be the "go/no-go" criteria for proceeding to Phase 2.

Phase 2 is a randomized open-label Phase 2 clinical trial of 64 patients with MBM, half receiving BMX-001 in combination with WBRT and half receiving WBRT alone.

Subjects are treated with BMX-001 for a total of 19 days, during which time they receive radiation therapy. Following completion of radiation therapy, subjects will be followed for an additional one year.

Being tested
BMX-001, Whole Brain Radiation Therapy

What participants receive

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

  • BMX-001Drug

    Also called Whole Brain Radiation Therapy

    Manganese butoxyethyl pyridyl porphyrin

  • Whole Brain Radiation TherapyRadiation

    Whole Brain Radiation Therapy per standard of care.

Study groups in NCT03608020
Study groupRoleWhat they receive
WBRT + BMX-001Active comparatorWhole brain radiation therapy in combination with BMX-001 (subcutaneous injection of 28 mg loading dose, followed by subsequent 14 mg twice per week for 2 weeks).
Receives: Drug: BMX-001; Radiation: Whole Brain Radiation Therapy
Whole Brain Radiation TherapyNo interventionWhole brain radiation therapy per standard of care.

What is being measured

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

  1. Assess safety and tolerability of WBRT + BMX-001 through proportion of patients who experience grade 4 or 5 study drug related adverse events.

    AEs will be assessed according to the CTCAE version 5.0. If CTCAE grading does not exist for an AE, the severity of the AE will be graded as mild (1), moderate (2), severe (3), life-threatening (4), or fatal (5). Initially 5 patients will be accrued and treated with WBRT + BMX-001 as a lead-in safety phase. Enrollment to the randomized phase of the study will not proceed if patients in the safety lead-in phase experience the following:

    • Two or more patients are unable to complete radiation therapy (RT) due to toxicity related to BMX-001 (alone or in combination with RT.
    • Two or more patients experience delay in starting RT due to toxicity related to BMX-001 (alone or in combination with RT).

    If any patient experiences a grade 4 or 5 BMX-001-related adverse event within Arm A (WBRT + BMX-001), accrual will be suspended and the experience of the patient will be carefully reviewed by the clinical team and the study's DSMB.

    Measured: 1 year

  2. Compare neurocognition in WBRT + BMX-001 vs. WBRT alone using cumulative score of HVLT-R, TMT A&B and COWA over time.

    Subjects will complete three standardized tests (Hopkins Verbal Learning Test - Revised, Trail Making Test A\&B, and Controlled Oral Word Association test) at baseline, 1 month after completion of WBRT and every 3 months after completion of WBRT. The cumulative score of these three tests will be used to assess change.

    Measured: 1 Year

Secondary outcomes (4)

  1. Compare survival in WBRT + BMX-001 vs WBRT alone

    Survival

    Measured: 1 Year

  2. Compare local recurrence rate in WBRT + BMX-001 vs WBRT alone

    Median time to local brain failure or progression

    Measured: 1 Year

  3. Compare distant brain failure rate in WBRT + BMX-001 vs WBRT alone

    Median time to distant brain failure

    Measured: 1 Year

  4. Compare rate of neurologic death in WBRT + BMX-001 vs WBRT alone

    Proportion of patients who are dead within 1 year of initiation of WBRT due to neurologic disease and/or disseminated leptomeningeal carcinomatosis.

    Measured: 1 Year

Timeline

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

  1. First posted31 Jul 2018
  2. Study start4 Oct 2018
  3. Primary completion31 Dec 2023
  4. Study completion15 Apr 2024

Why it stopped: Cessation of grant funding

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03608020
Sponsor's protocol ID
BMX-MBM-001
Other IDs
1R44CA228694-01
Status last verified
Apr 2024
First submitted
14 Jun 2018
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMX-001 and Whole Brain Radiation Therapy in people with Multiple Brain Metastases, run by BioMimetix JV, LLC at 4 sites in United States.

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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 stopped early (reason given: Cessation of grant funding). Results are not available in the source record.

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?

Assess safety and tolerability of WBRT + BMX-001 through proportion of patients who experience grade 4 or 5 study drug related adverse events. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03608020.

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 18 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in