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

NCT03608020 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-04-18

No results posted yet for this study

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). Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition.

Conditions

  • Multiple Brain Metastases

Interventions

DRUG

BMX-001

Manganese butoxyethyl pyridyl porphyrin

RADIATION

Whole Brain Radiation Therapy

Whole Brain Radiation Therapy per standard of care.

Sponsors & Collaborators

  • Duke Cancer Institute

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • BioMimetix JV, LLC

    lead INDUSTRY

Principal Investigators

  • John Kirkpatrick, MD · Duke Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2023-12-31
Completion
2024-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03608020 on ClinicalTrials.gov