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

Who is this study for? Adult patients with Brain Cancer
What treatments are being studied? Manganese Butoxyethyl Pyridyl Porphyrin
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

• 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

Locations
United States
Kentucky
University of Kentucky
Recruiting
Lexington
Michigan
Henry Ford Hospital
Recruiting
Detroit
North Carolina
Duke Cancer Institute
Recruiting
Durham
Washington
University of Washington
Recruiting
Seattle
Contact Information
Primary
Sara Penchev
contact@bmxpharma.com
303-862-7268
Time Frame
Start Date: October 4, 2018
Estimated Completion Date: September 30, 2024
Participants
Target number of participants: 69
Treatments
Active Comparator: WBRT + BMX-001
Whole 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).
No Intervention: Whole Brain Radiation Therapy
Whole brain radiation therapy per standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: Duke Cancer Institute, National Cancer Institute (NCI)
Leads: BioMimetix JV, LLC

This content was sourced from clinicaltrials.gov

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