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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    69
  • sponsor
    BioMimetix JV, LLC
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Updated on 18 October 2022
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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.

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.

Details
Condition Multiple Brain Metastases
Treatment BMX-001, whole brain radiation therapy
Clinical Study IdentifierNCT03608020
SponsorBioMimetix JV, LLC
Last Modified on18 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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)
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