Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03608020
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03608020
Study Brief:
Protocol Section:
NCT03608020