Clinical Trial Details
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NCT02215512 : Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Written informed consent

- Age ?18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- One or more brain metastases

- Prior radiation therapy to the brain is allowed with the exception of whole brain

- Subjects must be neurologically stable for at least 14 days prior to first dose of
study drug;

- Male and female subjects who are not surgically sterile or post-menopausal must agree
to use reliable methods of birth control for the duration of the study and for 90
days after the last dose of study drug administration; male partners of female
subjects should use condoms for the duration of the study, and for 90 days after the
last dose of study drug administration

Exclusion Criteria:

- Pregnant or lactating females

- Any evidence of severe or uncontrolled diseases

- Inadequate bone marrow reserve

- Previous whole brain radiotherapy

- Prior RRx-001 therapy

- Insufficient recovery from all side effects of previous anticancer therapies

- Evidence of blood clotting or bleeding abnormalities
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