drugset / Trial / NCT02215512

Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases

NCT02215512

Phase 1 Completed 29 enrolled EpicentRx, Inc.
NaSingle-groupOpen-labelTreatment

Summary

In this dose-escalation study, the safety and tolerability of escalating dose levels of RRx-001 administered intravenously twice a week in subjects with brain metastases receiving whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is identified, further (up to approximately 30) participants will be recruited. The study will use MRI to monitor changes in tumor blood flow associated with RRx-001.

Timeline

Start
2015-02-06
Primary completion
2016-11-28
Completion
2020-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject NIBROZETONE Other / unclassified 10 mg Intravenous
Subject NIBROZETONE Other / unclassified 17 mg Intravenous
Subject NIBROZETONE Other / unclassified 33 mg Intravenous
Subject NIBROZETONE Other / unclassified 55 mg Intravenous