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

Completed · Phase 1

Conditions studied: Brain Metastases

In brief

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.

Key facts

Study ID

NCT02215512

Run by

EpicentRx, Inc.

People needed

29

Starts

2015-02-06

Expected to finish

2020-11-12

Last updated by the study team

2021-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 irradiation
• 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

You may not qualify if…

• 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

Where it is running

• Providence Saint John's Health Center — Santa Monica, California, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Allegiance Health — Jackson, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Cancer Institute of New Jersey (Rutgers University) — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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