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

• Status: Completed
• Trial end date: 2020-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EpicentRx, Inc.

Criteria

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 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

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