Status:
COMPLETED
Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases
Lead Sponsor:
EpicentRx, Inc.
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 radiatio...
Detailed Description
The purpose of this research study is to test the safety and activity of whole brain radiation therapy with RRx-001, an experimental radiation sensitizer, in participants with brain metastases. As a r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02215512
Start Date
February 6 2015
End Date
November 12 2020
Last Update
November 3 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence Saint John's Health Center
Santa Monica, California, United States, 90404
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Allegiance Health
Jackson, Michigan, United States, 49201
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110