drugset / Trial / NCT03608020
A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy
Phase 1/2
Terminated
35 enrolled
BioMimetix JV, LLC
Duke Cancer Institute · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This protocol is for a lead-in safety study of 5 patients followed by a randomized Phase 2 clinical trial of BMX-001, a new class of pharmaceutical, in 64 patients with multiple brain metastases (MBM) undergoing whole brain radiation therapy (WBRT). Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition.
Timeline
- Start
- 2018-10-04
- Primary completion
- 2023-12-31
- Completion
- 2024-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BMX-001 | Small molecule | 14 mg | Subcutaneous |