drugset / Trial / NCT03332589
E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase 1 study of E6201 plus dabrafenib for the treatment of CNS metastases in BRAF V600-mutated metastatic melanoma. A total of up to N=28-34 subjects with melanoma metastasized to the CNS will be included.
Timeline
- Start
- 2018-07-02
- Primary completion
- 2021-04-30
- Completion
- 2021-10-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabrafenib | Small molecule | 50 mg | Oral |
| Subject | Dabrafenib | Small molecule | 75 mg | Oral |
| Subject | Dabrafenib | Small molecule | 100 mg | Oral |
| Subject | Dabrafenib | Small molecule | 150 mg | Oral |
| Subject | E6201 | Small molecule | 160 mg/m2 | Intravenous |
| Subject | E6201 | Small molecule | 240 mg/m2 | Intravenous |
| Subject | E6201 | Small molecule | 320 mg/m2 | Intravenous |