drugset / Trial / NCT03867123
A Study to Evaluate the Safety of LAM561 Added to Standard of Care in Newly-diagnosed Glioblastoma Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and tolerability of LAM561 added to first-line treatment for subjects with newly diagnosed glioblastoma (GBM), and to determine the highest safe dose of LAM561 administered orally when added to the concurrent phase of treatment with temozolomide (TMZ) and radiation therapy (RT) or when added to the maintenance phase of treatment with TMZ (once TMZ 200 g/m2/day is started).
Timeline
- Start
- 2018-12-04
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LAM561 | Small molecule | 4 g | Oral |
| Subject | LAM561 | Small molecule | 8 g | Oral |
| Subject | LAM561 | Small molecule | 12 g | Oral |
| Background | TMZ | Unknown | 75 mg/m2 | — |
| Background | TMZ | Unknown | 200 mg/m2 | — |