drugset / Trial / NCT02340156
Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma
NaSingle-groupOpen-labelTreatment
Summary
This Phase II clinical trial is an open label, single arm, multicenter study of the combination of intravenously administered SGT-53 and oral temozolomide in patients with confirmed glioblastoma who have proven tumor recurrence or progression. The objective of this trial is to assess 6 month progression free survival (PFS), overall survival (OS), anti-tumor activity, safety and possibly to evaluate, nanoparticle delivery to tumor site, and the induction of apoptosis in the tumor..
Timeline
- Start
- 2014-12
- Primary completion
- 2018-11
- Completion
- 2018-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SGT-53 | Other / unclassified | 1.2 mg | Intravenous |
| Subject | SGT-53 | Other / unclassified | 2.4 mg | Intravenous |
| Subject | SGT-53 | Other / unclassified | 3.6 mg | Intravenous |
| Subject | Temozolomide | Small molecule | 75 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 125 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |