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Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma
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..
Details
| Lead sponsor | SynerGene Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 1 |
| Start date | 2014-12 |
| Completion | 2018-11 |
Conditions
- RECURRENT GLIOBLASTOMA
Interventions
- SGT-53
- Temozolomide
Primary outcomes
- Tumor Response — 6 months
The 6 month progression-free survival (PFS) was evaluated using RANO Response Criteria.
Countries
United States, Taiwan