drugset / Trial / NCT02060955
Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan
RandomizedParallel-groupOpen-labelTreatment
Summary
The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Bevacizumab/Irinotecan second line treatments for these patients.
Timeline
- Start
- 2014-02
- Primary completion
- 2015-06
- Completion
- 2015-07
Outcome
Outcome not reported
Stopped: “Substantial design modifications required.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALECSAT | Cell therapy | — | Intravenous |
| Comparator | Bevacizumab | Monoclonal antibody | — | — |
| Comparator | Irinotecan | Small molecule | — | — |