drugset / Trial / NCT00638612
AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this Phase 1 study is to evaluate the safety and potential efficacy of Gene Mediated Cytotoxic Immunotherapy for pancreatic cancer. The approach uses an adenoviral vector (disabled virus) engineered to express the Herpes thymidine kinase gene (AdV-tk), followed by an antiherpetic prodrug, valacyclovir.
Timeline
- Start
- 2008-08
- Primary completion
- 2013-05
- Completion
- 2015-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valacyclovir | Unknown | 2 g | Oral |
| Subject | aglatimagene besadenovec | Unknown | 3e+10 unknown | Other |
| Subject | aglatimagene besadenovec | Unknown | 1e+11 unknown | Other |
| Subject | aglatimagene besadenovec | Unknown | 3e+11 unknown | Other |
| Subject | aglatimagene besadenovec | Unknown | 1e+12 unknown | Other |