drugset / Trial / NCT00618917
MnSOD (Esophageal Protectant) to Prevent Esophagitis During Radiation/Chemotherapy Treatment for Non-Small Cell Lung Cancer (NSCLC)
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation in subjects with locally advanced non-small cell lung cancer (NSCLC).
Timeline
- Start
- 2005-11-11
- Primary completion
- 2010-02-26
- Completion
- 2011-08-11
Outcome
Outcome not reported
Stopped: “MnSOD longer available during Phase II”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Manganese Superoxide Dismutase Plasmid Liposome | Unknown | 0.3 mg | Oral |
| Subject | Manganese Superoxide Dismutase Plasmid Liposome | Unknown | 3 mg | Oral |
| Subject | Manganese Superoxide Dismutase Plasmid Liposome | Unknown | 30 mg | Oral |
| Background | Carboplatin | Small molecule | 45 mg/m2 | — |
| Background | Paclitaxel | Small molecule | — | — |