drugset / Trial / NCT00545545
Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.
Timeline
- Start
- 2007-10
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imprime PGG | Other / unclassified | 2 mg/kg | Other |
| Subject | Imprime PGG | Other / unclassified | 4 mg/kg | Other |
| Subject | Imprime PGG | Other / unclassified | 6 mg/kg | Other |
| Subject | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Other |