drugset / Trial / NCT02884128
A Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid tumors.
Timeline
- Start
- 2006-01
- Primary completion
- 2008-08
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan Sucrosofate | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 100 mg/m2 | Intravenous |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 120 mg/m2 | Intravenous |
| Background | LV | Unknown | 200 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2000 mg/m2 | Intravenous |