drugset / Trial / NCT01415713
The Study of Metastatic Pancreatic Adenocarcinoma
Phase 1/2
Completed
73 enrolled
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study
Timeline
- Start
- 2012-03
- Primary completion
- 2016-04
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 20 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 20 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 30 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 35 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 40 mg/m2 | Oral |