drugset / Trial / NCT00758381
Metastatic Advanced Pancreas Sorafenib
Phase 2
Unknown
114 enrolled
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Mario Negri Institute for Pharmacological Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.
Timeline
- Start
- 2007-08
- Primary completion
- 2008-08
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 400 mg | Oral |
| Comparator | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |