Phase I-II to Evaluate Efficacy/Safety of Sorafenib+Gemcitabine+Radiotherapy in Locally Advanced Pancreatic Carcinoma

Phase 1 Completed 12 enrolled Grupo Espanol Multidisciplinario del Cancer Digestivo

NaSingle-groupOpen-labelTreatment

Summary

Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy Phase II: Activity profile evaluating Progression-free rates (PFR) at 6 months, Response rate, Overall survival, Toxicity profile

Timeline

Start: 2007-12
Primary completion: 2011-01
Completion: 2012-01

Publications

Aparicio J, Garcia-Mora C, Martin M, Petriz ML, Feliu J, Sanchez-Santos ME, Ayuso JR, Fuster D, Conill C, Maurel J. A phase I, dose-finding study of sorafenib in combination with gemcitabine and radiation therapy in patients with unresectable pancreatic adenocarcinoma: a Grupo Espanol Multidisciplinario en Cancer Digestivo (GEMCAD) study. PLoS One. 2014 Jan 9;9(1):e82209. doi: 10.1371/journal.pone.0082209. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	200 mg	Oral
Subject	Sorafenib	Small molecule	400 mg	Oral
Subject	Sorafenib	Small molecule	800 mg	Oral
Background	Gemcitabine	Small molecule	300 mg/m2	Intravenous

Phase I-II to Evaluate Efficacy/Safety of Sorafenib+Gemcitabine+Radiotherapy in Locally Advanced Pancreatic Carcinoma

Summary

Timeline

Publications

Drugs

Indications