Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

Phase 3 Completed 630 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

Timeline

Start: 2007-07
Primary completion: 2009-01
Completion: 2010-11

Outcome

Missed primary endpoint

registry Axitinib + Gemcitabine vs Placebo + Gemcitabine; p = 0.5436; Hazard Ratio (HR) 1.014 (95% CI 0.786 to 1.309) NCT00471146 ↗

paper INTERPRETATION: The addition of axitinib to gemcitabine does not improve overall survival in advanced pancreatic cancer. PMID 21306953 ↗

Publications

Kindler HL, Ioka T, Richel DJ, Bennouna J, Letourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axitinib	Small molecule	5 mg	Oral
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous