NCT00471146

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

A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 630 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.

Conditions

• Carcinoma, Pancreatic Ductal

Interventions

Type	Name	Description
DRUG	AG-013736	oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression.
DRUG	Gemcitabine	intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
DRUG	Gemcitabine	intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
DRUG	placebo	placebo

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-01-01
• Completion: 2010-11-01
• First posted: 2007-05-09
• Last updated: 2012-07-16
• Results posted: 2012-07-16

Locations

204 sites across 24 countries: United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom