Conditions: Carcinoma, Pancreatic Ductal
Keywords: Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 630
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: AG-013736 intervention 2: Gemcitabine intervention 3: Gemcitabine intervention 4: placebo
Intervention descriptions: intervention 1: oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression. intervention 2: 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. intervention 3: 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. intervention 4: placebo

Protocol document: