CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 630 enrolled
Drug / intervention
AG-013736 +3 moredrug
Likely dose
AG-013736 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00471146
NCT00471146Phase 3Completed
CompareCT.gov

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.

Pfizer·interventional·Posted May 9, 2007·Updated Jul 16, 2012

In Brief

A Phase 3 clinical trial evaluating AG-013736, Gemcitabine, and 1 other intervention for Carcinoma, Pancreatic Ductal. Completed, enrolled 630 participants across 204 sites in 24 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Pancreatic Ductal
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2009
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.1 years ago

Interventions

AG-013736drug

oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression.

Gemcitabinedrug

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.

Gemcitabinedrug

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.

placebodrug

placebo