AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

Summary

This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

Timeline

Start

2005-07-05

Primary completion

2008-03-14

Completion

2008-03-14

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Axitinib + Gemcitabine vs Gemcitabine; p = 0.1026; Hazard Ratio (HR) 0.758 (95% CI 0.490 to 1.170); Log Rank NCT00219557 ↗

paper the small, non-statistically significant gain in overall survival needs to be assessed in a randomised phase III trial. PMID 18514303 ↗

Publications

• Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Letourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. doi: 10.1016/S0140-6736(08)60661-3. Epub 2008 May 29.

Drugs

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

Indications