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.
Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)
Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)
Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine
Plasma Decay Half-life (t1/2) of Gemcitabine
Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2
Percentage of Participants With Overall Response (OR)
Duration of Response (DR)
Progression-free Survival (PFS)
One Year Survival Probability
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study
Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Pfizer Investigational Site, Gent 9000, Belgium
Pfizer Investigational Site, Marseille 13005, France
Pfizer Investigational Site, Paris Cedex 13 75651, France
Pfizer Investigational Site, Saint Herblain Cedex, France
Pfizer Investigational Site, Toulouse 31052, France
Pfizer Investigational Site, Berlin 13353, Germany
Pfizer Investigational Site, Milano 20133, Italy
Pfizer Investigational Site, Roma 00168, Italy
Pfizer Investigational Site, Barcelona 08035, Spain
Pfizer Investigational Site, Barcelona 08036, Spain
Pfizer Investigational Site, Sevilla 41013, Spain
Pfizer Investigational Site, Edinburgh EH4 2XU, United Kingdom
Pfizer Investigational Site, London W12 OHS, United Kingdom
Pfizer Investigational Site, Edmonton, Alberta T6G 1Z2, Canada
Pfizer Investigational Site, Antioch, California 94509, United States
Pfizer Investigational Site, Berkeley, California 94704, United States
Pfizer Investigational Site, Concord, California 94520, United States
Pfizer Investigational Site, Stamford, Connecticut 06902-3628, United States
Pfizer Investigational Site, Miami, Florida 33136, United States
Pfizer Investigational Site, Tampa, Florida 33612-9497, United States
Pfizer Investigational Site, Southampton, Hampshire SO16 6YD, United Kingdom
Pfizer Investigational Site, Leicester, Leicestershire LE1 5WW, United Kingdom
Pfizer Investigational Site, Biddeford, Maine 04005, United States
Pfizer Investigational Site, Brunswick, Maine 04011, United States
Pfizer Investigational Site, Scarborough, Maine 04074, United States
Pfizer Investigational Site, Winnipeg, Manitoba R2H 2A6, Canada
Pfizer Investigational Site, Winnipeg, Manitoba R3E 0V9, Canada
Pfizer Investigational Site, St. Louis, Missouri 63141, United States
Pfizer Investigational Site, Washington, Missouri 63090, United States
Pfizer Investigational Site, Lincoln, Nebraska 68510, United States
Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States
Pfizer Investigational Site, Winston-Salem, North Carolina 27292, United States
Pfizer Investigational Site, Sault Ste Marie, Ontario P6A 2C4, Canada
Pfizer Investigational Site, Toronto, Ontario M5G 2M9, Canada
Pfizer Investigational Site, Montreal, Quebec H2X 3J4, Canada
Pfizer Investigational Site, Madison, Wisconsin 53792, United States