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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Neoplasms

Intervention: Gemcitabine (Drug); AG-013736 (Drug); Gemcitabine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combination With Gemcitabine In Patients With Chemotherapy Naive Advanced Pancreatic Cancer Preceded By A Phase 1 Portion

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival (OS)

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients with advanced (localized but surgically unresectable or metastatic)

histologically/cytologically proven epithelial cancer of the exocrine pancreas

- no prior therapy for metastatic disease

Exclusion Criteria:

- patients with locally advanced disease who are candidates for radiation therapy.

- uncontrolled brain metastases (a controlled brain metastasis must be previously

treated, asymptomatic, and without growth for 4 months)

Locations and Contacts

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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2005
Last updated: July 23, 2012

Page last updated: August 23, 2015

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