AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.

Key facts

Study ID

NCT00372944

Run by

AstraZeneca

People needed

70

Starts

2006-08-01

Expected to finish

2008-10-01

Last updated by the study team

2014-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed with pancreatic cancer
• Have failed first line gemcitabine therapy

You may not qualify if…

• Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.
• Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.

Where it is running

• Research Site — Alhambra, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — Orlando, Florida, United States
• Research Site — Chevy Chase, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — New York, New York, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Temple, Texas, United States
• Research Site — Seattle, Washington, United States
• Research Site — Heidelburg, Australia
• Research Site — Plovdiv, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Budapest, Hungary
• Research Site — Cluj-Napoca, Romania

Full record on ClinicalTrials.gov

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