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A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy


Inclusion Criteria:



- Confirmed with pancreatic cancer

- Have failed first line gemcitabine therapy

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of AZD6244

Outcome Time Frame:

assessed after 3 months of treatment

Safety Issue:

No

Principal Investigator

Emerging Oncology Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1532C00008

NCT ID:

NCT00372944

Start Date:

August 2006

Completion Date:

October 2008

Related Keywords:

  • Pancreatic Cancer
  • advanced pancreatic cancer
  • metastatic pancreatic cancer
  • AZD6244
  • Pancreatic Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAuburn, Washington