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
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer
Both
Pancreatic Cancer
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 Site | Anaheim, California |
| Research Site | Boca Raton, Florida |
| Research Site | Baltimore, Maryland |
| Research Site | Battle Kreek, Michigan |
| Research Site | Albany, New York |
| Research Site | Chattanooga, Tennessee |
| Research Site | Abilene, Texas |
| Research Site | Auburn, Washington |
