Trial Information
A Randomized, Double Blind Study of Biomarkers Predictive of Improvement in Progression Free Survival in Patients With Advanced Pancreatic Cancer Treated With Tarceva.
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically or cytologically documented locally advanced-unresectable or
metastatic pancreatic cancer;
- measurable disease according to RECIST;
- failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for
chemotherapy;
- ECOG performance status of 0-2.
Exclusion Criteria:
- local or locally advanced-resectable pancreatic cancer;
- any other malignancies within last 5 years, except for adequately treated cancer in
situ of the cervix, or basal or squamous cell skin cancer;
- major surgery within 2 weeks prior to randomization.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
EGFR expression and gene copy number, HER2, HER3 expression and k-RAS mutation status in tumor tissue, EGFR ligands in serum
Outcome Time Frame:
At screening
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Malaysia: Ministry of Health
Study ID:
BO21129
NCT ID:
NCT00674973
Start Date:
June 2008
Completion Date:
December 2013
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms