A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Phase 2
- Registration Number
- CTRI/2008/091/000081
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EGFR expression and gene copy number, HER2, HER3 expression and k-RAS mutation status in tumor tissue, EGFR ligands in serumTimepoint: At screening;Progression free survivalTimepoint: Event driven
- Secondary Outcome Measures
Name Time Method Adverse events, lab parametersTimepoint: Throughout study;Response rate, disease control rate and overall survivalTimepoint: Event driven