A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Erlotinib Hydrochloride

Criteria

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.