Conditions: Pancreatic Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 80
Healthy volunteers: no

Brief summary:
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.

Detailed description:

Arms:
arm 1: Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.

Interventions: intervention 1: Erlotinib intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily. intervention 2: Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.

Protocol document: