BO17706

Überprüfung der Wirksamkeit und Sicherheit, wenn man Bevacizumab mit Gemcitabin und Erlotinib verabreicht, bei Patienten mit metastasiertem Pankreaskarzinom

Rekrutierung

Die Studie nimmt keine neuen Patienten mehr auf.

Studiendesign

randomisierte, doppelblinde, Placebo kontrollierte, multizentrische Phase-III-Studie

Synopsis

This study will evaluate efficacy, safety and tolerability of Avastin (Bevacizumab) versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

Einschlusskriterien

adult patients, ≥18 years of age
metastatic pancreatic cancer (adenocarcinoma)
good liver, kidney, and bone marrow function

Ausschlusskriterien

previous systemic treatment for metastatic pancreatic cancer
pregnant or lactating females
fertile men, or women of childbearing potential, not using adequate contraception
major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study