BO17706

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

Rekrutierung

Die Studie ist geschlossen.

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

Studienassistentin

Frau Gudrun Gröger, Telefon: 06131 17-5443

Studienleiter

Herr PD Dr. Stephan Kanzler
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