Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
This trial will be conducted to evaluate the efficacy, safety and tolerability of a
combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a
first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong
scientific rationale for exploring the role of sorafenib in combination with gemcitabine in
advanced CCC.
Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and
angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the
receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β.
Mutations in these signaling pathways display by far the most common genetic alterations in
CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a
consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine,
suggesting that sorafenib can safely be combined with gemcitabine.
Clinical results of a combination of sorafenib and gemcitabine in a phase I study in
pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results
together with the knowledge of the molecular pathology of CCC provide a rationale for a
randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in
advanced CCC.
Phase:
Phase 2
Details
Lead Sponsor:
PD Dr Markus Möhler
Collaborators:
Interdisciplinary Center for Clinical Trials (IZKS) Johannes Gutenberg University Mainz