Adenocarcinoma Clinical Trial
Official title:
A Randomized, Double-blind, Multicenter Phase II Trial With Gemcitabine Plus Sorafenib Versus Gemcitabine Plus Placebo in Patients With Chemo-naive Advanced or Metastatic Adenocarcinoma of the Biliary Tract
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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