An Open-label, Uncontrolled, Phase II Trial Evaluating the Single-dose and Steady-state Pharmacokinetics of EndoTAG®-1 and Its Effect on the Blood Supply and the Angiogenesis of Hepatic Metastases in Patients With a Carcinomatous Primary Tumor Other Than Hepatocellular (HCC), Biliary or Bile Duct Carcinoma
Liver metastases are among the most frequent neoplasms of the liver and represent a quite
uniform clinical entity regardless from which carcinoma they originate. The treatment is
dependent on number and size of the hepatic lesions but still, none of the therapeutic
options leads to satisfying results. The growth of tumors and metastases is dependent on
blood vessels, which supply the tumors and metastases with nutrients. Liver metastases,
independent from which original tumor they come from, are especially well supplied with
blood. The aim of the treatment with the investigational medicinal product EndoTAG®-1 is to
target the blood vessels, which supply the metastases, and destroy them. Consequently, the
metastases themselves will be damaged.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Pharmacokinetic profile
Last patient out
No
Klaus Mross, PD
Principal Investigator
Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg
Germany: Federal Institute for Drugs and Medical Devices
CT 4003
NCT00542048
November 2007
September 2009
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