Doxorubicin Transdrug®
Phase I/II (BA/2002/03/02) Liver Cancer --
Hepatocellular Carcinoma (HCC) (completed)
This study was an open multicenter study conducted at 8 clinical
sites in France, evaluating the tolerance of Doxorubicin Transdrug®
in the hepatic intra-arterial treatment of advanced hepatocellular
carcinoma (HCC). The primary objective was to determine the
maximum tolerated dose (MTD) and the recommend dose for further
studies for treatment by the hepatic intra-arterial route. Four
dose levels have being assessed: 10, 20, 30, and 40 mg/m2 with
patients undergoing follow-up for 4 weeks after a single course
of treatment.
Upon the conclusion of this trial, a dose of 30 mg/m2 was
retained on the basis of drug tolerance and efficacy criteria
for the remainder of the clinical development of doxorubicin
Transdrug®. In the sub-group of patients treated at 30mg/m2,
the efficacy results of the study appeared to be promising
for doxorubicin Transdrug®, with an objective response
rate of 16.67% after a single injection.
Doxorubicin Transdrug® has been granted Orphan Drug Status
by the EMEA in Europe and the FDA in the U.S.
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