
Doxorubicin Transdrug®
Phase II/III (BA 2006/03/03) Liver Cancer--Hepatocellular
Carcinoma (HCC) (ongoing)
Doxorubicin Transdrug® has been granted Orphan Drug Status
by the EMEA in Europe and the FDA in the U.S.
This multi-centre randomised Phase II/III clinical trial
for the treatment of hepatocarcinoma, conducted versus local
standard treatment, will determine the efficacy of doxorubicin
Transdrug® administered via hepatic intra-arterial administration
in repeated cures (30mg/m2 dosage defined in the previous
trial). The efficacy will be assessed firstly, in a first
part of the trial, on a number of patients whose disease does
not progress within three months (50 patients). In the second
part of this same trial, in Phase III, extended to 200 patients,
the evaluation will deal concern the criteria of "time
without progression of the disease", monitored over 12
months versus local standard treatment.
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