Phase II multicenter,open-label, clinical and pharmacokinetic study of Aplidin® as a 3-hour infusion every 2 weeks, in patients with advanced or metastatic transitional cell carcinoma of the urotheli...

Update Il y a 4 ans
Reference: EUCTR2004-001118-15

Phase II multicenter,open-label, clinical and pharmacokinetic study of Aplidin® as a 3-hour infusion every 2 weeks, in patients with advanced or metastatic transitional cell carcinoma of the urothelium, relapsing or progressing after first line chemotherapy

Woman and Man

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Extract

To assess the anti-tumor activity of Aplidin® administered as a 3 h iv infusion every 2 weeks, in patients with advanced or metastatic transitional cell carcinoma of the urothelium, relapsing or progressing after first line chemotherapy.


Inclusion criteria

  • More than 90% of bladder carcinomas are transitional cell carcinomas (TCC) derived from the uroepithelium. About 6% to 8% are squamous cell carcinomas, and 2% are adenocarcinomas. Adenocarcinomas may be either of urachal origin or of nonurachal origin; the latter type is generally thought to arise from metaplasia of chronically irritated transitional epithelium

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