A Phase II Open-Label, Randomised, Comparative, International Multicentre Study to Compare the Safety and Efficacy of Two Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposom...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-007622-22

A Phase II Open-Label, Randomised, Comparative, International Multicentre Study to Compare the Safety and Efficacy of Two Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer Who Have Failed Previous Platinum Based Chemotherapy

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Extrait

To compare the efficacy of 2 different dose levels of AZD2281 versus liposomal doxorubicin in patients with advanced BRCA1 or BRCA2 associated ovarian cancer. This will be assessed by the following: primary variable · progression free survival (PFS) secondary variables · objective response rate (complete response (CR) and partial response (PR)) at various timepoints and overall · overall duration of response · tumour size · CA 125 levels · Overall survival (OS)


Critère d'inclusion

  • Advanced BRCA1 or BRCA2 associated ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy