Clinical trial
Phase I / II Study Of ColoAd1 Intraperitoneally in Ovarian Cancer Patients (OCTAVE)
This study is a phase I/II open label clinical study in patients with platinum-resistant epithelial ovarian cancer. The Phase I part of the study will determine the dose of ColoAd1 to be recommended for further studies and will examine primarily the safety and tolerability but also the pharmacokinetics of administering ColoAd1 intraperitoneally. Once the dose of IP ColoAd1 to be used in combination with IV weekly paclitaxel has been determined, the phase II stage will begin as an open label dose expansion of that regimen. The phase II stage aims to determine whether intraperitoneal ColoAd1 has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian Cancer.
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Study start date | 2014-01-03 |