A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients with Platinum-Resistant Ovarian Cancer
- To evaluate the efficacy of DNIB0600A compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer as determined by progression-free survival - To evaluate the efficacy of DNIB0600A compared with PLD in patients s assessed by overall survival
- recurrent platinum resistant ovarian cancer - maximum of 2 prior chemo regimens - No prior pegylated liposomal doxorubicin - Must have measurable disease - No known HIV, Hep C or Hep B - Good lab values and performance status
- Patients are randomized to receive either DNIB0600A on Day 1 of each 28 day cycle or pegylated liposomal doxorubicin on Day 1 of each 28 day cycle. - This is an outpatient treament that can continue until disease progression or side effect prohibit further therapy.
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