At a glance
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A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
In Brief
A Phase 2 clinical trial evaluating SGI-110, Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine), and 1 other intervention for Ovarian Cancer. Completed, enrolled 120 participants across 24 sites in 3 countries.
Detailed Summary
A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.
Study Details
Timeline
Interventions
Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine