NCT01696032

SGI-110 in Combination With Carboplatin in Ovarian Cancer

A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	SGI-110
DRUG	Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)	Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
DRUG	Carboplatin

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2012-09-28
• Last updated: 2024-08-27
• Results posted: 2021-05-25

Locations

24 sites across 3 countries: United States, Canada, United Kingdom