SGI-110 in Combination With Carboplatin in Ovarian Cancer
Completed
Astex Pharmaceuticals
Phase 2
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.
SGI-110 in Combination With Carboplatin in Ovarian Cancer
Completed
Astex Pharmaceuticals, Inc.
Phase 2
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.
Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer
Completed
Astex Pharmaceuticals, Inc.
Phase 1/Phase 2
This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously
treated metastatic colorectal cancer patients. This study will be conducted in two
components. First, patients will be enrolled in a phase I study of SGI-110 combined with
irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined,
patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and
irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
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