Ovarian Cancer Clinical Trial
SGI-110 in Combination With Carboplatin in Ovarian Cancer
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.
Eligibility Criteria
Inclusion Criteria:
Participants who are women 18 years of age or older.
Participants who have histologically or cytologically confirmed recurrent high-grade serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or fallopian tube cancer.
Participants who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen). There is no limit on the number of prior treatment regimens in Part 1. In Part 2, participants may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.
Participants must have had prior paclitaxel treatment.
Participants who have measurable disease according to RECIST v1.1 or detectable disease.
Participants with ECOG performance status of 0 or 1.
Participants with acceptable organ function.
Participants must be at least 3 weeks from last chemotherapy.
Exclusion Criteria:
Participants who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.
Participants who have received prior therapy with any hypomethylating agents.
Participants who are refractory to platinum treatment i.e., progressed while on platinum treatment.
Participants with abnormal left ventricular ejection fraction.
Participants with Grade 2 or greater neuropathy.
Participants with known brain metastases.
Participants with known history of HIV, HCV or HBV.
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There are 24 Locations for this study
Los Angeles California, 90033, United States
Gainesville Florida, 32610, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Covington Louisiana, 70433, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02115, United States
Brightwaters New York, 11718, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45267, United States
Dallas Texas, 75201, United States
Falls Church Virginia, 22042, United States
Calgary Alberta, T2N 4, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2L 4, Canada
Bristol , BS2 8, United Kingdom
Leeds , LS9 7, United Kingdom
London , EC1V , United Kingdom
London , NW1 2, United Kingdom
London , W12 0, United Kingdom
Middlesex , HA6 2, United Kingdom
Sutton , SM2 5, United Kingdom
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