SGI-110 in Combination With Carboplatin in Ovarian Cancer
Completed · Phase 2
Conditions studied: Ovarian Cancer
In brief
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.
Key facts
- Study ID
- NCT01696032
- Run by
- Astex Pharmaceuticals, Inc.
- People needed
- 120
- Starts
- 2012-09-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2024-08-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Norris Comprehensive Cancer Center- University of Southern California — Los Angeles, California, United States
- University of Florida Shands Cancer Center — Gainesville, Florida, United States
- Georgia Health Sciences University — Augusta, Georgia, United States
- University of Chicago — Chicago, Illinois, United States
- Melvin and Bren Simon Cancer Center- Indiana University — Indianapolis, Indiana, United States
- Women's Cancer Care — Covington, Louisiana, United States
- Johns Hopkins Kimmel Cancer Center — Baltimore, Maryland, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Island Gynecologic Oncology — Brightwaters, New York, United States
- Duke Cancer Institute- Duke University Medical Center — Durham, North Carolina, United States
- University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
- Mary Crowley Medical Research Center — Dallas, Texas, United States
- Inova Fairfax Hospital — Falls Church, Virginia, United States
- Tom Baker Cancer Centre — Calgary, Alberta, Canada
- Juravinski Cancer Centre — Hamilton, Ontario, Canada
- Princess Margaret Hospital — Toronto, Ontario, Canada
- CHUM Gynecologie-Oncologie, Notre Dame Hospital — Montreal, Quebec, Canada
- Bristol Heamatology and Oncology Centre — Bristol, United Kingdom
- St. James Univesity Hospital - St. James Institute of Oncology — Leeds, United Kingdom
- Cambridge University Hospitals NHS Foundation and Trust — London, United Kingdom
- Univesity College Hospital — London, United Kingdom
- Imperial College Health Care NHS Trust-Garry Weston Centre — London, United Kingdom
- Mount Vernon Cancer Centre — Middlesex, United Kingdom
- Royal Marsden Foundation Trust — Sutton, United Kingdom
Full record on ClinicalTrials.gov
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