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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT01696032

Recruitment Status:

Completed

Sponsor:

Astex Pharmaceuticals, Inc.

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There are 24 Locations for this study

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Norris Comprehensive Cancer Center- University of Southern California
Los Angeles California, 90033, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
Georgia Health Sciences University
Augusta Georgia, 30912, United States
University of Chicago
Chicago Illinois, 60637, United States
Melvin and Bren Simon Cancer Center- Indiana University
Indianapolis Indiana, 46202, United States
Women's Cancer Care
Covington Louisiana, 70433, United States
Johns Hopkins Kimmel Cancer Center
Baltimore Maryland, 21231, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Island Gynecologic Oncology
Brightwaters New York, 11718, United States
Duke Cancer Institute- Duke University Medical Center
Durham North Carolina, 27710, United States
University of Cincinnati Cancer Institute
Cincinnati Ohio, 45267, United States
Mary Crowley Medical Research Center
Dallas Texas, 75201, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
CHUM Gynecologie-Oncologie, Notre Dame Hospital
Montreal Quebec, H2L 4, Canada
Bristol Heamatology and Oncology Centre
Bristol , BS2 8, United Kingdom
St. James Univesity Hospital - St. James Institute of Oncology
Leeds , LS9 7, United Kingdom
Cambridge University Hospitals NHS Foundation and Trust
London , EC1V , United Kingdom
Univesity College Hospital
London , NW1 2, United Kingdom
Imperial College Health Care NHS Trust-Garry Weston Centre
London , W12 0, United Kingdom
Mount Vernon Cancer Centre
Middlesex , HA6 2, United Kingdom
Royal Marsden Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT01696032

Recruitment Status:

Completed

Sponsor:


Astex Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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