SGI-110 in Combination With Carboplatin in Ovarian Cancer
NCT ID: NCT01696032
Last Updated: 2024-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2012-09-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SGI-110 + Carboplatin
Stage 1 was a safety lead-in stage with a dose escalation design. Participants were evaluated with the combination of SGI-110 (guadecitabine) plus carboplatin (G+C), given as 28-day treatment cycles: guadecitabine administered subcutaneous (SC) daily on Days 1-5, at a starting dose of 45 mg/m2/day in Cohort 1, followed by carboplatin intravenous (IV) based on a targeted dose of area under the curve (AUC) 5 on Day 8. After dose limiting toxicities were noted, guadecitabine dose was reduced to 30 mg/m2/day for subsequent cycles for 4 participants. Cohort 2 received 30 mg/m2/day guadecitabine and carboplatin IV AUC 4.
SGI-110
Carboplatin
SGI-110 + Carboplatin or TC
Stage 2 was an open-label, randomized, controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either (1) G+C combination treatment in 28-day cycles at 30 mg/m2 SC once daily on Days 1-5 and carboplatin IV AUC 4 on Day 8, or (2) treatment of choice (TC) of topotecan, pegylated liposomal doxorubicin (PLD), paclitaxel, or gemcitabine based on recommended dosing in 28-day cycles; participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
SGI-110
Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)
Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
Carboplatin
Interventions
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SGI-110
Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)
Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
Carboplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Participants must have had prior paclitaxel treatment.
5. Participants who have measurable disease according to RECIST v1.1 or detectable disease.
6. Participants with ECOG performance status of 0 or 1.
7. Participants with acceptable organ function.
8. Participants must be at least 3 weeks from last chemotherapy.
Exclusion Criteria
2. Participants who have received prior therapy with any hypomethylating agents.
3. Participants who are refractory to platinum treatment i.e., progressed while on platinum treatment.
4. Participants with abnormal left ventricular ejection fraction.
5. Participants with Grade 2 or greater neuropathy.
6. Participants with known brain metastases.
7. Participants with known history of HIV, HCV or HBV.
18 Years
FEMALE
No
Sponsors
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Astex Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Cardenas H, Fang F, Jiang G, Perkins SM, Zhang C, Emerson RE, Hutchins G, Keer HN, Liu Y, Matei D, Nephew K. Methylomic Signatures of High Grade Serous Ovarian Cancer. Epigenetics. 2021 Nov;16(11):1201-1216. doi: 10.1080/15592294.2020.1853402. Epub 2020 Dec 8.
Oza AM, Matulonis UA, Alvarez Secord A, Nemunaitis J, Roman LD, Blagden SP, Banerjee S, McGuire WP, Ghamande S, Birrer MJ, Fleming GF, Markham MJ, Hirte HW, Provencher DM, Basu B, Kristeleit R, Armstrong DK, Schwartz B, Braly P, Hall GD, Nephew KP, Jueliger S, Oganesian A, Naim S, Hao Y, Keer H, Azab M, Matei D. A Randomized Phase II Trial of Epigenetic Priming with Guadecitabine and Carboplatin in Platinum-resistant, Recurrent Ovarian Cancer. Clin Cancer Res. 2020 Mar 1;26(5):1009-1016. doi: 10.1158/1078-0432.CCR-19-1638. Epub 2019 Dec 12.
Other Identifiers
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SGI-110-02
Identifier Type: -
Identifier Source: org_study_id
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