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SGI-110 in Combination With Carboplatin in Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

SGI-110 in Combination With Carboplatin in Ovarian Cancer

A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer

NCT01696032•Astex Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Participants who are women 18 years of age or older.
•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

•1. Participants who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.
•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.

Locations (24)

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

Key Dates

Start Date

September 1, 2012

Primary Completion Date

August 1, 2016

Completion Date

August 1, 2016

Last Updated

August 27, 2024

Enrollment

120

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

SGI-110

DRUG

Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)

DRUG

Carboplatin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SGI-110 in Combination With Carboplatin in Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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