SGI-110 in Combination With Carboplatin in Ovarian Cancer

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01696032 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-026

 

A 2-part, Phase 1-2 controlled, open-label, randomized study in patients with platinum-resistant recurrent ovarian cancer. In Part 1, patients will receive SGI-110 and carboplatin. The optimum dose will be identified in Part 1 based on safety and efficacy. In Part 2, patients will be randomized to receive the dose identified in Part 1 plus carboplatin or one of three treatment of choice at the discretion of the investigator. The treatment of choice consists of topotecan, pegylated liposomal doxorubicin, or paclitaxel.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Ursula Matulonis, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Michael Birrer, MD, PhD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: 1. Patients who are women 18 years of age or older. 2. Patients 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. Patients 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, patients may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy. 4. Patients must have had prior paclitaxel treatment. 5. Patients who have measurable disease according to RECIST v1.1 or detectable disease. 6. Patients with ECOG performance status of 0 or 1. 7. Patients with acceptable organ function. 8. Patients must be at least 3 weeks from last chemotherapy. Exclusion Criteria: 1. Patients who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products. 2. Patients who have received prior therapy with any hypomethylating agents. 3. Patients who are refractory to platinum treatment i.e., progressed while on platinum treatment. 4. Patients with abnormal left ventricular ejection fraction. 5. Patients with Grade 2 or greater neuropathy. 6. Patients with known brain metastases. 7. Patients with known history of HIV, HCV or HBV.
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