SGI-110 in Combination With Carboplatin in Ovarian Cancer

Launched by ASTEX PHARMACEUTICALS, INC. · Sep 27, 2012

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• 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.