Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DNMT inhibitor SGI-110, S110, SGI-110
Guadecitabine · 1 trial · 3 indications
Objective response rate (ORR) is defined as the number of patients who's best response is complete response plus those with partial response. Imaging scans will be assessed using RECIST 1.1 to measure ORR to guadecitabine and pembrolizumab in patients with recurrent platinum resistant Ovarian Cancer. In general the following definitions apply Complete Response - Disappearance of all lesions Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Treatment (guadecitabine, pembrolizumab) | EXPERIMENTAL | Patients receive guadecitabine SC on days 1-4 and pembrolizumab IV over 30 minutes on day 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Guadecitabine | DRUG | Given SC |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Patients must have a histological or cytological evidence/confirmation of recurrent epithelial ovarian cancer, primary peritoneal carcinomatosis, or fallopian tube cancer * Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)...