Phase 2
Completed N=120
SGI-110 in Combination With Carboplatin in Ovarian Cancer
Source: ClinicalTrials.gov NCT01696032 ↗Enrolled (actual)
120
Serious AEs
50.3%
Results posted
May 2021
Primary outcomePrimary: Stage 1: Dose Limiting Toxicities — 0; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 1: Dose Limiting Toxicities |
0; 4 | — |
| PRIMARY Stage 2: Progression Free Survival |
114; 64 | 0.0654 |
| SECONDARY Objective Response Rate |
21; 0; 16; 8; 4 | — |
| SECONDARY Progression Free Survival at 6 Months |
0.36; 0.33; 0.37; 0.11; 0.19 | — |
| SECONDARY Clinical Benefit Rate |
43; 50; 41; 29; 19 | — |
| SECONDARY CA-125 Levels |
27; 50; 36; 32; 29 | — |
| SECONDARY Duration of Response |
225; 195; 186; 173; 182 | — |
| SECONDARY Overall Survival |
341; 195; 331; 221; 279 | — |
| SECONDARY Stage 1: Pharmacokinetic Parameter Cmax |
96.2; 109; 22.6; 26.3; 19600; 21900 | — |
| SECONDARY Stage 1: Pharmacokinetic Parameter Tmax |
1.42; 1.98; 1.98; 3.95; 1.03; 1.05 | — |
| SECONDARY Stage 1: Pharmacokinetic Parameter AUC0-8 |
239; 416; 71.1; 129; 51200; 41900 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who are women 18 years of age or older.
- 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.
- 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.
- Participants must have had prior paclitaxel treatment.
- Participants who have measurable disease according to RECIST v1.1 or detectable disease.
- Participants with ECOG performance status of 0 or 1.
- Participants with acceptable organ function.
- Participants must be at least 3 weeks from last chemotherapy.
Exclusion Criteria
- Participants who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.
- Participants who have received prior therapy with any hypomethylating agents.
- Participants who are refractory to platinum treatment i.e., progressed while on platinum treatment.
- Participants with abnormal left ventricular ejection fraction.
- Participants with Grade 2 or greater neuropathy.
- Participants with known brain metastases.
- Participants with known history of HIV, HCV or HBV.
Data sourced from ClinicalTrials.gov (NCT01696032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.