SGI-110 in Combination With Carboplatin in Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: SGI-110; Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine); Carboplatin
Intervention description: Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Topotecan; Guadecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer

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 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.