SGI-110 in Combination With Carboplatin in Ovarian Cancer

Astex Pharmaceuticals, Inc.120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Ovarian Cancer

Interventions

SGI-110DRUG

Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)DRUG

Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine

CarboplatinDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Norris Comprehensive Cancer Center- University of Southern California

Outcomes

Primary Outcomes

Stage 1: Dose Limiting Toxicities

Number of participants with dose limiting toxicities (DLTs) in Stage 1

Time frame: Up to 12 months

Stage 2: Progression Free Survival

Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment \[guadecitabine+carboplatin (G+C) or treatment choice (TC)\] until disease progression or unacceptable treatment-related toxicity occurred.

Time frame: Up to 24 months

Secondary Outcomes

Objective Response Rate

The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.

Time frame: Up to 24 months

Progression Free Survival at 6 Months

Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.

Time frame: 6 months

Clinical Benefit Rate

Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.

Data from ClinicalTrials.gov

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