Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatments sgi-110 and carboplatin, treatment of choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel)
Phase phase 1/phase 2
Sponsor Astex Pharmaceuticals
Start date September 2012
End date March 2016
Trial size 116 participants
Trial identifier NCT01696032, SGI-110-02

Summary

A 2-part, Phase 1-2 controlled, open-label, randomized study in patients with platinum-resistant recurrent ovarian cancer. In Part 1, patients will receive SGI-110 and carboplatin. The optimum dose will be identified in Part 1 based on safety and efficacy. In Part 2, patients will be randomized to receive the dose identified in Part 1 plus carboplatin or one of three treatment of choice at the discretion of the investigator. The treatment of choice consists of topotecan, pegylated liposomal doxorubicin, or paclitaxel.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Part 1: Patients will be dosed with SGI-110 and carboplatin
sgi-110 and carboplatin
(Experimental)
Part 2: Patients will be randomized to receive SGI-110 and carboplatin or Treatment of Choice. Treatment of choice is at the discretion of the investigator and can be one of three standard of care treatments (topotecan, paclitaxel or pegylated liposomal doxorubicin).
sgi-110 and carboplatin
treatment of choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel)
Investigator may choose to treat with either topotecan, pegylated liposomal doxorubicin, or paclitaxel

Primary Outcomes

Measure
Part 1 (Safety Lead-In): Assess the safety and tolerability of SGI-110 and carboplatin by the incidence of dose limiting toxicities and other adverse events to determine the maximum tolerated dose for Part 2
time frame: 9 months
Part 2 (Randomized, Controlled, Open Label): Assess and compare progression free survival (PFS) between SGI-110 and carboplatin and Treatment of Choice arms
time frame: 12 months

Secondary Outcomes

Measure
Objective response rate (complete and partial responses)
time frame: 12 months
Progression free survival at 6 months
time frame: 12 months
Clinical benefit rate (complete response + partial response + stable disease for at least 3 months)
time frame: 12 months
CA-125 reduction
time frame: 12 months
Duration of Response
time frame: 12 months
Overall survival
time frame: 12 months
Pharmacokinetics of combination treatment of SGI-110 and carboplatin
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Patients who are women 18 years of age or older. 2. Patients 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. Patients 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, patients may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy. 4. Patients must have had prior paclitaxel treatment. 5. Patients who have measurable disease according to RECIST v1.1 or detectable disease. 6. Patients with ECOG performance status of 0 or 1. 7. Patients with acceptable organ function. 8. Patients must be at least 3 weeks from last chemotherapy. Exclusion Criteria: 1. Patients who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products. 2. Patients who have received prior therapy with any hypomethylating agents. 3. Patients who are refractory to platinum treatment i.e., progressed while on platinum treatment. 4. Patients with abnormal left ventricular ejection fraction. 5. Patients with Grade 2 or greater neuropathy. 6. Patients with known brain metastases. 7. Patients with known history of HIV, HCV or HBV.

Additional Information

Official title A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Astex Pharmaceuticals.