SGI-110 in patients with platinum-resistant recurrent ovarian cancer
Research type
Research Study
Full title
A Randomised, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects with Platinum-Resistant Recurrent Ovarian Cancer
IRAS ID
121001
Contact name
Sarah Blagden
Contact email
Sponsor organisation
Astex Pharmaceuticals Inc
Eudract number
2012-001576-12
Research summary
This is a 2-stage study to investigate the use of SGI-110 in combination with carboplatin for the treatment of platinum-resistant ovarian cancer: A safety lead-in stage (Stage 1) followed by a randomised, controlled, open-label stage (Stage 2).
Since there is no clinical data available on combining SGI-110 with carboplatin, Stage 1 of the study will evaluate the safety and tolerability of the combination in a dose-escalation design. For Stage 2, the randomised design is selected to evaluate the efficacy and safety of the combination of SGI-110+carboplatin at the Maximum Tolerated Dose against established second-line treatment in platinum-resistant ovarian cancer. The selected treatments in the Treatment Choice arm have all demonstrated similar activity in the disease and are the most prevalent treatment choices per licensed indication for recurrent platinum-resistant ovarian cancer. This will provide a broad comparison of SGI-110+carboplatin to other treatments and provide more choice to treating physician
Stage 1: A minimum of 14 participants will be evaluated with the combination of SGI-110+carboplatin, given as 28-day treatment cycles.
Stage 2: The second stage of this study will be conducted as an open-label, randomised, controlled trial. 96 eligible participants will be randomised in a 1:1 ratio to receive either (1) SGI-110+carboplatin combination treatment in 28-day cycles or (2) Treatment Choice of either topotecan, pegylated liposomal doxorubicin (PLD) or paclitaxel in 28-day cycles.
In both Stage 1 and Stage 2, participants should continue receiving their assigned treatment throughout the study until disease progression or unacceptable treatment-related toxicity.
REC name
London - Dulwich Research Ethics Committee
REC reference
13/LO/0615
Date of REC Opinion
22 Jul 2013
REC opinion
Further Information Favourable Opinion