Imetelstat is an inhibitor of telomerase, which is upregulated in most human tumours and is required for tumour cell immortality and growth.
The Phase II trial was launched in December 2010 as an open label, multi-centre, randomized study designed to assess the efficacy and safety of treatment with imetelstat plus paclitaxel versus paclitaxel alone in patients with locally recurrent or MBC who have not received chemotherapy or have received one non-taxane based chemotherapy for MBC.
The primary efficacy endpoint for the study will be estimated based on progression-free survival (PFS) for patients receiving imetelstat plus paclitaxel. Secondary efficacy endpoints are objective response rate and clinical benefit rate of imetelstat when added to paclitaxel.
Top-line results are expected to be reported before the end of 2012.
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