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news.Geron has initiated a randomised Phase II clinical trial of its telomerase inhibitor drug, imetelstat, in patients with locally recurrent or metastatic breast cancer.
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The open label, multi-centre, randomised Phase 2 study will evaluate the efficacy and safety of treatment with imetelstat plus paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab).
The study will enroll 150 patients with locally recurrent or metastatic breast cancer (MBC), who have not received chemotherapy or have received one non-taxane based chemotherapy for MBC.
The patients will be randomised in 1:1 ratio to receive either imetelstat plus paclitaxel or paclitaxel only.
The primary endpoint of the study will be progression-free survival (PFS) for patients receiving imetelstat plus paclitaxel, while the secondary efficacy points will be objective response rate and clinical benefit of imetelstat plus paclitaxel.
The study will also assess the safety and tolerability of imetelstat.
The study will be conducted at approximately 80 clinical sites across the US and Canada.