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ORIGINAL ARTICLE Phase I/II Trial of Custirsen (OGX-011), an Inhibitor of Clusterin, in Combination with a Gemcitabine and Platinum Regimen in Patients with Previously Untreated Advanced Non-small Cell Lung Cancer Janessa J. Laskin, MD,* Garth Nicholas, MD,† Christopher Lee, MD,‡ Barbara Gitlitz, MD,§ Mark Vincent, MD, Yvon Cormier, MD,¶ Joe Stephenson, MD,# Yee Ung, MD,** Rachel Sanborn, MD,†† Bryn Pressnail, MD,‡‡ Francis Nugent, MD,§§ John Nemunaitis, MD, Martin E. Gleave, MD,¶¶ Nevin Murray, MD,## and Desiree Hao, MD*** decreased serum CLU levels in 95% of patients evaluated. Patients who Purpose: Clusterin (CLU), an antiapoptotic, stress-associated pro- achieved a minimum median CLU level for the population of 38 tein, confers resistance to therapy when overexpressed. This trial g/ml during treatment had a median survival of 27.1 compared with tested custirsen (OGX-011), an inhibitor of CLU protein production, 16.1 months for patients who did not (p 0.02). combined with gemcitabine/platinum in patients with advanced Conclusion: Based on the above results, a randomized phase 3 trial non-small cell lung cancer (NSCLC). to evaluate the survival benefit of custirsen in patients with NSCLC Patients and Methods: This was a single-arm, multicenter, phase is warranted. I/II study in chemotherapy-naive stage IIIB/IV NSCLC. Custirsen
Journal of Thoracic Oncology – Wolters Kluwer Health
Published: Mar 1, 2012
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