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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

Phase I/II Trial of Custirsen (OGX-011), an Inhibitor of Clusterin, in Combination with a... 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 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Thoracic Oncology Wolters Kluwer Health

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

Journal of Thoracic Oncology , Volume 7 (3) – Mar 1, 2012

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Copyright
Copyright © 2012 by the International Association for the Study of Lung Cancer
ISSN
1556-0864
DOI
10.1097/JTO.0b013e31823f459c
pmid
22198426
Publisher site
See Article on Publisher Site

Abstract

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

Journal of Thoracic OncologyWolters Kluwer Health

Published: Mar 1, 2012

References