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Brief Title: An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
Official Title: A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment
Study ID: NCT01646125
Brief Summary: The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr., Los Angeles, California, United States
Maryland Oncology Hematology, P.A. SC, Rockville, Maryland, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5, Madison, Wisconsin, United States
Novartis Investigative Site, Marseille cedex 20, Bouches Du Rhone, France
Novartis Investigative Site, Creteil, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Monza, MB, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Parma, PR, Italy
Novartis Investigative Site, Orbassano, TO, Italy
Novartis Investigative Site, Koto ku, Tokyo, Japan
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Groningen, , Netherlands
Novartis Investigative Site, Bergen, , Norway
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Gdansk, , Poland
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan
Novartis Investigative Site, Taichung, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Leicester, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR