Spots Global Cancer Trial Database for Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy
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Trial Identification
Brief Title: Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy
Official Title: Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Study ID: NCT01852292
Conditions
Study Description
Brief Summary: Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, Fayetteville, Arkansas, United States
Dana Farber Cancer Institute IRB, Boston, Massachusetts, United States
Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201, Saint Louis, Missouri, United States
The Mount Sinai Hospital Dept of Oncology, New York, New York, United States
University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr., Chapel Hill, North Carolina, United States
University Hospitals Case Medical Center Univ. Hospitals of Cleveland, Cleveland, Ohio, United States
UPMC Cancer Centers BKM120H2201, Pittsburgh, Pennsylvania, United States
Novartis Investigative Site, St Leonards, New South Wales, Australia
Novartis Investigative Site, Hamilton, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Saint Herblain cedex, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Nyiregyhaza, , Hungary
Novartis Investigative Site, Nashik, Maharashtra, India
Novartis Investigative Site, Dehli, New Delhi, India
Novartis Investigative Site, Jaipur, Rajasthan, India
Novartis Investigative Site, Kolkata, West Bengal, India
Novartis Investigative Site, Kerala, , India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, Dublin 4, , Ireland
Novartis Investigative Site, Firenze, FI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Palermo, PA, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Salerno, SA, Italy
Novartis Investigative Site, Torino, TO, Italy
Novartis Investigative Site, Venezia, VE, Italy
Novartis Investigative Site, Kashiwa, Chiba, Japan
Novartis Investigative Site, Koto-ku, Tokyo, Japan
Novartis Investigative Site, Minato-ku, Tokyo, Japan
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Seocho-gu, Korea, Republic of
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Leningrad Region, Russia, Russian Federation
Novartis Investigative Site, Nizhniy Novgorod, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Basel, , Switzerland
Novartis Investigative Site, Genève, , Switzerland
Novartis Investigative Site, Tainan, Taiwan ROC, Taiwan
Novartis Investigative Site, Kaohsiung City, , Taiwan
Novartis Investigative Site, Taichung City, , Taiwan
Novartis Investigative Site, Songkla, Hat Yai, Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Glasgow, Scotland, United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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