Spots Global Cancer Trial Database for Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
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Trial Identification
Brief Title: Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
Official Title: A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.
Study ID: NCT01457846
Study Description
Brief Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.
Detailed Description: A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Brussels (Anderlecht), , Belgium
Research Site, Brussels (Woluwé-St-Lambert), , Belgium
Research Site, Leuven, , Belgium
Research Site, Liege, , Belgium
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Vratza, , Bulgaria
Research Site, Fredericton, New Brunswick, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Brno, , Czech Republic
Research Site, Olomouc, , Czech Republic
Research Site, Praha 2, , Czech Republic
Research Site, Saint Cloud, , France
Research Site, Villejuif, , France
Research Site, Hamburg, , Germany
Research Site, Mainz, , Germany
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Nyíregyháza, , Hungary
Research Site, Bangalore, , India
Research Site, Chennai, , India
Research Site, Hyderabad, , India
Research Site, Nagpur, , India
Research Site, Pune, , India
Research Site, Vellore, , India
Research Site, Ancona, , Italy
Research Site, Milano, , Italy
Research Site, Pisa, , Italy
Research Site, Roma, , Italy
Research Site, Chiba-shi, , Japan
Research Site, Chuo-ku, , Japan
Research Site, Koto-ku, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Takatsuki-shi, , Japan
Research Site, Anyang-si, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Hwasun-gun, , Korea, Republic of
Research Site, Jeonju-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Brasov, , Romania
Research Site, Cluj Napoca, , Romania
Research Site, A Coruña, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Oviedo, , Spain
Research Site, Santander, , Spain
Research Site, Sevilla, , Spain
Research Site, Keelung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Kharkiv, , Ukraine
Research Site, Lviv, , Ukraine
Research Site, Aberdeen, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Maidstone, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Sutton, , United Kingdom
Research Site, Wolverhampton, , United Kingdom
Contact Details
Name: Paul Stockman, MD PHD
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
Name: Eric Van Cutsem, MD PHD
Affiliation: University Hospital, Gasthuisberg
Role: PRINCIPAL_INVESTIGATOR
Name: Yung-Jue Bang, MD, PHD
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
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