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.
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)
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Investigate the efficacy of AZD4547 vs paclitaxel by assessment of Progression-Free Survival in: all randomised patients; patients with tumours that have FGFR2 amplification & patients with tumours have high FGFR2 amplification alone
RECIST assessments will be performed at baseline and every 8 weeks until progression
No
Paul Stockman, MD PHD
Study Director
AstraZeneca
United Kingdom: Medicines and Healthcare Products Regulatory Agency
D2610C00004
NCT01457846
November 2011
May 2016
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