Conditions: Gastro-oesophageal Junction Cancer Gastric Cancer
Keywords: gastro-oesophageal junction cancer gastric cancer lower third oesophageal cancer polysomy amplification FGFR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 960
Healthy volunteers: no

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.

Arms:
arm 1: AZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule arm 2: Paclitaxel - 80mg/m² as a 1 hour infusion given weekly on days 1, 8 and 15 of a 28 day cycle (up to the maximum number of cycles per local practice)

Interventions: intervention 1: AZD4547 intervention 2: paclitaxel
Intervention descriptions: intervention 1: Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule. intervention 2: Infusion administered once a week, 3 weeks on and 1 week off

Protocol document: