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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
960
Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule.
Infusion administered once a week, 3 weeks on and 1 week off
Median Progression Free Survival
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).
Time frame: Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)
Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)
Time frame: Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)
Objective Response Rate
ORR=Percentage of patients with at least one visit response of CR (complete response) or PR (partial response) that is confirmed at least 4 weeks later; CR:disappearance of target lesions and no new lesions; PR is at least 30% decrease in sum of diameters of lesions taking as a reference the smallest sum since treatment started.
Time frame: Week 8 (±1 week) and then every 8 weeks (±1 week)
Percentage Change From Baseline at Week 8 in Target Lesion Size
A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.
Time frame: Baseline, Week 8 (±1 week)
Percentage of Patients Without Progressive Disease at 8 Weeks
PD = A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diamters
Time frame: Week 8 (±1 week)
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Research Site
Brussels (Anderlecht), Belgium
Research Site
Brussels (Woluwé-St-Lambert), Belgium
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Leuven, Belgium
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Liège, Belgium
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Vratsa, Bulgaria
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Fredericton, New Brunswick, Canada
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Toronto, Ontario, Canada
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Brno, Czechia
...and 51 more locations