Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer (SHINE)
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|ClinicalTrials.gov Identifier: NCT01457846|
Recruitment Status : Terminated
First Posted : October 24, 2011
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastro-oesophageal Junction Cancer Gastric Cancer||Drug: AZD4547 Drug: paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||960 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||February 2015|
AZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule
Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule.
Active Comparator: Paclitaxel
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)
Infusion administered once a week, 3 weeks on and 1 week off
- Median Progression Free Survival [ Time Frame: Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week) ]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).
- 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 [ Time Frame: Week 8 (±1 week) and then every 8 weeks (±1 week) ]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.
- Percentage Change From Baseline at Week 8 in Target Lesion Size [ Time Frame: Baseline, Week 8 (±1 week) ]A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.
- Percentage of Patients Without Progressive Disease at 8 Weeks [ Time Frame: Week 8 (±1 week) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457846
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|Study Director:||Paul Stockman, MD PHD||AstraZeneca|
|Principal Investigator:||Eric Van Cutsem, MD PHD||University Hospital, Gasthuisberg|
|Principal Investigator:||Yung-Jue Bang, MD, PHD||Seoul National University Hospital|