Ignite Creation Date:
2024-05-05 @ 11:57 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01457846
Status:
TERMINATED
Last Update Posted:
2017-03-07
First Post:
2011-09-16
Brief Title:
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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 JunctionWith FGFR2 Polysomy or Gene Amplification
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None