NCT01579578|TerminatedPhase 2Results
Study Stopped
AstraZeneca sponsored trials of AZD8931 have been halted
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AstraZeneca sponsored trials of AZD8931 have been halted
A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Metastatic, Gastric or Gastro-oesophageal Junction, Cancer Who Progress Following First Line Therapy and Are Ineligible for Treatment With Trastuzumab by HER2 Status (SAGE)
Sponsor study identifier
interventional
39
5 countries
15
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 13, 2012
Actual (reported)April 18, 2012
Actual (reported)March 2013
Actual (reported)March 2013
Actual (reported)September 12, 2014
Actual (reported)Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
Baseline and 8 weeks, accessed up to data cut off on 4 December 2012
Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012
The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
Baseline and 8 weeks, accessed up to data cut off on 4 December 2012
40 mg, oral dose twice daily
Placebo, oral dose twice daily
Research Site
Cologne, Germany
Research Site
Hamburg, Germany
Research Site
Chūōku, Japan
Research Site
Fukuoka, Japan
Research Site
Kawasaki-shi, Japan
Research Site
Matsuyama, Japan
Research Site
Sapporo, Japan
Research Site
Serban Ghiorghiu, M. D.
Scarborough General Hospital
39 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2012
First Posted
April 18, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
IV once weekly for 3 weeks followed by a week off.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Jeonju, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Valencia, Spain
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
September 12, 2014
Results First Posted
September 12, 2014
Record last verified: 2014-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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