Trials / Terminated
TerminatedNCT01457846
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
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.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 960 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 25 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD4547 | Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule. |
| DRUG | paclitaxel | Infusion administered once a week, 3 weeks on and 1 week off |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-08-01
- Completion
- 2015-02-01
- First posted
- 2011-10-24
- Last updated
- 2017-03-07
- Results posted
- 2017-03-07
Locations
61 sites across 16 countries: Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, India, Italy, Japan, Romania, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01457846. Inclusion in this directory is not an endorsement.