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Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

NCT01457846 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 960

Last updated 2017-03-07

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Paul Stockman, MD PHD · AstraZeneca

  • Eric Van Cutsem, MD PHD · University Hospital, Gasthuisberg

  • Yung-Jue Bang, MD, PHD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-08-31
Completion
2015-02-28

Countries

  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01457846 on ClinicalTrials.gov