NCT00404924

ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,140 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	ZD6474 (vandetanib)	once daily oral tablet
OTHER	Best Supportive Care	standard of care

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-10-01
• Completion: 2014-11-01
• First posted: 2006-11-29
• Last updated: 2016-09-30
• Results posted: 2012-03-26

Locations

102 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Mexico, Netherlands, Peru, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom