Iressa as Second line Therapy in Advanced NSCLC-Asia - ISTANA
Study identifier:D7913L00039
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Open Label, Parallel Group, Regional, Multicenter, Phase III Study of Oral Gefitinib (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer Who Have Previously Received Platinum Based Chemotherapy (ISTANA)
Medical condition
NSCLC
Phase
Phase 3
Healthy volunteers
No
Study drug
Gefitinib, Docetaxel
Sex
All
Actual Enrollment
163
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Sept 2005
Primary Completion Date: 01 May 2007
Study Completion Date: 01 Feb 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Docetaxel | Drug: Docetaxel intravenous infusion Other Name: Taxotere |
| Experimental: 2 Gefitinib | Drug: Gefitinib 250 mg oral tablet Other Name: ZD1839 Other Name: IRESSA |
Contacts
Investigators
Principal Investigator
SangWe Kim
Asan Medical Center
