Study identifier:D7913L00039
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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)
NSCLC
Phase 3
No
Gefitinib, Docetaxel
All
163
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The total number of patients expected to be exposed to study procedures is approximately 150 patients will be recruited by investigational sites throughout the Asia Pacific region that have expertise in treating patients with NSCLC.
Location
Location
In Cheon, Republic of Korea
Location
Kyonggi-do, Republic of Korea
Location
Seoul, Republic of Korea
Location
Suwon, Republic of Korea
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 |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.