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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00059722 |
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Drug: ZD6474 Drug: Placebo Drug: ZD1839 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Efficacy Study |
Official Title: | A Phase II, Randomized Double-Blind, 2-Part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-Small Cell Lung Cancer After Failure of First-Line Platinum-Based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839. |
Estimated Enrollment: | 160 |
Study Start Date: | April 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Oncology Medical Director, MD | AstraZeneca |
Study ID Numbers: | 6474IL/0003 |
Study First Received: | May 2, 2003 |
Last Updated: | October 5, 2005 |
ClinicalTrials.gov Identifier: | NCT00059722 |
Health Authority: | United States: Food and Drug Administration |
NSCLC locally advanced or metastatic second-line |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Gefitinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |