Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00090675 |
In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.
Condition | Intervention | Phase |
---|---|---|
Non-Small-Cell Lung Carcinoma |
Drug: ZD1839 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA®) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Research Site | |
Fort Smith, Arkansas, United States | |
United States, California | |
Research Site | |
Sacramento, California, United States | |
Research Site | |
Martinez, California, United States | |
United States, Florida | |
Research Site | |
Tampa, Florida, United States | |
Research Site | |
Tamarac, Florida, United States | |
Research Site | |
Port St. Lucie, Florida, United States | |
United States, Kentucky | |
Research Site | |
Louisville, Kentucky, United States | |
United States, Maryland | |
Research Site | |
Chevy Chase, Maryland, United States | |
United States, Michigan | |
Research Site | |
Ann Arbor, Michigan, United States | |
United States, New Jersey | |
Research Site | |
Mountain Lakes, New Jersey, United States | |
United States, New York | |
Research Site | |
Buffalo, New York, United States | |
Research Site | |
Great Neck, New York, United States | |
Research Site | |
New York, New York, United States | |
Research Site | |
Northport, New York, United States | |
United States, North Carolina | |
Research Site | |
Chapel Hill, North Carolina, United States | |
United States, Pennsylvania | |
Research Site | |
Langhorne, Pennsylvania, United States | |
Research Site | |
Drexel Hill, Pennsylvania, United States | |
United States, Rhode Island | |
Research Site | |
Providence, Rhode Island, United States | |
United States, Texas | |
Research Site | |
Houston, Texas, United States | |
Research Site | |
Dallas, Texas, United States | |
United States, West Virginia | |
Research Site | |
Huntington, West Virginia, United States |
Study Director: | Iressa Medical Science Director | AstraZeneca |
Study ID Numbers: | D7913L00019, Herbst trial |
Study First Received: | September 2, 2004 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00090675 |
Health Authority: | United States: Food and Drug Administration |
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 |