Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD6474 | Drug | |||
| Placebo | Drug | |||
| ZD1839 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcomes: | ||
| Part A | ||
| i. Time to progression | ||
| ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes | ||
| Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcomes: | ||
| Part A | ||
| i. Objective response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pine Bluff | Arkansas | United States | |||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ii. Disease control at 8 weeks |
| iii. Time to death |
| iv. WHO performance status |
| v. QOL and LCS from the FACT-L questionnaire |
| Part B |
| i. Objective response in subjects following treatment with the alternate study treatment |
| ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment |
| iii. WHO performance status in subjects following treatment with the alternate study treatment |
| iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment |
| Los Angeles |
| California |
| United States |
| Research Site | Palm Springs | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Orange Park | Florida | United States |
| Research Site | Coeur d'Alene | Idaho | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Saint Loius | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Greenville | North Carolina | United States |
| Research Site | Bismarck | North Dakota | United States |
| Research Site | Madison | Wisconsin | United States |
| Research Site | Buenos Aires | Argentina |
| Research Site | Mendoza | Argentina |
| Research Site | Brussels | Belgium |
| Research Site | Brussels (Jette) | Belgium |
| Research Site | Brussels (Woluwé-St-Lambert) | Belgium |
| Research Site | Edegem | Belgium |
| Research Site | Liège | Belgium |
| Research Site | Wilrijk | Belgium |
| Research Site | Hamburg | Free and Hanseatic City of Hamburg | Germany |
| Research Site | Essen | North Rhine-Westphalia | Germany |
| Research Site | Mainz | Rhineland-Palatinate | Germany |
| Research Site | Berlin | State of Berlin | Germany |
| Research Site | Ryhope | Sunderland | Germany |
| Research Site | Berlin | Germany |
| Research Site | Essen | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Mainz | Germany |
| Research Site | Bloemfontein | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Lyttelton Manor | South Africa |
| Research Site | Parktown | South Africa |
| Research Site | Port Elizabeth | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Northwood | Middlesex | United Kingdom |
| Research Site | Cardiff | South Glamorgan | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| Research Site | Leeds | United Kingdom |
| Research Site | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C452423 | vandetanib |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided