A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- Signed informed consent
- 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- No prior chemotherapy/biological therapy/radiation therapy
- One or more measurable lesions
- Life expectancy more than 12 weeks
Exclusion Criteria:
- Brain metastases or spinal cord compression
- Currently active skin disease
- History of significant hemoptysis
- Abnormal blood chemistry
- Cardiac abnormalities
- Recent significant cardiac event
- Coexisting malignancies
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Principal Investigator
AstraZeneca ZD6474 Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D4200C00007
NCT ID:
NCT00071188
Start Date:
February 2004
Completion Date:
October 2007
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Non-Small-Cell Lung Carcinoma
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Arlington Heights, Illinois |
| Research Site | Beverly, Massachusetts |
| Research Site | Branson, Missouri |
| Research Site | Pawtucket, Rhode Island |
| Research Site | Chattanooga, Tennessee |
| Research Site | Abilene, Texas |
| Research Site | Abington, Virginia |
| Research Site | Auburn, Washington |
