Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non-small Cell Lung Cancer
Trial Information
Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Inclusion Criteria:
- Histologically proven NSCLC
- Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
- No prior therapy for NSCLC
- Evidence of unidimensionally measurable disease
Exclusion Criteria:
- Previous treatment with systemic chemotherapy for lung cancer
- History of or known brain metastases
- NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
- Evidence of hemoptysis within 4 weeks of starting study treatment
- Serious acute or chronic illness or recent history of significant cardiac abnormality
- Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors
of EGFR and PDGFR
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of Subjects Surviving at One Year
Outcome Description:
Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.
Outcome Time Frame:
From start of treatment until 1 year or death
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181057
NCT ID:
NCT00113516
Start Date:
September 2005
Completion Date:
March 2009
Related Keywords:
- Non-Small Cell Lung Cancer
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Newark, Delaware 19713 |
