An Open-label, Multicenter, Non-comparative, Phase II Study of Oral Topotecan in Combination With Bevacizumab for Second-line Treatment in Subjects With Relapsed Small-cell Lung Cancer (SCLC)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Progression-free Survival (PFS) at 3 Months
PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): >=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.
3 months
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
104864/111127
NCT00698516
July 2008
May 2010
Name | Location |
---|---|
GSK Investigational Site | Little Rock, Arkansas 72205 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Green Bay, Wisconsin 54301 |
GSK Investigational Site | Savannah, Georgia 31405 |
GSK Investigational Site | Columbia, South Carolina 29210 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | Hattiesburg, Mississippi 39401 |
GSK Investigational Site | Seattle, Washington 98133 |