A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Baseline up to End of Treatment (EOT) (within 30 days of last dose)
Yes
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
3066K1-139
NCT00106353
March 2005
January 2012
Name | Location |
---|---|
Pfizer Investigational Site | Birmingham, Alabama 35205 |
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
Pfizer Investigational Site | Bronx, New York 10461 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Federal Way, Washington 98003 |
Pfizer Investigational Site | Carmel, Indiana 46032 |
Pfizer Investigational Site | North Adams, Massachusetts 01247 |
Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
Pfizer Investigational Site | Easley,, South Carolina 29640 |
Pfizer Investigational Site | Bristol, Tennessee 37620 |