Topotecan Pharmacokinetic Characterization Study
This study has been completed.
Information provided by (Responsible Party):
First received: August 7, 2006
Last updated: May 31, 2012
Last verified: March 2011
A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Characterize the Pharmacokinetics of Topotecan at 4 mg/m2 Administered Weekly as a 30-Minute Intravenous Infusion in Patients With Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- CL and Vss of total topotecan
Secondary Outcome Measures:
- Cmax tmax t½ AUC(0-t) AUC(0-8) of total topotecan. Safety and tolerability will also be evaluated.
|Study Start Date:||September 2006|
Other Name: topotecan
Contacts and Locations