Topotecan Pharmacokinetic Characterization Study

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: topotecan

• Registration Number: NCT00361803
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-09
• Study Start: 2006-09-12
• Primary Completion: 2007-08-09
• Study Completion: 2007-08-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All treated subjects	topotecan	All subjects received Topotecan, administered intravenously over 30 minutes at 4 milligrams per meter\^2 weekly for 3 weeks every 28 days.

Primary Outcome Measures

Name	Time	Method
CL and Vss of total topotecan	Predose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.5, 4.5, 6.5, 8.5, 12, and 24 hours after the start of infusion on Day 1

Secondary Outcome Measures

Name	Time	Method
Cmax tmax t½ AUC(0-t) AUC(0-8) of total topotecan. Safety and tolerability will also be evaluated.	Up to 77 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Scottsdale, Arizona, United States