Status:
COMPLETED
A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.
Eligibility Criteria
Inclusion
- Subjects with advanced solid tumors.
- At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
- Subjects must be free of post-treatment side effects.
Exclusion
- Women who are pregnant or lactating
- Subjects with uncontrolled emesis, regardless of etiology, active infection.
Key Trial Info
Start Date :
October 4 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2007
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00259935
Start Date
October 4 2004
End Date
July 5 2007
Last Update
November 14 2017
Active Locations (8)
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1
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
2
GSK Investigational Site
The Bronx, New York, United States, 10461
3
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
4
GSK Investigational Site
Nashville, Tennessee, United States, 37203