A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
NCT ID: NCT00259935
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
107 participants
INTERVENTIONAL
2004-10-04
2007-07-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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All treated subjects
Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.
topotecan
topotecan
Interventions
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topotecan
topotecan
Eligibility Criteria
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Inclusion Criteria
* At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
* Subjects must be free of post-treatment side effects.
Exclusion Criteria
* Subjects with uncontrolled emesis, regardless of etiology, active infection.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Lebanon, New Hampshire, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Morgantown, West Virginia, United States
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Utrecht, , Netherlands
Countries
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Other Identifiers
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104864/692
Identifier Type: -
Identifier Source: org_study_id