A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors (4C)
1 other identifier
interventional
107
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2004
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2004
CompletedFirst Submitted
Initial submission to the registry
November 30, 2005
CompletedFirst Posted
Study publicly available on registry
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2007
CompletedNovember 14, 2017
November 1, 2017
2.8 years
November 30, 2005
November 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2.
Days 1, 8
Secondary Outcomes (1)
Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1
Up to 38 days
Study Arms (1)
All treated subjects
EXPERIMENTALSubjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who are pregnant or lactating
- Subjects with uncontrolled emesis, regardless of etiology, active infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (8)
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19111, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Morgantown, West Virginia, 26506, United States
GSK Investigational Site
Amsterdam, 1066 CX, Netherlands
GSK Investigational Site
Utrecht, 3584 CX, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2005
First Posted
December 1, 2005
Study Start
October 4, 2004
Primary Completion
July 5, 2007
Study Completion
July 5, 2007
Last Updated
November 14, 2017
Record last verified: 2017-11