Last updated: 11/03/2018 01:17:58
A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: Days 1, 8
Secondary outcomes:
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
Timeframe: Up to 38 days
Interventions:
Drug: topotecan
Enrollment:
107
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
October 2004 to July 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Subjects with advanced solid tumors.
- Women who are pregnant or lactating
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- Women who are pregnant or lactating -Subjects with uncontrolled emesis, regardless of etiology, active infection.
Trial location(s)
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26506
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bronx, New York, United States, 10461
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-05-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 104864/692 can be found on the GSK Clinical Study Register.
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