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

GSK study ID
104864/692
See study documents
Clinicaltrials.gov ID
NCT00259935
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    AMSTERDAM, Netherlands, 1066 CX
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Morgantown, West Virginia, United States, 26506
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Bronx, New York, United States, 10461
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    UTRECHT, Netherlands, 3584 CX
    Status
    Terminated/Withdrawn
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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

    Participate in clinical trial
    Additional information
    Results for study 104864/692 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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