Last updated: 11/04/2018 12:58:06

Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide

GSK study ID
TRC105499
See study documents
Clinicaltrials.gov ID
NCT00358540
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: An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen
Trial description: The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.
Primary purpose:
Supportive Care
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters

Timeframe: Approximately 42 weeks

Secondary outcomes:

OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir

Timeframe: Approximately 18 weeks

Eltrombopag AUC(0-t)

Timeframe: Approximately 4 weeks

Doxorubicin and doxorubicinol PK

Timeframe: Approximately 4 weeks

Interventions:
  • Drug: eltrombopag
    • Enrollment:
    18
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Hayes S, Mudd PN, Ouellet D, Johnson BM, Williams D, Gibiansky E. Population PK/PD Modeling of Eltrombopag in Subjects with Advanced Solid Tumors with Chemotherapy-Induced Thrombocytopenia. Cancer Chemother Pharmacol. 2013;71(6):1507-1520.
    Chawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Mostafa Kamel Y.Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide.BMC Cancer.2013;13(121)
    Medical condition
    Thrombocytopaenia
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to October 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Adult subjects, 18 years or older
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Adult subjects, 18 years or older
    • Adequate liver and kidney function
    • Prior history of ≥grade 2 thrombocytopenia (platelet nadir ≤ 75,000/microliters)
    • Ability to ingest and retain oral medication
    • Practice acceptable birth control
    • Ability to understand and follow study requirements
    • Life expectancy of at least 3 months Exclusion criteria:
    • History of platelet disorders, dysfunction, or a bleeding disorder
    • Anti-coagulant used within 2 weeks prior to study start
    • Females who are lactating or expecting
    • History of thromboembolic events or drug induced thrombocytopenia
    • History of central nervous system, brain and/or leptomeningeal metastases
    • Prior surgery within 2 weeks or radiotherapy within 4 weeks of study start
    • Pre-existing cardiac disease

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33612
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33136
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29605
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Santa Monica, California, United States, 90403
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75246
    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
    2010-22-10

    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 105499 can be found on the GSK Clinical Study Register.
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