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Completed

NCT Number: NCT00358540

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

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.

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Key information

Conditions

Thrombocytopaenia Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Santa Monica, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eltrombopag

Drug

Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.

Primary outcomes

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

    Time frame: Approximately 42 weeks

Secondary outcomes

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

    Time frame: Approximately 18 weeks

  2. Eltrombopag AUC(0-t)

    Time frame: Approximately 4 weeks

  3. Doxorubicin and doxorubicinol PK

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 1, 2006
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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