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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma, Thrombocytopenia, Thrombocytopaenia, Thrombopoiesis

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Trial Information

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

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

Approximately 42 weeks

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

TRC105499

NCT ID:

NCT00358540

Start Date:

June 2006

Completion Date:

October 2010

Related Keywords:

  • Sarcoma
  • Thrombocytopenia
  • Thrombocytopaenia
  • Thrombopoiesis
  • sarcoma
  • thrombocytopenia
  • eltrombopag
  • thrombopoiesis
  • Thrombocytopenia
  • Sarcoma

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SitePittsburgh, Pennsylvania  15213