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

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ClinicalTrials.gov Identifier: NCT00358540
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombocytopaenia Drug: eltrombopag Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 1, 2006
Actual Primary Completion Date : October 22, 2010
Actual Study Completion Date : October 22, 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group B
Group B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide
Drug: eltrombopag
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
Experimental: Group A
Group A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag.
Drug: eltrombopag
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358540


Locations
United States, California
GSK Investigational Site
Santa Monica, California, United States, 90403
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Tampa, Florida, United States, 33612
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29605
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358540     History of Changes
Obsolete Identifiers: NCT00408837
Other Study ID Numbers: TRC105499
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
sarcoma
eltrombopag
thrombopoiesis
thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Doxorubicin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors