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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00358540
First received: July 28, 2006
Last updated: March 15, 2012
Last verified: May 2011
  Purpose

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 Intervention Phase
Sarcoma
Thrombocytopenia
Thrombocytopaenia
Thrombopoiesis
Drug: eltrombopag
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • Eltrombopag AUC(0-t) [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
  • Doxorubicin and doxorubicinol PK [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: eltrombopag
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.
Other Name: eltrombopag

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358540

Locations
United States, California
GSK Investigational Site
Santa Monica, California, United States, 90403
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
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
  More Information

No publications provided by GlaxoSmithKline

Additional 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
Study First Received: July 28, 2006
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
sarcoma
thrombocytopenia
eltrombopag
thrombopoiesis

Additional relevant MeSH terms:
Thrombocytopenia
Sarcoma
Blood Platelet Disorders
Hematologic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014