Dose Evaluation Study Of Oral Eltrombopag In Patients With Sarcoma Receiving The Adriamycin And Ifosfamide Regimen

This study is currently recruiting participants.

Verified by GlaxoSmithKline, October 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00358540

Purpose

The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag administered with ADRIAMYCIN and ifosfamide (AI) chemotherapy in subjects with sarcoma who have a low platelet count.

Condition	Intervention	Phase
Sarcoma Thrombocytopenia Thrombopoiesis	Drug: eltrombopag	Phase I

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety and tolerability Optimal biologic dose Pharmacokinetics [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Degree and duration of thrombocytopenia Platelet recovery with AI chemotherapy [ Time Frame: throughout the study ]

Estimated Enrollment:	38
Study Start Date:	June 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Adequate liver and kidney function
Ability to ingest and retain oral medication
Practice acceptable birth control
Ability to understand and follow study requirements

Exclusion criteria:

History of platelet disorders, dysfunction, or a bleeding disorder
Life expectancy is less than six months
Anti-coagulant used within 4 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 or radiotherapy within 2 weeks of study start
Consumption of antacids, asprin, herbal supplements, rosuvastatin, pravastatin
Pre-existing cardiac disease

Contacts and Locations

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

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

United States, California
GSK Investigational Site	Withdrawn
Santa Monica, California, United States, 90403
GSK Investigational Site	Recruiting
Santa Monica, California, United States, 90403
United States, Illinois
GSK Investigational Site	Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Pennsylvania
GSK Investigational Site	Recruiting
Philadelphia, Pennsylvania, United States, 19106
GSK Investigational Site	Withdrawn
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
GSK Investigational Site	Completed
Houston, Texas, United States, 77030-4009
GSK Investigational Site	Withdrawn
Houston, Texas, United States, 77030-4009
Russian Federation
GSK Investigational Site	Active, not recruiting
Moscow Region, Russian Federation, 143 423
GSK Investigational Site	Active, not recruiting
Moscow, Russian Federation, 115478
GSK Investigational Site	Active, not recruiting
St. Petersburg, Russian Federation, 197758

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRC105499
Study First Received:	July 28, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00358540
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

sarcoma
thrombocytopenia
eltrombopag
thrombopoiesis

Study placed in the following topic categories:

Thrombocytopathy
Neoplasms, Connective and Soft Tissue
Ifosfamide
Thrombocytopenia
Hematologic Diseases
Malignant mesenchymal tumor

Blood Platelet Disorders
Sarcoma
Doxorubicin
Soft tissue sarcomas
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009