Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
NCT ID: NCT00358540
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2006-06-01
2010-10-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
eltrombopag
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
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.
eltrombopag
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
Interventions
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eltrombopag
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Santa Monica, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States
Countries
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References
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Hayes S, Mudd PN Jr, Ouellet D, Johnson BM, Williams D, Gibiansky E. Population PK/PD modeling of eltrombopag in subjects with advanced solid tumors with chemotherapy-induced thrombocytopenia. Cancer Chemother Pharmacol. 2013 Jun;71(6):1507-20. doi: 10.1007/s00280-013-2150-9. Epub 2013 Apr 6.
Chawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Kamel YM. Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide. BMC Cancer. 2013 Mar 16;13:121. doi: 10.1186/1471-2407-13-121.
Other Identifiers
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TRC105499
Identifier Type: -
Identifier Source: org_study_id
NCT00408837
Identifier Type: -
Identifier Source: nct_alias