Back to resultsDose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
Primary Purpose
Thrombocytopaenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eltrombopag
Sponsored by
About this trial
This is an interventional supportive care trial for Thrombocytopaenia focused on measuring sarcoma, eltrombopag, thrombopoiesis, thrombocytopenia
Eligibility 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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group B
Group A
Arm Description
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
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.
Outcomes
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
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
Eltrombopag AUC(0-t)
Doxorubicin and doxorubicinol PK
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00358540
Brief Title
Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2006 (Actual)
Primary Completion Date
October 22, 2010 (Actual)
Study Completion Date
October 22, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopaenia
Keywords
sarcoma, eltrombopag, thrombopoiesis, thrombocytopenia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B
Arm Type
Experimental
Arm Description
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
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
eltrombopag
Intervention Description
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Eltrombopag AUC(0-t)
Time Frame
Approximately 4 weeks
Title
Doxorubicin and doxorubicinol PK
Time Frame
Approximately 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
GSK Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23564375
Citation
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.
Results Reference
background
PubMed Identifier
23497336
Citation
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.
Results Reference
derived
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Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
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