Last updated: 11/04/2018 12:58:06

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

GSK study ID
TRC105499
See study documents
Clinicaltrials.gov ID
NCT00358540
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Supportive Care
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters

Timeframe: Approximately 42 weeks

Secondary outcomes:

OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir

Timeframe: Approximately 18 weeks

Eltrombopag AUC(0-t)

Timeframe: Approximately 4 weeks

Doxorubicin and doxorubicinol PK

Timeframe: Approximately 4 weeks

Interventions:
Drug: eltrombopag
Enrollment:
18
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Hayes S, Mudd PN, 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;71(6):1507-1520.
Chawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Mostafa Kamel Y.Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide.BMC Cancer.2013;13(121)
Medical condition
Thrombocytopaenia
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
June 2006 to October 2010
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Adult subjects, 18 years or older
  • Adequate liver and kidney function
  • History of platelet disorders, dysfunction, or a bleeding disorder
  • Anti-coagulant used within 2 weeks prior to study start
Inclusion and exclusion 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Tampa, Florida, United States, 33612
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Miami, Florida, United States, 33136
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Greenville, South Carolina, United States, 29605
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Santa Monica, California, United States, 90403
Status
Study Complete
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Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
Status
Study Complete
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Location
GSK Investigational Site
Dallas, Texas, United States, 75246
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Houston, Texas, United States, 77030-4009
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-22-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study 105499 can be found on the GSK Clinical Study Register.
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