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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thrombocytopaenia

Intervention / Treatment
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* Drug: eltrombopag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br>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<br>* Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.<br>|
| Experimental: Group A<br>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<br>* Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters |  | Approximately 42 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir |  | Approximately 18 weeks | 
| Eltrombopag AUC(0-t) |  | Approximately 4 weeks | 
| Doxorubicin and doxorubicinol PK |  | Approximately 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcoma, eltrombopag, thrombopoiesis, thrombocytopenia