Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

Study Overview
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Brief Summary
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The purpose of this study is to study the effect of eltrombopag on chemotherapy induced thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.

Detailed Description
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The combination chemotherapy regimen of gemcitabine and docetaxel has become an increasingly used treatment choice for subjects with advanced sarcomas. The regimen has shown activity in first and second line for subjects with metastatic uterine leiomyosarcoma, relapsed/refractory pediatric sarcomas, and improved progression-free survival and overall survival in persons with metastatic sarcoma when compared to gemcitabine alone. The regimen has additionally been recognized as a treatment option for subjects with advanced sarcoma. Chemotherapy-induced toxicity in the blood such as low platelet level is a common and often therapy-limiting side effect of treatment. There are two phases in this study. The purpose of the Phase I study is to determine the recommended dose of eltrombopag. The purpose of the Phase II study is to determine the safety, tolerability, and efficacy (how well the drug works) of eltrombopag in subjects who are receiving gemcitabine and docetaxel chemotherapy. Eltrombopag (Promacta) is an FDA approved drug for the treatment of chronic idiopathic thrombocytopenic purpura (ITP)- a condition of having an abnormally low platelet count. Eltrombopag is now being further investigated for other thrombocytopenic (low platelet)disorders. Participants will take the assigned dose of eltrombopag once a day starting five days before each cycle of chemotherapy and for 5 days after chemotherapy. Eltrombopag is not taken on the day of chemotherapy. Eltrombopag is taken orally.

Official Title
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A Phase I/II Open-label Study of Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia (CIT) in Subjects With Advanced Soft Tissue and Bone Sarcomas Receiving Gemcitabine and Docetaxel Chemotherapy

Conditions
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Sarcoma, Soft Tissue, Osteosarcoma, Neoplasms, Connective and Soft Tissue

Intervention / Treatment
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* Drug: Eltrombopag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic soft tissue or bone sarcoma 18 years of age or older Adequate blood counts Adequate kidney and liver function At least 1 but no more than 3 prior systemic therapy regimens for this cancer Good performance status - able to carry out work of a light or sedentary nature Exclusion Criteria: Pre-existing hear disease such as congestive heart failure, or arrhythmia known to increase the risk of thromboembolic events (blood clots) Blood clot in the last 6 months, known clotting problem or platelet disorder History of brain cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Eltrombopag|Eltrombopag is taken by mouth daily beginning 5 days before the start of each chemotherapy cycle for 10 days. In the phase 1 part of the study the dose will be 100, 150, 225, or 300 mg.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerated Eltrombopag Dose | Measured in milligrams (mg). The primary objective of the phase I study is to determine the recommended phase II dose. The maximum dose is the dose of which less than 2 of 6 patients experienced an unacceptable event/side effect | 1 year | 
| Efficacy | The primary outcome for the Phase II study is the proportion of subjects without grade 3 or 4 thrombocytopenia | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic sarcoma, Bone sarcoma