Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia
Sarcoma, Soft Tissue
Neoplasms, Connective and Soft Tissue
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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|
- Tolerated Eltrombopag Dose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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
- Efficacy [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]The primary outcome for the Phase II study is the proportion of subjects without grade 3 or 4 thrombocytopenia
|Study Start Date:||April 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491594
|United States, North Carolina|
|Duke Cancer Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Richard F Riedel, MD||Duke University|