Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

Duke University

Status and phase

Terminated

Phase 1

Conditions

Osteosarcoma

Neoplasms, Connective and Soft Tissue

Sarcoma, Soft Tissue

Treatments

Drug: Eltrombopag

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01491594

Pro00032798

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1 patient

Sex

All

Ages

18 to 82 years old

Volunteers

No Healthy Volunteers

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