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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Duke University
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Tolerated Eltrombopag Dose
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 82 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Tolerated Eltrombopag Dose
Time Frame: 1 year
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
The primary outcome for the Phase II study is the proportion of subjects without grade 3 or 4 thrombocytopenia
Secondary Outcomes
No secondary outcomes reported