Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

Osteosarcoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01491594
• Other study ID #: Pro00032798
• Status: Terminated
• Phase: Phase 1
• First received: December 12, 2011
• Last updated: April 1, 2014
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neoplasms, Connective and Soft Tissue
• Osteosarcoma
• Sarcoma
• Sarcoma, Soft Tissue
• Thrombocytopenia
• Thrombocytosis

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Efficacy	The primary outcome for the Phase II study is the proportion of subjects without grade 3 or 4 thrombocytopenia	20 weeks	No