Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide

Thrombocytopaenia Clinical Trial

Official title:

An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358540
• Other study ID #: TRC105499
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2006
• Last updated: November 8, 2017
• Start date: June 1, 2006
• Est. completion date: October 22, 2010

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.

Other known NCT identifiers

• NCT00408837

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 22, 2010
• Est. primary completion date: October 22, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult subjects, 18 years or older

• Adequate liver and kidney function

• Prior history of =grade 2 thrombocytopenia (platelet nadir = 75,000/microliters)

• Ability to ingest and retain oral medication

• Practice acceptable birth control

• Ability to understand and follow study requirements

• Life expectancy of at least 3 months

Exclusion criteria:

• History of platelet disorders, dysfunction, or a bleeding disorder

• Anti-coagulant used within 2 weeks prior to study start

• Females who are lactating or expecting

• History of thromboembolic events or drug induced thrombocytopenia

• History of central nervous system, brain and/or leptomeningeal metastases

• Prior surgery within 2 weeks or radiotherapy within 4 weeks of study start

• Pre-existing cardiac disease

Related Conditions & MeSH terms

• Thrombocytopaenia
• Thrombocytopenia

Intervention

Drug:
• eltrombopag
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hayes S, Mudd PN Jr, Ouellet D, Johnson BM, Williams D, Gibiansky E. Population PK/PD modeling of eltrombopag in subjects with advanced solid tumors with chemotherapy-induced thrombocytopenia. Cancer Chemother Pharmacol. 2013 Jun;71(6):1507-20. doi: 10.1007/s00280-013-2150-9. Epub 2013 Apr 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters		Approximately 42 weeks
Secondary	OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir		Approximately 18 weeks
Secondary	Eltrombopag AUC(0-t)		Approximately 4 weeks
Secondary	Doxorubicin and doxorubicinol PK		Approximately 4 weeks

External Links

•   Results for study 105499 can be found on the GSK Clinical Study Register.