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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00358540

Collaborator

(none)

Enrollment

Locations

Arms

52.7

Actual Duration (Months)

2.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopaenia	Drug: eltrombopag	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Oct 22, 2010

Actual Study Completion Date :

Oct 22, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group B Group B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide	Drug: eltrombopag Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
Experimental: Group A Group A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag.	Drug: eltrombopag Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.

Arm

Intervention/Treatment

Experimental: Group B

Group B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide

Drug: eltrombopag

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

Experimental: Group A

Group A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag.

Drug: eltrombopag

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Eltrombopag AUC(0-t) [Approximately 4 weeks]
Doxorubicin and doxorubicinol PK [Approximately 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Santa Monica	California	United States	90403
2	GSK Investigational Site	Miami	Florida	United States	33136
3	GSK Investigational Site	Tampa	Florida	United States	33612
4	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19106
5	GSK Investigational Site	Greenville	South Carolina	United States	29605
6	GSK Investigational Site	Dallas	Texas	United States	75246
7	GSK Investigational Site	Houston	Texas	United States	77030-4009