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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00358540

Enrollment

Registered

2006-08-01

Start date

2006-06-01

Completion date

2010-10-22

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopaenia

Keywords

sarcoma, eltrombopag, thrombopoiesis, thrombocytopenia

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.

Interventions

DRUGeltrombopag

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026