Clinical trial NCT00358540: Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombocytopaenia
Keywords: sarcoma
eltrombopag
thrombopoiesis
thrombocytopenia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters
timeFrame: Approximately 42 weeks
Secondary outcomes:
measure: OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir
timeFrame: Approximately 18 weeks
measure: Eltrombopag AUC(0-t)
timeFrame: Approximately 4 weeks
measure: Doxorubicin and doxorubicinol PK
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Chawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Kamel YM. Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide. BMC Cancer. 2013 Mar 16;13:121. doi: 10.1186/1471-2407-13-121.