NCT00358540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2010

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

4.4 years

First QC Date

July 28, 2006

Last Update Submit

November 8, 2017

Conditions

Thrombocytopaenia

Keywords

sarcomaeltrombopagthrombopoiesisthrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Group B

EXPERIMENTAL

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

Group A

EXPERIMENTAL

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

Interventions

eltrombopagDRUG

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

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Santa Monica, California, 90403, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Tampa, Florida, 33612, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19106, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29605, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Houston, Texas, 77030-4009, United States

Location

Related Publications (2)

  • 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.

    PMID: 23564375BACKGROUND

  • 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.

    PMID: 23497336DERIVED

Related Links

MeSH Terms

Conditions

ThrombocytopeniaSarcoma

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

June 1, 2006

Primary Completion

October 22, 2010

Study Completion

October 22, 2010

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

US(7)