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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00358540
Other study ID # TRC105499
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01440374 - A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia Phase 2
Completed NCT01957176 - A Rollover Study to Provide Continued Treatment With Eltrombopag Phase 4
Withdrawn NCT01055600 - Milk-only Lactation Study for Patients on Eltrombopag Phase 4
Completed NCT01147809 - Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag Phase 2
Terminated NCT02158936 - A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS) Phase 3
Completed NCT00102726 - SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy Phase 2
Completed NCT01235988 - Meta-analysis - Eltrombopag N/A
Completed NCT01236014 - Indirect Comparison Between Eltrombopag & Romiplostim N/A
Completed NCT01657552 - Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects Phase 1