Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

This study has been terminated.
(Unable to accrue subjects to the study.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01491594
First received: December 12, 2011
Last updated: April 1, 2014
Last verified: April 2013
  Purpose

The purpose of this study is to study the effect of eltrombopag on chemotherapy induced thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.


Condition Intervention Phase
Sarcoma, Soft Tissue
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Drug: Eltrombopag
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I/II Open-label Study of Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia (CIT) in Subjects With Advanced Soft Tissue and Bone Sarcomas Receiving Gemcitabine and Docetaxel Chemotherapy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Tolerated Eltrombopag Dose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Measured in milligrams (mg). The primary objective of the phase I study is to determine the recommended phase II dose. The maximum dose is the dose of which less than 2 of 6 patients experienced an unacceptable event/side effect

  • Efficacy [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    The primary outcome for the Phase II study is the proportion of subjects without grade 3 or 4 thrombocytopenia


Enrollment: 1
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Eltrombopag
    Eltrombopag is taken by mouth daily beginning 5 days before the start of each chemotherapy cycle for 10 days. In the phase 1 part of the study the dose will be 100, 150, 225, or 300 mg.
    Other Name: Promacta
Detailed Description:

The combination chemotherapy regimen of gemcitabine and docetaxel has become an increasingly used treatment choice for subjects with advanced sarcomas. The regimen has shown activity in first and second line for subjects with metastatic uterine leiomyosarcoma, relapsed/refractory pediatric sarcomas, and improved progression-free survival and overall survival in persons with metastatic sarcoma when compared to gemcitabine alone. The regimen has additionally been recognized as a treatment option for subjects with advanced sarcoma.

Chemotherapy-induced toxicity in the blood such as low platelet level is a common and often therapy-limiting side effect of treatment.

There are two phases in this study. The purpose of the Phase I study is to determine the recommended dose of eltrombopag. The purpose of the Phase II study is to determine the safety, tolerability, and efficacy (how well the drug works) of eltrombopag in subjects who are receiving gemcitabine and docetaxel chemotherapy.

Eltrombopag (Promacta) is an FDA approved drug for the treatment of chronic idiopathic thrombocytopenic purpura (ITP)- a condition of having an abnormally low platelet count. Eltrombopag is now being further investigated for other thrombocytopenic (low platelet)disorders.

Participants will take the assigned dose of eltrombopag once a day starting five days before each cycle of chemotherapy and for 5 days after chemotherapy. Eltrombopag is not taken on the day of chemotherapy. Eltrombopag is taken orally.

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic soft tissue or bone sarcoma
  • 18 years of age or older
  • Adequate blood counts
  • Adequate kidney and liver function
  • At least 1 but no more than 3 prior systemic therapy regimens for this cancer
  • Good performance status - able to carry out work of a light or sedentary nature

Exclusion Criteria:

  • Pre-existing hear disease such as congestive heart failure, or arrhythmia known to increase the risk of thromboembolic events (blood clots)
  • Blood clot in the last 6 months, known clotting problem or platelet disorder
  • History of brain cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491594

Locations
United States, North Carolina
Duke Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
GlaxoSmithKline
Investigators
Principal Investigator: Richard F Riedel, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01491594     History of Changes
Other Study ID Numbers: Pro00032798
Study First Received: December 12, 2011
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
Metastatic sarcoma
Bone sarcoma

Additional relevant MeSH terms:
Neoplasms
Osteosarcoma
Thrombocytopenia
Neoplasms, Connective and Soft Tissue
Sarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms by Histologic Type
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014