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 11, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2011

Last Updated Date

April 11, 2013

Start Date ^ICMJE

April 2012

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01491594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Sarcoma, Soft Tissue
Osteosarcoma
Neoplasms, Connective and Soft Tissue

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 82 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01491594

Other Study ID Numbers ^ICMJE

Pro00032798

Has Data Monitoring Committee

Responsible Party

Duke University

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Richard F Riedel, MD

Duke University

Information Provided By

Duke University

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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