NCT01491594

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.

Trial Health

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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

December 12, 2011

Last Update Submit

April 1, 2014

Conditions

Sarcoma, Soft TissueOsteosarcomaNeoplasms, Connective and Soft Tissue

Keywords

Metastatic sarcomaBone sarcoma

Outcome Measures

Primary Outcomes (2)

  • Tolerated Eltrombopag Dose

    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

    1 year

  • Efficacy

    The primary outcome for the Phase II study is the proportion of subjects without grade 3 or 4 thrombocytopenia

    20 weeks

Interventions

EltrombopagDRUG

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.

Also known as: Promacta

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic soft tissue or bone sarcoma
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

SarcomaOsteosarcomaNeoplasms, Connective and Soft TissueBone Neoplasms

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Study Officials

  • Richard F Riedel, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 2, 2014

Record last verified: 2013-04

Locations

US(1)