Pegteograstim in Children With Solid Tumors

September 17, 2018 updated by: Samsung Medical Center

Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors

To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen

Exclusion Criteria:

  • Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)
  • Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.
  • Patients with bleeding tendency to whom subcutaneous injection should be avoided.
  • Active infection or infectious fever during the screening period.
  • Genetic problem to fructose tolerance.
  • Patients who participated in other clinical trial within 4 weeks before enrollment.
  • Pregnant and nursing women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy induced neutropenia
Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
Drug: Pegteograstim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of adverse events
Time Frame: Up to 3 weeks after the injection of pegteograsim
Up to 3 weeks after the injection of pegteograsim
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)
Time Frame: Up to 6 weeks
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of severe neutropenia (ANC < 100/uL)
Time Frame: Up to 6 weeks
Up to 6 weeks
Lowest value of ANC
Time Frame: Up to 6 weeks
Up to 6 weeks
Days with neutropenic fever
Time Frame: Up to 6 weeks
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Green Cross Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-12-121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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