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Pegteograstim in Children With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02787876
Recruitment Status : Unknown
Verified September 2017 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : September 18, 2018
Green Cross Corporation
Information provided by (Responsible Party):
Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Neutropenia Pediatric Solid Tumor Drug: Pegteograstim Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Rate of adverse events [ Time Frame: Up to 3 weeks after the injection of pegteograsim ]
  2. Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL) [ Time Frame: Up to 6 weeks ]

Secondary Outcome Measures :
  1. Duration of severe neutropenia (ANC < 100/uL) [ Time Frame: Up to 6 weeks ]
  2. Lowest value of ANC [ Time Frame: Up to 6 weeks ]
  3. Days with neutropenic fever [ Time Frame: Up to 6 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02787876

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Contact: Ki Woong Sung, MD, PhD 82-2-3410-3529

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Ki Woong Sung    82-2-3410-3529   
Principal Investigator: Ki Woong Sung         
Sponsors and Collaborators
Samsung Medical Center
Green Cross Corporation
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Responsible Party: Samsung Medical Center Identifier: NCT02787876    
Other Study ID Numbers: 2015-12-121
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2017
Additional relevant MeSH terms:
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Leukocyte Disorders
Hematologic Diseases