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Pegteograstim in Children With Solid Tumors

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE May 24, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE October 4, 2016
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
  • Rate of adverse events [ Time Frame: Up to 3 weeks after the injection of pegteograsim ]
  • Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL) [ Time Frame: Up to 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
  • Duration of severe neutropenia (ANC < 100/uL) [ Time Frame: Up to 6 weeks ]
  • Lowest value of ANC [ Time Frame: Up to 6 weeks ]
  • Days with neutropenic fever [ Time Frame: Up to 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegteograstim in Children With Solid Tumors
Official Title  ICMJE Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
Brief Summary To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chemotherapy Induced Neutropenia
  • Pediatric Solid Tumor
Intervention  ICMJE Drug: Pegteograstim
Study Arms  ICMJE Experimental: Chemotherapy induced neutropenia
Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
Intervention: Drug: Pegteograstim
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 26, 2016)		 34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787876
Other Study ID Numbers  ICMJE 2015-12-121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Green Cross Corporation
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date September 2017

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