Pegteograstim in Children With Solid Tumors | NCT02787876

Studies
Pegteograstim in Children With Solid Tumors

NCT02787876

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Sep 18, 2018Actual

Enrollment

34Estimated

Phase

Phase 2

Conditions

Chemotherapy Induced Neutropenia
Pediatric Solid Tumor

Interventions

Pegteograstim

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2016Actual

Primary Completion Date

Oct 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

May 24, 2016

First Submission Date that Met QC Criteria

May 26, 2016

First Posted Date

Jun 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2018

Last Update Posted Date

Sep 18, 2018Actual

Name	Class
Green Cross Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pegteograstim	Drug		Chemotherapy induced neutropenia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ki Woong Sung, MD, PhD	Contact	82-2-3410-3529		kiwoong.sung@samsung.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34010932	Derived	Cho HW, Lee JW, Ju HY, Hyun JK, Yoo KH, Koo HH, Kim K, Sung KW. Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors. J Pediatr Hematol Oncol. 2022 Mar 1;44(2):e362-e367. doi: 10.1097/MPH.0000000000002206.