NCT02787876

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 4, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

May 24, 2016

Last Update Submit

September 17, 2018

Conditions

Chemotherapy Induced NeutropeniaPediatric Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • Duration of severe neutropenia (ANC < 100/uL)

    Up to 6 weeks

  • Lowest value of ANC

    Up to 6 weeks

  • Days with neutropenic fever

    Up to 6 weeks

Study Arms (1)

Chemotherapy induced neutropenia

EXPERIMENTAL

Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle

Drug: Pegteograstim

Interventions

PegteograstimDRUG
Chemotherapy induced neutropenia

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34010932DERIVED

Central Study Contacts

Ki Woong Sung, MD, PhD

CONTACT

82-2-3410-3529kiwoong.sung@samsung.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 1, 2016

Study Start

October 4, 2016

Primary Completion

October 1, 2018

Study Completion

November 1, 2018

Last Updated

September 18, 2018

Record last verified: 2017-09

Locations

KR(1)