NCT02963389

Brief Summary

This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 4, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

October 13, 2016

Last Update Submit

January 13, 2019

Conditions

Solid TumorLymphoma

Outcome Measures

Primary Outcomes (5)

  • PK parameter

    Time to reach Cmax of Tripegfilgrastim \[Tmax\]

    Day 1(Hour 0) ~ Day 21

  • PK parameter

    Peak plasma concentration of Tripegfilgrastim \[Cmax\]

    Day 1(Hour 0) ~ Day 21

  • PK parameter

    Area under the plasma concentration of Tripegfilgrastim versus time curve \[AUC\]

    Day 1(Hour 0) ~ Day 21

  • PK parameter

    Half-life of Tripegfilgrastim \[T1/2\]

    Day 1(Hour 0) ~ Day 21

  • PK parameter

    The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered \[Ctrough\]

    Day 1(Hour 0) ~ Day 21

Secondary Outcomes (3)

  • PD parameter

    Day 1(Hour 0) ~ Day 14

  • PD parameter

    Day 1(Hour 0) ~ Day 14

  • PD parameter

    Day 1(Hour 0) ~ Day 14

Study Arms (4)

Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients

EXPERIMENTAL

A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy

Drug: Tripegfilgrastim

Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients

EXPERIMENTAL

A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy

Drug: Tripegfilgrastim

Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients

EXPERIMENTAL

A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy

Drug: Tripegfilgrastim

Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients

EXPERIMENTAL

A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy

Drug: Tripegfilgrastim

Interventions

TripegfilgrastimDRUG
Also known as: DA-3031
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patientsTripegfilgrastim 100ug/kg, >=6 and <12-year-old patientsTripegfilgrastim 60ug/kg, >=12 and <19-year-old patientsTripegfilgrastim 60ug/kg, >=6 and <12-year-old patients

Eligibility Criteria

Age6 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \>=6 and \<19-year-old pediatrics with solid tumor/lymphoma
  • Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC \< 0.5x10\^9/L
  • ANC \> 0.75x10\^9/L, platelet \> 75x10\^9/L
  • ECOG performance status 0 or 1

You may not qualify if:

  • Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases
  • History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
  • Women who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 82, South Korea

Location

Related Publications (2)

  • Lee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9.

    PMID: 37559343DERIVED

  • Lee S, Hong KT, Moon SJ, Choi JY, Hong CR, Shin HY, Cho JY, Jang IJ, Yu KS, Oh J, Kang HJ. Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G-CSF, in Pediatric Patients with Solid Tumors. Clin Pharmacol Ther. 2022 Jan;111(1):293-301. doi: 10.1002/cpt.2433. Epub 2021 Oct 27.

    PMID: 34605552DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

pegylated granulocyte colony-stimulating factor, human

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

November 15, 2016

Study Start

October 4, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

KR(1)