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A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients

Primary Purpose

Solid Tumor, Lymphoma

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tripegfilgrastim
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Solid Tumor

Eligibility Criteria

6 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >=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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

PK parameter
Time to reach Cmax of Tripegfilgrastim [Tmax]
PK parameter
Peak plasma concentration of Tripegfilgrastim [Cmax]
PK parameter
Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC]
PK parameter
Half-life of Tripegfilgrastim [T1/2]
PK parameter
The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough]

Secondary Outcome Measures

PD parameter
Peak plasma concentration of Absolute Neutrophil Count [ANCmax]
PD parameter
Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)]
PD parameter
Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)]

Full Information

First Posted
October 13, 2016
Last Updated
January 13, 2019
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02963389
Brief Title
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients
Official Title
A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Lymphoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients
Arm Type
Experimental
Arm Description
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Arm Title
Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients
Arm Type
Experimental
Arm Description
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Arm Title
Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients
Arm Type
Experimental
Arm Description
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Arm Title
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients
Arm Type
Experimental
Arm Description
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Intervention Type
Drug
Intervention Name(s)
Tripegfilgrastim
Other Intervention Name(s)
DA-3031
Primary Outcome Measure Information:
Title
PK parameter
Description
Time to reach Cmax of Tripegfilgrastim [Tmax]
Time Frame
Day 1(Hour 0) ~ Day 21
Title
PK parameter
Description
Peak plasma concentration of Tripegfilgrastim [Cmax]
Time Frame
Day 1(Hour 0) ~ Day 21
Title
PK parameter
Description
Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC]
Time Frame
Day 1(Hour 0) ~ Day 21
Title
PK parameter
Description
Half-life of Tripegfilgrastim [T1/2]
Time Frame
Day 1(Hour 0) ~ Day 21
Title
PK parameter
Description
The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough]
Time Frame
Day 1(Hour 0) ~ Day 21
Secondary Outcome Measure Information:
Title
PD parameter
Description
Peak plasma concentration of Absolute Neutrophil Count [ANCmax]
Time Frame
Day 1(Hour 0) ~ Day 14
Title
PD parameter
Description
Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)]
Time Frame
Day 1(Hour 0) ~ Day 14
Title
PD parameter
Description
Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)]
Time Frame
Day 1(Hour 0) ~ Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >=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 Exclusion Criteria: 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
82
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34605552
Citation
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.
Results Reference
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A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients

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