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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963389
• Other study ID #: DA3031_PNP_I
• Status: Completed
• Phase: Phase 1
• Start date: October 4, 2016
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

Drug:
• Tripegfilgrastim

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter	Time to reach Cmax of Tripegfilgrastim [Tmax]	Day 1(Hour 0) ~ Day 21
Primary	PK parameter	Peak plasma concentration of Tripegfilgrastim [Cmax]	Day 1(Hour 0) ~ Day 21
Primary	PK parameter	Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC]	Day 1(Hour 0) ~ Day 21
Primary	PK parameter	Half-life of Tripegfilgrastim [T1/2]	Day 1(Hour 0) ~ Day 21
Primary	PK parameter	The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough]	Day 1(Hour 0) ~ Day 21
Secondary	PD parameter	Peak plasma concentration of Absolute Neutrophil Count [ANCmax]	Day 1(Hour 0) ~ Day 14
Secondary	PD parameter	Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)]	Day 1(Hour 0) ~ Day 14
Secondary	PD parameter	Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)]	Day 1(Hour 0) ~ Day 14