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

January 13, 2019 updated by: Dong-A ST Co., Ltd.

A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Drug: Tripegfilgrastim
Other Names:
  • DA-3031
Experimental: Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Drug: Tripegfilgrastim
Other Names:
  • DA-3031
Experimental: Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Drug: Tripegfilgrastim
Other Names:
  • DA-3031
Experimental: Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Drug: Tripegfilgrastim
Other Names:
  • DA-3031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK parameter
Time Frame: Day 1(Hour 0) ~ Day 21
Time to reach Cmax of Tripegfilgrastim [Tmax]
Day 1(Hour 0) ~ Day 21
PK parameter
Time Frame: Day 1(Hour 0) ~ Day 21
Peak plasma concentration of Tripegfilgrastim [Cmax]
Day 1(Hour 0) ~ Day 21
PK parameter
Time Frame: Day 1(Hour 0) ~ Day 21
Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC]
Day 1(Hour 0) ~ Day 21
PK parameter
Time Frame: Day 1(Hour 0) ~ Day 21
Half-life of Tripegfilgrastim [T1/2]
Day 1(Hour 0) ~ Day 21
PK parameter
Time Frame: Day 1(Hour 0) ~ Day 21
The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough]
Day 1(Hour 0) ~ Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD parameter
Time Frame: Day 1(Hour 0) ~ Day 14
Peak plasma concentration of Absolute Neutrophil Count [ANCmax]
Day 1(Hour 0) ~ Day 14
PD parameter
Time Frame: Day 1(Hour 0) ~ Day 14
Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)]
Day 1(Hour 0) ~ Day 14
PD parameter
Time Frame: Day 1(Hour 0) ~ Day 14
Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)]
Day 1(Hour 0) ~ Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3031_PNP_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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