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Completed

NCT Number: NCT02963389

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim 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

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Key information

Conditions

Solid Tumor Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

6 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 82, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tripegfilgrastim

Drug

Other names: DA-3031

Primary outcomes

  1. PK parameter

    Time frame: Day 1(Hour 0) ~ Day 21

    Time to reach Cmax of Tripegfilgrastim [Tmax]

  2. PK parameter

    Time frame: Day 1(Hour 0) ~ Day 21

    Peak plasma concentration of Tripegfilgrastim [Cmax]

  3. PK parameter

    Time frame: Day 1(Hour 0) ~ Day 21

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

  4. PK parameter

    Time frame: Day 1(Hour 0) ~ Day 21

    Half-life of Tripegfilgrastim [T1/2]

  5. PK parameter

    Time frame: Day 1(Hour 0) ~ Day 21

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

Secondary outcomes

  1. PD parameter

    Time frame: Day 1(Hour 0) ~ Day 14

    Peak plasma concentration of Absolute Neutrophil Count [ANCmax]

  2. PD parameter

    Time frame: Day 1(Hour 0) ~ Day 14

    Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)]

  3. PD parameter

    Time frame: Day 1(Hour 0) ~ Day 14

    Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)]

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2016
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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