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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-04

Study Completion Date

2018-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Solid Tumor Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

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Tripegfilgrastim

Intervention Type DRUG

Other Intervention Names

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DA-3031

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No