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

D

Dong-A ST

Status and phase

Completed
Phase 1

Conditions

Solid Tumor
Lymphoma

Treatments

Drug: Tripegfilgrastim

Study type

Interventional

Funder types

Industry

Identifiers

NCT02963389
DA3031_PNP_I

Details and patient eligibility

About

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

Enrollment

27 patients

Sex

All

Ages

6 to 19 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 4 patient groups

Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients
Experimental group
Description:
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Treatment:
Drug: Tripegfilgrastim
Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients
Experimental group
Description:
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Treatment:
Drug: Tripegfilgrastim
Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients
Experimental group
Description:
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Treatment:
Drug: Tripegfilgrastim
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients
Experimental group
Description:
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Treatment:
Drug: Tripegfilgrastim

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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