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GCPGC in Chemotherapy-induced Neutropenia

NCT01328938 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2013-11-06

No results posted yet for this study

Summary

This study is adaptive design and it consists of stage I and stage II.

Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.

Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.

Conditions

  • Chemotherapy Induced Neutropenia

Interventions

BIOLOGICAL

GCPGC 3.6mg

Stage I:Single blinded

BIOLOGICAL

GCPGC 6mg

Stage I: Single blinded;

BIOLOGICAL

Neulasta (pegfilgrastim) 6mg

Stage II: Active comparator, double blinded

BIOLOGICAL

GCPGC 6mg

Experimental: Stage II

Sponsors & Collaborators

  • Symyoo

    collaborator INDUSTRY

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Do-Youn Oh, M.D., Ph.D. · Seoul National University Hospital

  • Chang-Hee Lee, M.D., Ph.D. · Green Cross Corporation

  • Seock-Ah Im, M.D., Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328938 on ClinicalTrials.gov