GCPGC in Chemotherapy-induced Neutropenia

Green Cross Corporation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chemotherapy Induced Neutropenia

Treatments: Biological: Neulasta (pegfilgrastim) 6mg; Biological: GCPGC 6mg; Biological: GCPGC 3.6mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328938

GCPGC P2/3

Details and patient eligibility

About

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.

Full description

GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol (PEG) which has long half life compared to filgrastim, resulting in dosing advantage.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia
• body weight of 45kg and more
• ECOG performance status 2 and less
• ANC ≥1,500mm3 and Platelet ≥100,000/mm3
• life expectancy of 3 months and more
• given written informed consent

Exclusion criteria

• had previous exposure to pegfilgrastim or filgrastim
• had received systemic antibiotics within 72hrs of chemotherapy
• prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 4 patient groups

Stage I - Arm I: GCPGC I (3.6mg)

Experimental group

Description:

GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)

Treatment:

Biological: GCPGC 3.6mg

Stage I - Arm II: GCPGC II (6mg)

Experimental group

Description:

GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)

Treatment:

Biological: GCPGC 6mg

Biological: GCPGC 6mg

Stage II - Arm I: GCPGC

Experimental group

Description:

GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1). The recommended dose in Stage II was determinated as GCPGC 6mg in Stage I.

Treatment:

Biological: GCPGC 6mg

Biological: GCPGC 6mg

Stage II - Arm II: Neulasta

Active Comparator group

Description:

Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)

Treatment:

Biological: Neulasta (pegfilgrastim) 6mg