GCPGC in Chemotherapy-induced Neutropenia

Chemotherapy Induced Neutropenia Clinical Trial

Official title:

A Randomized,Multi-center,Parallel-group, Phase II(Single-blind)/Phase III(Double- Blind)Study to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to Neulasta(Pegfilgrastim)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328938
• Other study ID #: GCPGC P2/3
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 6, 2011
• Last updated: November 5, 2013
• Start date: October 2010
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy Induced Neutropenia
• Neutropenia

Intervention

Biological:
• GCPGC 3.6mg
Stage I:Single blinded
• GCPGC 6mg
Stage I: Single blinded;
• Neulasta (pegfilgrastim) 6mg
Stage II: Active comparator, double blinded
• GCPGC 6mg
Experimental: Stage II

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Chungju	Chungchungbuk
Korea, Republic of	Keimyung University Dongsan medical Center	Daegu
Korea, Republic of	National Cancer Center	Ilsan	KyungKi
Korea, Republic of	Gachon University Gil Hospital	Incheon	KyungKi
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Inha University Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Seoul Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam	Kyungki
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Green Cross Corporation	Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of antibody development in patients receiving GCPGC compared to Neulasta		3 months after last treatment	Yes
Other	Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions		in all cycles	Yes
Primary	Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1	Stage I: The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by check ANC in cycle I.; Stage II : The difference in mean duration of grade 4 neutropenia between GCPGC which dose was determined at Stage I and Neulasta is measured by check ANC in cycle 1.	in cycle 1	No
Secondary	Time to ANC recovery (=2,000/mm3) after nadir in cycle 1		in cycle 1	No
Secondary	Depth of ANC nadir in cycle 1		in cycle 1	No
Secondary	Rates of Febrile neutropenia in all cycles	Stage I: only in cycle 1; Stage II: in all cycles	in all cycles	No
Secondary	Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)		in cycle 1	No
Secondary	ANC values at Day 7 in all cycles (only for Stage II)		Day 7 in alll cycles	No
Secondary	Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)		all cycles	No
Secondary	Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)		in clycle 2-6	No
Secondary	Number of intravenous antimicrobial treatments due to febrile neutropenia		in all cycles	No