GCPGC in Chemotherapy-induced Neutropenia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chemotherapy Induced Neutropenia	Biological: GCPGC 3.6mg Biological: GCPGC 6mg Biological: Neulasta (pegfilgrastim) 6mg	Phase 2 Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

Drug Information available for: Pegfilgrastim

U.S. FDA Resources

Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:

Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1 [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1 [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]
Depth of ANC nadir in cycle 1 [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]
Rates of Febrile neutropenia in all cycles [ Time Frame: in all cycles ] [ Designated as safety issue: No ]
Stage I: only in cycle 1; Stage II: in all cycles
Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II) [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]
ANC values at Day 7 in all cycles (only for Stage II) [ Time Frame: Day 7 in alll cycles ] [ Designated as safety issue: No ]
Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II) [ Time Frame: all cycles ] [ Designated as safety issue: No ]
Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II) [ Time Frame: in clycle 2-6 ] [ Designated as safety issue: No ]
Number of intravenous antimicrobial treatments due to febrile neutropenia [ Time Frame: in all cycles ] [ Designated as safety issue: No ]

Other Outcome Measures:

Incidence of antibody development in patients receiving GCPGC compared to Neulasta [ Time Frame: 3 months after last treatment ] [ Designated as safety issue: Yes ]
Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions [ Time Frame: in all cycles ] [ Designated as safety issue: Yes ]

Enrollment:	177
Study Start Date:	October 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stage I - Arm I: GCPGC I (3.6mg) GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)	Biological: GCPGC 3.6mg Stage I:Single blinded Other Name: Pegfilgrastim
Experimental: Stage I - Arm II: GCPGC II (6mg) GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)	Biological: GCPGC 6mg Stage I: Single blinded; Other Name: Pegfilgrastim
Experimental: Stage II - Arm I: GCPGC 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.	Biological: GCPGC 6mg Experimental: Stage II Other Name: Pegfilgrastim
Active Comparator: Stage II - Arm II: Neulasta Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)	Biological: Neulasta (pegfilgrastim) 6mg Stage II: Active comparator, double blinded

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328938

Locations

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

Sponsors and Collaborators

Green Cross Corporation

Symyoo

Investigators

Principal Investigator:	Do-Youn Oh, M.D., Ph.D.	Seoul National University Hospital
Study Director:	Chang-Hee Lee, M.D., Ph.D.	Green Cross Corporation
Principal Investigator:	Seock-Ah Im, M.D., Ph.D.	Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Green Cross Corporation
ClinicalTrials.gov Identifier:	NCT01328938 History of Changes
Other Study ID Numbers:	GCPGC P2/3
Study First Received:	February 6, 2011
Last Updated:	October 23, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Green Cross Corporation:

Pegfilgrastim
neutropenia

Additional relevant MeSH terms:

Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013