Clinical trial NCT01328938: GCPGC in Chemotherapy-induced Neutropenia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chemotherapy Induced Neutropenia
Keywords: Pegfilgrastim
neutropenia
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
Collaborators: name: Symyoo
First posted: 2011-04-05
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1
timeFrame: in cycle 1
Secondary outcomes:
measure: Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1
timeFrame: in cycle 1
measure: Depth of ANC nadir in cycle 1
timeFrame: in cycle 1
measure: Rates of Febrile neutropenia in all cycles
timeFrame: in all cycles
measure: Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)
timeFrame: in cycle 1
measure: ANC values at Day 7 in all cycles (only for Stage II)
timeFrame: Day 7 in alll cycles
measure: Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)
timeFrame: all cycles
measure: Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)
timeFrame: in clycle 2-6
measure: Number of intravenous antimicrobial treatments due to febrile neutropenia
timeFrame: in all cycles
Other outcomes:
measure: Incidence of antibody development in patients receiving GCPGC compared to Neulasta
timeFrame: 3 months after last treatment
measure: Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions
timeFrame: in all cycles
Locations:
city: Chungju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungchungbuk
city: Ilsan
country: Korea, Republic of
facility: National Cancer Center
state: KyungKi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
state: KyungKi
city: Sungnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyungki
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Do-Youn Oh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Green Cross Corporation
name: Chang-Hee Lee, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Seock-Ah Im, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: