Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

Chemotherapy Induced Neutropenia Clinical Trial

— PEG-G-CSF  

Official title:

Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674855
• Other study ID #: DA3031_NP_III
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2012
• Last updated: September 29, 2014
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2014
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.

Description:

Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle is repeated every 21 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age : =18, =70

2. Diagnosis of stage II, III or IV breast cancer

3. ANC=1,500/mm3, Platelet=100,000/mm3, ECOG : 0 or 1

4. Creatinine < 1.5 x ULN

5. Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN

6. Have given a written, informed consent

Exclusion Criteria:

1. Prior chemotherapy

2. Prior bone marrow or stem cell transplantation

3. Other malignancy history within 5 years

4. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors

5. Received any other investigational drugs within 30 days of informed consent date

6. Radiation therapy within 4 weeks of informed consent date

7. Infective symptom before chemotherapy into this study

8. Received systemic antibiotics within 72 hours of randomization into this study.

9. HIV positive

10. Pregnant or lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Induced Neutropenia
• Neutropenia

Intervention

Drug:
• PEG-G-CSF
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
• G-CSF
Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle

Locations

Country	Name	City	State
Korea, Republic of	Korea University GURO hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of grade 4 neutropenia in cycle 1	Grade 4 neutropenia means the ANC count is less than 500/mm3.	21 day	No
Secondary	ANC nadir in cycle 1	ANC nadir means the lowest point of ANC count.	21 day	No
Secondary	Time to ANC recovery in cycle 1	ANC recovery means the ANC count is more than 2,000/mm3.	21 day	No
Secondary	Incidence of febrile neutropenia	Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.	126 day	Yes
Secondary	Incidence of IV antibiotics administration	IV antibiotics administration means that antibiotics are administered through intravenous route.	126 day	No