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

Chemotherapy Induced Neutropenia Clinical Trial

— PEG-G-CSF  

Official title:

Multi-Center, Randomized, Open, Phase II 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: NCT01923545
• Other study ID #: DA3031_NP_II
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2013
• Last updated: September 29, 2014
• Start date: July 2010
• Est. completion date: May 2011

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 examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared 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 1 cycles of chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of stage II or III breast cancer

2. Age : =18, =70

3. TAC regimen as adjuvant therapy

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

5. Creatinine < 1.5 x ULN

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

7. Have given a written, informed consent

Exclusion Criteria:

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

2. Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date

3. Infective symptom before chemotherapy into this study

4. Pregnant or lactating women

5. Prior bone marrow or stem cell transplantation

6. Other malignancy history within 5 years

7. HIV positive

8. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date

9. Prior chemotherapy

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
Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle
• G-CSF
Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 1 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 in cycle 1	Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius.	21 day	Yes
Secondary	Incidence of IV antibiotics administration in cycle 1	IV antibiotics administration means that antibiotics are administered through intravenous route.	21 day	No