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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01923545
• Date of registration: 13/08/2013
• Prospective Registration: No
• Primary sponsor: Dong-A ST Co., Ltd.
• Public title: Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia PEG-G-CSF
• Scientific 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
• Date of first enrolment: July 2010
• Target sample size: 61
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01923545
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: JaeHong Seo, M.D.
• Affiliation: Korea University Guro Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chemotherapy Induced Neutropenia

Intervention(s)

Drug: PEG-G-CSF

Drug: G-CSF

Primary Outcome(s)

Duration of grade 4 neutropenia in cycle 1 [Time Frame: 21 day]

Secondary Outcome(s)

ANC nadir in cycle 1 [Time Frame: 21 day]

Time to ANC recovery in cycle 1 [Time Frame: 21 day]

Incidence of febrile neutropenia in cycle 1 [Time Frame: 21 day]

Incidence of IV antibiotics administration in cycle 1 [Time Frame: 21 day]

Secondary ID(s)

DA3031_NP_II

Source(s) of Monetary Support

Please refer to primary and secondary sponsors