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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Chemotherapy Induced Neutropenia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Duration of grade 4 neutropenia in cycle 1

Outcome Description:

Grade 4 neutropenia means the ANC count is less than 500/mm3.

Outcome Time Frame:

21 day

Safety Issue:

No

Principal Investigator

JaeHong Seo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea University Guro Hospital

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

DA3031_NP_III

NCT ID:

NCT01674855

Start Date:

February 2012

Completion Date:

June 2013

Related Keywords:

  • Chemotherapy Induced Neutropenia
  • PEG-G-CSF
  • Neutropenia

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