Status:
COMPLETED
Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
Lead Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be enrolled in this study. Eligible patients receive single SC injection of pegcyte or neulastim 24 hours af...
Eligibility Criteria
Inclusion
- Female patients aged between 18 - 65 years.
- Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
- Patients had no prior chemotherapy treatments.
- Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
- Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
- Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2.
- Willing to give written and signed informed consent
Exclusion
- Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
- Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
- Received systemic antibiotic treatment within 72 hours of chemotherapy.
- Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
- Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
- Severe medical disease: cardiovascular, hepatic, renal, pulmonary…
- Known cases of hematological disease (sickle cell anemia, AML…)
- History of HIV positive, active hepatitis.
- Pregnant and lactating women or patients planning to become pregnant.
- Known allergic reactions to study medications.
- Positive to anti-pegfilgrastim antibody test.
Key Trial Info
Start Date :
May 25 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03376503
Start Date
May 25 2016
End Date
November 6 2017
Last Update
December 19 2017
Active Locations (1)
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1
Vietnam National Cancer Institute (Hospital K)
Hanoi, Vietnam