Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
- Registration Number
- NCT03376503
- 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 after administration of chemotherapy (Doxorubicin and Cyclophosphamide) in the first cycle (14 days each cycle). Blood samples are collected to determine the serum concentration of investigational drugs at specific time points in the first cycle. Absolute neutrophil count, CD34+ count, Cmax (maximum serum concentration), AUC0-t (area under the curve of the plasma concentration time) and Tmax (time required to reach Cmax) will be calculated from the serum concentration profile
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pegcyte (Nanogen pegfilgrastim) Pegfilgrastim pegcyte 6 mg in the first cycle Neulastim (Roche pegfilgrastim) Pegfilgrastim Neulastim 6 mg in the first cycle
- Primary Outcome Measures
Name Time Method Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF) day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle (AUC0-t)
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax) for serum Pegfilgrastim day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Time to maximum concentration (Tmax) for serum Pegfilgrastim day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Apparent clearance (CL) for serum Pegfilgrastim day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Time of maximum change from baseline for ANC in days (ANC_Tmax) day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Area under the serum concentration-time curve (AUC0-inf) of Pegfilgrastim day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Terminal elimination rate constant (λz) for serum Pegfilgrastim day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Maximum change in CD34+ count day 2 (0h), day 5 (72h), day 7 (120h), and day 8 (144h) of the first cycle. Maximum change from baseline in absolute neutrophil count from time 0 to the last time point ANC AUC0-t day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Incidence of adverse events cycle 1 from day 2 to day 14 Including changes in vitals and laboratory investigations
Half-life (T½) for serum Pegfilgrastim (PEG-GCSF) day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle Area under the curve above baseline of ANC [ANC_AUC(0-tlast)] day 2 (0h, 3h, 6h, 12±4h), day 3 (24h), day 4 (48h), day 5 (72h), day 7 (120h), day 8 (144h), day 9 (168h), day 11 (216h), and day 14 (288h) of the first cycle
Trial Locations
- Locations (1)
Vietnam National Cancer Institute (Hospital K)
🇻🇳Hanoi, Vietnam