Clinical trial · Interventional
Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
A Randomized, Double-blind, Parallel Study Comparing Pharmacokinetic (PK) and Pharmacodynamic (PD) Parameters of Pegcyte (Nanogen) and Reference Product Neulastim (Roche) for Chemotherapy-induced Neutropenia in Breast-cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pegcyte (Nanogen pegfilgrastim)
- description
- pegcyte 6 mg in the first cycle
- interventionNames
- Drug: Pegfilgrastim
- type
- ACTIVE_COMPARATOR
- label
- Neulastim (Roche pegfilgrastim)
- description
- Neulastim 6 mg in the first cycle
- interventionNames
- Drug: Pegfilgrastim
Primary outcomes (1)
- measure
- Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available