NCT03376503已完成1 期
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
Nanogen Pharmaceutical Biotechnology Joint Stock Company1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年5月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Willing to give written and signed informed consent
排除标准
- •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.
研究组 & 干预措施
Pegcyte (Nanogen pegfilgrastim)
Experimental
pegcyte 6 mg in the first cycle
干预措施: Pegfilgrastim (Drug)
Neulastim (Roche pegfilgrastim)
Active Comparator
Neulastim 6 mg in the first cycle
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)
时间窗: 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)
次要结局
- 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)
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Docetaxel vs. Docetaxel-Gemcitabine in Breast CancerBreast CancerNCT00191243Eli Lilly and Company237
已完成
不适用
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast CancerBreast Cancer FemaleHER2-negative Breast CancerNCT06636591Fudan University14
已完成
2 期
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant MesotheliomaAdvanced Malignant MesotheliomaEpithelial MesotheliomaLocalized Malignant MesotheliomaRecurrent Malignant MesotheliomaSarcomatous MesotheliomaNCT00027703National Cancer Institute (NCI)106
Unknown
3 期
Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer PatientsBreast CancerPulmonary FibrosisNCT00896155Tata Memorial Hospital260
已完成
3 期
TBP Study With Capecitabine Plus Minus TrastuzumabBreast CancerNCT00148876German Breast Group482