Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.
详细描述
This is a Phase 1, single-arm multicenter study to evaluate the PK and safety of SPI-2012 (a long acting myeloid growth factor) in breast cancer patients treated with TC chemotherapy.
Approximately 25 patients will be enrolled.
Each cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. On Day 1 of each cycle, patients will receive TC chemotherapy and on Day 2 of each cycle, patients will receive SPI-2012.
Pharmacokinetics will be evaluated only in Cycles 1 and 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
- •Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
- •ANC ≥1.5x10^9/L
- •Platelet count ≥100x10^9/L
- •Hemoglobin >9 g/dL
- •Calculated creatinine clearance >50 mL/min
- •Total bilirubin ≤1.5 mg/dL
- •AST and ALT ≤2.5xULN
- •Alkaline phosphatase ≤2.0xULN
排除标准
- •Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
- •Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.
- •Concurrent adjuvant cancer therapy.
- •Locally recurrent/metastatic breast cancer.
- •Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
- •Active infection, receiving antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.
- •Prior bone marrow or hematopoietic stem cell transplant
- •Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
- •Prior radiation therapy within 30 days prior to enrollment.
- •Major surgery within 30 days prior to enrollment.
研究组 & 干预措施
SPI-2012
- SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF per cycle)
- Supplied in 1 mL prefilled, single-use syringes for subcutaneous injection
- Administered on Day 2 of each cycle after TC administration
干预措施: SPI-2012 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: Up to 42 days
PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.
Area under the plasma concentration versus time curve (AUC)
时间窗: Up to 42 days
PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03(6 months)
- Population slope of the relationship between the change from baseline in QTc intervals and plasma concentrations of SPI-2012(Up to 42 days)