NCT03559387终止2 期
A Randomized and Open-label Dose-finding, Ph. 2, Efficacy, Safety, and Pharmacokinetic Study of Once-per-cycle Prophylactic Injections of ANF-RHO™ Versus Pegfilgrastim (Neulasta®) in Non-metastatic Breast Cancer Patients at High-risk of Chemotherapy-induced Neutropenia
Prolong Pharmaceuticals8 个研究点 分布在 2 个国家目标入组 9 人开始时间: 2017年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C).
研究概览
简要总结
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia
详细描述
Forty Eight (48) adult female, chemotherapy treatment-naïve, stage I to III, breast cancer patients scheduled to receive FEC100 (3 cycles)/docetaxel (3 cycles) myelosuppressive chemotherapy will be enrolled into the study after they meet all the inclusion/exclusion criteria. Four (4) Cohorts of 12 patients each will be studied; they will be randomized either in the ANF-RHO™ treatment arm at different doses (10 μg/kg, 20 μg/kg, or 30 μg/kg, for the cohorts 1-3, respectively) or Neulasta® (6 mg / 0.6 ml SC injection, for cohort 4). For the cohorts 1-3, 12 patients from each of the respective ANF-RHO™ cohorts will be randomized with four patients from cohort 4 (Neulasta®). Patients in the ANF-RHO™ cohorts will receive study drug on Day 1 of each Chemotherapy cycle. Patients in the Neulasta® cohort will receive study drug on Day 2 of each Chemotherapy cycle. Doses of ANF-RHO™/Neulasta® will be provided for a total of 6 cycles (21 days each). The total duration of the study 129 ± 2 days (126 Days of treatment period followed by end of study visit)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients, 18 years of age or older
- •Signed and dated written consent/assent by the patient or legally authorized representative
- •Histologically confirmed non-metastatic breast cancer
- •ECOG performance status ≤ 2
- •Myelosuppressive chemotherapy naive
- •Scheduled to receive and anticipated to complete the following chemotherapy regimen
- •FEC (fluorouracil/epirubicin (100) / cyclophosphamide) (3 cycles);
- •Docetaxel (3 cycles) chemotherapy
- •White blood cells (WBC) ≥ 3 × 10^9/L; Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L; platelet count ≥ 100 × 10^9/L; and hemoglobin ≥ 10 g/dL (6.2 mmol/L)
- •Adequate cardiac function (e.g. LVEF > 50% as determined by standard care) and adequate hepatic function (e.g. liver transaminases < 2.5 x ULN)
- •Women of childbearing potential with a negative serum pregnancy test and using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives and intrauterine devices (IUDs)). Periodic abstinence is not an acceptable contraceptive method during the study period.
排除标准
- •A subject will not be enrolled if any they meet any of the following criteria:
- •Known hypersensitivity to E.coli derived products or polyethylene glycol
- •No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥ 5 years ago with curative intent
- •Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease
- •Clinical diagnosis or history of chronic infection such as hepatitis B virus (HBV), hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or history of tuberculosis
- •Previous exposure to filgrastim, perfilgrastim or lipegfilgrastim within 30 days before randomization
- •Treatment with systemically active antibiotics within 72 hours before chemotherapy
- •Chronic use of oral corticosteroids
- •Participation in a pharmacological clinical trial within 30 days before randomization
- •Clinical diagnosis of drug abuse or substance abuse within 30 days prior to screening
- •Documented alcohol abuse within 30 days prior to screening
- •Unwilling and/or not capable of ensuring compliance with the provisions of the study protocol
- •Pregnant or breastfeeding women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum HCG laboratory test
- •Other serious medical condition that would prevent individual from receiving protocol treatment
研究组 & 干预措施
ANF-RHO™
Experimental
Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg as a subcutaneous injection.
干预措施: ANF-RHO™ (Drug)
Neulasta®
Active Comparator
Neulasta® will be administered to the subjects at a dose of 6.0 mg in 0.6 ml as a subcutaneous injection.
干预措施: Neulasta® (Drug)
结局指标
主要结局
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C).
时间窗: 21 days
次要结局
- Incidence of anti-drug antibodies to ANF-RHO and Neulasta(~ 128 ± 2 days)
- Incidence and duration of infection and infection-related events based on use of antibiotics during all chemotherapy cycles(~ 128 ± 2 days)
- Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Blood pressure(~ 128 ± 2 days)
- Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Heart rate(~ 128 ± 2 days)
- Incidence of bone pain, determined by a numerical rating scale, as well as other reported adverse events(~ 128 ± 2 days)
- Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Time taken to reach the maximum concentration (Tmax)(~ 128 ± 2 days)
- Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the first chemotherapy cycle (21-day cycle FE100C)(21 days)
- Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the fourth chemotherapy cycle (21-day cycle docetaxel)(21 days)
- Incidence of severe neutropenia (ANC < 0.5 x 10^9/L) during all chemotherapy cycles(~ 128 ± 2 days)
- Incidence and duration of moderate (ANC ≥ 50 x 10^9/L) leukocytosis during all chemotherapy cycles(~ 128 ± 2 days)
- Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Respiratory rate(~ 128 ± 2 days)
- Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Maximum Plasma Concentration (Cmax)(~ 128 ± 2 days)
- Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the fourth cycle of chemotherapy (docetaxel).(21 days)
- Incidence and duration of febrile neutropenia defined as peak temperature ≥38.0°C for two readings over two hours and ANC < 0.5 x 10^9/L, during all chemotherapy cycles(~ 128 ± 2 days)
- Incidence and duration of infection and infection-related events based on the need for hospitalization during all chemotherapy cycles(~ 128 ± 2 days)
- Incidence and duration of severe (ANC ≥ 100 x 10^9/L) leukocytosis during all chemotherapy cycles(~ 128 ± 2 days)
- Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Body Temperature(~ 128 ± 2 days)
- Duration of bone pain, determined by a numerical rating scale, as well as other reported adverse events(~ 128 ± 2 days)
- Incidence and duration of febrile neutropenia defined as peak temperature ≥38.5°C and ANC < 0.5 x 10^9/L, during all chemotherapy cycles(~ 128 ± 2 days)
- Severity of bone pain, determined by a numerical rating scale, as well as other reported adverse events(~ 128 ± 2 days)
- Site of bone pain, determined by a numerical rating scale, as well as other reported adverse events(~ 128 ± 2 days)
- Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of half-life (T1/2)(~ 128 ± 2 days)
- Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-∞])(~ 128 ± 2 days)
- Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t])(~ 128 ± 2 days)
- Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t]/AUC[0-∞])(~ 128 ± 2 days)
研究者
研究点 (8)
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