A Phase IIa, Open Label, Controlled, Dose Ranging Study of Maxy-G34 as an Adjunct to TAC Chemotherapy in High-Risk Patients With Stage I, II, or IIIa Breast Cancer.

Maxygen Holdings Ltd.15 个研究点分布在 4 个国家目标入组 30 人开始时间: 2007年7月最近更新: 2007年12月24日

适应症

试验速览

阶段: 2 期
发起方: Maxygen Holdings Ltd.
入组人数: 30
试验地点: 15
主要终点: To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six chemotherapy cycles.

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: All
接受健康志愿者: 否

入选标准

•Males and females at least 18 years of age
•Diagnosis of high-risk stage I, II or IIIa breast cancer suitable for adjuvant TAC chemotherapy as based on investigator judgment
•Candidates for TAC chemotherapy, and no prior treatment with anthracyclines

排除标准

•Received chemotherapy within last 3 month prior to screening, or expected to receive any chemotherapy other than TAC and / or immunotherapy between screening and 30 days after last planned study drug administration
•Any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of TAC chemotherapy in the full dose, including abnormal liver function, inadequate cardiac function or clinically significant cardiac disease, neuropathy or other disease
•Prior bone marrow or peripheral blood hematopoietic stem cell transplant
•Any active cancer or history of prior malignancy within the last 5 years except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancy diagnosed 5 years or more before diagnosis of breast cancer

结局指标

主要结局

To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.

时间窗: over 1 cycle of TAC chemotherapy (approximately 3 weeks)

次要结局

To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6.(over cycles 2-6 of TAC chemotherapy (approximately from weeks 4-18))
To determine the incidence of grade 4 neutropenia after administration of each of the 6 doses of Maxy-G34.(over all 6 cycles of TAC chemotherapy (approximately 18 weeks))

研究者

发起方

Maxygen Holdings Ltd.

申办方类型

Industry

研究点 (15)

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