NCT00678626撤回2 期
A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.
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
- •histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
- •Her-2negative breast cancer or unknown Her-2 status.
- •at least 1 measurable lesion as defined by RECIST.
- •ECOG status 0-1
- •adequate bone marrow, hepatic and renal function.
- •left ventricular ejection fraction of greater than or equal to 50%.
- •willingness to discontinue hormonal therapy.
排除标准
- •any previous chemotherapy for advanced disease.
- •prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
- •symptomatic brain metastases.
- •prior anti-IGF-1R based investigational therapy.
- •peripheral neuropathy greater than grade 2.
研究组 & 干预措施
Arm A
Experimental
combination of CP-751,871 + docetaxel administered
干预措施: CP-751,871 (Drug)
Arm B
Active Comparator
chemotherapy
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 3 years
次要结局
- Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire(3 years)
- Overall Response(3 years)
- Optional tissue markers of the IGF-1R pathway from tumor tissue obtained(3 years)
- Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)(3 years)
- Overall Survival(3 years)
- Safety and tolerability(3 years)
- Pharmacokinetics of CP-751,871(3 years)
研究者
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