NCT00091806已完成1 期
An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 86
- 主要终点
- To evaluate the safety and PK of 2 dose schedules of panitumumab in subjects with advanced solid tumors, refractory to or with no available standard therapy.
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Pathologic diagnosis of advanced solid tumors that are refractory to at least 1 standard therapy or for which no standard therapy is available and have not received more than 3 prior treatment regimens (not inclusive of hormonal therapies for breast and prostate cancer subjects) for the advanced solid tumor (tumor must be diagnosed by standard criteria for the specific tumor type)
- •Measurable disease or evaluable (non-measurable) disease per RECIST guidelines (all sites of disease must be evaluated within 28 days before enrollment)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of > 3 months as documented by the investigator
- •If history of other primary cancer, subject will be eligible only if she or he has:
- •Non-melanomatous skin cancer, not requiring treatment
- •Curatively treated cervical carcinoma in situ
- •Other primary solid tumor curatively treated with no known active disease present for the last 5 years and no treatment administered for the last 3 years
- •Man or woman 18 years of age or older
- •Paraffin-embedded tumor tissue (from primary or metastatic tumor tissue) available for immunohistochemistry studies of EGFr expression (biopsy or archived tissue are acceptable). The immunohistochemical EGFr staining and evaluation must be conducted at the designated central laboratory using the DakoCytomation EGFR pharmDXTM kit. Local laboratory EGFr expression is not permitted for the purpose of eligibility in this study
- •Hematologic function, as follows:
- •Absolute neutrophil count (ANC) > 1.5 x 109/L
- •Platelet count > 100 x 109/L
- •Hemoglobin > 8 g/dL
- •Renal function, as follows:
- •o Creatinine < 2.0 mg/dL
- •Hepatic function, as follows:
- •Aspartate aminotransferase (AST) < 3 x ULN (if liver metastases ≤ 5 x ULN)
- •Alanine aminotransferase (ALT) < 3 x ULN (if liver metastases ≤ 5 x ULN)
- •Bilirubin < 2 x ULN
- •Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Experimental
6mg/kg of panitumumab administered once every 2 weeks until subjects develop disease progression or are unable to tolerate the study drug
干预措施: panitumumab (ABX-EGF) (Drug)
Cohort 2
Experimental
Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug.
干预措施: Panitumumab (Drug)
结局指标
主要结局
To evaluate the safety and PK of 2 dose schedules of panitumumab in subjects with advanced solid tumors, refractory to or with no available standard therapy.
时间窗: 2 years
次要结局
- To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors.(2 years)
研究者
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