A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer
2012年12月10日 更新者:Astellas Pharma Inc
A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma
The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.
研究概览
研究类型
介入性
注册 (实际的)
26
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
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New York
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New York、New York、美国、10021
- Memorial Sloan Kettering Cancer Center
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Washington
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Seattle、Washington、美国、98109
- Seattle Cancer Care Alliance
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amenable to cure by surgery or other means.
- Non-measurable or measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
- Eastern Cooperative Group (ECOG) performance status of 0-1
- Negative pregnancy test (women of childbearing potential)
Hematologic function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL (transfusions are allowed)
Renal function, as follows:
- creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN
Hepatic function, as follows:
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases
- Total bilirubin ≤ 1.5 x ULN
- International Normalized Ratio (INR) < 1.3 (or ≤ 3.0 if on therapeutic anticoagulation)
- Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for four weeks after the last AGS-16M8F infusion administration
Exclusion Criteria:
- Past or present documented central nervous system (CNS) tumor or CNS metastasis
- Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening
- History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., DVT or PE)
- Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication
- Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
- Women who are pregnant (confirmed by positive pregnancy test) or lactating
- Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
- Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:剂量水平 1
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IV
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实验性的:剂量水平 2
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IV
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实验性的:剂量等级 3
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IV
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实验性的:剂量等级 4
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IV
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实验性的:Dose Level 5
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IV
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实验性的:Dose Level 6
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IV
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实验性的:Dose Level 7
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IV
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实验性的:Dose Level 8
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IV
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实验性的:Dose Level 9
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IV
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Safety assessed by recording adverse events, vital signs and laboratory assessments
大体时间:For 12 weeks during treatment period and up to 4 weeks follow up
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For 12 weeks during treatment period and up to 4 weeks follow up
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Pharmacokinetic variables assessment through analysis of blood samples
大体时间:Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter
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Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter
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次要结果测量
结果测量 |
大体时间 |
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Incidence of anti-AGS-16M8F antibody formation
大体时间:Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter
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Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter
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Incidence of Tumor Response (complete or partial response)
大体时间:Baseline and every 12 weeks while on study drug
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Baseline and every 12 weeks while on study drug
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年8月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2010年4月29日
首先提交符合 QC 标准的
2010年4月30日
首次发布 (估计)
2010年5月3日
研究记录更新
最后更新发布 (估计)
2012年12月12日
上次提交的符合 QC 标准的更新
2012年12月10日
最后验证
2012年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
AGS-16M8F的临床试验
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McGill University Health Centre/Research Institute...Université de Montréal; Argos Therapeutics完全的
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Agensys, Inc.完全的癌,肾细胞 | 乳头状组织学肾细胞癌 | 具有透明细胞组织学的肾细胞癌 | 具有非透明细胞组织学的肾细胞癌美国, 加拿大
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Astellas Pharma IncSeagen Inc.; Agensys, Inc.完全的