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Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors

2015年1月15日 更新者：Pfizer

A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

34

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

  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85258
        • Premiere Oncology of Arizona
      • Scottsdale、Arizona、美国、85255
        • Scottsdale Medical Imaging, Ltd.
    • California
      • Santa Monica,、California、美国、90404
        • Premiere Oncology, A Medical Corporation
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center

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:

  • Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
  • Adequate coagulation, liver, and renal function.
  • Candidate for DCE-MRI evaluations.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Exclusion Criteria:

  • Evidence of significant bleeding problems.
  • History of certain gastrointestinal problems including fistula and abscess.
  • Chronic, uncontrolled hypertension.
  • Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.

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
实验性的：1个
生物：CVX-060
Weekly, intravenous dose

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
大体时间：Baseline (Day 0) up to 30 days after last dose of study medication
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Baseline (Day 0) up to 30 days after last dose of study medication

次要结果测量

结果测量
措施说明
大体时间
Maximum Observed Serum Concentration (Cmax)
大体时间：0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Serum Decay Half-Life (t1/2)
大体时间：0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
大体时间：0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Volume of Distribution (Vss)
大体时间：0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Apparent Clearance (CL)
大体时间：0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Time to Reach Maximum Observed Serum Concentration (Tmax)
大体时间：0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Recommended Phase 2 Dose (RP2D): Stage 1
大体时间：Baseline (Day 0) up to 42 days after the last dose of study medication
RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.
Baseline (Day 0) up to 42 days after the last dose of study medication
Number of Participants With Anti-CVX-060 Antibodies
大体时间：Baseline (Day 0) up to 42 days after last dose
Baseline (Day 0) up to 42 days after last dose
Number of Samples From Participants With Anti-CVX-060 Antibodies
大体时间：Baseline (Day 0) up to 42 days after last dose
Baseline (Day 0) up to 42 days after last dose
Number of Participants With Best Overall Response (BOR)
大体时间：Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.
Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)

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。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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

2008年1月1日

初级完成 (实际的)

2011年4月1日

研究完成 (实际的)

2011年4月1日

研究注册日期

首次提交

2009年4月9日

首先提交符合 QC 标准的

2009年4月9日

首次发布 (估计)

2009年4月10日

研究记录更新

最后更新发布 (估计)

2015年1月26日

上次提交的符合 QC 标准的更新

2015年1月15日

最后验证

2015年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • B1131002
  • CVX-060-101 (其他标识符：Alias Study Number)

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.

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