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Study of PM060184 in Patients With Advanced Solid Tumors

2015年10月30日 更新者:PharmaMar

Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors

The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.

研究类型

介入性

注册 (实际的)

60

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

    • Texas
      • San Antonio、Texas、美国、78229
        • START- South Texas Accelerated Research Therapeutics, LLC

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

  1. Voluntary signed and dated written informed consent.
  2. Patients with advanced solid tumors refractory to Standard therapy.
  3. Age >/= 18 years.
  4. Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia.
  5. Normal laboratory values within seven days prior to treatment administration.
  6. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.

Exclusion criteria

  1. Pregnant or lactating women.
  2. Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy
  3. Prior treatment with any investigational product less than 30 days prior to the first.
  4. Central Nervous System metastases
  5. Other relevant diseases or adverse clinical conditions:

    • Increased cardiac risk:
    • Presence of significant neurological or psychiatric disorders
    • Neuropathy
    • Active infection requiring treatment.
    • Liver disease (e.g., cirrhosis, hepatitis).
    • Immunocompromised patients.
    • Any other major illness.
  6. Limitation of the patient's ability to comply with the treatment.
  7. Known hypersensitivity to any of the components of the drug product.

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

  • 分配:不适用
  • 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:PM060184
PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days.

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
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
大体时间:From treatment onset to end of treatment
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.
From treatment onset to end of treatment

次要结果测量

结果测量
措施说明
大体时间
To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.
大体时间:Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle.
The complete plasma concentration-time profiles of PM06184 will be analyzed by standard non-compartmental methods.The percent of PM060184 total dose excreted unchanged into the urine over the collection interval will be calculated from the urine samples.
Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle.
Antitumor activity
大体时间:Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first.
Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers
Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first.

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

调查人员

  • 首席研究员:Kyriakos Papadopoulos, MD、START- South Texas Accelerated Research Therapeutics, LLC

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

2011年1月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2011年2月9日

首先提交符合 QC 标准的

2011年2月17日

首次发布 (估计)

2011年2月18日

研究记录更新

最后更新发布 (估计)

2015年11月1日

上次提交的符合 QC 标准的更新

2015年10月30日

最后验证

2015年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PM60184-A-002-10

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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