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A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas

2006年6月19日更新者：Synta Pharmaceuticals Corp.

The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992.

研究概览

地位

完全的

条件

软组织肉瘤

干预/治疗

药品：STA-4783

详细说明

STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

研究类型

介入性

注册

阶段

阶段2

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

加拿大
- Ontario
  - Toronto、Ontario、加拿大、M5G 1X5
    - Mount Sinai Hospital
美国
- Arizona
  - Scottsdale、Arizona、美国、85258
    - Arizona Cancer Center
  - Tucson、Arizona、美国、85724
    - Arizona Cancer Center
- California
  - Los Angeles、California、美国、90095
    - UCLA
- Connecticut
  - New Haven、Connecticut、美国、06520
    - Yale University School Of Medicine
- Florida
  - Gainesville、Florida、美国、32610
    - University of Florida
  - Tampa、Florida、美国、33612
    - H. Lee Moffitt Cancer Center
  - West Palm Beach、Florida、美国、33401
    - Palm Beach Cancer Institute
- Georgia
  - Atlanta、Georgia、美国、30322
    - Winship Cancer Institute
- Illinois
  - Chicago、Illinois、美国、60637
    - University of Chicago Department of Medicine
- Kansas
  - Wichita、Kansas、美国、67214
    - Via Christi Regional Med. Center (Wichita CCOP)
- Kentucky
  - Louisville、Kentucky、美国、40202
    - University of Louisville Hospital
- Louisiana
  - Shreveport、Louisiana、美国、71103
    - Feist-Weiller Cancer Center
- Massachusetts
  - Boston、Massachusetts、美国、02115
    - Dana-Farber Cancer Institute
- Michigan
  - Ann Arbor、Michigan、美国、48109
    - University of Michigan
  - Detroit、Michigan、美国、48201
    - Wayne State University
  - Flint、Michigan、美国、48503
    - Genesys Hurley Cancer Institute
- Missouri
  - St. Louis、Missouri、美国、63110
    - Washington University School of Medicine
- Nebraska
  - Omaha、Nebraska、美国、68198
    - University of Nebraska Medical Center
- New York
  - New York、New York、美国、10016
    - NYU Cancer Institute Clinical Center
  - New York、New York、美国、10032
    - Herbert Irving Cancer Center
- North Carolina
  - Charlotte、North Carolina、美国、28203
    - Carolinas Medical Center/Blumenthal Cancer Center
- Oregon
  - Portland、Oregon、美国、97239
    - Oregon Health and Science University
- Pennsylvania
  - Pittsburg、Pennsylvania、美国、15232
    - Hillman Cancer Center
- Tennessee
  - Memphis、Tennessee、美国、38120
    - The West Clinic
  - Nashville、Tennessee、美国、37203
    - The Sarah Cannon Cancer Center
- Texas
  - Houston、Texas、美国、77030
    - MD Anderson 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:

Must be 18 years of age or older with histologic diagnosis of soft tissue sarcoma
Must have disease not suitable for curative resection
Must have failed >1 first line treatment with evidence of progression. Adjuvant therapy does not count as 1st line therapy unless recurrence occurs within 6 months of administration
Must have ability to understand and the willingness to sign a written informed consent document
Must have Eastern Cooperative Oncology Group (ECOG) performance status of < 2
Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
At least 4 weeks have passed since the last chemotherapy, immunotherapy, or radiation therapy
There must be measurable disease outside the radiotherapy fields or progression of the indicator lesions within the field since the completion of the radiotherapy
Must have a life expectancy of greater than 12 weeks
Must have clinical laboratory values at screening as defined below:
Hemoglobin >9 g/dL,
Absolute neutrophil count >1500/mm3,
Platelet count >100,000/mm3,
Creatinine <1.5 X ULN,
Bilirubin <1.5 X ULN,
Asparate aminotransferase and alanine aminotransferase <2.5 X ULN (<5 X ULN in presence of liver metastases)

Exclusion Criteria:

Female patients who are pregnant or breast feeding
Patients of childbearing potential not using or not willing to use a barrier method of contraception
Prior malignancy other than soft tissue sarcoma (STS) within the last 5 yrs with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri;
- Basal or squamous cell carcinoma of the skin
Presence of a clinically significant and uncontrolled infection
Presence of >Grade 2 neuropathy
Symptomatic central nervous system metastases within last 8 weeks or on corticosteroids for CNS symptom management
Presence of clinically significant arrythmias
Presence of a serious concurrent illness or other conditions (e.g., psychological, family, sociological, or geographical circumstances) that do not permit adequate follow-up and compliance with the protocol
History of severe hypersensitivity reactions to taxanes or cremaphore in spite of premedication
Use of any investigational agents within 4 weeks prior to the first dose of study drug(s)
Major surgery within 2 weeks of screening
Radiation treatment in past >25% of bone marrow

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）

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

Synta Pharmaceuticals Corp.

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

2004年7月1日

研究完成

2005年10月1日

研究注册日期

首次提交

2004年7月19日

首先提交符合 QC 标准的

2004年7月22日

首次发布 (估计)

2004年7月23日

研究记录更新

最后更新发布 (估计)

2006年6月20日

上次提交的符合 QC 标准的更新

2006年6月19日

最后验证

2006年6月1日