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BCX-1777 in Treating Patients With Refractory Cancer

2013年5月29日 更新者:BioCryst Pharmaceuticals

Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.

研究概览

地位

完全的

条件

详细说明

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies.
  • Determine the safety and dose-limiting toxicity of this drug in these patients.

Secondary

  • Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients.
  • Determine the oral bioavailability of this drug in these patients.
  • Determine, preliminarily, the antitumor activity of this drug in these patients.

OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.

  • Courses 1 and 2: Patients receive oral BCX-1777 on days 1 and 15* and BCX-1777 IV over 30 minutes on days 8* and 22*.
  • Course 3: Beginning approximately 6 days* after the completion of courses 1 and 2, patients receive BCX-1777 IV over 30 minutes once daily on days 1-5 and 8-12 (total of 10 doses).

NOTE: *+/- 1 day

Patients with stable disease or better and no dose-limiting toxicity (DLT) may receive an additional 10-dose treatment course (as in course 3) after a 10- to 16-day drug-free interval.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.

Patients are followed at 14 and 30 days.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

研究类型

介入性

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

    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Taussig 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

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Hematologic malignancy that is refractory to at least 1 prior curative treatment
    • Non-hematologic tumor that is refractory to at least 2 prior therapies, with or without measurable disease, including the following:

      • Gastrointestinal adenocarcinoma of 1 of the following sites:

        • Pancreatic
        • Biliary
        • Gastric
        • Colorectal
        • Esophageal
      • Melanoma
      • Ovarian cancer
      • Astrocytoma brain tumor
  • Not immediately eligible for any other treatment that would be potentially curative or life-prolonging, in the opinion of the investigator

    • Patients who may be candidates for future bone marrow transplantation are eligible
  • No brain metastases (other than astrocytomas)
  • No clinically significant pleural effusion
  • No complete tumor obstruction (e.g., bronchus, ureter, or bowel)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,500/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 50,000/mm^3
  • Hematocrit stable without the need for transfusion (epoetin alfa support allowed)

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
  • SGOT and SGPT less than 2 times ULN
  • No active hepatitis B or C

Renal

  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • No American Heart Association class III or IV cardiac disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active systemic infection requiring IV antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Concurrent corticosteroids allowed provided the patient is on a stable regimen

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Recovered from prior therapy

    • No grade 2-4 toxicity
  • More than 3 weeks since prior antineoplastic and/or investigational therapy
  • No other concurrent systemic antineoplastic or investigational therapy

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
  • 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。

调查人员

  • 学习椅:Alex Shalaurov, MD, PhD、Inveresk Research Group, Incorporated

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

2003年4月1日

初级完成 (实际的)

2005年1月1日

研究注册日期

首次提交

2003年12月10日

首先提交符合 QC 标准的

2003年12月10日

首次发布 (估计)

2003年12月11日

研究记录更新

最后更新发布 (估计)

2013年5月30日

上次提交的符合 QC 标准的更新

2013年5月29日

最后验证

2004年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • BIOCRYST-1777BC-101
  • CDR0000341332 (注册表标识符:PDQ (Physician Data Query))
  • CCF-5909

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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