To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors
2021年11月5日 更新者:Teva Branded Pharmaceutical Products R&D, Inc.
An Open-Label Study to Determine the Maximum Tolerated Dose of Oral CEP-37440 Administered as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.
研究概览
研究类型
介入性
注册 (实际的)
32
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
-
-
Illinois
-
Chicago、Illinois、美国
- Teva Investigational Site 10689
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国
- Teva Investigational Site 10687
-
-
Texas
-
San Antonio、Texas、美国
- Teva Investigational Site 10686
-
-
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:
- Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.
- Patients must have evidence of recurrent, locally advanced, or metastatic disease.
- Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.
- Patients must have a predicted life expectancy of more than 3 months.
- Patients must have presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1.
- Patients must have an ECOG performance score of 0, 1, or 2.
- Patients with central nervous system (CNS) metastases will be allowed on this study. Patients may have received surgical and/or radiation treatment. The metastases must be neurologically stable, on or off corticosteroids. Patients can have low level, asymptomatic brain lesions that do not require surgical/radiation intervention acutely. Patients with symptomatic lesions with impending neurologic compromise should be appropriately treated with high dose steroids/radiation and may be re-evaluated for this study when neurologically stable.
- Patients must have completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy and at least 2 to 3 weeks for all other modalities of therapy including chemotherapy, monoclonal antibody therapy, immunotherapy, other investigational drugs, or other kinase inhibitors.
- Other criteria apply.
Exclusion Criteria:
- The patient has ongoing or active infection requiring parenteral antibiotics.
- The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
- The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
- The patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.
- The patient has a primary brain tumor. Patients may have brain metastases from another primary site.
- The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes.
- The patient has a prior ALK-inhibitor-related toxicity or any other prior therapy-related acute toxicity that has not resolved prior to the first dose of study drug.
- Other criteria apply.
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: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:CEP-37440
|
CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily. Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
大体时间:8 months
|
8 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Time to Response (TTR)
大体时间:8 months
|
The time interval from the date of first dose to the first documented response (complete or partial response)
|
8 months
|
Number of participants with adverse events
大体时间:From signing of the informed consent to the end of the follow-up visit (approximately Month 10)
|
From signing of the informed consent to the end of the follow-up visit (approximately Month 10)
|
|
Time to Progression (TTP)
大体时间:8 months
|
The time interval from date of first dose to first documented disease progression
|
8 months
|
Progression-free Survival (PFS)
大体时间:10 months
|
Time interval from date of first does to first documented disease progression or death from any cause (whichever occurs first)
|
10 months
|
Time to New Metastases (TTNM)
大体时间:8 months
|
Time interval from date of first dose to first documented new metastatic lesion not reported at baseline
|
8 months
|
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
2013年7月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2013年8月12日
首先提交符合 QC 标准的
2013年8月12日
首次发布 (估计)
2013年8月14日
研究记录更新
最后更新发布 (实际的)
2021年11月12日
上次提交的符合 QC 标准的更新
2021年11月5日
最后验证
2021年11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.
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