Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
2018年8月1日 更新者:Plexxikon
A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX7486 as a Single Agent in Patients With Advanced Solid Tumors
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
研究概览
地位
终止
干预/治疗
详细说明
Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
研究类型
介入性
注册 (实际的)
59
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
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California
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Los Angeles、California、美国、90095
- Ronald Reagan UCLA Medical Center
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Maryland
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Baltimore、Maryland、美国、21231
- John Hopkins Sidney Kimmel Comprehensive Cancer Center
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital Cancer Center
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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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
- Male or female ≥18 years old
Patients with histologically confirmed solid tumors who:
o Part 1: have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapy
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug.
- All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤Grade 1 or Baseline) prior to study treatment administration
- Patients with stable, treated brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening.
- Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
- Karnofsky performance status ≥70%
- Life expectancy ≥3 months
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria
- Other than the primary malignancy, active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g., chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in-situ of the cervix
- Chemotherapy within 28 days prior to C1D1
- Biological therapy within 5 half-lives prior to C1D1
- Radiation therapy within 28 days or 5 half-lives prior to C1D1, whichever is longer
- Investigational drug use within 28 days or 5 half-lives, whichever is longer, prior to C1D1
- Part 1 only: (a) Patients with active or a history of glucose intolerance or diabetes mellitus and (b) Hemoglobin A1c ≥7%
- ≥Grade 2 sensory neuropathy at baseline
- Uncontrolled intercurrent illness (i.e., active infection) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the patient's ability to participate
- Refractory nausea and vomiting, malabsorption, small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption
- Mean QTcF ≥450 msec (for males) or ≥470 msec (for females) at Screening
- The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study
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:PLX7486-TsOH, Dose escalation and RP2D
Part 1: Open-label, sequential PLX7486-TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
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PLX7486 TsOH capsules, 50mg
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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 |
---|---|---|
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
大体时间:1 year
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1 year
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Area under the plasma concentration-time curve [AUC0-t, AUC0-inf]
大体时间:1 year
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Area under the plasma concentration-time curve [AUC0-t, AUC0-inf] will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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Peak concentration (Cmax)
大体时间:1 year
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Peak concentration (Cmax) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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Time to peak concentration (Tmax)
大体时间:1 year
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Time to peak concentration (Tmax) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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Half life (t1/2)
大体时间:1 year
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Half life (t1/2) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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Terminal elimination rate constant (Kel)
大体时间:1 year
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Terminal elimination rate constant (Kel) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
总生存期(OS)
大体时间:1年
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1年
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Duration of response (DOR)
大体时间:1 year
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Duration of response is defined as the number of days from the date of initial response (PR or better) to the date of first documented disease progression/relapse or death, whichever occurs first.
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1 year
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Progression-Free Survival (PFS)
大体时间:6 month
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Progression-free survival (PFS) is defined as the number of days from start of therapy to the date of documented disease progression/relapse, whichever occurs first.
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6 month
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Overall Response Rate (ORR)
大体时间:1year
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1year
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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
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8月1日
初级完成 (实际的)
2018年1月24日
研究完成 (实际的)
2018年1月24日
研究注册日期
首次提交
2013年3月1日
首先提交符合 QC 标准的
2013年3月2日
首次发布 (估计)
2013年3月5日
研究记录更新
最后更新发布 (实际的)
2018年8月2日
上次提交的符合 QC 标准的更新
2018年8月1日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
其他研究编号
- PLX119-01
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.
实体瘤的临床试验
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AstraZeneca招聘中Adv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃癌、乳腺癌和卵巢癌西班牙, 美国, 比利时, 英国, 法国, 匈牙利, 加拿大, 大韩民国, 澳大利亚