A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid Tumors
2019年6月11日 更新者:Celldex Therapeutics
A Phase 1, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CDX-0158 in Adult Patients With KIT Positive Advanced Solid Tumors.
This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists.
研究概览
研究类型
介入性
注册 (实际的)
28
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
-
-
Massachusetts
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Boston、Massachusetts、美国、02215
- Dana Farber Cancer Institute
-
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Oregon
-
Portland、Oregon、美国、97239
- Oregon Health & Sciences University
-
-
Tennessee
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Nashville、Tennessee、美国、37203
- Sarah Cannon Research Institute
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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
16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:
- Written informed consent and any locally required authorization (eg, HIPAA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Metastatic or unresectable cancer that expresses KIT as documented in the patient's pathology report.
- For patients with GIST, patients will have progressed on at least one prior tyrosine kinase inhibitor therapy or be intolerant. If documented to have SDH deficient or PDGFRA-D842V GIST, no prior therapy is required for study entry. Other patients with KIT positive cancers will have progressed on at least one prior therapy.
- Patients must have at least 1 lesion that is measurable using RECIST guidelines.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 60 days after the final dose of study medication. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- Nonsterilized males who are sexually active with a female partner of childbearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of study medication.
- ECOG status of 0 or 1.
Adequate organ function as defined below:
- Hemoglobin ≥ 9 g/dL. This criterion must be met without transfusion.
- Absolute neutrophil count ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN) for cases involving liver metastasis and ≤ 2.5 ×ULN for all other cases
- Bilirubin ≤ 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ≤ 5 × ULN
- Serum creatinine ≤ 1.5 g/dL
Exclusion Criteria:
Receipt of anticancer therapy:
- Within 3 weeks prior to the first dose of CDX-0158 of any biologic treatment or IV chemotherapy.
- Within 2 weeks prior to the first dose of CDX-0158 of any oral therapy or 5.5 half lives whichever is longer or following palliative radiation therapy.
Concurrent use of hormones for non-cancer related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
- Requirement for chronic immunosuppressive medication including systemic corticosteroids above the physiologic dose (30 mg/day hydrocortisone or the equivalent).
- Known allergy or past administration reaction including infusion related reaction (IRRs), anaphylactic, or anaphylactoid reactions to any component of the CDX-0158 formulation.
- History of clinically significant allergic reactions or atopic disease that may pose an increased risk of severe CDX-0158 IRRs.
- Symptomatic or untreated central nervous system metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids; if treated, patient must be asymptomatic for 3 months prior to study entry.
- Other invasive malignancy within 2 years prior to enrollment (localized prostate cancer, cervical carcinoma in situ, non-melanoma skin cancer, or ductal carcinoma in situ of the breast that has/have been surgically cured would not be exclusionary).
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v 4.03 < Grade 2 or normalized to baseline, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
- Major surgical procedure (as defined by the investigator) within 30 days prior to Study Day 1 or incomplete recovery from any prior surgery.
- Pregnancy or breast feeding
- Uncontrolled intercurrent illness that would limit compliance with study requirements or compromise the patient such as ongoing or active infection, symptomatic congestive heart failure, hypertension requiring adjustment of medication, idiopathic and symptomatic hypotension, unstable angina pectoris, clinically significant cardiac arrhythmia including uncontrolled atrial fibrillation, active peptic ulcer disease or gastritis with ongoing blood loss, or psychiatric illness/social situations that would limit compliance or compromise the ability of the patient to give written informed consent.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the study medication or interpretation of patient safety or study results.
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study.
- Patients with a left ventricular cardiac ejection fraction < 50% as assessed by an echocardiogram or MUGA scan or prolonged QTc interval of Grade 2 or higher or history of prolonged QTc interval from other drugs.
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:CDX-0158
|
Single agent CDX-0158 until unacceptable toxicity or progressive disease
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Dose limiting toxicities for CDX-0158
大体时间:Participants will be evaluated for DLTs from the first adminstration of CDX-0158 through 21 days following initial dosing.
|
Participants will be evaluated for DLTs from the first adminstration of CDX-0158 through 21 days following initial dosing.
|
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
2015年12月1日
初级完成 (实际的)
2018年1月30日
研究完成 (实际的)
2019年6月4日
研究注册日期
首次提交
2015年12月16日
首先提交符合 QC 标准的
2015年12月24日
首次发布 (估计)
2015年12月30日
研究记录更新
最后更新发布 (实际的)
2019年6月12日
上次提交的符合 QC 标准的更新
2019年6月11日
最后验证
2019年6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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