NCT01384799已完成1 期
A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 With Concurrent Cisplatin and Radiation Therapy in Subjects With Locally Advanced Head and Neck Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Curis, Inc.
- 入组人数
- 12
- 试验地点
- 14
- 主要终点
- The number of participants with adverse events.
研究概览
简要总结
This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 when administered in combination with concurrent cisplatin and radiation over an 8-week treatment course, consisting of a one week run-in period of CUDC-101 administered alone, followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with locally advanced, pathologically confirmed diagnosis of squamous cell carcinoma of the head and neck at the following sites: oral cavity, oropharynx, hypopharynx and larynx with either:
- •Stage IV p16 positive tumors and >10 pack-years smoking history.
- •Stage III/IV p16 negative tumors, regardless of smoking history.
- •At least evaluable disease; one measurable site of disease according to RECIST (Version 1.1) criteria (at least 10 mm for conventional CT/MRI or spiral CT scan) is desirable.
- •Subjects enrolled in the MTD expansion cohort must have at least 1 tumor lesion that is suitable for repeat biopsy (pre- and post-CUDC-101 infusion).
- •Age ≥ 18 years
- •ECOG performance < 2
- •Life expectancy ≥ 3 months
- •If female, neither pregnant nor lactating
- •If of child bearing potential, must use adequate birth control throughout the participation in the treatment phase and for 60 days following the last study treatment.
- •Absolute neutrophil count ≥ 1,800/µL; platelets ≥ 100,000/µL; hemoglobin ≥ 8.0 g/dL, creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2 x ULN.
- •Serum magnesium and potassium within normal limits (may be supplemented to achieve normal values)
- •Able to render informed consent and to follow protocol requirements.
排除标准
- •Prior radiotherapy to the region of the study cancer or adjacent anatomical sites, or > 25% of marrow-bearing area.
- •Prior chemotherapy for the current indication.
- •Prior therapy that specifically and directly targets EGFR, HER2 or HDAC.
- •Use of investigational agent(s) within 30 days prior to study treatment.
- •Primary tumor site of nasopharynx, sinuses, or salivary gland.
- •History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
- •Patients with prolonged QTc Interval >450 msec.
- •Acquired Immune Deficiency Syndrome (AIDS) or known infection with human immunodeficiency virus (HIV). Testing is not required.
- •Known history of gastrointestinal bleeding, ulceration, or perforation within 6 months prior to study treatment.
- •Known history of stroke or cerebrovascular accident within 6 months prior to study treatment.
- •Symptomatic cardiac conduction abnormality within 12 months prior to study treatment.
- •Prior history of hearing impairment.
- •Known history of renal disease or ongoing renal impairment.
- •Any uncontrolled condition (such as active systemic infection, diabetes, hypertension), which in the opinion of the investigator, could affect the subjects participation in the study.
- •Prior allergic reaction to cisplatin, carboplatin or other platinum-containing compounds.
- •Central nervous system metastases.
结局指标
主要结局
The number of participants with adverse events.
时间窗: 18-24 months
Safety and tolerability will be assessed by evaluating the number of patients with adverse events
次要结局
- The number of subjects disease free at the completion of the treatment period.(18-24 months)
- The number of subjects disease free in the follow up period.(18-24 months)
- Concentration of CUDC-101 in the blood over time.(18-24 months)
- Number of circulating tumor cells pre treatment on Day -7 and 1 hour post treatment on Day -3.(18-24 months)
研究者
研究点 (14)
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