NCT01171924已完成1 期
A Phase Ib Open Label, Expansion Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
适应症
干预措施
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
- 47
- 试验地点
- 7
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. 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 compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 histopathologically confirmed diagnosis of advanced breast, gastric, head and neck, liver and non-small cell lung cancer.
- •For subjects with non-small cell lung cancer only:
- •Most recent treatment must be erlotinib and subjects must have had a radiographic partial or complete response to treatment as defined by RECIST criteria and should be currently progressing after the documented response.
- •A documented mutation in EGFR exons 19 or 21
- •Subjects must have no further standard of care options or have refused standard therapy
- •Measurable or evaluable disease
- •Age ≥ 18 years
- •ECOG performance < 2
- •Life expectancy ≥ 3 months
- •If female, neither pregnant or lactating
- •If of child bearing potential, must use adequate birth control
- •Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
- •Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
- •Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
- •Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
- •Serum magnesium and potassium within normal limits (may use supplements to achieve normal values)
- •Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
- •Able to render informed consent and to follow protocol requirements.
排除标准
- •Anticancer therapy within 4 weeks of study entry.
- •Use of investigational agent(s) within 30 days of study entry
- •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.
- •Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Subjects with liver cancer and hepatitis may be eligible.
研究组 & 干预措施
Arm A: 5 days/week schedule
Experimental
干预措施: CUDC-101 (Drug)
Arm B: 3 days/week schedule
Experimental
干预措施: CUDC-101 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 12-15 months
Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
次要结局
未报告次要终点
研究者
研究点 (7)
Loading locations...
相似试验
已完成
1 期
A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid TumorsTumorsNCT00728793Curis, Inc.25
已完成
2 期
(-)- Epicatechin Becker Muscular DystrophyBecker Muscular DystrophyNCT03236662Craig McDonald, MD2
Unknown
1 期
Safety and Efficacy of Genolimzumab (GB226) in Combination With FruquintinibMetastatic Non-small Cell Lung CancerNCT03976856Genor Biopharma Co., Ltd.42
已完成
2 期
Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)Post-Polycythemia Vera MyelofibrosisPost-Essential Thrombocythemia MyelofibrosisPrimary MyelofibrosisNCT01236638Sierra Oncology LLC - a GSK company120
已完成
1 期
TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced CancersMetastatic Castration Resistant Prostate CancerSquamous Cell Carcinoma of Head and NeckHepatocellular CarcinomaNon-small Cell Lung CancerRenal Cell CarcinomaUrothelial CarcinomaGastroEsophageal CancerPancreatic CancerSarcomaColorectal CancerTriple-Negative Breast CancerCholangiocarcinomaNCT03829436Tempest Therapeutics38