NCT02307240已完成1 期
Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid 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
- 43
- 试验地点
- 4
- 主要终点
- To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors
研究概览
简要总结
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.
详细描述
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined:
Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.
- •Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.
- •Measurable or evaluable disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).
排除标准
- •Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
- •Radiotherapy within one week prior to starting study treatment.
- •Other investigational agent(s) within 21 days prior starting to study treatment.
- •Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.
- •Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease or cardiac amyloidosis.
研究组 & 干预措施
CUDC-907 - five days on/two days off
Experimental
60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met.
干预措施: CUDC-907 (Drug)
结局指标
主要结局
To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors
时间窗: 21 day cycle
次要结局
- To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).(21 day cycle)
- To assess the preliminary anti-cancer activity of CUDC-907(24 months)
- To evaluate biomarkers of CUDC-907 activity(24 months)
研究者
研究点 (4)
Loading locations...
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