NCT00820560已完成1 期
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB007839 Following Multiple Oral Doses in Patients With 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
- 入组人数
- 41
- 主要终点
- Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
研究概览
简要总结
To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
- •Evidence of venous thrombosis by flow Doppler examination at Screening
- •A history of thrombosis or a coagulation disorder
- •Patients with a contraindication to use of low dose warfarin and/or aspirin.
- •Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
- •Brain metastases or spinal cord compression
- •Impaired renal function
- •Inadequate bone marrow reserve
研究组 & 干预措施
INCB07839 100mg, immediate release (IR) capsules
Experimental
干预措施: INCB007839 (Drug)
INCB07839 200 mg IR capsules
Experimental
干预措施: INCB007839 (Drug)
结局指标
主要结局
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
时间窗: Baseline through study completion
次要结局
- Evaluation of response rates as measured by RECIST criteria(At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.)
- Evaluation of PSA laboratory values for response(Baseline and every visit through study termination)
- Evaluation of PD markers for HER2 and ErbB ligand levels(Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.)
研究者
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