A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs
研究概览
简要总结
This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.
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 neoplastic disease refractory to currently available therapies or for which no effective treatment is available
- •Subjects with life expectancy of 12 weeks or longer.
- •Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
排除标准
- •Subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.
- •Subjects with history of brain metastases or spinal cord compression.
- •Subjects who have undergone a bone marrow or solid organ transplant.
- •Subjects who have had major surgery within 4 weeks prior to study entry or had minor surgical procedure within 7 days prior to initiating treatment.
- •Subjects with clinically significant non-healing or healing wounds or subjects with lung tumor lesions with increased likelihood of bleeding
- •Subjects with a history of any gastrointestinal condition
研究组 & 干预措施
INCB028060
Subjects will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group of patients may be enrolled and receive study drug. The initial cohort will be treated with 10 mg QD. The second cohort will be treated with 20 mg QD. The third cohort will be treated with 50 mg QD. Subsequent cohorts will be treated with two times the dose of the prior cohort to a limited toxicity level.
干预措施: INCB028060 (Drug)
结局指标
主要结局
Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs
时间窗: Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit.
次要结局
- c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation(Predose, specific hours post-dose on day and Day 15 of Cycle 1.)