NCT00610194已完成1 期
A Multi-Center Phase 1, Dose-Escalation Trial to Determine the Safety and Pharmacokinetics/Pharmacodynamics of RDEA119, A MEK Inhibitor, in Advanced Cancer Patients
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
- Bayer
- 入组人数
- 69
- 试验地点
- 3
- 主要终点
- Safety will be assessed as adverse and drug related events, clinical laboratory test results (hematology, chemistry, coagulation, and urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination
研究概览
简要总结
Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK inhibitor, in advanced cancer patients.
Secondary Objectives:
- To describe the initial PK of different doses of RDEA119 when given once orally on Day 1 of the study
- To describe the PK of different doses of RDEA119 when given orally as continuous dosing.
- To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein biomarkers
- To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the recommended Phase 2 dose
- To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis, in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a minimum of 10 patients in the expanded cohort
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
- •Histological or cytological confirmed solid tumor. - Advanced metastatic or locally recurrent disease for which no proven effective therapy exists. - In the expanded MTD cohort, a minimum of 10 patients must have an accessible tumor that is amendable to biopsy (cut or needle) at the start and during the study. For patients not in the biopsy group, a block from the patient's original diagnostic biopsy/excision, if available, may be used for genotype analysis. - ECOG performance status of 0-
- •Life expectancy of > or equal to 3 months. - Acceptable hematology, clinical chemistry, and coagulation laboratory values. - Patient must be acceptable for treatment and follow up according to the Investigator. - Patent must have agreed to and signed the Informed Consent. - Patient has within normal range cardiac function as measured by echocardiogram or MUGA scan.
排除标准
- •Use of investigational agents or devices within the last 28 days. - Major surgery within 30 days of start of study. - Patients with documented CNS metastasis who are not off steroids and other CNS therapies - Evidence of uncontrolled active infections. - Other serious medical or psychiatric illness. - Significant cardiac dysfunction including congestive heart failure (NYHA Class III or IV); myocardial infarction or ventricular tachyarrhythmia within the last 6 months; major conduction abnormalities unless corrected with a cardiac pacemaker; prolonged QTc >460msec. - Patients with known hypersensitivity to any of the drugs or components given in this protocol. - Pregnancy. - Women or men of childbearing potential not willing to use effective contraception, including barrier protection. - Patients with abdominal fistula, GI perforation, intra-abdominal abscess, or small bowel resection, any of which is within 6 months of study entry. - Patients with abdominal radiation resulting in chronic diarrhea. - Because RDEA119 is primarily metabolized by CYP3A4 and CYP2C19, inhibitors and inducers of these enzymes should be avoided. - Patients with known HIV infection will be excluded.
研究组 & 干预措施
Arm 1
Experimental
In the dose escalation phase, subjects will receive a single oral dose of RDEA119 on Day 1, wait 1 week, then begin a 28-day course of daily continuous dosing of RDEA119. In the expanded MTD phase, subjects will receive RDEA119 once or twice a day beginning on Day 1, and begin a 28-day course of continuous dosing at that time.
干预措施: RDEA119 (Drug)
结局指标
主要结局
Safety will be assessed as adverse and drug related events, clinical laboratory test results (hematology, chemistry, coagulation, and urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination
时间窗: 35 Days
次要结局
- Pharmacokinetics and Pharmacodynamics(35 Days)
研究者
研究点 (3)
Loading locations...
相似试验
终止
1 期
M3541 in Combination With Radiotherapy in Solid TumorsSolid TumorsNCT03225105EMD Serono Research & Development Institute, Inc.15
Unknown
1 期
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid TumorsSolid TumorsNCT03634982Revolution Medicines, Inc.133
终止
1 期
Ph1 Study of SL-172154 Administered Intratumorally in Subjects With Squamous Cell Carcinoma of the Head and Neck or SkinCutaneous Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and NeckNCT04502888Shattuck Labs, Inc.5
尚未招募
1 期
A Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05344742CSPC ZhongQi Pharmaceutical Technology Co., Ltd.116
撤回
1 期
RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCCCutaneous Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaNCT05220748Rakuten Medical, Inc.