NCT02671513Unknown1 期
A Tolerability and Pharmacokinetics Phase 1 Study of SHR6390 in Advanced Melanoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in Chinese advanced melanoma patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed melanoma
- •Unresectable stage III or IV melanoma patient
- •companion with cell cycle pathway abnormal (e.g CDK4 amplify and/or CCND1 amplify and/or CDKN2A loss)
- •Eastern Cooperative Oncology Group (ECOG) performance status:0-1
- •Life expectancy ≥ 3 months
- •Adequate function of major organs, meaning the following criteria should be met within 14 days before randomization:
- •Hemoglobin > 100g/L Neutrophils > 2.0×10^9/L Platelets > 100×10^9/L Total bilirubin < 1.5×the upper limit of normal (ULN) ALT and AST ≤ 1.5×ULN (≤ 5×ULN, if existing liver metastases) Creatinine ≤ 1 ULN Left ventricular ejection fraction (LVEF) ≥ 50% QTcF(Fridericia correction) male≤450 ms, female≤470 ms
- •Good compliance of patient by physician's judgement
- •Signed and dated informed consent
排除标准
- •Previously received therapy of anti-tumor agent targeting at CDK4/6
- •Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
- •Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
- •Having joined in other clinical trials within 4 weeks
- •Uncontrolled/untreated brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed)
- •existing abnormal CTCAE≥grade 2 resulted from previous treatment
- •uncontrollable symptomatic pleural effusion or ascites or require clinical intervention
- •require continous treatment by steroids
- •Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.)
- •existing uncontrollable hypokalemia or hypomagnesemia
- •history of serious allergy events or known being allergy constitution
- •active HBV or HCV infection (HBV virus≥10e4 copies/ml, HCV virus≥10e3 copies/ml)
- •History of immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation
- •history of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥grade 2 found in screening
- •Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test
- •childbearing female who refuse to accept any contraception practice
- •determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,etc.)
- •history of neuropathy or dysphrenia, including epilepsy and dementia
研究组 & 干预措施
SHR6390
Experimental
Each subject will receive a single dose of SHR6390 and then repeat doses following a 3 week/1 week off regimen.
干预措施: SHR6390 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 3 weeks
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the first 3 week of the first cycle of multiple dosing.
次要结局
- Evaluation of pharmacokinetic parameter of SHR6390: AUC(6 weeks)
- Number of patients experience adverse events(6 months)
- objective response rate(every 8 weeks, up to 12 months)
- Evaluation of pharmacokinetic parameter of SHR6390: Cmax(6 weeks)
- Evaluation of pharmacokinetic parameter of SHR6390: Tmax(6 weeks)
- Evaluation of pharmacokinetic parameter of SHR6390: t1/2(6 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of SHR6390 in Advanced Solid Tumor PatientsNeoplasmNCT02684266Jiangsu HengRui Medicine Co., Ltd.40
已完成
1 期
A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT02127476Kyowa Kirin Co., Ltd.57
已完成
1 期
A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.Alzheimer's DiseaseNCT02377713Kyowa Kirin Co., Ltd.20
已完成
1 期
A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's DiseaseAlzheimer DiseaseNCT03093519Kyowa Kirin Co., Ltd.21
Unknown
2 期
A Study of SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer.Metastatic Breast CancerAdvanced Breast CancerNCT04733417Tianjin Medical University Cancer Institute and Hospital35