NCT01291017已完成2 期
A Phase II Clinical Trail of the Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Previously Treated, Advanced NSCLC Patients With Wildtype Retinoblastoma Protein (RB) and Inactive Cyclin Dependent Kinase (CDK)N2a
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Tumor Response by Direct RECIST Measurement
研究概览
简要总结
The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in the tumor.
详细描述
The oral drug PD0332991 is a highly selective reversible inhibitor of cyclin-dependent kinases 4 & 6 that is being studied for use in the treatment of advanced non-small cell lung cancer.
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
- •Histologically or cytologically proven non small cell lung cancer
- •Stage IV (M1a or M1b) disease. Patients may also have recurrence of early-stage disease or locally advanced disease with the presence of new distant metastases.
- •Cyclin dependent kinase (CDK)N2a (p16) protein absent or expressed at a low level in tumor biopsy specimen
- •Failed or intolerant of at least one prior systemic chemotherapy regimen (there is no maximum number of prior chemotherapy regimens)
- •Eastern cooperative oncology group (ECOG) performance status 0-2
- •Age >18 years.
- •Adequate organ and bone marrow function
- •Measurable disease by standard RECIST v1.1 criteria
- •Life expectancy of greater than 3 months
排除标准
- •Inability to understand or sign the informed consent document
- •Inability or unwillingness to take oral medications
- •No available tissue specimen for p16 analysis
- •Chemotherapy or radiotherapy within 3 weeks prior to beginning the study drug
- •Other investigational agents within 4 weeks prior to beginning the study drug
- •All side effects from previous chemotherapy, radiotherapy or investigational agents not resolved, returned to baseline or returned to Grade 1 toxicity (exceptions are grade 2 alopecia and grade 2 peripheral neuropathy)
- •Major surgery within 4 weeks prior to beginning the study drug
- •Surgical scar from previous surgery not healed prior to beginning the study drug
- •High-dose or chronic steroid use
- •High-dose statins within 7 days
- •History of rhabdomyolysis
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, stroke or myocardial infarction within 3 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Baseline corrected QT interval (QTc) >470ms
- •Pre-existing clinically significant cardiac, hepatic or renal dysfunction at the discretion of the treating physician
- •Untreated or uncontrolled (symptomatic or asymptomatic) brain metastases
- •Leptomeningeal carcinomatosis
- •Inability or unwillingness to use contraception during the treatment period by patients with reproductive potential.
- •Pregnant or breastfeeding women
- •HIV-positive patients on combination antiretroviral therapy
研究组 & 干预措施
PD0332991
Experimental
PD0332991 125 mg PO days 1 - 21
干预措施: PD0332991 (Drug)
结局指标
主要结局
Tumor Response by Direct RECIST Measurement
时间窗: 6 months
Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.
次要结局
- Overall Survival(14 months)
- Progression-free Survival(12 months)
- Plasma Levels(6 months)
- Grade of Study Drug Toxicity(24 months)
研究者
研究点 (2)
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