A Phase 1 Study of LY2606368 in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Determination of a Recommended Phase 2 Dosing Regimen: Maximum Tolerated Dose (Parts A and B)
研究概览
简要总结
The primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of prexasertib (an inhibitor of checkpoint kinase 1[chk 1]) in participants with advanced or metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three different groups of participants; those with squamous cell cancer of the head and neck that has recurred or spread to other parts of the body, those with squamous non-small cell lung cancer that has recurred or spread, and those with squamous cell cancer of the anus that is not curable by existing therapy.
详细描述
Part C added per protocol amendment (February, 2013).
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
- •Must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
- •Have adequate organ function
- •Prior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment
- •Part A: Must have diagnosis of cancer that is advanced or metastatic
- •Part B: Must have histologically confirmed squamous cell cancer of the head and neck or must have squamous cell cancer of any tumor type
- •Part C: Must have histological diagnosis of squamous cell cancer of the head and neck, histological or cytological diagnosis of squamous non-small-cell lung cancer, or histological diagnosis of Stage IIIB (N2 or N3) or Stage IV squamous cell cancer of the anus that is not curable by local therapy
- •Must be available during the duration of the study and willing to follow the study procedures
- •If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug
- •If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding
排除标准
- •Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
- •Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
- •Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
- •Must not have systolic blood pressure <90 millimeters of mercury (mmHg) or recurrent symptomatic orthostatic hypotension
- •Must not have a family history of long QTc syndrome or be taking drugs known to cause QTc prolongation or Torsades de Pointes
- •Must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome
- •Must not have acute leukemia
研究组 & 干预措施
Prexasertib
干预措施: Prexasertib (Drug)
结局指标
主要结局
Determination of a Recommended Phase 2 Dosing Regimen: Maximum Tolerated Dose (Parts A and B)
时间窗: Time of first dose until last dose (estimated as up to 156 weeks)
Determination of Clinically Significant Safety Effects (Parts A and B)
时间窗: Time of first dose until last dose (estimated as up to 156 weeks)
Percentage of Participants With a Complete or Partial Response (Overall Response Rate) (Part C)
时间窗: Baseline until disease progression or death from any cause (estimated as up to 24 weeks)
次要结局
- Duration of Response (Parts B and C)(First observation of complete response (CR), partial response (PR), or stable disease (SD) to first observation of progressive disease or death (estimated up to 24 weeks))
- Preliminary Pharmacokinetics of Prexasertib (Cmax) (Parts A, B, and C)(During Cycles 1 and 2)
- Preliminary Pharmacokinetics of Prexasertib (AUC) (Parts A, B, and C)(During Cycles 1 and 2)
- Percentage of Participants with Complete Response, Partial Response, or Stable Disease (Disease Control Rate) (Parts A, B, and C)(Baseline until disease progression or death from any cause (estimated as up to 24 weeks))
- Progression Free Survival (Parts B and C)(Baseline to measured progressive disease (estimated up to 24 weeks))