A Phase 2 Indication Identification Study of LY2523355 in Patients With Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.
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
- •Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck
- •Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Are willing to follow study procedures for the duration of the study
- •Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment
排除标准
- •Have a serious preexisting medical condition that would preclude participation in the study
- •Are pregnant or lactating
- •Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication
- •Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases
- •Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
- •Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG)
- •Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis
- •Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
研究组 & 干预措施
LY2523355
干预措施: LY2523355 (Drug)
LY2523355
干预措施: pegfilgrastim (Drug)
结局指标
主要结局
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
时间窗: Baseline until progressive disease up to 36 weeks post-baseline
The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
次要结局
- Progression Free Survival (PFS)(Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment)
- Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)(Baseline until progressive disease up to 36 weeks post-baseline)
- Tumor Marker Values as Relevant to Specific Tumor Types at Baseline(Baseline)
- Change in Tumor Size at Smallest Size (Best Response)(Baseline until cycle with maximum change from baseline up to 36 weeks)
- Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355(Day 1 and Day 3 of Cycle 1 (21-day cycle))
- Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307(Day 3 of Cycle 1 (21-day cycle))