NCT01139788已完成1 期
A Phase 1 Study of LY2624587 in Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Recommended dose for Phase 2 studies
研究概览
简要总结
Study CXBA is a multicenter nonrandomized, dose escalation, open-label, Phase 1 study of intravenous LY2624587 in patients with advanced or metastatic cancer for which no treatment of higher priority exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Present with histological or cytological evidence of a diagnosis of cancer (solid tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic. The patient must be, in the judgement of the investigator, an appropriate candidate for experimental therapy after available standard therapies have been used.
- •Have the presence of measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Revised International Working Group Lymphoma Response Criteria, or National Cancer Institute Working Group Guidelines for Chronic Lymphocytic Leukemia.
- •Have adequate organ function.
- •Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
- •Females with child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.
- •Have discontinued chemotherapy and cancer-related hormonal therapy with commercially-available agents for at least 21 days (6 weeks for mitomycin-C or nitrosoureas) and radiotherapy for at least 14 days prior to study enrollment and recovered from the acute effects of therapy (less than or equal to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE v 4.02; Grade 1). Hormone refractory prostate cancer patients receiving gonadotropin releasing hormone (GnRH) agonist therapy or breast cancer patients on anti-estrogen therapy (for example, an aromatase inhibitor) prior to entrance on the study may have that treatment continued while they are enrolled in Study CXBA.
- •Have an estimated life expectancy of greater than or equal to 12 weeks.
排除标准
- •Have received treatment with an investigational drug, which has not received regulatory approval for any indication, within 28 days of study treatment with LY
- •Have medical conditions that, in the opinion of the investigator, would preclude participation in this study.
- •Have symptomatic central nervous system malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without history of CNS metastases is not required.
- •Have a history of major organ transplant.
- •Have current acute leukemia.
- •Have active human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C antibodies.
- •Have QTc greater than 470 msec (female) or greater than450 msec (male), history of congenital long QT syndrome or other conduction abnormality.
- •Have had an autologous or allogenic bone marrow transplant.
- •Previously treated with a CXCR4 antagonist, or have had a significant allergy to biologic agents.
研究组 & 干预措施
LY2624587
Experimental
干预措施: LY2624587 (Drug)
结局指标
主要结局
Recommended dose for Phase 2 studies
时间窗: Baseline to study completion
次要结局
- Number of participants with clinically significant effects(Baseline to cycle 12)
- Radiological tumor measurement(Baseline, Cycle 1 Day-1, Cycle 2 - Day 1, Cycle 3 - Day 1)
- Pharmacokinetics of LY2624587, area under the concentration-time curve (AUC)(Cycle 1 - Cycle 12)
- Pharmacodynamic, maximum peak concentration (Cmax).(Baseline to date last subject discontinues from study drug)
研究者
研究点 (1)
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