NCT01338831已完成1 期
A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast 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
- 73
- 试验地点
- 6
- 主要终点
- Incidence rate of Dose Limiting Toxicity
研究概览
简要总结
The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.
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
- •Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma
- •Detectable metastases by bone scan, CT-scan, or MRI.
- •Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
- •Suitable venous access for blood sampling
排除标准
- •Prior treatment with any anti-prolactin receptor antibody
- •Major surgery within 28 days before study treatment
- •Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
- •Prior anaphylactic or other severe infusion reaction to antibody formulations
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Breast & Prostate Cancer Group
Experimental
Dose Escalation
干预措施: LFA102 (Drug)
Breast Cancer Group
Experimental
Dose Expansion
干预措施: LFA102 (Drug)
Prostate Cancer Group
Experimental
Dose Expansion
干预措施: LFA102 (Drug)
Uterine Leiomyoma Group
Experimental
Dose Expansion
干预措施: LFA102 (Drug)
结局指标
主要结局
Incidence rate of Dose Limiting Toxicity
时间窗: 4 weeks
次要结局
- Concentrations of antibodies to LFA102(every month)
- LFA102 serum concentration(6 months)
- Disease response(every 2 to 3 months)
研究者
研究点 (6)
Loading locations...
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