NCT02053636已完成2 期
An Open, 3-cohort, Phase II Trial Testing Oral Administration of Lucitanib in Patients With FGFR1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 29
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast adenocarcinoma.
- •Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
- •Prior first-line systemic therapy in the metastatic setting.
- •Demonstrated progression of disease by radiological or clinical assessment.
- •Female patient, aged ≥18 years old.
- •Estimated life expectancy >3 months.
- •Normal Left ventricular function
- •Adequate haematological, hepatic and renal functions.
- •For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
- •Ability to swallow oral capsules or tablets.
排除标准
- •More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
- •Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
- •Active central nervous system metastases, cerebral oedema, and/or progressive growth.
- •Patients with impaired cardiac function.
- •Uncontrolled arterial hypertension
- •Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
- •Serum potassium level below Lower Limit of Normal
- •Uncontrolled hypothyroidism.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
lucitanib
Experimental
Hard gelatine capsules of 2,5, 5 and 10 mg or film coated tablets of 5 and 7,5 mg.
5 to 10 mg orally on a daily basis until unacceptable toxicity according to the investigator, disease progression or withdrawal of consent
干预措施: lucitanib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Every 8 weeks
Tumor evaluation every 8 weeks throughout the study
次要结局
未报告次要终点
研究者
研究点 (29)
Loading locations...
相似试验
已完成
2 期
A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive LymphomaAnaplastic Large Cell Lymphoma, ALK-PositiveNCT03505554University of Milano Bicocca9
终止
2 期
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic AlterationsSquamous Non-Small Cell Lung CancerMetastatic Lung CancerStage IV Lung CancerLung CancerNon-Small Cell Lung CancerSCLCNSCLCSmall Cell Lung CancerAdvanced Lung CancerNCT02109016Clovis Oncology, Inc.18
已完成
2 期
GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or OxaliplatinColorectal CancerNCT00044343GlaxoSmithKline80
已完成
2 期
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.Neoplasms, BreastMetastatic Breast CancerNCT00051103GlaxoSmithKline
终止
2 期
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)Lymphoma, Mantle-CellNCT02455297Bayer4