NCT02390986Unknown不适用
An Extension Study of LON002 in Patients With Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability.
研究概览
简要总结
The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.
详细描述
This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit.
Long term safety and efficacy will be evaluated.
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
- •Written informed consent;
- •Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator;
- •Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol;
- •Able to comply with the protocol LON002-003;
- •Women of child bearing potential must have a negative pregnancy test before the start of treatment;
- •Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter;
- •Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter
排除标准
- •Has not completed a LondonPharma sponsored parent trial of LON002;
- •Unequivocal evidence of disease progression;
- •Unacceptable toxicity experienced in the parent trial;
结局指标
主要结局
Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability.
时间窗: Participants will be followed for the duration of their study treatment, an expected average of 6 months
次要结局
未报告次要终点
研究者
研究点 (4)
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