Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmacodynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult Patients With Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- - DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844
研究概览
简要总结
Primary Objective:
In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.
In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients).
Secondary Objectives:
To characterize and confirm the global safety profile of SAR125844 including cumulative toxicities.
To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the relationship of MET gene amplification status with antitumor effects.
To evaluate other pharmacodynamic biomarkers.
详细描述
For both cohorts, escalation and expansion, the duration of the study for one patient will include a period for inclusion of up to 3 weeks and a 4-week treatment cycle(s).The patient may continue treatment until disease progression, unacceptable toxicity or willingness to stop, followed by a minimum of 30-days follow-up.
If a patient treated in dose escalation part or in an expansion cohort, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment for a maximum of 1 year and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose escalation
SAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose will be either 1 dose level (DL) below the highest cleared dose level in a European TED11449 ongoing study or DL4 (260 mg/m^2), if the highest cleared dose in TED11449 is >340 mg/m^2.
干预措施: SAR125844 (Drug)
结局指标
主要结局
- DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844
时间窗: At d28 of Cycle 1 of each treated patient, DLT is assessed
- EXPANSION Cohort To evaluate the preliminary anti-tumoral effect of SAR125844
时间窗: Antitumor activity is assessed at the end of Cycle 1, then every 2 cycles up to treatment discontinuation
次要结局
- Assessment of PK parameter Cmax(Up to a maximum of 2 years)
- Assessment of PD parameter HGF(Up to a maximum of 2 years)
- Number of patients with treatment emergent events(Up to a maximum of 2 years)
- Assessment of PK parameter CL(Up to a maximum of 2 years)
- Assessment of PD parameter ShedMET(Up to a maximum of 2 years)
- Assessment of PK parameter AUCs(Up to a maximum of 2 years)