NCT01529307
终止
1 期
A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors
概览
- 阶段
- 1 期
- 干预措施
- TAS266
- 疾病 / 适应症
- Advanced Solid Tumors
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Frequency and characteristics of Dose limiting toxicities at each dose level
- 状态
- 终止
- 最后更新
- 5年前
概览
简要总结
This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.
研究者
入排标准
入选标准
- •Confirmed diagnosis of solid tumors
- •18 years or older
- •ECOG performance status of 0, 1 or 2
- •Adequate bone marrow, hepatic and renal function
- •Obtained written informed consent
排除标准
- •Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
- •Major surgery within 4 weeks before study treatment
- •Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
- •Impaired cardiac functions
- •Previous hepatitis viral infection such as hepatitis B or hepatitis C
- •Diagnosis of HIV infection
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TAS266
干预措施: TAS266
结局指标
主要结局
Frequency and characteristics of Dose limiting toxicities at each dose level
时间窗: 2 years
次要结局
- Type, frequency, and severity of AEs, changes in laboratory and clinical assessments(2 years)
- Presence and concentration of anti-TAS266 antibodies(2 Years)
- Tumor response(2 Years)
- TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266(8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment)
研究点 (3)
Loading locations...
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