跳至主要内容
临床试验/NCT01529307
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

Novartis Pharmaceuticals3 个研究点 分布在 1 个国家目标入组 6 人2012年6月
干预措施TAS266
相关药物TAS266

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.

注册库
clinicaltrials.gov
开始日期
2012年6月
结束日期
2012年9月
最后更新
5年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

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)

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