ACTRN12623000307606招募中1 期
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of RX108-A Tablet in Patients with Locally Advanced or Metastatic Solid Tumors
euPharma Pty Ltd0 个研究点目标入组 20 人开始时间: 2023年3月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •A patient will be eligible for study participation if the patient meets all of the following criteria:
- •1.Signed Informed Consent Form.
- •2.18 years and over.
- •3.Patients with locally advanced or metastatic solid tumors that have failed at least one standard of care therapy or were intolerant to, or have refused such treatment, are eligible.
- •4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •5.Life expectancy of at least 3 months.
- •6.Must agree to use adequate contraception (females and males).
排除标准
- •1. History of certain cardiac abnormalities
- •2. History of inadequate pulmonary function
- •3. Symptomatic brain metastasis
- •4. Treatment with prohibited medications
- •5. Known contra-indication to digoxin
- •6. Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks
- •7. Any toxicity related to prior treatment must have resolved to Grade 1 or less, except for alopecia
- •8. Clinically significant active infection requiring systemic antibiotic treatment
- •9. Females who are pregnant or breastfeeding.
研究者
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