ACTRN12613001061729终止1 期
A Phase 1, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CX-5461 in Patients with Advanced Haematologic Malignancies
Peter MacCallum Cancer Centre0 个研究点目标入组 20 人开始时间: 2013年9月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
研究概览
简要总结
Seventeen patients with advanced blood cancers were treated with CX-5461 with escalating doses on this first-in-human study and a maximum tolerated dose of 170 mg/ sqm was defined. The most common side-effect observed was photosensitivity in about half the patients. One patient with T-cell lymphoma had a good disease response and received treatment for more than 1 year. The second phase of the study was terminated early after 3 patients due to inadequate recruitment, with no new safety or efficacy findings noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients with any histologically confirmed relapsed or refractory advanced haematologic malignancies for which no effective standard therapies are available. These patients must have progressed following at least one prior treatment regimen. There must be evidence of measurable disease.
排除标准
- •Pregnant or lactating women, uncontrolled intercurrent illness, history of other malignancy within 2 years of study entry (excluding treated nonmelanotic skin cancer and in-situ carcinoma), known CNS involvement unless previously treated and well controlled for a period of >=3 months and does not require the use of steroids.
研究者
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