NCT00869388已完成1 期
A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.
研究概览
简要总结
This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors preferred.
- •18 years and above
- •GOG performance status greater than or equal to 2
- •Life expectancy greater than 6 months
- •Acceptable organ and marrow function
- •Willingness to agree to use adequate contraception prior to study entry and for the duration of study participation
排除标准
- •Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Not receiving any other investigational agents
- •Known brain metastasis
- •Uncontrolled intercurrent illness including, but not limited to ongoing ore active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnancy
- •Immunosuppression including subjects with known HIV infection on immunosuppressive drugs or having an autoimmune disorder
- •Penicillin allergy
- •Symptomatic prostate hypertrophy
结局指标
主要结局
To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.
时间窗: Four bi-weekly 5 day courses
次要结局
- To evaluate the pharmacokinetic and pharmacodynamics of bi-weekly rBBX-01. To correlate the inter-patient sensitivity to rBBX-01 with in vitro studies on patient blood. To describe any anti-tumor activity of rBBX-01.(4 bi-weekly 5 day courses)
研究者
研究点 (2)
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