NCT00582985已完成1 期
An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable
Tracon Pharmaceuticals Inc.4 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2007年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Safety and Tolerability will be evaluated
研究概览
简要总结
This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.
详细描述
In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •The patient has given informed consent.
- •The patient is willing and able to abide by the protocol.
- •The patient has cancer and curative therapy is unavailable.
- •The patient is at least 18 years old.
- •The patient has adequate ability to perform activities of daily living.
- •Significant toxicities from prior therapy must have recovered.
- •The patient has adequate organ function as assessed by laboratory test.
排除标准
- •The patient weighs more than 264 lbs.
- •The patient has a known allergy to gentamicin
- •The patient has had prior treatment with high-dose chemotherapy requiring stem cell rescue
- •The patient is currently on treatment on another therapeutic clinical trial or has received an investigational agent within 4 weeks prior to first dose with study drug
- •The patient has had prior surgery (including open biopsy), radiation therapy or systemic therapy within 4 weeks of starting the study treatment
- •The patient has hypertension > 160/90
- •The patient has a history of CNS cancer
- •The patient has an unstable medical condition including, but not limited to, cardiac disease, history of stroke, active hepatitis, or significant pericardial, pleural or peritoneal effusion
- •The patient received recent thrombolytic or anticoagulant therapy
- •The patient has lung cancer with central chest lesions
- •The patient has had hemorrhage or unhealed wounds within 30 days of dosing
- •The patient has used systemic corticosteroids within 3 months of dosing
- •The patient has known HIV/AIDS
- •The patient has a history of hypersensitivity reaction to human or mouse antibody products
- •The patient is pregnant or breastfeeding.
- •The patient has a history of peptic ulcer disease or gastritis within 6 months of dosing, unless complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 30 days of dosing
结局指标
主要结局
Safety and Tolerability will be evaluated
时间窗: Through last patient last visit
Dose Limiting Toxicities
时间窗: 28 day evaluation period
次要结局
- Pharmacokinetics of TRC105 monoclonal antibody(through last patient last visit)
- Number of responses by tumor type(through last patient last visit)
研究者
研究点 (4)
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