NCT00873756已完成1 期
A Phase Ib Study of the Safety and Pharmacokinetics of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Incidence and nature of dose-limiting toxicities
研究概览
简要总结
This is a multicenter, open-label study enrolling a total of up to 23 patients.
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
- •Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease (i.e., by radiographic imaging or biopsy) and measurable tumor lesions
- •Life expectancy > 3 months
- •For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial
- •Willingness and capability to be accessible for study follow-up
排除标准
- •Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment =< 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred > 6 months from concluding adjuvant therapy
- •Peripheral neuropathy Grade >= 2
- •Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
- •Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
- •Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1
- •Evidence of clinically detectable ascites
- •Other invasive malignancies within 5 years prior to Cycle 1, Day 1
- •Current or recent participation in another experimental drug study
- •Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease on Cycle 1, Day 1
- •Active infection requiring parenteral antibiotics
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations or minor surgery (such as port placement) within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study
- •Known or suspected to be positive for the human immunodeficiency virus (HIV)
- •Known to be positive for hepatitis C or hepatitis B surface antigen
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment, or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
- •Inadequately controlled hypertension
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1
- •History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1
- •Bleeding diathesis or coagulopathy
- •Pregnancy (positive pregnancy test) or breast feeding
- •Serious, non-healing wound, ulcer, or bone fracture
研究组 & 干预措施
A
Experimental
干预措施: FOLFOX regimen (Drug)
A
Experimental
干预措施: bevacizumab (Drug)
A
Experimental
干预措施: dulanermin (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities
时间窗: Until study discontinuation or the end of Cycle 26
次要结局
- Incidence, nature, and severity of adverse events(Until study discontinuation or the end of Cycle 26)
- Change in vital signs(Until study discontinuation or the end of Cycle 26)
- Incidence of anti-dulanermin antibodies(Until study discontinuation or the end of Cycle 26)
- Change in clinical laboratory results(Until study discontinuation or the end of Cycle 26)
研究者
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