A Phase 1-2 Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With rhuMAb VEGF (Bevacizumab) in Patients With Locally Advanced or Metastatic Carcinoid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- To assess the safety of Panzem NCD administered orally in combination with intravenous infusion of bevacizumab by evaluation of the frequency and severity of treatment emergent adverse events
研究概览
简要总结
This single center, open-label study will evaluate the safety and efficacy of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Dispersion (NCD) administered orally with recombinant human monoclonal antibody against vascular endothelial growth factor (bevacizumab) administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.
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 documented locally unresectable or metastatic carcinoid neuroendocrine tumor
- •Measurable disease, according to RECIST, with at least one lesion that is unidimensionally measurable by conventional techniques to be greater than or equal to 2 cm in diameter, or by spiral CT to be greater than or equal to 1 cm in diameter
- •18 years or older
- •Laboratory data to include (next 7 bullet points):
- •Aspartate aminotransferase(AST)and alanine aminotransferase (ALT)less than 2.5 times the upper limit of normal (less than 5 times upper limit of normal if liver metastasis present)
- •Total bilirubin less than or equal to 2 mg/dL
- •Serum creatinine less than or equal to 1.5 mg/dL
- •Total white blood cell count greater than 3,500/mm3
- •Absolute neutrophil count greater than or equal to 1,500/mm3
- •International normalized ratio less then or equal to 1.5
- •Platelets greater than or equal to 100,000/mm3
- •Agree to use effective contraceptive methods
- •Have an ECOG performance status of less than 2
- •Life expectancy of greater than 12 weeks
- •Ability to understand the requirements of the study, have provided written consent, and agree to abibe by the study restrictions
排除标准
- •Pregnant or nursing, or refusal to use appropriate birth control
- •An active infection
- •Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 12 months (the patient may be on antianginal medications if the symptoms can be fully controlled), or have uncontrolled congestive heart failure
- •Have apparent central nervous system metastasis or carcinomatous meningitis
- •Have had any active cancer in addition to the carcinoid tumor within the last 5 years, with the exception of superficial skin cancer
- •Be receiving concurrent treatment with therapeutic doses of any anticoagulant including all forms of heparin and Coumadin
- •Have current or a history of severe bleeding
- •Uncontrolled / severe hypertension
- •Previous history of nephrotic syndrome
- •Urine protein: creatinine ratio greater than or equal to 1.0 at screening
- •Have received radiotherapy or chemotherapy within the previous 4 weeks
- •Participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
- •Have had major surgery within 4 weeks or plan to undergo elective surgery during treatment
- •Additional uncontrolled serious medical condition or psychiatric illness
- •Have any condition that is likely to interfere with regular follow-up
研究组 & 干预措施
1
Panzem NCD will be dosed orally at a level of 1,000 mg, four times daily for 28 consecutive days and bevacizumab will be administered at a dose of 5 mg/kg as an intravenous bolus on Day 1 and Day 15 of the Treatment Period
干预措施: Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab) (Drug)
结局指标
主要结局
To assess the safety of Panzem NCD administered orally in combination with intravenous infusion of bevacizumab by evaluation of the frequency and severity of treatment emergent adverse events
时间窗: Approximately monthly
To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors
时间窗: Approximately every 8 weeks
To determine the overall survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab
时间窗: Approximately every 3 months
次要结局
- To determine the progression-free survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab(Approximately every 3 months)
- To monitor the steady-state trough plasma levels of 2ME2 following 28-day dosing cycles of Panzem NCD when administered orally in combination with intravenous infusion of bevacizumab(Approximately monthly)