NCT00493441终止2 期
A Phase II Study of AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 16
- 主要终点
- Safety
研究概览
简要总结
The study was designed to find the optimum AVN944 dose to use in combination with gemcitabine in patients with pancreatic cancer and see if the combination of the 2 drugs was more effective for treating pancreatic cancer than using gemcitabine alone.
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
- •Patients with histologically or cytologically confirmed adenocarcinoma of the pancreas not eligible for curative intent resection with or without adjuvant radiation therapy
- •Measurable disease as defined by RECIST criteria
- •No prior chemotherapy for pancreatic cancer including no prior "radiosensitizing" chemotherapy
- •Patients are candidates to receive gemcitabine as first line treatment for adenocarcinoma of the pancreas
- •Age > 18 years
- •Karnofsky Performance Score of less than or equal to 60
- •Patients must be recovered from the clinically significant effects of any prior surgery or prior radiotherapy
- •Adequate bone marrow, hepatic and renal function as evidenced by:
- •Serum total bilirubin < 2.0 mg/dL
- •AST/ALT (SGOT/SGPT) < 4X the ULN for the reference lab;
- •Serum creatinine < 2.0 mg/dL;
- •ANC > 1.5 x 109/L;
- •Platelet count > 100 x 109/L,
- •Hgb > 9.0 g/dL
- •Female patients of childbearing potential as well as fertile men and their partners who agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
- •Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
排除标准
- •Patients with a life expectancy < 3 months
- •Patients with known CNS metastases
- •Patients with an uncontrolled active infection
- •Prior treatment with an IMPDH-inhibitor
- •Patients with known hypersensitivity to any of the components of AVN944 or gemcitabine
- •History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers; cervical intraepithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL
- •Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to < Grade
- •Patients who are pregnant or lactating
- •Myocardial Infarction within the past 6 months
- •Patients with clinically significant intraventricular conduction delays
- •Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- •History of solid organ transplant
- •Known HIV or Hepatitis B or C (active, previously treated or both)
- •Previous treatment under this protocol
研究组 & 干预措施
Treatment
Experimental
干预措施: AVN944 (Drug)
结局指标
主要结局
Safety
时间窗: 4 weeks
Pharmacokinetics
时间窗: Days 1, 8, 15, and 22
次要结局
未报告次要终点
研究者
研究点 (16)
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