NCT00099294已完成3 期
A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 210
- 主要终点
- Overall Survival
研究概览
简要总结
The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.
详细描述
TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.
Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care.
Comparison: Glufosfamide versus best supportive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •At least 18 years of age
- •Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
- •Metastatic pancreatic cancer
- •Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer
- •Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
- •Recovered from reversible toxicities of prior therapy
- •Karnofsky performance status ≥70
- •All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose
- •Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
排除标准
- •More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
- •Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start
- •Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
- •Active clinically significant infection requiring antibiotics
- •Known HIV positive or active hepatitis B or C
- •Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
- •No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
- •Major surgery within 3 weeks of the start of study treatment, without complete recovery
- •Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain))
结局指标
主要结局
Overall Survival
次要结局
- Objective tumor response rate
- Duration of objective tumor response rate
- Progression-free survival
- 6 month and 12 month survival
- Serum CA 19-9
- Pain Intensity
- Performance Status
研究者
研究点 (210)
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