NCT00102752已完成1 期
A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 18
- 主要终点
- Overall objective response rate
研究概览
简要总结
The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.
详细描述
This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.
Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.
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
- •At least 18 years of age
- •Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
- •Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
- •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
- •Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose
- •Ability to understand the purposes and risks of the study and provide written informed consent.
排除标准
- •Prior chemotherapy for metastatic/locally advanced pancreatic cancer
- •Prior administration of gemcitabine
- •Radiation therapy within 28 days prior to study start
- •Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 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
- •History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
- •Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
- •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),
- •ANC <1500/μL,
- •Platelet count <100,000/μL,
- •Total bilirubin > 1.5 ×ULN,
- •AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases),
- •Serum creatinine > 2 mg/dL,
- •Creatinine clearance < 60 mL/min (calculated)
- •Females who are pregnant or breast-feeding
- •Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
- •Concomitant disease or condition that could interfere with the conduct of the study
- •Unwillingness or inability to comply with the study protocol for any other reason
结局指标
主要结局
Overall objective response rate
次要结局
- Overall survival
- 6- and 12- month survival
- Progression-free survival
- Duration of objective response
- Serum CA-19-9
研究者
研究点 (18)
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