NCT01335958已完成1 期
A Phase I, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of DMUC5754A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Incidence of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase I, multi-center, open-label, dose-escalation study of DMUC5754A administered as a single agent by intravenous (IV) infusion to patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Life expectancy of at least 12 weeks
- •Documented willingness to use an effective means of contraception for women of childbearing potential
- •Measurable disease with at least one lesion that can be accurately measured in at least one dimension
- •Inclusion Criteria Specific to Patients with Ovarian Cancer:
- •Advanced, epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months of the most recent treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists
- •For patients in the dose-expansion cohort of the study only, no more than two prior chemotherapy regimens for the treatment of platinum-resistant ovarian cancer
- •Inclusion Criteria Specific to Patients with Pancreatic Cancer:
- •Incurable, locally advanced, or metastatic disease for which no standard therapy exists, consisting of unresectable pancreatic ductal adenocarcinoma, including recurrence of previously-resected disease that is considered unresectable with curative intent
- •No more than one chemotherapy regimen (approved or experimental) administered in the metastatic setting
排除标准
- •Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to Day 1
- •Palliative radiation to bone metastases within 2 weeks prior to Day 1
- •Major surgical procedure within 4 weeks prior to Day 1
- •Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
- •Current Grade >1 toxicity (except alopecia and anorexia) from prior therapy or Grade >1 neuropathy from any cause
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and the screening CNS radiographic study is >= 8 weeks since completion of radiotherapy and >= 4 weeks since the discontinuation of corticosteroids and anticonvulsants.
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmias, and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
- •Pregnancy or breast-feeding
研究组 & 干预措施
A
Experimental
干预措施: DMUC5754A (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs)
时间窗: Up to 21 days
Nature of dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.0
时间窗: Up to 21 days
次要结局
- Incidence of adverse events(Up to 1 year)
- Nature of adverse events graded per NCI CTCAE v4.0(Up to 1 year)
- Severity of adverse events(Up to 1 year)
- Area under the concentration-time curve(up to 1 year)
- Maximum concentrations(up to 1 year)
- Minimum concentrations(up yo 1 year)
- Clearance(up to 1 year)
- Half-life(up to 1 year)
- Volume of distribution(up to 1 year)
研究者
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