NCT00597129已完成1 期
A Phase I, Dose-Escalating Study to Investigate the Safety, Tolerability, Pharmacokinetics and Dosimetry of a Single Dose of 90YHumanized PAM4 IgG in Patients With Locally Advanced/Metastatic Pancreatic Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 8
- 主要终点
- safety MTD
研究概览
简要总结
Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
详细描述
radiolabeled anti-MUC1 humanized antibody) administered intravenously as a single dose to patients with locally advanced and/or metastatic pancreatic cancer. The primary objective is to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of 90Y-hPAM4 in this population. Secondary objectives include the assessment of tumor targeting, biodistribution, organ dosimetry and pharmacokinetics (PK) of 90Y-hPAM4 as determined by pre-therapy administration of 111In-hPAM4, the assessment of the antigenicity of 90Y-hPAM4, as determined by development of human anti-humanized antibodies (HAHA), and to obtain preliminary information on the efficacy of single dose 90Y-hPAM4 in this patient population.
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
- •Male or female patients, >18 years of age, who are able to understand and give written informed consent.
- •Histologically or cytologically confirmed, Stage III or IV pancreatic adenocarcinoma.
- •Patients with Stage III (locally advanced) disease must have documented progression after failing primary therapy
- •Patients with Stage IV (metastatic) disease must not have received more than one chemotherapy regimen.
- •Measurable disease by CT, with at least on lesion >1.5 cm in one dimension.
- •Karnofsky performance status > 70 % (Appendix A).
- •Expected survival > three months.
- •At least 4 weeks beyond chemotherapy, radiotherapy, major surgery, other experimental treatments, and recovered from all acute toxicities.
- •At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
- •Adequate hematology without ongoing transfusional support (hemoglobin > 10 g/dL, ANC > 1,500 per mm3, platelets > 150,000 per mm3)
- •Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN)
- •Otherwise, all toxicity at study entry <Grade 1 by NCI CTC v3.0.
排除标准
- •Women who are pregnant or lactating.
- •Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
- •Known metastatic disease to the central nervous system.
- •Presence of bulky disease (defined as any single mass >10 cm in its greatest dimension)
- •Patients with >Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
- •Prior treatment with nitrosureas, actinomycin-D, radioimmunotherapy or other antibody-based therapies (murine, chimeric, humanized or human) Prior radiation dose >3,000 cGy to the liver, >2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow.
- •Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 5- year disease free interval.
- •Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
- •Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
- •Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
- •Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids).
- •Infection requiring intravenous antibiotic use within 1 week.
- •Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation
结局指标
主要结局
safety MTD
时间窗: over the first 12 weeks, then over 2 years
次要结局
- targeting, biodistribution, organ dosimetry(first 2 weeks)
- pharmacokinetics (PK), antigenicity,(first 12 weeks)
- efficacy(over first 12 weeks, then over 2 years)
研究者
研究点 (8)
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