A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 24
- 主要终点
- Safety (change in hematology and chemistry laboratory values from baseline)
研究概览
简要总结
90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are then followed weekly for 12 weeks and afterwards for up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female patients, ≥ 18 years of age, who are able to understand and give written informed consent
- •Histologically or cytologically confirmed pancreatic adenocarcinoma
- •Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections
- •Previously treated and received two prior treatment regimens for advanced disease
- •Karnofsky performance status ≥ 60 % (Appendix A)
- •Expected survival ≥ 3 months
- •At least 4 weeks beyond major surgery, 2 weeks beyond chemotherapy, radiotherapy, other experimental treatments
- •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 > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3)
- •Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN [5.0 X IULN if due to liver metastases])
- •Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v3.0 or recovered to baseline or discussed with and agreed to with Immunomedics' Medical Monitor.
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 nausea or vomiting and/or signs of intestinal obstruction
- •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 3-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 (other than stable atrial fibrillation) 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 or prevent completion of study procedures and follow-up examinations
研究组 & 干预措施
90Y-hPAM4
90Y-hPAM4 is administered weekly for 3 weeks
干预措施: 90Y-hPAM4 (Drug)
90Y-hPAM4 + gemcitabine
90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.
干预措施: 90Y-hPAM4 (Drug)
90Y-hPAM4 + gemcitabine
90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.
干预措施: 90Y-hPAM4 + gemcitabine (Drug)
结局指标
主要结局
Safety (change in hematology and chemistry laboratory values from baseline)
时间窗: 1 year
Acute safety will be assessed weekly for the 1st 12 weeks, and then for up to 1 year after completion of study drug treatment. Safety will be assessed by comparing baseline hematology and chemistry laboratory values with the values obtained weekly after treatment. Safety will also be assessed by the adverse events that are reported.
次要结局
- Efficacy(1 year)
- Dosage determination(2 years)