NL-OMON32581尚未招募2 期
A phase I/ II, non-randomized, feasibility/ safety and efficacy study of the combination of everolimus, cetuximab and capecitabine in patients with metastatic pancreatic cancer - CEC-study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Cytological or histological confirmed adenocarcinoma of the pancreas
- •*Metastatic pancreatic cancer
- •*ECOG/ WHO performance 0-2
- •*Age > 18 years
- •*Life expectancy > 3 months
- •*Adequate renal function (creatinine < 150 µmol/L)
- •*Adequate liver function (bilirubin < 2.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases
- •*Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)
- •*Mentally, physically, and geographically able to undergo treatment and follow up
排除标准
- •*Clinical or radiological evidence of CNS metastases
- •*Pregnancy (positive serum pregnancy test) or patients (male/female with reproductive potential (without effective contraception) or lactation
- •*Concomitent treatment with other experimental drugs or any other anticancer therapy
- •*Previous treatment with cetuximab
- •*Other malignancy within the last 5 years, except adequately treated basocellular skin carcinoma or cervical carcinoma
- •*Medical or physiological conditions that would not permit the subject to complete the study or sign informed consent
- •*Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
研究者
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