EUCTR2010-019552-50-DE进行中（未招募）不适用
Dose-escalation-, PK- and safety study with single agent CetuGEXTM in patients with EGFR positive locally advanced and/or metastatic cancer - Single agent CetuGEXTM in advanced cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.1.Male or female and age =18 yrs
- •2.Histologically confirmed locally advanced and/or metastatic solid organ tumour
- •3.Measurable or non-measurable tumour
- •4.Not eligible for standard therapy
- •5.All anti-tumor therapies must be completed 4 weeks before start of study treatment; treatment with Cetuximab must be completed at least 6 weeks prior to study start
- •6.ECOG Performance Status =1 and estimated life expectancy of = 3 months
- •7.Adequate organ function:
- •Bone marrow function: hemoglobin = 100 g/L; white blood cell count (WBC) = 3.0 x 109/L; absolute neutrophil count (ANC) = 1.5 x 109/L; platelet count = 100 x 109/L
- •Hepatic: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) = 2.5 times upper limit of normal (ULN) (? 5 x ULN if hepatic metastases present); bilirubin = 1.5 x ULN; alkaline phosphatase = 5.0 x upper limit of normal (ULN)
- •Renal: creatinine < 1.5 xULN
- •8.Patients of both genders with procreative potential must use effective contraception while enrolled in the study and for at least 4 weeks after the last study drug infusion
- •9.Written informed consent must be obtained prior to conducting any study-specific procedures
- •For Expansion Phase only:
- •10. EGFR-positive patients
- •11. No prior treatment with Cetuximab allowed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1.Chemotherapy, radiation, other anti-cancer therapies including any investigational agents at the study enrolment within 4 weeks prior to study enrolment
- •2.Concurrent anti-tumour therapy or concurrent immunotherapy
- •3.Concurrent systemic steroids except topical (inhaled, topical, nasal) or replacement therapy for the last 28 days. Steroids at low and stable dose (up to 20 mg prednisone) given for chronic disease are also permitted
- •4.Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
- •5.Primary or secondary immune deficiency
- •6.Clinically active infections > CTCAE grade 2
- •7.Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or Bevazicumab)
- •8.Active hepatitis B assessed by serology, hepatitis C by histology; human immunodeficiency virus (HIV) seropositivity
- •9.Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for = 3 years will be allowed to enter the study
- •10.Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, chronic symptomatic respiratory disease
- •11.Clinical signs of brain metastasis or leptomeningeal involvement
- •12.Symptomatic congestive heart failure (New York Heart Association [NYHA] 3 or 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, or history of stroke or transient ischemic attack within 1 year
- •13.Active drug abuse or chronic alcoholism
- •14.Pregnancy or Breastfeeding
研究者
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