EUCTR2007-005939-28-ES进行中（未招募）1 期
Estudio de fase I/II multicéntrico, abierto, de escalada de dosis, para evaluar la seguridad, farmacocinética y actividad de RO5083945, un anticuerpo glico-modificado anti-EGFR, en pacientes con tumores sólidos malignos metastáticos y/o localmente avanzados EGFR+. Open-label, multicenter, dose-escalation Phase I/II study to evaluate safety, pharmacokinetics and activity of RO5083945, a Glycoengineered Antibody against EGFR, in patients with metastatic and/or locally advanced malignant EGFR+ Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Patients in both Parts I and II of the study must meet the following criteria to be eligible for study entry:
- •1. Signed informed consent
- •2. Age = 18 years
- •3. ECOG Performance Status (PS) 0-1
- •4. Able and willing to comply with protocol requirements
- •5. Centrally confirmed EGFR expression in tumor tissue: >10%
- •of tumor cells show membrane staining of any intensity
- •6. Evidence of radiologically measurable or clinically evaluable disease
- •7. Last dose of systemic anti-neoplastic therapy or radiotherapy = 28 days prior to first RO5083945 infusion
- •8. All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade = 1, except alopecia and Grade 2 peripheral
- •9. Neutrophil count of = 1.5 x 10 exp9 cells/L, platelet count of = 75 x 10 exp9/L, Hb = 8 g/dL
- •10. Total bilirubin within normal limits (excluding Gilbert Syndrome)
- •11. AST and/or ALT = 2.5× ULN
- •12. Serum creatinine = 1.5 ULN
- •13. Female patients of childbearing potential must commit to using a reliable and appropriate methods of contraception until at least two months after the end of study treatment. A serum pregnancy test should be performed within 7 days
- •prior to the first dose of study treatment. Male patients with a partner of childbearing potential must agree to use a barrier contraception (condom) in addition to having their partner use another contraceptive method during the trial and for two months after the last dose. Reliable and appropriate methods of contraception include hormonal implants, oral contraceptives, intra-uterine devices or a barrier method used in conjunction with spermicidal jelly.
- •Patients in Part I of the study must also meet the following criteria to
- •be eligible for study entry:
- •14. Histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ solid tumors
- •15. No standard therapy exists Patients in Part II of the study must also meet the following criteria to be eligible for study entry:
- •16. Histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ and mutant KRAS colorectal cancer
- •17. Not more than 2 previous cytotoxic regimens for metastatic disease
- •18. Evidence of radiologically measurable and documented progressive disease
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients in Parts I and II who meet any of the following criteria will be
- •excluded from the study:
- •1. Concurrent therapy with any other investigational drug
- •2. History of NCI CTCAE Grade 3-4 toxicity resulting from previous anti-EGFR treatment (Grade 4 for skin toxicity)
- •3. Grade 3-4 peripheral neuropathy toxicity
- •4. Pregnant or lactating women
- •5. Known or suspected CNS metastases including leptomeningeal metastases
- •6. Poorly controlled hypertension (systolic >180 mm Hg or diastolic > 100 mm Hg)
- •7. Severe uncontrolled illness including poorly controlled diabetes mellitus, active or uncontrolled infection
- •8. Known infection with HBV, HCV and HIV
- •9. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would
- •contraindicate the use of an investigational drug
- •10. Dementia or altered mental status that would prohibit informed consent
- •11. Major surgery or significant traumatic injury < 28 days prior to the 1st RO5083945 infusion (excluding biopsies)
- •Patients in Part II who also meet the following exclusion criteria will be excluded from the study:
- •12. wild type KRAS colorectal cancer
研究者
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