EUCTR2008-006946-24-ES进行中（未招募）1 期
Estudio multicéntrico, aleatorizado, doble ciego,controlado con placebo, de grupos paralelos sobre laseguridad y tasa de respuesta de 3 dosis administradas por vía subcutánea de 5x107 ufp de RO5217790 en pacientes con alto grado de neoplasia intraepitelial cervical de grado 2 ó 3 asociado con la infección por VPH de alto riesgo.A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5x10E7pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- Female
入选标准
- •1. Are greater than or equal to 18 years old
- •2. Have provided written informed consent
- •3. Have a negative serum pregnancy test at screening
- •4. Use effective contraception for the first 6 months of the study; 2 methods of contraception, one of which must be barrier, should be used; abstinence is acceptable
- •5. Have a pap smear test documenting, ASCUS, ASC-H, LSIL or HSIL within 3 months of screening
- •6. Have a diagnosis within 2 months prior to the first dose of RO5217790 of CIN 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual CIN2/3 disease remaining after biopsy. Entry to the trial will be allowed based on the local assessment of this criterion; however, CIN 2/3 diagnosis will have to be confirmed by the central pathologist for the purposes of analyzing the study
- •7. Have satisfactory colposcopy, i.e. the entire aceto-white or disease area as well as the entire squamocolumnar junction visualized by colposcopy
- •8. Have detection at screening of a single or multiple HR-HPV infection by analysis of liquid based cytology (LBC) material on the Roche Linear Array assay consistent with any of the trial strata as specified in section 3.1
- •9. Have no clinically significant out of range hematological, renal, or hepatic laboratory tests. Specifically, patients should have white blood cell count >3x1'000'000'000/L, hemoglobin>10g/dL, platelet count >150'000/µL; ALT<2.0xULN, AST <2xULN (upper limit of normal) and serum creatinine <2mg/dL
- •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
- •1. Have colposcopically visible CIN2/3 disease extending over more than 2 quadrants
- •2. Have had any previous excisional or ablative surgical treatment for CIN
- •3. Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
- •4. Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy
- •5. Have any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the transformation zone and surveillance of CIN. If an ECC is performed, and the endocervical curettings reveal CIN, patients are eligible as long as the endocervical lesion is directly extending from the primary lesion and is colposcopically visible in its entirety
- •6. Have previously received a prophylactic HPV vaccine
- •7. Have a serious, concomitant disorder, including active systemic infection requiring treatment
- •8. Have a prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma), unless the history of skin cancer is at the site of study treatment administration
- •9. Have a proven or suspected immunosuppressive disorder or autoimmune disease
- •10. Have any significant cardiac, hepatic or renal disease
- •11. Are breast-feeding
- •12.Have a known allergy to eggs
- •13. Have previous (within 4 weeks prior to Day 1) concomitant long term treatment with systemic steroids, immunosuppressive/immunomodulating drugs (e.g. cyclosporine, corticosteroids). Steroid nasal sprays, inhaled steroids for asthma and/or topical steroids are permissible
- •14. Have received any vaccination within 30 days of study treatment
- •15. Have active significant viral infections including HIV, HCV, HBV, CMV, and EBV within 30 days of receiving study treatment. Mild viral infections such as HSV-1 or common cold are not excluded
- •16. Have participated in another experimental protocol/use of investigational drug during the prior 6 months
- •17. Are unable to comply with the protocol requirements
- •18. Have any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives.
研究者
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