A Study of RO5217790 (HPV Targeted Immunotherapy) in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection - NCT01022346-35233 (Clinical Trial 424440)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy424440.aspx
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| City: |
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Birmingham |
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State:
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AL |
| Zip Code: |
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35233 |
| Conditions: |
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Cervical Intraepithelial Neoplasia |
| Purpose: |
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This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety
and the efficacy of RO5217790 on histologic resolution in patients with high grade cervical
intraepithelial neoplasia associated with high risk HPV infection. Patients will be
randomized to receive 3 sc injections of either placebo or RO5217790 on days 1, 8 and 15.
Histologic and viral assessments will be made at baseline, at month 3 and 6, and every 6
months thereafter for an overall of 2.5 years. Target sample size is 200 patients.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- females >/= 18 years of age
- diagnosis of CIN 2/3 within 2 months prior to study entry confirmed by
colposcopy-directed punch biopsy
- patients must have at least 1 quadrant of residual CIN 2/3 disease remaining after
biopsy
- single or multiple HR-HPV infection at screening by analysis of liquid based cytology
material by Roche HPV genomic testing
Exclusion Criteria:
- colposcopically visible CIN 2/3 disease extending over more than 2 quadrants
- previous excisional or ablative surgical treatment for CIN
- any anatomical condition of the cervix that would interfere with a complete
evaluation of the transformation zone and surveillance of CIN
- vulvar(VIN) or vaginal (VAIN) intraepithelial neoplasia
- atypical endometrial or glandular cells or evidence of carcinoma on biopsy
- proven or suspected immunosuppressive disorder or autoimmune disease |
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| Study is available at: |
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Birmingham, AL 35233
United States
Primary Contact:
Please reference Study ID Number: NV25025
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only) |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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