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Therapeutic Areas: Oncology | Obstetrics/Gynecology
Disease Category: Cervical Intraepithelial Neoplasia
Trial Information
A Study of RO5217790 (HPV Targeted Immunotherapy) in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection
Status: Recruiting
Protocol Number: NV25025
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific Title: A randomized, double blind, placebo controlled, parallel group study of the safety and the response rate as to histologic resolution of 3 sc administered doses of RO5217790 in patients with high grade cervical intraepithelial neoplasia associated with High Risk HPV infection
Brief Summary: 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.
Target sample size is
200
.
Study Phase: II
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Placebo
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Cervical Intraepithelial Neoplasia
Intervention Type: Drug
Intervention Name: RO5217790
Primary Outcome: 1
.
Histologic resolution
Time frame:
at month 6
Key Secondary Outcomes: 1. Viral clearance by Roche HPV genomic testing Time frame: at month 6
2. Immunological response to HPV antigens Time frame: after treatment and at intervals during follow-up
3. Safety and tolerability Time frame: day 1 to month 6, and at intervals during the 2 years of follow-up
Inclusion Criteria:
- females >/= 18 years of age
- diagnosis of CIN 2/3 within 2 months prior to study entry confirmed by colpscopy-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
Gender: Females
Age Limits: Min: 18 Years Max: NA Years
Accepts Healthy Volunteers: No
Anticipated Start Date: October, 2009
Trial Registration Date: 07/14/2009
Date Last Updated: 10/15/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
New York, NY 10003
Phone: 888-662-6728 (U.S. Only)
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