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
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia
Female
Cervical Intraepithelial Neoplasia
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Histologic resolution
Outcome Time Frame:
at month 6
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NV25025
NCT ID:
NCT01022346
Start Date:
October 2009
Completion Date:
January 2014
Related Keywords:
- Cervical Intraepithelial Neoplasia
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
Name | Location |
|---|---|
| New Britain, Connecticut 06052 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| McLean, Virginia 22101 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma | |
| Washington, District of Columbia | |
| Las Vegas, Nevada 89109 | |
| Salt Lake City, Utah 84112 |
