A Two-Stage Phase 2 Study Of Dose-Intense 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-Hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
This is a non-randomized, two-stage phase II study with pathological response rate as the
primary objective. Following biopsy confirmation of CIN 2/3 within the last 12 weeks, women
will treat themselves with gel applied to the cervix via an intravaginal applicator.
Patients will apply gel once daily for 14 consecutive days of a 28-day cycle for 2 cycles.
Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and
immunologic testing (see schedule of events in attachment TG-003.01 for visit intervals).
Following the two cycles of treatment with A-007, treating physicians will perform a LEEP at
the month 4 visit. The investigator is responsible for ensuring that the LEEP is conducted
according to the procedures and guidelines of their institution.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine overall pathological response (complete and partial, based on independent review at month 4) of A-007 when applied topically for two 28-day cycles of 14 consec. days of treatment each to the uterine cervix of women with HSIL [CIN 2/3].
Over the course of the trial
Keith A Aqua, MD
Visions Clinical Research
United States: Food and Drug Administration
|NYU School of Medicine||New York, New York 10016|
|Visions Clinical Research||Boynton Beach, Florida 33472|
|Visions Clinical Research-Tucson||Tucson, Arizona 85712|
|Robin Black OGNP||Costa Mesa, California 92629|
|Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health||Bronx, New York 10461|