NCT00596258

A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Tigris Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

Detailed description

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.

Conditions

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Interventions

Type	Name	Description
DRUG	A-007	applied topically for two 28-day cycles of 14 consecutive days of treatment each to the uterine cervix

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2008-01-16
• Last updated: 2009-05-22

Locations

5 sites across 1 country: United States