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Sponsored by: |
Tigris Pharmaceuticals |
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Information provided by: | Tigris Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00596258 |
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.
Condition | Intervention | Phase |
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Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia |
Drug: A-007 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 46 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Visions Clinical Research-Tucson | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Robin Black OGNP | |
Costa Mesa, California, United States, 92629 | |
United States, Florida | |
Visions Clinical Research | |
Boynton Beach, Florida, United States, 33437 | |
United States, New York | |
Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health | |
Bronx, New York, United States, 10461 | |
NYU School of Medicine | |
New York, New York, United States, 10016 |
Principal Investigator: | Keith A Aqua, MD | Visions Clinical Research |
Principal Investigator: | Mark H Einstein, MD | Montefiore Medical Center-Weiler Division |
Principal Investigator: | Cynthia J Goldberg, MD | Visions Clinical Research-Tucson |
Principal Investigator: | Robert Pfeffer, MD | Robin Black OGNP, Costa Mesa California |
Principal Investigator: | Stephanie Blank, MD | NYU School of Medicine |
Responsible Party: | Tigris Pharmaceuticals, Inc. ( Anne White ) |
Study ID Numbers: | TG-003 |
Study First Received: | January 4, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00596258 |
Health Authority: | United States: Food and Drug Administration |
Cervical Intraepithelial Neoplasia (CIN) High-grade Cervical Intraepithelial Neoplasia High-grade Squamous Intraepithelial Lesions (HSIL) Human Papilloma Virus (HPV) High-Grade Cervical Intraepithelial Lesions (CIN 2/3) |
Genital Diseases, Female Virus Diseases Uterine Cervical Diseases Precancerous Conditions Cervical intraepithelial neoplasia Carcinoma in Situ |
Uterine Diseases Papilloma Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Neoplasms Neoplasms by Histologic Type |