Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)

• Status: Withdrawn
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DFB Soria, LLC
• Collaborator: US Biotest, Inc.
• Treatments: Paclitaxel

Criteria

Inclusion Criteria:

• Signed informed consent;

• Female adults ≥ 18 years of age;

• Presence of newly diagnosed (within 8 weeks prior to administration of SOR007), histologically confirmed CIN 2, CIN 2/3 or CIN 3;

• Candidate for observation, treatment, or removal of CIN;

• Satisfactory colposcopy (visualization of the entire squamocolumnar junction and margins of any visible lesions);

• Appropriate contraception throughout study period;

Exclusion Criteria:

• Pap smear and/or colposcopy suspicious for invasive disease;

• History of previous conization/LEEP;

• History of toxic shock syndrome;

• Known allergy or prior intolerance to paclitaxel;

• Immunodeficiency (including HIV/AIDS and immunosuppressive medication);

• Current, reported participation in another experimental, interventional protocol;

• Active lower genital infection(s);

• Malignant disease at the time of inclusion, with the exclusion of basal cell carcinoma (BCC) or dermal carcinoma-in-situ;

• Concurrent treatment with cytotoxic, radiation, immune-stimulative, or immune-suppressive therapy, or with systemic corticosteroid dose of > 5 mg/d or prednisone (or its equivalent);

• Concomitant use of topical vaginal medications or products;

• Pregnant or lactating;

• Pregnancy planned within six (6) months following study drug application;

• Significant acute or chronic medical or psychiatric illness or other environmental or social factors that, in the opinion of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study