Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)

Launched by DFB SORIA, LLC · May 4, 2017

Keywords

ClinConnect Summary

In this Phase 2, open-label, dose-rising study, subjects with high grade (CIN 2 or 3) CIN will receive once-weekly topical application of SOR007 ointment to the ectocervix for four weeks. Subjects will be enrolled in three dose-escalating cohorts of three subjects assigned consecutively to receive 0.15%, 1.0%, or 2.0% SOR007 ointment. At the final study visit (Visit 7) subjects will undergo an excision or punch biopsy to record the stage of CIN. PK samples will be obtained post-application on Day 0 at 1, 2, 4, 6, and 24 hours' post-application on Day 1. Additional PK samples will be collect...

Gender

FEMALE

Eligibility 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