Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Phase 2a Dose-Rising, Safety, Tolerability, and Efficacy Study of Topical SOR007 for Cervical Intraepithelial Neoplasia (CIN)
Verified date | October 2017 |
Source | DFB Soria, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 1, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
DFB Soria, LLC | US Biotest, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment emergent adverse events | Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs. | 49 days | |
Secondary | Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of SOR007 | Plasma samples for pharmacokinetic (PK) analysis will be obtained on Day 0 at 1, 2, 4, and 6 hours post-application, at 24 hours' post-application (Day 1), and at each subsequent clinic visit (samples on Days 7, 14, and 21 will be obtained prior to dose application). | 49 days | |
Secondary | Pharmacokinetics: Peak plasma concentration (Cmax) of SOR007 | Plasma samples for pharmacokinetic (PK) analysis will be obtained on Day 0 at 1, 2, 4, and 6 hours post-application, at 24 hours' post-application (Day 1), and at each subsequent clinic visit (samples on Days 7, 14, and 21 will be obtained prior to dose application). | 49 days | |
Secondary | Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of SOR007 | Plasma samples for pharmacokinetic (PK) analysis will be obtained on Day 0 at 1, 2, 4, and 6 hours post-application, at 24 hours' post-application (Day 1), and at each subsequent clinic visit (samples on Days 7, 14, and 21 will be obtained prior to dose application). | 49 days | |
Secondary | Regression of CIN | Colposcopic changes as defined by the modified Reid Colposcopic Index (RCI) and confirmed by biopsy histology | Baseline and 49 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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