Clinical Trial: Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase 2a Dose-Rising, Safety, Tolerability, and Efficacy Study of Topical SOR007 for Cervical Intraepithelial Neoplasia (CIN)

Brief 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).

Detailed 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 collected at each visit. Plasma samples for PK analysis on Days 7, 14 and 21 will be collected prior to SOR007 application.

The Medical Monitor will review all available data prior to dose escalation. Dose-escalation of SOR007 will be determined by the Medical Monitor. This will be repeated for each escalated dose until all dose levels have been enrolled or a dose is determined unsafe. Safety will be assessed in an ongoing manner and formal safety reviews will be conducted twice for each cohort: after Day 14 and after Day 49 of the last subject in the cohort. If a safety or tolerability issue becomes apparent in a cohort, an additional three subjects will be enrolled at that dose level, for a maximum of six subjects in that cohort. If ≥ 1 safety or tolerability issue occurs in the additional 3 subjects, the prior dose-level will be determined to be the highest dose with an acceptable safety and tolerability profile. If no further safety and tolerability issues are identified in the expanded cohort, dose-escalation will continue.

Once the highest dose with an acceptable safety and tolerability profile has been determined by the Medical Monitor, PI, and Sponsor Medical Director, a further 3 subjects will be enrolled to that dose level in or
Sponsor: DFB Soria, LLC

Current Primary Outcome: Incidence of treatment emergent adverse events [ Time Frame: 49 days ]

Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of SOR007 [ Time Frame: 49 days ]
    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).
  • Pharmacokinetics: Peak plasma concentration (Cmax) of SOR007 [ Time Frame: 49 days ]
    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).
  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of SOR007 [ Time Frame: 49 days ]
    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).
  • Regression of CIN [ Time Frame: Baseline and 49 days ]
    Colposcopic changes as defined by the modified Reid Colposcopic Index (RCI) and confirmed by biopsy histology


Original Secondary Outcome: Same as current

Information By: DFB Soria, LLC

Dates:
Date Received: May 4, 2017
Date Started: October 1, 2017
Date Completion: March 1, 2019
Last Updated: May 4, 2017
Last Verified: May 2017