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Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)

NCT03143491 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-10-18

No results posted yet for this study

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).

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

DRUG

SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment

1 mL of SOR007 applied topically to the ectocervix once-weekly for four weeks.

Sponsors & Collaborators

  • US Biotest, Inc.

    collaborator INDUSTRY

  • DFB Soria, LLC

    lead INDUSTRY

Principal Investigators

  • Karen K McCune, MD, PhD · University of California, San Francisco

  • Lisa Rahangdale, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-12-01
Completion
2019-03-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143491 on ClinicalTrials.gov