Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)

NCT03143491 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: SOR007-2017-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of SOR007

  49 days

• Pharmacokinetics: Peak plasma concentration (Cmax) of SOR007

  49 days

• Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of SOR007

  49 days

• Regression of CIN

  Baseline and 49 days

Study Arms (3)

SOR007 0.15%

EXPERIMENTAL

1 mL of 0.15% SOR007 Ointment

Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment

SOR007 1.0%

EXPERIMENTAL

1 mL of 1.0% SOR007 Ointment

Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment

SOR007 2.0%

EXPERIMENTAL

1 mL of 2.0% SOR007 Ointment

Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment

Interventions

SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment DRUG

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

SOR007 0.15%; SOR007 1.0%; SOR007 2.0%

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• DFB Soria, LLC: lead
• US Biotest, Inc.: collaborator

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Ointments

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Karen K McCune, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Lisa Rahangdale, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2, open-label, dose-rising trial. Subjects will enroll in three dose-rising cohorts of three subjects each. he next dose level cohort will enroll upon a finding of safety and tolerability at the previous cohort's first safety review. If a safety or tolerability issue arises in the first three subjects of a cohort, an additional three subjects will be enrolled at the same dose level. If ≥ 1 of the same safety and tolerability issue recurs 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.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: October 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 18, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share