Clinical Trial: NCT04098744 - My Cancer Genome

NCT04098744

Description:

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3). Participants who receive placebo in this study have the option to receive active drug (artesunate) after their week 15 colposcopy visit.

Related Conditions:

High Grade Cervical Intraepithelial Neoplasia

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04098744

Trial Eligibility

Document

Title

Brief Title: Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Official Title: A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)

Clinical Trial IDs

ORG STUDY ID: ART-CIN IIB
SECONDARY ID: 2020 0237
SECONDARY ID: 20 1148
NCT ID: NCT04098744

Conditions

CIN 2/3
HPV Infection
Pre-Cancerous Dysplasia
Cervical Dysplasia
HPV Related Disease

Interventions

Drug	Synonyms	Arms
Artesunate vaginal insert	Artesunic acid, DHA, artemisinin	Artesunate vaginal insert
Placebo vaginal insert		Placebo vaginal inserts

Purpose

Detailed Description

      Eligible participants in this study are randomized to receive either artesunate or placebo
      vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the
      respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits
      (medication is mailed to the patient's home). Participants are followed closely with
      colposcopies at weeks 6, 15, and 28. After the week 15 colposcopy visit the investigator is
      unblinded. Participants in the placebo group who still have CIN2/3 have the option to start
      treatment with artesunate within 4 weeks. Participants in the artesunate treatment who still
      have CIN2/3 at the week 15 visit, will undergo standard of care surgical treatment (LEEP or
      cold knife conization) within 6 weeks.

      Primary Objective: To evaluate the histopathologic regression after three 5-day cycles of
      artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.

      Secondary Objectives:

        -  To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3

        -  To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts
           in adult females with biopsy-proven HPV-associated CIN 2/3.

        -  To evaluate histopathologic regression after the week 15 time point

Trial Arms

Name	Type	Description	Interventions
Artesunate vaginal insert	Experimental	Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.	Artesunate vaginal insert
Placebo vaginal inserts	Placebo Comparator	Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. Unblinding will take place at week 15. Participants who do not have histologic regression at week 15 will have the opportunity to cross over to the experimental arm, and start treatment with artesunate vaginal inserts within 4 weeks of the week 15 visit.	Placebo vaginal insert

Eligibility Criteria

        Inclusion Criteria:

          -  Adult females age ≥ 25 years

          -  Capable of informed consent

          -  Any HPV genotype detectable by DNA test/HPV genotyping

          -  Colposcopically-directed, histologically confirmed tissue diagnosis of either CIN2,
             CIN3, or CIN2/3

          -  Women of childbearing potential agree to use birth control through week 28 of the
             study.

          -  Weight ≥ 50kg

        Exclusion Criteria:

          -  Pregnant and nursing women

          -  Active autoimmune disease

          -  Taking immunosuppressive medication

          -  HIV seropositivity

          -  Immunocompromised subjects

          -  Evidence of concurrent cervical adenocarcinoma in situ

          -  Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other
             cancers have systemic effects

Maximum Eligible Age:	100 Years
Minimum Eligible Age:	25 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Proportion of participants with histologic regression by week 15
Time Frame:	15 weeks
Safety Issue:
Description:	Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 15, following 3 cycles of artesunate vaginal inserts, as determined by biopsy histopathologic analysis

Secondary Outcome Measures

Measure:	Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 15
Time Frame:	15 weeks
Safety Issue:
Description:	Number of participants who had HPV strains detected at study entry which become undetectable within the study window (15 weeks)

Measure:	Proportion of participants with histologic regression after week 15
Time Frame:	21 weeks
Safety Issue:
Description:	Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less after week 15 following 3 cycles of artesunate vaginal inserts, as determined by biopsy histopathologic analysis

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Frantz Viral Therapeutics, LLC

Trial Keywords

treatment study
cancer prevention
non-surgical
HPV related disease
CIN
topical treatment
vaginal inserts
artesunate
artemisinin
non-invasive
high risk HPV
vaginal suppository

Last Updated

June 30, 2021

Clinical Trials /

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)