Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

Cervical Cancer Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239223
• Other study ID #: ABI-1968-102
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2019
• Source: Antiva Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women, 25 to 50 years old.

• Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.

• Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.

• Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).

Exclusion Criteria:

• Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.

• History of cancer, except basal cell or squamous cell carcinoma of the skin.

• History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.

• Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.

• History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Cervical Neoplasm
• CIN
• High-grade Cervical Intraepithelial Neoplasia
• High-Grade Squamous Intraepithelial Lesions
• HSIL
• HSIL of Cervix
• Human Papilloma Virus
• Neoplasms
• Papilloma
• Squamous Intraepithelial Lesions of the Cervix
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Drug:
• ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts

Locations

Country	Name	City	State
Australia	Research Center	Camperdown	New South Wales
Australia	Research Center	Darlinghurst	New South Wales
Australia	Research Center	South Brisbane	Queensland
United States	Research Center	Chapel Hill	North Carolina
United States	Research Center	Idaho Falls	Idaho
United States	Research Center	Lake Worth	Florida
United States	Research Center	Los Angeles	California
United States	Research Center	Norfolk	Virginia
United States	Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Antiva Biosciences

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL	Number of participants with Adverse Events related to treatment to determine MTD	85 Days
Secondary	Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.	Plasma concentrations of ABI-1968 over time to determine systemic exposure	85 Days
Secondary	Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.	Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses	85 Days