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)
Verified date | July 2019 |
Source | Antiva Biosciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Antiva Biosciences |
United States, Australia,
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 |
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