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Completed

NCT Number: NCT03202992

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

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.

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Key information

Conditions

HSIL, High-Grade Squamous Intraepithelial Lesions Anal Cancer Anus Diseases Anus Neoplasms Blood-Borne Infections Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases HIV Infection HIV Infections Human Papilloma Virus Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Intestinal Neoplasms Lentivirus Infections Morphological and Microscopic Findings Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Rectal Diseases Rectal Neoplasms Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Intraepithelial Lesions Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

27 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Center, Sydney, Darlinghurst, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male subjects, at least 27 years old.
  • Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
  • Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
  • For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.

Exclusion criteria

  • Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
  • Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
  • History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
  • History of genital herpes with > 3 outbreaks per year.
  • Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Treatment and study plan

ABI-1968

Drug

Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL

    Time frame: SAD portion is 29 days/MAD portion is 84 days

    Number of participants with Adverse Events related to treatment

Secondary outcomes

  1. Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.

    Time frame: SAD portion is 29 days/MAD portion is 84 days

    Plasma concentrations of ABI-1968 over time

  2. Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.

    Time frame: SAD portion is 29 days/MAD portion is 84 days

    Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology

Sponsors and collaborators

Lead sponsor

Antiva Biosciences

Industry

Registry information

Official study title

Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2017
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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