Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03677960




Registration number
NCT03677960
Ethics application status
Date submitted
18/09/2018
Date registered
19/09/2018
Date last updated
24/07/2019

Titles & IDs
Public title
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Scientific title
Open-Label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
Secondary ID [1] 0 0
ABI-1968-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HSIL, High-Grade Squamous Intraepithelial Lesions 0 0
Human Papilloma Virus Infection 0 0
HIV Infection 0 0
Anal Cancer 0 0
Anus Neoplasm 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Cancer 0 0 0 0
Bowel - Anal
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Topical ABI-1968 cream

Experimental: Dose 1 - Multiple Ascending Dose(MAD) - Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Experimental: Dose 2 - Multiple Ascending Dose(MAD) - Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Experimental: Dose 3 - Multiple Ascending Dose(MAD) - Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic


Treatment: Drugs: Topical ABI-1968 cream
Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
Timepoint [1] 0 0
MAD portion is 84 days
Secondary outcome [1] 0 0
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
Timepoint [1] 0 0
MAD portion is 84 days

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Female or male subjects, at least 27 years old.

2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and
confirmed by histopathology (with p16 positive staining)

3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no
lesion(s) is suspicious for invasive cancer.

4. 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.
Minimum age
27 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating
females.

2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to
enrolment.

3. History of cancer involving the anogenital region, or history of other cancers that
have not been fully resolved and free of symptoms in the past 5 years

4. History of genital herpes with > 3 outbreaks per year.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2019
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
Sydne
Recruitment hospital [1] 0 0
Research Center - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Antiva Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT03677960
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03677960