Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT03677960
Status:
TERMINATED
Last Update Posted:
2019-07-24
First Post:
2018-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Pre-Clinical Toxicology Findings', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Histopathology of areas with biopsy-proven disease following multiple doses of ABI-1968 Topical Cream.', 'timeFrame': 'MAD portion is 84 days', 'description': 'Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology'}], 'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL', 'timeFrame': 'MAD portion is 84 days', 'description': 'Number of participants with Adverse Events related to treatment'}], 'secondaryOutcomes': [{'measure': 'Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.', 'timeFrame': 'MAD portion is 84 days', 'description': 'Plasma concentrations of ABI-1968 over time'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HSIL, High-Grade Squamous Intraepithelial Lesions', 'Human Papilloma Virus Infection', 'HIV Infection', 'Anal Cancer', 'Anus Neoplasm']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '27 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Female or male subjects, at least 27 years old.\n2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)\n3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.\n4. 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.\n\nExclusion Criteria:\n\n1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.\n2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.\n3. 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\n4. History of genital herpes with \\> 3 outbreaks per year.\n5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.'}, 'identificationModule': {'nctId': 'NCT03677960', 'briefTitle': 'Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Antiva Biosciences'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ABI-1968-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 - Multiple Ascending Dose(MAD)', 'description': 'Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic', 'interventionNames': ['Drug: Topical ABI-1968 cream']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 - Multiple Ascending Dose(MAD)', 'description': 'Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic', 'interventionNames': ['Drug: Topical ABI-1968 cream']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 - Multiple Ascending Dose(MAD)', 'description': 'Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic', 'interventionNames': ['Drug: Topical ABI-1968 cream']}], 'interventions': [{'name': 'Topical ABI-1968 cream', 'type': 'DRUG', 'description': 'Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29', 'armGroupLabels': ['Dose 1 - Multiple Ascending Dose(MAD)', 'Dose 2 - Multiple Ascending Dose(MAD)', 'Dose 3 - Multiple Ascending Dose(MAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'Sydney', 'country': 'Australia', 'facility': 'Research Center', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antiva Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}