NCT03239223

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

August 1, 2017

Last Update Submit

July 8, 2019

Conditions

HSILHSIL of CervixHigh-Grade Squamous Intraepithelial LesionsHigh-grade Cervical Intraepithelial NeoplasiaHuman Papilloma VirusCervical CancerCervical Intraepithelial NeoplasiaCervical NeoplasmCervical DysplasiaCIN

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.

    85 Days

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

    85 Days

Study Arms (2)

Dose 1 - Multiple Ascending Dose (MAD)

EXPERIMENTAL

ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22

Drug: ABI-1968

Dose 2 - Multiple Ascending Dose (MAD)

EXPERIMENTAL

ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22

Drug: ABI-1968

Interventions

ABI-1968DRUG

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

Dose 1 - Multiple Ascending Dose (MAD)Dose 2 - Multiple Ascending Dose (MAD)

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Center

Los Angeles, California, 90036, United States

Location

Research Center

Lake Worth, Florida, 33461, United States

Location

Research Center

Idaho Falls, Idaho, 83404, United States

Location

Research Center

Chapel Hill, North Carolina, 27517, United States

Location

Research Center

Winston-Salem, North Carolina, 27101, United States

Location

Research Center

Norfolk, Virginia, 84304, United States

Location

Research Center

Camperdown, New South Wales, 2050, Australia

Location

Research Center

Darlinghurst, New South Wales, 2010, Australia

Location

Research Center

South Brisbane, Queensland, 4101, Australia

Location

MeSH Terms

Conditions

Squamous Intraepithelial LesionsUterine Cervical NeoplasmsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

January 1, 2018

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(6)AU(3)