Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03239223
Other study ID # ABI-1968-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 1, 2018
Est. completion date October 30, 2018

Study information

Verified date July 2019
Source Antiva Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Antiva Biosciences

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Withdrawn NCT04806945 - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer Phase 3
Active, not recruiting NCT04185389 - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Recruiting NCT05483491 - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer Phase 1
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Completed NCT05862844 - Promise Women Project N/A
Recruiting NCT04934982 - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) N/A
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Terminated NCT04864782 - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer Phase 2/Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A