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| ID | Type | Description | Link |
|---|---|---|---|
| 2020 0237 | Other Identifier | MD Anderson IRB | |
| 20 1148 | Other Identifier | CCF IRB |
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| Name | Class |
|---|---|
| Amarex Clinical Research | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Harris Health System (L.B.J. Hospital) | UNKNOWN |
| The Cleveland Clinic |
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This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.
Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artesunate vaginal insert | Experimental | Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4. |
|
| Placebo vaginal inserts | Placebo Comparator | Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate vaginal insert | Drug | Artesunate formulated as vaginal inserts, 200mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with histologic regression by week 17 | Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis | 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17 | Number of participants who had HPV strains detected at study entry which become undetectable by week 17 | 17 weeks |
| Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-Emergent Adverse Events (TEAE) | Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention | 6 weeks |
| Number of participants who withdrew from the study due to TEAEs |
Inclusion Criteria:
Exclusion Criteria:
This study is for women only as it is a treatment for cervical intraepithelial neoplasia (CIN2/3)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihaela Plesa, BA, CCRP | Contact | 440-255-1155 | 100 | FVTinfo@frantzgroup.com |
| Ahmad Bayat, MD | Contact | (301) 956-2523 | ahmadb@amarexcro.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Gynecologic Oncology | Recruiting | Fort Myers | Florida | 33905 | United States |
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| OTHER |
| University of Michigan | OTHER |
| Florida Gynecologic Oncology | UNKNOWN |
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Participants, study team, and sponsor are blinded to the treatment assignment.
| Placebo vaginal insert | Drug | Placebo for artesunate vaginal inserts |
|
Number of participants who had HPV strains detected at study entry which become undetectable after three 5-day cycles of artesunate and the LEEP procedure |
| 40 weeks |
Number of participants who were withdrawn from the study due to adverse events related to the study drug
| 6 weeks |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Cleveland Clinic Fairview Hospital | Recruiting | Cleveland | Ohio | 44111 | United States |
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| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Hillcrest Hospital | Recruiting | Mayfield Heights | Ohio | 44124 | United States |
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| The Harris Health System (L.B.J Hospital) | Recruiting | Houston | Texas | 77026 | United States |
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| University of Texas, M.D. Anderson | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C111789 | artesunic acid |
| C031327 | artemisinin |
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