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| Name | Class |
|---|---|
| Frantz Viral Therapeutics, LLC | INDUSTRY |
| University of Wisconsin, Madison | OTHER |
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This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART 200 mg, 2 cycles | Experimental | Two five-day cycles of Artesunate suppositories, 200 mg/day |
|
| ART 200 mg, 3 cycles | Experimental | Three five-day cycles of Artesunate suppositories, 200 mg/day |
|
| ART 400 mg, 2 cycles | Experimental | Two five-day cycles of Artesunate suppositories, 400 mg/day |
|
| ART 400 mg, 3 cycles | Experimental | Three five-day cycles of Artesunate suppositories, 400 mg/day |
|
| ART 600 mg, 2 cycles | Experimental | Two five-day cycles of Artesunate suppositories, 600 mg/day |
|
| ART 600 mg, 3 cycles | Experimental | Three five-day cycles of Artesunate suppositories, 600 mg/day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate Suppositories | Drug | Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3) | Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0 | 6 weeks from the date of the first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less | Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy | 16 weeks |
| Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandy H Fang, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States | ||
| University of Wisconsin Carbone Cancer Center |
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Subjects will be enrolled sequentially in each treatment cohort.
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|
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Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy |
| 28 weeks |
| Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping | Number of patients with HPV genotypes present at study entry which become undetectable during the study window | 40 weeks |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C031327 | artemisinin |
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