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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00045376 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| Frantz Viral Therapeutics, LLC | INDUSTRY |
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This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).
The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.
Phase I open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg Artesunate suppositories, 1 cycle | Experimental | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). |
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| 200 mg Artesunate suppositories, 1 cycle | Experimental | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). |
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| 200 mg Artesunate suppositories,2 cycles | Experimental | Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). |
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| 200 mg Artesunate suppositories,3 cycles | Experimental | Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate Suppositories | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. | 41 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Clearance of HPV | Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation. | 41 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia L Trimble, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Outpatient Center | Baltimore | Maryland | 21205 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| ID | Title | Description |
|---|---|---|
| FG000 | 50 mg Artesunate Suppositories, 1 Cycle | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| FG001 | 200 mg Artesunate Suppositories, 1 Cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2017 |
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| Histologic Regression of CIN2/3 | Number of participants who had histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies. Histologic regression is defined as disappearance of the high grade lesion (CIN2/3) without surgical intervention. | 41 weeks |
| Baltimore |
| Maryland |
| 21231-2410 |
| United States |
| Greater Baltimore Medical Center | Towson | Maryland | 21204 | United States |
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| FG002 | 200 mg Artesunate Suppositories,2 Cycles | Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| FG003 | 200 mg Artesunate Suppositories,3 Cycles | Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 50 mg Artesunate Suppositories, 1 Cycle | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| BG001 | 200 mg Artesunate Suppositories, 1 Cycle | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| BG002 | 200 mg Artesunate Suppositories,2 Cycles | Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| BG003 | 200 mg Artesunate Suppositories,3 Cycles | Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type of HPV at baseline | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events | Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. | Posted | Count of Participants | Participants | 41 weeks |
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| Secondary | Viral Clearance of HPV | Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation. | Subjects enrolled in the study who received at least one dose of the investigational drug, and on whom we have outcomes data. 2 participants did not have data collected for this outcome. | Posted | Count of Participants | Participants | 41 weeks |
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| Secondary | Histologic Regression of CIN2/3 | Number of participants who had histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies. Histologic regression is defined as disappearance of the high grade lesion (CIN2/3) without surgical intervention. | All participants who received at least one dose of the interventional drug and on whom we have outcomes data. 2 participants did not have data collected for this outcome measure. | Posted | Count of Participants | Participants | 41 weeks |
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41 weeks
All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention.
Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 50 mg Artesunate Suppositories, 1 Cycle | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | 200 mg Artesunate Suppositories, 1 Cycle | Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | 9 | 0 | 9 | 9 | 9 |
| EG002 | 200 mg Artesunate Suppositories,2 Cycles | Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | 10 | 0 | 10 | 8 | 10 |
| EG003 | 200 mg Artesunate Suppositories,3 Cycles | Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories | 0 | 8 | 0 | 8 | 8 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | Ringing in the ear |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Loss in appetite |
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| Salivary duct inflammation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Change in taste |
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| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Flu-like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Vaginal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | bacterial or yeast infections |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Vaginal twitching | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | sensation of movement, unsteadiness |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | painful urination |
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| Uterine cramping | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspareunia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Vaginal dryness | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | pruritus due to dryness |
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| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | light spotting |
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| vaginal inflammation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| vaginal pain/burning | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | eczema |
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| pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | body itching |
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| Vaginal pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cornelia L. Trimble, MD | Johns Hopkins University | 410-502-0512 | CervixDoctor@jhmi.edu |
| Mar 5, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| White |
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| Asian |
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| Hispanic |
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| HPV16 and other genotypes |
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| Non-16 HPV genotypes |
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| OG003 | 200 mg Artesunate Suppositories,3 Cycles | Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
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| OG003 | 200 mg Artesunate Suppositories,3 Cycles | Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories |
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