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| Name | Class |
|---|---|
| US Biotest, Inc. | INDUSTRY |
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A Phase 2, randomized, double-blind, dose rising study to determine the safety, tolerability, and preliminary efficacy of four concentrations of SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment (SOR007) compared to SOR007 ointment vehicle applied to actinic keratosis (AK) lesions on the face twice daily for up to 28 days.
In this Phase 2, randomized, double-blind, dose rising trial, subjects with actinic keratosis will receive topical application of SOR007 Ointment (in four concentrations) or SOR007 Ointment vehicle to the face twice daily for up to 28 days. Subjects will be enrolled in four dose-escalating cohorts of eight subjects and randomized to SOR0007 or Ointment vehicle in a ratio of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration.
Safety will be assessed in an ongoing manner and formal safety reviews will be conducted four times for each cohort: at Day 8, Day 15, Day 21, and Day 28 for the last subject enrolled in each cohort. The next dose level cohort will enroll upon a finding of safety and tolerability at the previous cohort's second (Day 15) safety review.
The safety and tolerability of SOR007 will be demonstrated by local toxicity, adverse events, laboratory assessments and vital signs. Subjects will be observed for reduction in the number of AK lesions to determine preliminary efficacy. Plasma samples will be taken at various time points throughout the study to characterize the pharmacokinetics of SOR007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOR007 0.15% | Experimental | SOR007 Ointment 0.15% applied to the face twice daily for 28 days |
|
| SOR007 0.3% | Experimental | SOR007 Ointment 0.3% applied to the face twice daily for 28 days |
|
| SOR007 1.0% | Experimental | SOR007 Ointment 1.0% applied to the face twice daily for 28 days |
|
| SOR007 | Experimental | SOR007 Ointment 2.0% applied to the face twice daily for 28 days |
|
| Ointment Vehicle | Sham Comparator | SOR007 Ointment vehicle applied to the face twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment | Drug | SOR007 will be applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolve. The maximum total amount of SOR007 that will be applied daily will be 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, will be treated. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Treatment emergent adverse events including all reported adverse events, laboratory assessments, physical examination findings, and vital signs. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of SOR007 | Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne Drummond | US Biotest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moore Clinical Research | Tampa | Florida | 33609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SOR007 0.15% | SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| FG001 | SOR007 0.3% | SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| FG002 | SOR007 1.0% | SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| FG003 | SOR007 2.0% | SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| FG004 | Ointment Vehicle | SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SOR007 0.15% | SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Treatment Emergent Adverse Events | Treatment emergent adverse events including all reported adverse events, laboratory assessments, physical examination findings, and vital signs. | Posted | Count of Participants | Participants | 56 days |
|
56 Days
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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 | SOR007 0.15% | SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gere diZerega, MD; President & CEO | US Biotest, Inc. | 805-595-1300 | gere.dizerega@usbiotest.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2017 | Sep 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2018 | Sep 27, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Phase 2, randomized, dose-rising, double-blind trial. Subjects will enroll in four dose-escalating cohorts of eight subjects each. Each cohort will be randomized to SOR007 or Ointment vehicle in a ratio of 3:1. Safety will be assessed in an ongoing manner and formal safety reviews will be conducted four times for each cohort: at Day 8, Day 15, Day 21, and Day 28 for the last subject enrolled in each cohort. The next dose level cohort will enroll upon a finding of safety and tolerability at the previous cohort's second safety review. Once the last cohort has completed the study, all available data, including safety, pharmacokinetics, and preliminary efficacy will be analyzed. The PK blood samples will be analyzed per cohort when the last subject of each cohort completes Day 28.
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|
| SOR007 Ointment Vehicle | Other | SOR007 ointment vehicle will be applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolve. The maximum total amount of Ointment vehicle that will be applied daily will be 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, will be treated. |
|
| Pharmacokinetics: Peak Plasma Concentration (Cmax) of SOR007 |
Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application. |
| 28 days |
| Pharmacokinetics: Time at Which Peak Plasma Concentration is Observed (Tmax) of SOR007 | Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application. | 28 days |
| Percent Change in Number of AK Lesions | AK lesions in the target test field were photographed and tracings were created at baseline and at subsequent visits to track whether lesions were clear or still present. | Baseline and 56 days |
| Percent Change in Size of AK Lesions | Percent change in size of AK lesions was determined with measurements obtained at Baseline and 56 days. A measurement was also obtained at Day 28, but was not used to calculated percent change for the purposes of this outcome measure. | Baseline and 56 days |
| Withdrawal by Subject |
|
| BG001 |
| SOR007 0.3% |
SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| BG002 | SOR007 1.0% | SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| BG003 | SOR007 2.0% | SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| BG004 | Ointment Vehicle | SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | SOR007 1.0% | SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| OG003 | SOR007 2.0% | SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
| OG004 | Ointment Vehicle | SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. |
|
|
| Secondary | Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of SOR007 | Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application. | Posted | Mean | Standard Deviation | pg·hr/mL | 28 days |
|
|
|
| Secondary | Pharmacokinetics: Peak Plasma Concentration (Cmax) of SOR007 | Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application. | Posted | Mean | Standard Deviation | pg/mL | 28 days |
|
|
|
| Secondary | Pharmacokinetics: Time at Which Peak Plasma Concentration is Observed (Tmax) of SOR007 | Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application. | Posted | Mean | Standard Deviation | hr | 28 days |
|
|
|
| Secondary | Percent Change in Number of AK Lesions | AK lesions in the target test field were photographed and tracings were created at baseline and at subsequent visits to track whether lesions were clear or still present. | Two subjects, both receiving Vehicle, were withdrawn early from the study; one of these subjects participated long enough to be included in the analysis of the efficacy endpoint and one did not. Therefore, there are 8 subjects in the Ointment Vehicle arm of the study. | Posted | Mean | Standard Deviation | Percent Change | Baseline and 56 days |
|
|
|
| Secondary | Percent Change in Size of AK Lesions | Percent change in size of AK lesions was determined with measurements obtained at Baseline and 56 days. A measurement was also obtained at Day 28, but was not used to calculated percent change for the purposes of this outcome measure. | Two subjects, both receiving Vehicle, were withdrawn early from the study; one of these subjects participated long enough to be included in the analysis of the efficacy endpoint and one did not. Therefore, there are 8 subjects in the Ointment Vehicle arm of the study. | Posted | Mean | Standard Deviation | Percent Change | Baseline and 56 days |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | SOR007 0.3% | SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | SOR007 1.0% | SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | SOR007 2.0% | SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Ointment Vehicle | SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. | 0 | 9 | 0 | 9 | 1 | 9 |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Breast Pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |