Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

SOR007 Ointment 0.15% applied to the face twice daily for 28 days

SOR007 Ointment 0.3% applied to the face twice daily for 28 days

SOR007 Ointment 1.0% applied to the face twice daily for 28 days

SOR007 Ointment 2.0% applied to the face twice daily for 28 days

SOR007 Ointment vehicle applied to the face twice daily for 28 days

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.

SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment

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.

SOR007 Ointment Vehicle

Leanne Drummond

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.

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.

Study of SOR007 Ointment for Actinic Keratosis

Phase 2 Dose-Rising Study of SOR007 Ointment for Actinic Keratosis

Treatment emergent adverse events including all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

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.

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.

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.

US Biotest, Inc.

DFB Soria, LLC

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.

SOR007 0.15%

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.

SOR007 0.3%

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.

SOR007 1.0%

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.

SOR007 2.0%

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.

Ointment Vehicle

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Gere diZerega, MD; President & CEO

Number of Participants With Treatment Emergent Adverse Events

Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of SOR007

Pharmacokinetics: Peak Plasma Concentration (Cmax) of SOR007

Pharmacokinetics: Time at Which Peak Plasma Concentration is Observed (Tmax) of SOR007

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.

Percent Change in Number of AK Lesions

Percent Change in Size of AK Lesions

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma in Situ

Uterine Cervical Dysplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

1 mL of SOR007 applied topically to the ectocervix once-weekly for four weeks.

Karen K McCune, MD, PhD

Lisa Rahangdale, MD, MPH

This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN).

In this Phase 2, open-label, dose-rising study, subjects with high grade (CIN 2 or 3) CIN will receive once-weekly topical application of SOR007 ointment to the ectocervix for four weeks. Subjects will be enrolled in three dose-escalating cohorts of three subjects assigned consecutively to receive 0.15%, 1.0%, or 2.0% SOR007 ointment. At the final study visit (Visit 7) subjects will undergo an excision or punch biopsy to record the stage of CIN. PK samples will be obtained post-application on Day 0 at 1, 2, 4, 6, and 24 hours' post-application on Day 1. Additional PK samples will be collected at each visit. Plasma samples for PK analysis on Days 7, 14 and 21 will be collected prior to SOR007 application.

The Medical Monitor will review all available data prior to dose escalation. Dose-escalation of SOR007 will be determined by the Medical Monitor. This will be repeated for each escalated dose until all dose levels have been enrolled or a dose is determined unsafe. Safety will be assessed in an ongoing manner and formal safety reviews will be conducted twice for each cohort: after Day 14 and after Day 49 of the last subject in the cohort. If a safety or tolerability issue becomes apparent in a cohort, an additional three subjects will be enrolled at that dose level, for a maximum of six subjects in that cohort. If ≥ 1 safety or tolerability issue occurs in the additional 3 subjects, the prior dose-level will be determined to be the highest dose with an acceptable safety and tolerability profile. If no further safety and tolerability issues are identified in the expanded cohort, dose-escalation will continue.

Once the highest dose with an acceptable safety and tolerability profile has been determined by the Medical Monitor, PI, and Sponsor Medical Director, a further 3 subjects will be enrolled to that dose level in order to increase the subject numbers.

Phase 2, open-label, dose-rising trial. Subjects will enroll in three dose-rising cohorts of three subjects each. he next dose level cohort will enroll upon a finding of safety and tolerability at the previous cohort's first safety review. If a safety or tolerability issue arises in the first three subjects of a cohort, an additional three subjects will be enrolled at the same dose level. If ≥ 1 of the same safety and tolerability issue recurs in the additional 3 subjects, the prior dose-level will be determined to be the highest dose with an acceptable safety and tolerability profile. If no further safety and tolerability issues are identified in the expanded cohort, dose-escalation will continue.

Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)

Phase 2a Dose-Rising, Safety, Tolerability, and Efficacy Study of Topical SOR007 for Cervical Intraepithelial Neoplasia (CIN)

Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

Plasma samples for pharmacokinetic (PK) analysis will be obtained on Day 0 at 1, 2, 4, and 6 hours post-application, at 24 hours' post-application (Day 1), and at each subsequent clinic visit (samples on Days 7, 14, and 21 will be obtained prior to dose application).

Colposcopic changes as defined by the modified Reid Colposcopic Index (RCI) and confirmed by biopsy histology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of SOR007 Ointment for Actinic Keratosis	NCT03083470	Actinic Keratos...	SOR007 (Uncoate... SOR007 Ointment...	45 Years - 85 Years	DFB Soria, LLC
Study of SOR007 Ointment for Actinic Keratosis	NCT03083470	Actinic Keratos...	SOR007 (Uncoate... SOR007 Ointment...	45 Years - 85 Years	DFB Soria, LLC
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)	NCT03143491	Cervical Intrae...	SOR007 (Uncoate...	18 Years -	DFB Soria, LLC

Spots Global Cancer Trial Database for sor007 (uncoated nanoparticulate paclitaxel) ointment