Study of SOR007 Ointment for Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment; SOR007 Ointment Vehicle
Intervention type(s): Drug; Other
Intervention description(s): 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 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.
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment