Study of SOR007 Ointment for Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment; SOR007 Ointment Vehicle
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 33.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Men and women with actinic keratosis.

          -  Age 45-85.

          -  Women who have had surgical sterilization or are post-menopausal (absence of menses
             for at least one year) are eligible. Women of child-bearing potential who are
             non-pregnant, non-nursing, and willing to avoid pregnancy during the course of the
             study and during the menstrual cycle following completion of their participation in
             the study are eligible. (Adequate contraception is defined as regular use of diaphragm
             with condoms, IUD with condoms, or systemic contraceptives if used for at least three
             months prior to enrollment in the study.) A negative pregnancy test is required as an
             entry criteria. Women must continue to use the method of contraceptive for at least 30
             days after the last administration of study drug.

          -  Male subjects must agree to sexual abstinence or use adequate contraception when
             sexually active in combination with their female partners, if they are of childbearing
             potential. That means the volunteer must be vasectomized or use a condom and his
             female partner must either be surgically sterile (hysterectomy or tubal ligation) or
             agree to use a reliable method of contraception with a failure rate of less than 1%
             per year when used consistently and correctly such as implants, injectables, combined
             oral contraceptives, or non-DalKon Shield IUDs. This applies from signing of informed
             consent form until 90 days after the last study drug administration. Methods of
             contraception must have been effective for at least 30 days on the day of signing of
             informed consent. Male volunteers must also refrain from sperm donation from the time
             of singing informed consent form until 90 days after the last study drug
             administration.

          -  Presence of 4-8 AK lesions total in a 25 cm2 area identified on the face through
             transparency mapping and photographs. The face area will be defined from hair line to
             jaw line. The scalp will not be included. An imaginary normal hair line will be the
             upper boundary for bald men.

          -  Able to refrain from the use of all other topical medications to the facial area
             during the treatment period.

          -  Considered reliable and capable of understanding their responsibility and role in the
             study.

        Exclusion Criteria:

          -  History of allergy or hypersensitivity to paclitaxel.

          -  Lesions that are thicker than 1 mm or larger than 9 mm will not be included in the
             lesion counts.

          -  Lesions suspicious for squamous cell carcinoma, basal cell carcinoma, or melanoma will
             not be included in lesion counts and cannot be in the 25 cm2 area of treatment.

          -  Abnormal pre-existing dermatologic conditions which might affect the normal course of
             the disease (e.g. albinism or chronic vesiculobullous disorders).

          -  Positive urine pregnancy test in women of child-bearing potential.

          -  Inability to use adequate birth control measures for men or women of child-bearing
             potential, as defined above.

          -  Serious psychological illness.

          -  Significant history within the past year of alcohol or drug abuse.

          -  During the 30 day period preceding study entry: Participating in any clinical
             research; using topical paclitaxel for AK; using any other topical agents including
             but not limited to actinex, glycolic acid products, alpha-hydroxy acid products, and
             chemical peeling agents for the treatment of AK; using any systemic steroids or
             topical corticosteroids, having cryosurgery.

          -  Use of sun lamps or sun tanning beds or booths during the 2 weeks prior to first
             application and until final visit.

          -  Prior treatment with systemic paclitaxel or systemic cancer therapy within 6 months of
             study entry.

          -  Medical history which, based on the clinical judgment of the Investigator implied an
             unlikelihood of successful completion of the study.