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Trial record 3 of 4 for:    sor007

Study of SOR007 Ointment for Actinic Keratosis

This study is currently recruiting participants.
Verified June 2017 by DFB Soria, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03083470
First Posted: March 20, 2017
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
DFB Soria, LLC
  Purpose
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.

Condition Intervention Phase
Actinic Keratosis Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment Other: SOR007 Ointment Vehicle Phase 2

Study Type: Interventional
Study Design: 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
Official Title: Phase 2 Dose-Rising Study of SOR007 Ointment for Actinic Keratosis

Resource links provided by NLM:


Further study details as provided by DFB Soria, LLC:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events [ Time Frame: 56 days ]
    Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.


Secondary Outcome Measures:
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of SOR007 [ Time Frame: 28 days ]
    Pharmacokinetic (PK) samples will be 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.

  • Pharmacokinetics: Peak plasma concentration (Cmax) of SOR007 [ Time Frame: 28 days ]
    Pharmacokinetic (PK) samples will be 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.

  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of SOR007 [ Time Frame: 28 days ]
    Pharmacokinetic (PK) samples will be 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.

  • Reduction in number of AK lesions [ Time Frame: Baseline and 56 days ]
    AK lesions in the target test field will be photographed and tracings will be created at baseline and at subsequent visits to track whether lesions are clear or still present.


Estimated Enrollment: 32
Actual Study Start Date: May 18, 2017
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOR007 0.15%
SOR007 Ointment 0.15% applied to the face twice daily for 28 days
Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
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.
Experimental: SOR007 0.3%
SOR007 Ointment 0.3% applied to the face twice daily for 28 days
Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
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.
Experimental: SOR007 1.0%
SOR007 Ointment 1.0% applied to the face twice daily for 28 days
Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
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.
Experimental: SOR007
SOR007 Ointment 2.0% applied to the face twice daily for 28 days
Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
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.
Sham Comparator: Ointment Vehicle
SOR007 Ointment vehicle applied to the face twice daily for 28 days
Other: SOR007 Ointment Vehicle
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083470


Contacts
Contact: Leanne Drummond 805-595-1300 leanne.drummond@usbiotest.com
Contact: Gere diZerega, MD 805-595-1300 gere.dizerega@usbiotest.com

Locations
United States, Florida
Moore Clinical Research Recruiting
Tampa, Florida, United States, 33609
Contact: Jared Myerly, BS, CCRP    813-948-7550 ext 402      
Principal Investigator: Reginold Simmons, MD         
Sponsors and Collaborators
DFB Soria, LLC
US Biotest, Inc.
Investigators
Study Director: Leanne Drummond US Biotest
  More Information

Responsible Party: DFB Soria, LLC
ClinicalTrials.gov Identifier: NCT03083470     History of Changes
Other Study ID Numbers: SOR007-2017-04
First Submitted: March 14, 2017
First Posted: March 20, 2017
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms