Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis

Completed · Phase 1

Conditions studied: Actinic Keratosis

In brief

This is a phase 1 study to access the safety and tolerability of KX2-391 ointment in subjects who have Actinic Keratosis. This study will also access the amount of KX2-391 drug that enters the blood stream through dermal application of the ointment.

Key facts

Study ID

NCT02337205

Run by

Athenex, Inc.

People needed

29

Starts

2014-12-01

Expected to finish

2016-03-01

Last updated by the study team

2018-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is at least 18 years old
• Subject has a clinical diagnosis of stable, clinically typical AK
• Subject has a treatment area on 1 dorsal forearm that in:
• Cohort 1:
• Is one contiguous area
• Measures 25 cm2
• Contains 4 to 8 AK lesions that are clinically typical.
• Cohort 2:
• Is one contiguous area
• Measures 100 cm2
• Contains 8 to 16 AK lesions that are clinically typical.
• All women of childbearing potential (WOCBP) must be:
• Post-menopausal, defined as at least 50 years of age with amenorrhea for at least 18 months, or
• Surgically sterile, defined as having undergone a hysterectomy, bilateral oophorectomy or tubal ligation, or otherwise incapable of pregnancy.
• Pre or perimenopausal and practicing a highly effective method of birth control, including hormonal prescription, oral contraceptives, contraceptive injections, contraceptive patch, and intrauterine device, for the duration of their participation in the study. Abstinence and double-barrier methods do not qualify as highly effective methods of birth control.
• All woman of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2) prior to administration of KX2-391 Ointment dose.
• Contraception
• Contraception must be consistently used for at least 3 months prior to screening to 3 months after the last KX2-391 Ointment dose.
• Male Contraception: All men who are sexually active with female partners of child bearing potential must agree to ensure their partners use highly effective contraception and therefore will not father a child from screening to 3 months after the last dose of study medication.
• Male and Female Contraception: All men and women subjects must agree to not donate sperm or eggs or attempt conception from screening to 3 months after the last KX2-391 Ointment dose.
• Subject is, in the opinion of the investigator, in good general health based on medical history, physical examination, electrocardiogram (ECG), and clinical laboratory evaluations at screening.
• Subject has clinically acceptable liver function at screening as demonstrated by:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2x upper limit of normal (ULN)
• Total bilirubin ≤ ULN
• No other screening laboratory test, including CBC results, considered clinically significant by the investigator

You may not qualify if…

• Subject has clinically atypical and/or rapidly changing AK lesions on the treatment area
• Subject has current systemic malignancy
• Subject has used any of the following systemic therapies within the specific period before Visit 1:
• Retinoids; 180 days
• Glucocortico-steroids; 28 days
• Methotrexate or other anti-metabolites; 28 days
• Subject has used any of the following topical therapies on the treatment area within the specified period before Visit 1:
• Retinoids; 90 days
• Glucocortico-steroids; 14 days
• Subject has had any of the following of the AK therapies on the treatment area:
• Medical Therapies within 90 days (or until the site has healed, whichever is longer) before Visit 1:
• Ingenol mebutate (eg, Picato)
• 5-fluorouracil (eg, 5-FU; Efudex)
• Imiquimod (eg, Aldara; Zyclara)
• Diclofenac with or without hyaluronic acid (eg, Solaraze)
• Moisturizer, emollients (12 hours prior to Visit 1)
• Surgical Modalities on the treatment area within 30 days (or until the site has healed following treatment, whichever is longer) before Visit 1:
• Cryotherapy
• Electrodesiccation
• Laser, light (eg, photodynamic therapy, intense pulsed light) or any other energy based therapy
• Chemical peels (eg, tricholoracetic acid)
• Dermabrasion
• Surgical removal (eg, curettage, excision)
• Subject currently has, or has experienced any of the following on the treatment area within the specified period before Visit 1:
• A cutaneous malignancy; 180 days

Where it is running

• DermResearch, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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