Actinic KeratosisPhase 1NCT02337205
Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis
A Phase 1 study testing KX2-391 Ointment in people with Actinic Keratosis, run by Athenex, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- KX2-391 Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Subject is not lactating
- Subject is willing and able to follow all study instructions and to attend all study visits
- Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)
Who cannot join
- 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
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- 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
- Sunburn; 28 days
- Body art (eg, tattoo, piercing); currently
- Excessive tan; currently
- Subject has a history of sensitivity to any of the ingredients in the study medications
- Subject is chronically taking a known strong inhibitor of CYP3A4
- Subject has a skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the investigator, might interfere with the study conduct or evaluations, or which exposes the subject to an unacceptable risk by study participation.
- Subject has other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the investigator, would expose the patient to unacceptable risk from study participation.
- Subject has participated in an investigational drug trial during which an investigational study medication was administered within 30 days before Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Safety, Tolerability, and Pharmacokinetic Study of KX2 391 Ointment in Subjects With Actinic Keratosis
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.
- Conditions
- Actinic Keratosis
- Being tested
- KX2-391 Ointment
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KX2-391 OintmentDrug
KX2-391 Ointment will be applied at a predetermined concentration to the treatment area for a predetermined time period.
| Study group | Role | What they receive |
|---|---|---|
| KX2-391 Ointment | Experimental | Not described Receives: Drug: KX2-391 Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall safety and tolerability assessment as determined by laboratory, adverse event (AE) and serious adverse event (SAE) information.
Safety assessments will consist of determining and recording all AEs (including for both increasing and decreasing severity) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine analytes; periodic measurement of vital signs and ECGs; and the performance of physical examinations as detailed in Table 3 of the protocol.
Measured: 45 days
The amount of KX2-391 in the blood stream as determined by pharmacokinetic (PK) analysis: Cmax, Cmin, AUC0-t, AUC0-inf
Individual PK data will be listed by time. Cmax, Cmin, AUC0-t, AUC0-inf will be calculated for KX2-391 to determine systemic exposure.
Measured: 7 days
Secondary outcomes (1)
Actinic Keratosis (AK) lesion count
The AK lesion count is the investigator's assessment of the number of AK lesions in the treatment area.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Kramer, MD, Study director, Kinex Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337205
- Sponsor's protocol ID
- KX01-AK-01-US
- Status last verified
- Dec 2016
- First submitted
- 5 Jan 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kempers S, DuBois J, Forman S, Poon A, Cutler E, Wang H, Cutler D, Fang J, Kwan R. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. J Drugs Dermatol. 2020 Nov 1;19(11):1093-1100. doi: 10.36849/JDD.2020.5576.
PubMed 33196758
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Safety, Tolerability, and Pharmacokinetic Study of KX2 391 Ointment in Subjects With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT02337205
- Acronym / sponsor ID
- KX01-AK-01-US
- Conditions
- Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KX2-391 Ointment | Experimental | Drug: KX2-391 Ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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:
- All women of childbearing potential (WOCBP) must be:
- Contraception
Key exclusion criteria (33 listed)
- 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:
- Subject has used any of the following topical therapies on the treatment area within the specified period before Visit 1:
- Subject has had any of the following of the AK therapies on the treatment area:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KX2-391 OintmentKX2-391 Ointment will be applied at a predetermined concentration to the treatment area for a predetermined time period. | Drug | KX2-391 Ointment |
Primary outcome
Overall safety and tolerability assessment as determined by laboratory, adverse event (AE) and serious adverse event (SAE) information.
Time frame: 45 days
Safety assessments will consist of determining and recording all AEs (including for both increasing and decreasing severity) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine analytes; periodic measurement of vital signs and ECGs; and the performance of physical examinations as detailed in Table 3 of the protocol.
The amount of KX2-391 in the blood stream as determined by pharmacokinetic (PK) analysis: Cmax, Cmin, AUC0-t, AUC0-inf
Time frame: 7 days
Individual PK data will be listed by time. Cmax, Cmin, AUC0-t, AUC0-inf will be calculated for KX2-391 to determine systemic exposure.
1 secondary outcome
Actinic Keratosis (AK) lesion count
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 33196758Kempers S, DuBois J, Forman S, Poon A, Cutler E, Wang H, Cutler D, Fang J, Kwan R. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. J Drugs Dermatol. 2020 Nov 1;19(11):1093-1100. doi: 10.36849/JDD.2020.5576.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Kramer, MD study director
Kinex Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KX2-391 Ointment in people with Actinic Keratosis, run by Athenex, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall safety and tolerability assessment as determined by laboratory, adverse event (AE) and serious adverse event (SAE) information. (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02337205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.