Your session is about to expire
← Back to Search
Microtubule Inhibitor
Tirbanibulin Ointment for Basal Cell Carcinoma
Phase 2
Waitlist Available
Led By Edward Lain, MD, MBA
Research Sponsored by Austin Institute for Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new ointment to treat superficial basal cell carcinoma on the neck, trunk and extremities. It looks at safety and effectiveness.
Who is the study for?
Adults with a single, untreated superficial basal cell carcinoma (sBCC) on the neck, trunk, or limbs (not near hairline or sensitive areas like face/scalp). Participants must be healthy or stable in their condition and willing to avoid sun exposure and certain cosmetics. Women of childbearing age must use effective contraception.
What is being tested?
The trial is testing Tirbanibulin Ointment 1% for treating sBCC. It's an open-label study where all participants receive the ointment to assess its effectiveness and safety when applied to a specific area of the body affected by cancer.
What are the potential side effects?
While not explicitly listed here, potential side effects may include local skin reactions such as redness, itching, irritation at the application site; systemic effects are less common but could involve general symptoms like fatigue if absorbed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete clearance rate of sBCC lesion
Side effects data
From 2019 Phase 3 trial • 351 Patients • NCT0328549013%
Application site pain
11%
Application site pruritus
5%
Viral upper respiratory tract infection
4%
Upper respiratory tract infection
2%
Skin abrasion
2%
Squamous cell carcinoma
2%
Basal cell carcinoma
1%
Dysgeusia
1%
Arrhythmia
1%
Diarrhoea
1%
Non-cardiac chest pain
1%
Pulmonary embolism
1%
Chest pain
1%
Application site inflammation
1%
Influenza
1%
Angular cheilitis
1%
Application site nodule
1%
Chest discomfort
1%
Application site scab
1%
Bronchitis
1%
Carbuncle
1%
Nodule
1%
Application site folliculitis
1%
Onychomycosis
1%
Post procedural infection
1%
Tooth infection
1%
Animal bite
1%
Arthropod bite
1%
Concussion
1%
Contusion
1%
Postoperative wound infection
1%
Face injury
1%
Fall
1%
Laceration
1%
Crystal urine present
1%
Headache
1%
Urobilinogen urine increased
1%
Back pain
1%
Seborrhoeic keratosis
1%
Haemochromatosis
1%
Haemangioma of skin
1%
Malignant melanoma in situ
1%
Melanocytic naevus
1%
Cough
1%
Nasal congestion
1%
Sinus congestion
1%
Hypoaesthesia
1%
Ketonuria
1%
Dermatitis
1%
Actinic keratosis
1%
Skin tightness
1%
Tongue disorder
1%
Blister
1%
Dermatitis contact
1%
Erythema
1%
Lentigo
1%
Rosacea
1%
Scab
1%
Arthrodesis
1%
Bacteriuria
1%
Intervertebral disc degeneration
1%
Myalgia
1%
Glycosuria
1%
Skin ulcer
1%
Food poisoning
1%
Seasonal allergy
1%
Cellulitis
1%
Urinary tract infection
1%
Pyuria
1%
Cardiac murmur
1%
Renal cancer recurrent
1%
Hypertension
1%
Colon cancer
1%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
KX2-391 Ointment 1%
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 5 Day treatment course 2 with Tirbanibulin Ointment 1%Experimental Treatment1 Intervention
Subjects with unresolved lesion will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.
Group II: 5 Day treatment course 1 with Tirbanibulin Ointment 1%Experimental Treatment1 Intervention
10 Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirbanibulin Ointment 1%
2023
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Austin Institute for Clinical ResearchLead Sponsor
5 Previous Clinical Trials
130 Total Patients Enrolled
Edward Lain, MD, MBAPrincipal InvestigatorAustin Institute for Clinical Research
6 Previous Clinical Trials
161 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently been treated with specific medications or therapies.My treatment is for a specific part of my body.I am healthy or have a stable medical condition.I do not have any uncontrolled or serious health conditions.I am postmenopausal, surgically sterile, or using contraception.I have a specific skin condition.I am not pregnant or nursing.I expect to be hospitalized or need surgery during the study.I am 18 years old or older.I am willing and able to sign the consent and HIPAA forms.I have a new skin cancer spot on my neck, trunk, or limbs.The area around my lesion is free from significant physical abnormalities.I am generally healthy or my medical condition is stable.I agree to use barrier methods for contraception.I haven't taken certain medications recently.I am willing to stop using moisturizers, sunscreens, and cosmetics on the treatment area.
Research Study Groups:
This trial has the following groups:- Group 1: 5 Day treatment course 2 with Tirbanibulin Ointment 1%
- Group 2: 5 Day treatment course 1 with Tirbanibulin Ointment 1%
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger