Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

NCT06112522 | Recruiting Phase 2

• 1 other identifier: 23-PP-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

his is a Phase 2, Single-Arm, Open-Label, Single Center, to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) not arising on the face or scalp

Conditions

Cell Carcinoma

Keywords

TIRBANIBULIN

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  IMC

  up to 17 months

Secondary Outcomes (3)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  up to 17 months

• Number of Participants With complete remission

  After the treatment at 17 months

• Number of participants with sBCC thickness.

  Baseline visit

Study Arms (1)

Experimental : 5 Day treatment course 1 with Tirbanibulin Ointment 1%

EXPERIMENTAL

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. Subjects with unresolved lesion at d28 or d56 or d72 or d84 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.

Drug: Tirbanibulin

Interventions

Tirbanibulin DRUG

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. Subjects with unresolved lesion at d28 or d56 or d72 or d84 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.

Also known as: Tirbaso

Experimental : 5 Day treatment course 1 with Tirbanibulin Ointment 1%

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Histologically confirmed,
• primary, previously untreated,
• superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis)

You may not qualify if:

• BCC of the face or scalp
• BCC of non-superficial subtype
• BCC with large axis \> 15mm
• Relapsing BCC
• Allergy to treatment
• Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the BCC area during the 6 months prior to the screening visit

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, 06200, France

RECRUITING

MeSH Terms

Interventions

tirbanibulin

Study Officials

• philippe Bahadoran, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Bahadoran, PhD

CONTACT

+33492036223; bahadoran.p@chu-nice.fr

Henri Montaudie, PhD

CONTACT

+33492036223

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-Arm, Open-Label, Single Center

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 1, 2023
• Study Start: February 16, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)