Clinical trial • Phase II • Dermatology|Oncology

Brimonidine tartrate for EGFR inhibitor-induced folliculitis|Metastatic colorectal carcinoma

Phase II trial of Brimonidine tartrate for EGFR inhibitor-induced folliculitis|Metastatic colorectal carcinoma.

Overview

Trial Therapeutic Area
Dermatology|Oncology
Trial Disease
EGFR inhibitor-induced folliculitis|Metastatic colorectal carcinoma
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-07-2024
First CTIS Authorization Date
13-11-2024

Trial design

TAR-0520 gel matching vehicle without active ingredients (placebo vehicle) and TAR-0520 Gel (active). Dose details for TAR-0520 Gel: topical gel, max daily dose 1.60 g, max total dose 44.80 g, max treatment period 28 days. (No formal comparator dosing schedule beyond these product-level details provided.)-controlled Phase II trial across 11 sites in France.

Comparator
TAR-0520 gel matching vehicle without active ingredients (placebo vehicle) and TAR-0520 Gel (active). Dose details for TAR-0520 Gel: topical gel, max daily dose 1.60 g, max total dose 44.80 g, max treatment period 28 days. (No formal comparator dosing schedule beyond these product-level details provided.)
Target Sample Size
60
Trial Duration For Participant
28

Eligibility

Recruits 60 No vulnerable populations selected; only adults (participants must be at least 18 years old). Subject information and informed consent forms for adults are included in the trial documentation (English and French versions available)..

Vulnerable Population
No vulnerable populations selected; only adults (participants must be at least 18 years old). Subject information and informed consent forms for adults are included in the trial documentation (English and French versions available).

Inclusion criteria

  • {"criterion_text":"- Male or female, who is at least 18 years of age or older at screening visit"}
  • {"criterion_text":"- Clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol"}

Exclusion criteria

  • {"criterion_text":"- Patient with a medical history of EGFRi treatment in the past two years"}
  • {"criterion_text":"- Patient has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or history of illness that, in the opinion of the Investigator, would confound results of the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Modified folliculitis CTCAE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Facial folliculitis severity score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Modified FACT-EGFR-18 questionnaire","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
60
Recruitment Window Months
23
Consent Approach
Informed consent obtained from adult participants (participants must be ≥18 years). Subject information and informed consent forms available in English and French (documented as L1_SIS and ICF adult_EN and FR in the dossier).

Geography

Total Number Of Sites
11
Total Number Of Participants
60

France

Earliest CTIS Part Ii Submission Date
05-09-2024
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
554
Number Of Sites
11
Number Of Participants
60

Sites

Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Medical oncology
Contact Person Name
May MABRO
Contact Person Email
m.mabro@isc84.org
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Gastroentérologie - Cancérologie digestive
Contact Person Name
Olivier Bouché
Contact Person Email
obouche@chu-reims.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Digestive oncology
Contact Person Name
Julien TAIEB
Contact Person Email
Julien.taieb@aphp.fr
Site Name
Centre Antoine Lacassagne
Department Name
Medical oncology
Contact Person Name
Ludovic EVESQUE
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Digestive oncology
Contact Person Name
Denis Smith
Contact Person Email
denis.smith@chu-bordeaux.fr
Site Name
Hopital Prive Jean Mermoz
Department Name
Gastroenterology and gastrointestinal oncology
Contact Person Name
Pascal ARTRU
Contact Person Email
dr.artru@wanadoo.fr
Site Name
Institut Paoli Calmettes
Department Name
Medical oncology
Contact Person Name
Emmanuel MITRY
Contact Person Email
mitryje@ipc.unicancer.fr
Site Name
Hopital Europeen Marseille
Department Name
Ocnco-digestif
Contact Person Name
Nicolas BARRIERE
Contact Person Email
n.barriere@hopital-europeen.fr
Site Name
Hopital Saint Joseph
Department Name
Medical oncology
Contact Person Name
Olivier MSIKA
Contact Person Email
omsika@hopital-saint-joseph.fr
Site Name
Centre azureen de cancerologie
Department Name
Oncology
Contact Person Name
Angélique SAINT
Contact Person Email
a.saint@cac-mougins.fr
Site Name
Groupe Hospitalier Saint Vincent
Department Name
Oncology
Contact Person Name
Louis Marie Dourthe
Contact Person Email
lmdourthe-rc@solcrr.org

Sponsor

Primary sponsor

Full Name
Tarian Pharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
TAR-0520 Gel
Active Substance
Brimonidine tartrate
Modality
Small molecule
Routes Of Administration
TOPICAL USE
Route
Topical
Authorisation Status
euMpNumber PRD11643666 (prodAuthStatus: 1)
Maximum Dose
1.60 g daily (max total 44.80 g over treatment period)
Investigational Product Name
TAR-0520 gel matching vehicle without active ingredients
Modality
Other
Authorisation Status
authorisationCountryCode: IS (no active substance)

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