Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
60
Countries
1
Sites
11
EGFR inhibitor-induced folliculitis
To confirm the good local tolerance of TAR-0520 gel applied to the face and chest of colorectal cancer patients treated with anti-EGFR antibodies
Key facts
- Sponsor
- Tarian Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 10 Feb 2025 → ongoing
- Decision date (initial)
- 2024-11-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- TARIAN Pharma
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Prophylaxis
To confirm the good local tolerance of TAR-0520 gel applied to the face and chest of colorectal cancer patients treated with anti-EGFR antibodies
Secondary objectives 1
- To explore the preventive efficacy of topically applied TAR-0520 gel on the EGFR inhibitor-induced folliculitis
Conditions and MedDRA coding
EGFR inhibitor-induced folliculitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | LLT | 10058163 | Papuloerythematous drug eruption | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Male or female, who is at least 18 years of age or older at screening visit
- Clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol
Exclusion criteria 2
- Patient with a medical history of EGFRi treatment in the past two years
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
Secondary endpoints 3
- Modified folliculitis CTCAE
- Facial folliculitis severity score
- Modified FACT-EGFRI-18 questionnaire
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11643666 · Product
- Active substance
- Brimonidine Tartrate
- Pharmaceutical form
- GEL
- Route of administration
- TOPICAL USE
- Max daily dose
- 1.60 g gram(s)
- Max total dose
- 44.80 g gram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- TARIAN PHARMA
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
TAR-0520 gel matching vehicle without active ingredients
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tarian Pharma
- Sponsor organisation
- Tarian Pharma
- Address
- 4 Traverse Dupont
- City
- Grasse
- Postcode
- 06130
- Country
- France
Scientific contact point
- Organisation
- Tarian Pharma
- Contact name
- Janusz Czernielewski
Public contact point
- Organisation
- Tarian Pharma
- Contact name
- Janusz Czernielewski
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 60 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Digestive oncology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire Reims
Gastroentérologie - Cancérologie digestive, Rue Du General Koenig, 51092, Reims Cedex
Centre Antoine Lacassagne
Medical oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Paoli Calmettes
Medical oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Assistance Publique Hopitaux De Paris
Digestive oncology, 20 Rue Leblanc, 75015, Paris
Hopital Prive Jean Mermoz
Gastroenterology and gastrointestinal oncology, 55 Avenue Jean Mermoz, 69008, Lyon
Sainte Catherine Institut Du Cancer Avignon-Provence
Medical oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Hopital Europeen Marseille
Ocnco-digestif, 6 Rue Desiree Clary, 13003, Marseille
Hopital Saint Joseph
Medical oncology, 26 Boulevard De Louvain, 13008, Marseille
Centre azureen de cancerologie
Oncology, 1 Place Du Docteur Jean Luc Broquerie, 06250, Mougins
Groupe Hospitalier Saint Vincent
Oncology, 182 Route De La Wantzenau, 67000, Strasbourg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-02-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516339-28-00 | 3.1 |
| Protocol (for publication) | D1_Protocol 2024-516339-28-00_TC | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and CIF_FR TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_EN | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_FR | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_EN TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2024-516339-28-00 | 1.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2024-516339-28-00 | 1.4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN 2024-516339-28-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-516339-28-00 | 1.3 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | France | Acceptable with conditions 2024-11-07
|
2024-11-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-14 | France | Acceptable with conditions | 2024-12-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-09 | France | Acceptable with conditions | 2025-05-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-24 | France | Acceptable with conditions | 2025-08-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-26 | France | Acceptable with conditions | 2026-03-13 |