Overview
Sponsor-declared trial summary
Taxanes-induced peripheral neuropathy
To confirm the local and systemic safety of TAR-0520 Gel applied twice daily to one hand and one foot, in breast cancer patients treated with taxanes.
Key facts
- Sponsor
- Tarian Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Nov 2025 → ongoing
- Decision date (initial)
- 2025-06-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- TARIAN Pharma
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Safety
To confirm the local and systemic safety of TAR-0520 Gel applied twice daily to one hand and one foot, in breast cancer patients treated with taxanes.
Secondary objectives 2
- To explore the preventative effect of TAR-0520 Gel on taxane-induced CIPN
- To explore the preventative effect of TAR-0520 Gel on taxane-induced onycholysis and other nail changes.
Conditions and MedDRA coding
Taxanes-induced peripheral neuropathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10079545 | Chemotherapy induced peripheral neuropathy | 10029205 |
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 breast cancer planned to be treated with weekly infusions of paclitaxel or docetaxel as part of the chemotherapy protocol
Exclusion criteria 4
- Patient already treated with taxanes or other chemotherapies known to induce neuropathies
- Patient with previously diagnosed peripheral neuropathy
- Patient with concomitant therapies known to induce neuropathies
- Patient treated for neuropathic pain
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 1
- Incidence and severity of NCI-CTCAE (Nervous system disorders) grading by oncologist
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
- 2.8 g gram(s)
- Max total dose
- 100.8 g gram(s)
- Max treatment duration
- 36 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- TARIAN PHARMA
- Paediatric formulation
- No
- Orphan designation
- 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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2025-11-05 | 2025-11-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2025-521674-33-00 TC | 2.0 |
| Protocol (for publication) | D1 Protocol_2025-521674-33-00 | 2.0 |
| Recruitment arrangements (for publication) | K1_recruitment arrangement EN | 1.2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangement FR | 1.2 |
| Subject information and informed consent form (for publication) | L1_Patient card_FR | 1 |
| Subject information and informed consent form (for publication) | L1_Patient CIPN Questionnaire | 1.1 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_Patient Nail Toxicity Questionnaire | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult_FR_TC | 2.0 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis FR 2025-521674-33-00 | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-21 | France | Acceptable 2025-06-27
|
2025-06-27 |