Chemotherapy Induced Peripheral NeuropathyPhase 2TARIAN 014NCT07082764
Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy
A Phase 2 study testing Brimonidine gel and No intervantion in people with Chemotherapy Induced Peripheral Neuropathy, run by Tarian Pharma at 1 site in France.
Trial summary
Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy
- What is being tested?
- Brimonidine gel and No intervantion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 15 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, who is at least 18 years of age or older
- Patients with clinical diagnosis of breast cancer
- Patients planned to be treated with paclitaxel or docetaxel
- Patients who can understand and sign the Informed Consent Form
- Patients who can apply the study gel by himself /herself or has a giver that can apply the product.
- Female patients of childbearing potential who agree to use a highly effective method of contraception throughout the study
Who cannot join
- 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
- Patient with comorbid factors known to induce neuropathies (such as Diabetes, Alcoholism, HIV, Peripheral vascular disease, Vitamin B deficiencies)
- Patient currently receiving monoamine oxidase (MAO) inhibitors therapy or patients on antidepressants which affect noradrenergic transmission e.g. tricyclic antidepressants and mianserin (as mentioned in the current topical brimonidine labeling of approved products).
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- Patient who will not be able to follow the protocol for physical or psychological reasons
- Patient with history of skin disorders, significant skin disease, irritated skin or open wounds within the same body areas planned for the IMP application.
- Known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label)
- Female who is pregnant or lactating
- Female who intends to conceive a child during the clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut Paoli-Calmettes
Marseille, 13009
Alexandre Tassin de Nonneville, MD, +33491223333, denonnevillea@ipc.unicancer.fr
Alexandre Tassin de Nonneville, MD,PhD
About this study
Official title: A Phase 2a Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy
Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool temperatures.
This study investigate the preventive effect of TAR-0520 gel on TIPN and on nail toxicity.
Read more
Breast cancer patients under taxanes therapy will apply TAR-0520 Gel to one hand and the homolateral foot including fingers and toes. Other hand and foot will be untreated and will serve as control.
Patients will be followed during the 12 cycles of taxane therapy. Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaires administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of taxane nail toxicity will include a clinical grading by a nurse and a patient questionnaire.
Read the detailed description
This is a Phase 2a, open label, intra-individual study with approximately 30 patients included.
Principal objective of the study is 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 of the study are:
- To explore the preventative effect of TAR-0520 Gel on taxane-induced TIPN,
- To explore the preventative effect of TAR-0520 Gel on taxane-induced onycholysis and other nail changes.
Each patient will receive the active drug candidate TAR-0520 gel for 3 days at each taxane cycle (usually 12 cycles with an infusion every week). During these 3 days, TAR-0520 gel will be applied to one hand and one foot, twice daily, starting the day of taxane infusion and continuing the next two days (thus covering the period when Paclitaxel will be circulating: elimination half-life of the drug is approximately 24 hours).
TAR-0520 gel will be applied by the patients themselves using their dominant hand wearing a glove, patients will apply TAR-0520 gel to the contro-lateral hand and foot. Test product is to be applied to both palmo-plantar and dorsal areas of hand and foot including fingers/toes and the skin surrounding nails. No product is to be applied to the hand and foot on the other side (dominant hand side).
Patients will be included one week before the taxane treatment initiation and followed during the 12 taxane cycles as well as 12 weeks later (follow-up visit). Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaire administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of nail toxicities will include clinical grading by a nurse and a patient questionnaire.
The study will include 17 visits: a Screening visit, 15 evaluations visits and a follow-up visit (Final assessment) that will occur approximately 12 weeks after the last taxane infusion.
Evaluations visits will be conducted one week before the first taxane infusion, the days of taxane infusions, between the 6th and the 7th cycle of taxane infusion, one week after the last taxane infusion and at a follow-up visit, 3 months after the last taxane infusion. This design will allow to assess TIPN progression during treatment as well as persistent TIPN following treatment discontinuation.
- Being tested
- Brimonidine gel, No intervantion
- Keywords
- taxane-induced peripheral neuropathy, taxane-induced nail toxicities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine gelDrug
TAR-0520 gel
No intervantionOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Intra-individual active comparator vs no intervention | Experimental | Tar-0520 gel will be applied to one hand and to homolateral foot ,other hand and foot will be not treated and will serve as control Receives: Drug: Brimonidine gel; Other: No intervantion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment related local adverse events
Treatement related local adverse events inluding erythema, oedema, pruritus
Measured: From Baseline up to the end of 12 taxane perfusions
Secondary outcomes (5)
CTCAE grade of peripheral neuropathy
CTCAE V5.0 Nervous system disorders grading ( Grade 0-5, 0-asymptomatic, 5- death)
Measured: From Baseline up to the end of 12 taxane perfusions
Instrumental objective measures of TIPN - heat thresold
Quantitative sensory testing - heat thresold measurement at each hand and feet
Measured: At Baseline and after 6th and 12th taxane perfusion
Instrumental objective measures of TIPN - cold thresold
Quantitative sensory testing - cold thresold measure on each hand and feet
Measured: At Baseline and after 6th and 12th perfusions
Instrumental objective measures of TIPN - vibration treshold
Quanitative sensory testing - vibration treshold
Measured: At Baseline and after 6th and 12th perfusion
Instrumental objective meeasures of TIPN - electrochemical skin conductance (ESC)
Quantitative skin conductance testing - skin conductance measurements at each hand and feet
Measured: At Baseline and after 6th and 12 perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- intra-individual comparaison
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarian Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janusz M Czernielewski, MD, PhD, Study director, Tarian Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082764
- Sponsor's protocol ID
- TARIAN 014
- Other IDs
- 2025-521674-33-00, 2025
- Acronym
- TARIAN 014
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No