Clinical trial • Phase II • Neurology

Brimonidine tartrate for Taxanes-induced peripheral neuropathy|Chemotherapy-induced peripheral neuropathy

Phase II trial of Brimonidine tartrate for Taxanes-induced peripheral neuropathy|Chemotherapy-induced peripheral neuropathy. 30 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Taxanes-induced peripheral neuropathy|Chemotherapy-induced peripheral neuropathy
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-03-2025
First CTIS Authorization Date
27-06-2025

Trial design

Phase II trial in France.

Target Sample Size
30

Eligibility

Recruits 30 No vulnerable population selected (isVulnerablePopulationSelected: false); participants are adults (at least 18 years). Informed consent documents available (e.g. 'L1_SIS and ICF_Adult_FR', 'L1_SIS and ICF_Adult_FR_TC', patient instructions and questionnaires listed among documents). No assent process described..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false); participants are adults (at least 18 years). Informed consent documents available (e.g. 'L1_SIS and ICF_Adult_FR', 'L1_SIS and ICF_Adult_FR_TC', patient instructions and questionnaires listed among documents). No assent process described.

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 breast cancer planned to be treated with weekly infusions of paclitaxel or docetaxel as part of the chemotherapy protocol"}

Exclusion criteria

  • {"criterion_text":"- Patient already treated with taxanes or other chemotherapies known to induce neuropathies"}
  • {"criterion_text":"- Patient with previously diagnosed peripheral neuropathy"}
  • {"criterion_text":"- Patient with concomitant therapies known to induce neuropathies"}
  • {"criterion_text":"- Patient treated for neuropathic pain"}

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":"- Incidence and severity of NCI-CTCAE (Nervous system disorders) grading by oncologist","definition_or_measurement_approach":"Grading by oncologist using NCI-CTCAE (Nervous system disorders)"}

Recruitment

Planned Sample Size
30
Recruitment Window Months
12
Consent Approach
Informed consent obtained from adult participants (18+). Subject information and informed consent forms available in French (documents include 'L1_SIS and ICF_Adult_FR' and 'L1_SIS and ICF_Adult_FR_TC', patient instructions 'L1_Patient instructions_FR'). No assent or paediatric consent described.

Geography

Total Number Of Sites
1
Total Number Of Participants
30

France

Earliest CTIS Part Ii Submission Date
14-05-2025
Latest Decision Or Authorization Date
27-06-2025
Processing Time Days
44
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Institut Paoli Calmettes
Department Name
Medical oncology
Contact Person Name
Alexandre TASSIN DE NONNEVILLE
Contact Person Email
denonnevillea@ipc.unicancer.fr
Number Of Participants
30

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 (gel)
Route
Topical
Frequency
Applied twice daily
Maximum Dose
2.8 g per day

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