Clinical trial • Phase II • Dermatology
BRIMONIDINE TARTRATE for Capecitabine-induced hand and foot syndrome | Hand-foot syndrome (palmar-plantar erythrodysesthesia)
Phase II trial of BRIMONIDINE TARTRATE for Capecitabine-induced hand and foot syndrome | Hand-foot syndrome (palmar-plantar erythrodysesthesia).
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Capecitabine-induced hand and foot syndrome | Hand-foot syndrome (palmar-plantar erythrodysesthesia)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-11-2025
- First CTIS Authorization Date
- 16-02-2026
Trial design
None/Not specified-controlled Phase II trial across 1 site in France.
- Comparator
- None/Not specified
- Target Sample Size
- 25
Eligibility
Recruits 25 No vulnerable population selected; study enrols adults (≥18 years). Standard informed consent from participants is indicated; no special assent or vulnerable-population measures are specified in the record..
- Vulnerable Population
- No vulnerable population selected; study enrols adults (≥18 years). Standard informed consent from participants is indicated; no special assent or vulnerable-population measures are specified in the record.
Inclusion criteria
- {"criterion_text":"- Male or female, who is at least 18 years of age or older at screening visit"}
- {"criterion_text":"- Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine monotherapy, either in adjuvant/neoadjuvant or palliative setting"}
- {"criterion_text":"- Starting capecitabine at a dose ≥ 1000 mg/ m² twice daily every 2 out of 3 weeks as single-agent chemotherapy"}
Exclusion criteria
- {"criterion_text":"- Patient with a medical history of capecitabine treatment"}
- {"criterion_text":"- Patient with pre-existing grade 2 or higher neuropathy confounding assessment of HFS"}
- {"criterion_text":"- Patient with Raynaud’s syndrome or other vascular peripheral disorders"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events","definition_or_measurement_approach":"Not specified in the record"}
Secondary endpoints
- {"endpoint_text":"- Incidence and severity of NCI-CTCAE (Palmar-plantar erythrodysesthesia syndrome) grading by oncologist","definition_or_measurement_approach":"Grading by oncologist using NCI-CTCAE (palmar-plantar erythrodysesthesia) as stated"}
Recruitment
- Planned Sample Size
- 25
- Recruitment Window Months
- 10
- Consent Approach
- Informed consent required from adult participants (≥18). Subject information and informed consent form documents are listed (L1_SIS and ICF files) in French and English versions are present in the submission materials.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 25
France
- Earliest CTIS Part Ii Submission Date
- 22-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 25
- Number Of Sites
- 1
- Number Of Participants
- 25
Sites
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical oncology
- Contact Person Name
- Emmanuel MITRY
- Contact Person Email
- mitryje@ipc.unicancer.fr
- Number Of Participants
- 25
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 USE
- Authorisation Status
- prodAuthStatus=1
- Maximum Dose
- 3.2 g per day (maxDailyDoseAmount 3.2 g); max total amount 128 g
- Combination Treatment
- Yes
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