Hand and Foot SyndromePhase 2TARIAN008NCT07457671
TAR-0520 Gel in Hand and Foot Syndrome
A Phase 2 study testing TAR-0520 gel in people with Hand and Foot Syndrome, run by Tarian Pharma at 1 site in France.
Trial summary
Hand and Foot Syndrome (HFS) is a weii-established and frequent cutaneous adverse event of capecitabine used in the treatment of different cancers.HFS is charectirized by a variety of symptoms ranging from mild discomfort to a painful sensation of palms and sols that could limit functionality and hamper patients on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand and Foot Syndrome
- What is being tested?
- TAR-0520 gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine
- at a dose > 1000mg/m² twice daily every 2 out of 3 weeks as single agent chemotherapy
- Patients with life expectancy graeter than 12 weeks
Who cannot join
- Patient with medical history of capecitabine treatment
- patient with pre-existing neuropathy confounding assessement of HFS
- Patient with Raynaud's syndrome or other vascular peripheral disorders
- Patient with dermatological lesions on hands or foot
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
Instiut Paoli-Calmettes
Marseille, 13009
Emmanuel Mitry, MD, +33491223333
About this study
Official title: A Phase 2a Exploratory Study of TAR-0520 Gel in Prevention of Hand and Foot Syndrome
Hand and Foot Syndrome (HFS) is a weii-established and frequent cutaneous adverse event of capecitabine used in the treatment of different cancers.HFS is charectirized by a variety of symptoms ranging from mild discomfort to a painful sensation of palms and sols that could limit functionality and hamper patients on their daily activities.
The aim of this study is to explore the TAR-0520 gel safety and preventive efficacy of HFS in patients with colorectal and breast cancer patients treated with capecitabine.
Read more
Is the product well tolerated locally and systemically ? Is the product reducing frequency and severity of HFS ? Is product improving Quality of Life (QoL) of treated patients ? Each patient will receive the active TAR-0520 gel and they will apply it to both hands,twice daily. Applications will be done 1 hour before each morning and evening capecitabine oral intake.
Feet will be not treated and will serve as controls. In total , this study will follow patients during 4 capecitabine Cycles (each Cycle=21 days) for a total of 12 weeks.
Clinical evaluations will take place at Day1 of each Cycle and will be conducted separetaly on hands and feet.
Read the detailed description
Hand-foot syndrome (HFS) is a well-established cutaneous adverse event of certain chemotherapeutic agents mainly capecitabine. HFS is characterized by a wide variety of symptoms ranging from mild discomfort to a painful sensation of palms and soles that could limit functionality and hamper patients on their daily activities. Although not life threatening, it may have a severe impact on quality of life, including incapacity in working or walking, leading possibly to cancer drug discontinuation or dose modification .
The current study aims at exploring the TAR-0520 gel safety and preventative efficacy of HFS in patients with colorectal and breast cancer treated with capecitabine.
This will be an open-label, intra-individual, monocentric, pilot study with approximately 25 patients included.
Patients with histologically confirmed breast cancer or colorectal cancer receiving capecitabine monotherapy with recommended dose (≥ 1000 mg/m² twice daily from day 1 to 14 every 3 weeks) will be enrolled in the trial.
Each patient will receive the active TAR-0520 gel containing 1.5% of Brimonidine tartrate. They will be instructed to apply it to both hands, twice daily. TAR-0520 gel applications will take place approximately one hour before each morning and evening capecitabine oral intake. Feet will be non-treated and will serve as controls.
During each chemotherapy Cycle (lasting 3 weeks), capecitabine will be administered for 14 days (BID regimen), followed by a 7-day treatment-free period. This dosing schedule corresponds to the standard-of-care regimen for capecitabine in patients receiving this chemotherapy as part of routine clinical practice.
TAR-0520 gel applications, BID to both hands will take place during the 14-day capecitabine treatment.From Day15 to Day21, neither capecitabine nor TAR-0520 gel will be administered.
TAR-0520 gel will be self-applied by patients or applied by somebody else (e.g. family member or caregiver) to the skin of both palmar and dorsal surfaces of both hands including fingers. Test product will be applied and massaged until full penetration.
In total, this study will follow patients during 4 capecitabine Cycles for a total of approximately 12 weeks of observation.
Evaluations will take place at Baseline (Day1 of the Cycle 1) and then at Day1 of the 2nd, 3rd, 4th and 5th (final visit) Cycle.
These evaluations will be conducted separately on hands and feet. During the evaluation visits, TAR-0520 gel safety will be evaluated with collection of adverse events and reactions.
The preventive efficacy will be assessed by measuring the incidence of grade 2 or higher HFS acording to NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) and via clinical grading of different HFS symptoms (numbness/tingling , pain, redness, swelling, bleesters, scalling/desquamation) on the scale 0-3 , 0-symptom absent,3-symptom severe.
The QoL will be assessed using HFS-14 questionnaire.
- Conditions
- Hand and Foot Syndrome
- Being tested
- TAR-0520 gel
- Keywords
- Hand and Foot Syndrome, Prevention of Hand and Foot Syndrome
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAR-0520 gelDrug
hands treatment
| Study group | Role | What they receive |
|---|---|---|
| TAR-0520 gel | Experimental | Treatment of the hands Receives: Drug: TAR-0520 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advers events
Measured: Baseline, Day 1 of each Cycle ( Cycle1,2,3,4 and 5), each Cycle duration is 21 days
Secondary outcomes (1)
Severity of HFS on hands and foot
NCI- CTCAE grading of HFS
Measured: Baseline, Day 1 of each Cycle (Cycle 1,2,3,4 and 5) each Cycle duration is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand and Foot SyndromeStudies 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 comparison
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarian Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457671
- Sponsor's protocol ID
- TARIAN008
- Other IDs
- 2025-524008-32-00, 2025
- Acronym
- TARIAN008
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Exploratory Study of TAR-0520 Gel in Prevention of Hand and Foot Syndrome
- ClinicalTrials.gov ID
- NCT07457671
- Acronym / sponsor ID
- TARIAN008 / TARIAN008
- Conditions
- Hand and Foot Syndrome
- Keywords
- Hand and Foot Syndrome, Prevention of Hand and Foot Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tarian PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand and Foot Syndrome (HFS) is a weii-established and frequent cutaneous adverse event of capecitabine used in the treatment of different cancers.HFS is charectirized by a variety of symptoms ranging from mild discomfort to a painful sensation of palms and sols that could limit functionality and hamper patients on their daily activities.
The aim of this study is to explore the TAR-0520 gel safety and preventive efficacy of HFS in patients with colorectal and breast cancer patients treated with capecitabine.
Is the product well tolerated locally and systemically ? Is the product reducing frequency and severity of HFS ? Is product improving Quality of Life (QoL) of treated patients ? Each patient will receive the active TAR-0520 gel and they will apply it to both hands,twice daily. Applications will be done 1 hour before each morning and evening capecitabine oral intake.
Feet will be not treated and will serve as controls. In total , this study will follow patients during 4 capecitabine Cycles (each Cycle=21 days) for a total of 12 weeks.
Clinical evaluations will take place at Day1 of each Cycle and will be conducted separetaly on hands and feet.
Detailed description
Hand-foot syndrome (HFS) is a well-established cutaneous adverse event of certain chemotherapeutic agents mainly capecitabine. HFS is characterized by a wide variety of symptoms ranging from mild discomfort to a painful sensation of palms and soles that could limit functionality and hamper patients on their daily activities. Although not life threatening, it may have a severe impact on quality of life, including incapacity in working or walking, leading possibly to cancer drug discontinuation or dose modification .
The current study aims at exploring the TAR-0520 gel safety and preventative efficacy of HFS in patients with colorectal and breast cancer treated with capecitabine.
This will be an open-label, intra-individual, monocentric, pilot study with approximately 25 patients included.
Patients with histologically confirmed breast cancer or colorectal cancer receiving capecitabine monotherapy with recommended dose (≥ 1000 mg/m² twice daily from day 1 to 14 every 3 weeks) will be enrolled in the trial.
Each patient will receive the active TAR-0520 gel containing 1.5% of Brimonidine tartrate. They will be instructed to apply it to both hands, twice daily. TAR-0520 gel applications will take place approximately one hour before each morning and evening capecitabine oral intake. Feet will be non-treated and will serve as controls.
During each chemotherapy Cycle (lasting 3 weeks), capecitabine will be administered for 14 days (BID regimen), followed by a 7-day treatment-free period. This dosing schedule corresponds to the standard-of-care regimen for capecitabine in patients receiving this chemotherapy as part of routine clinical practice.
TAR-0520 gel applications, BID to both hands will take place during the 14-day capecitabine treatment.From Day15 to Day21, neither capecitabine nor TAR-0520 gel will be administered.
TAR-0520 gel will be self-applied by patients or applied by somebody else (e.g. family member or caregiver) to the skin of both palmar and dorsal surfaces of both hands including fingers. Test product will be applied and massaged until full penetration.
In total, this study will follow patients during 4 capecitabine Cycles for a total of approximately 12 weeks of observation.
Evaluations will take place at Baseline (Day1 of the Cycle 1) and then at Day1 of the 2nd, 3rd, 4th and 5th (final visit) Cycle.
These evaluations will be conducted separately on hands and feet. During the evaluation visits, TAR-0520 gel safety will be evaluated with collection of adverse events and reactions.
The preventive efficacy will be assessed by measuring the incidence of grade 2 or higher HFS acording to NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) and via clinical grading of different HFS symptoms (numbness/tingling , pain, redness, swelling, bleesters, scalling/desquamation) on the scale 0-3 , 0-symptom absent,3-symptom severe.
The QoL will be assessed using HFS-14 questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-individual comparison
| Arm | Type | Receives |
|---|---|---|
| TAR-0520 gel | Experimental | Drug: TAR-0520 gelTreatment of the hands |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine
- at a dose > 1000mg/m² twice daily every 2 out of 3 weeks as single agent chemotherapy
- Patients with life expectancy graeter than 12 weeks
Key exclusion criteria (4 listed)
- Patient with medical history of capecitabine treatment
- patient with pre-existing neuropathy confounding assessement of HFS
- Patient with Raynaud's syndrome or other vascular peripheral disorders
- Patient with dermatological lesions on hands or foot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAR-0520 gelhands treatment | Drug | TAR-0520 gel |
Primary outcome
Advers events
Time frame: Baseline, Day 1 of each Cycle ( Cycle1,2,3,4 and 5), each Cycle duration is 21 days
1 secondary outcome
Severity of HFS on hands and foot
Time frame: Baseline, Day 1 of each Cycle (Cycle 1,2,3,4 and 5) each Cycle duration is 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Hand and Foot Syndrome
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SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
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Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAR-0520 gel in people with Hand and Foot Syndrome, run by Tarian Pharma at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janusz M Czernielewski, MD (+33680338274, janusz.czernielewski@tarianpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advers events (time frame: Baseline, Day 1 of each Cycle ( Cycle1,2,3,4 and 5), each Cycle duration is 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.