Health TrialsbyHealthPanel

TAR-0520 Gel in Hand and Foot Syndrome

ConditionHand and Foot Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTarian Pharma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • TAR-0520 gel

    Drug

    hands treatment

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: TAR-0520 gelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Advers events

Time frame
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

Time frame
Baseline, Day 1 of each Cycle (Cycle 1,2,3,4 and 5) each Cycle duration is 21 days

Other outcomes

1

HFS clinical grading

HFS symptoms and signs

Time frame
Baseline,Day 1 of each Cycle ( Cycle 1,2,3,4 and 5), each cycle duration is 21 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tarian Pharma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: