A clinical study to investigate the safety and efficacy of ATH008 cream in the treatment of the hand-foot syndrome (Palmar-Plantar Erythrodysesthesia – PPES) caused by chemotherapy with capecitabine.
- Conditions
- Palmar-Plantar Erythrodysesthesia Syndrome (PPES)MedDRA version: 16.0Level: LLTClassification code 10054524Term: Palmar-plantar erythrodysesthesia syndromeSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2010-022439-12-DE
- Lead Sponsor
- Advancell Advanced In Vitro Cell Technologies, S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 114
• Have signed Informed Consent.
• Are under capecitabine therapy for treatment of colon or breast cancer at a regimen of 2 weeks on and 1 week off (14+7) and a daily doses between 2000 and 2500 mg/m2.
• Diagnosis of PPES grade 1 in any hand or foot according to the NCI CTCAE v4.03 definition.
• Are able to apply topical medication or provide for another person to apply it.
• Have a life expectancy longer than 3 months.
• In Part II, subjects still have to undergo at least 2 planned cycles with capecitabine therapy
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
• Are younger than 18 years.
• Diagnosis of PPES grade 1in any hand or foot according to the NCI CTCAE v4.03 definition for more than 2 cycles previously to inclusion in this clinical study.
• Use of other chemotherapies for the treatment of cancer except trastuzumab (Herceptin®) or bevacizumab (Avastin®).
• Haematological limits indicating that capecitabine (Xeloda®) cannot be administered due to safety reasons, based on the PI review before each cycle of chemotherapy.
• Total bilirubin > 3 upper normal value.
• Serum creatinine level > 2 upper normal value.
• Have neurologic symptoms greater than grade 1, which under the criteria of the clinician could interfere with PPES diagnosis or study treatment (e.g. hands or feet neuropathy).
• Have any dermatologic condition that in the opinion of the investigator may affect hands or feet or may complicate evaluation during study treatment (e.g. neurodermatitis, psoriasis, etc).
• Have onycholysis with a non-stable grade 1 or onycholysis greater than grade 1 (nail loss, NCI CTCAE v4.03 criteria) which in the assessment of the clinician could interfere with PPES diagnosis or study treatment.
• Need to use other emollient creams or other topical treatments in hands and/or feet during the study.
• Are receiving radiotherapy.
• Are actively treated with systemic allopurinol (oral or parenteral) for the treatment of gout, or any other indication.
• Have developed a severe reaction to allopurinol in the past (e.g. Lyell syndrome).
• Known allergy to allopurinol or any of the excipients of the product.
• Previous contraindication to treatment with capecitabine.
• Have received topical corticosteroids in hands and/ or feet 7 days prior to planned inclusion in the study.
• Are participating in any other investigational studies for the treatment of PPES.
• Have participated in any other investigational studies for the treatment of PPES, or received an experimental therapeutic procedure, considered to potentially interfere with the study in the 4 weeks preceding Day 1.
• Have a serious medical or psychiatric condition that could, in the investigator’s opinion, potentially interfere with their study treatment or participation in the study.
• Pregnant women, women in child bearing age not using contraceptives or men not using contraceptives. Methods of contraception which have a failure rate (Pearl index) of less than 1% per year are regarded as highly effective.
• Are participating in other clinical trials.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method