Safety and Efficacy Placebo Controlled Study of ATH008 Cream in PPES Patients Secondary to Capecitabine

NCT01316406 | Completed Phase 2

• 1 other identifier: ATH008-CLN02
• Study Type: interventional
• Target: 122
• Locations: 4 countries
• Sites: 26

Brief Summary

The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy. In part I, the safety and plasmatic levels of the active ingredient and its metabolite will allow to determine the most appropriate and beneficial dose for the second part of the study. In Part II, the efficacy of ATH008 cream in reducing the number of patients presenting PPES grade 2/3 secondary to capecitabine therapy following a four times daily application will be tested.

Conditions

Palmar-Plantar Erythrodysesthesia Syndrome

Keywords

safety; efficacy; treatment; PPES; Palmar-Plantar Erythrodysesthesia Syndrome; Hand-foot syndrome; capecitabine

Outcome Measures

Primary Outcomes (3)

• Efficacy of ATH008 cream in reducing the number of subjects presenting PPES grade 2/3 secondary to capecitabine therapy

  percentage of subjects that develop PPES grade 2 or 3 according to the NCI CTCAE v4.03 criteria

  minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days

• Safety of ATH008 cream in patients presenting PPES secondary to capecitabine therapy

  adverse events and serious adverse events (incidence, causality, and severity) related to treatment with ATH008 cream

  minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days

• Plasmatic levels of ATH008 cream when given topically

  plasmatic levels of the active ingredient and its metabolite when given topically

  blood sampling at specific timepoints (Pre-dose, Day 1 and Day 21)

Secondary Outcomes (4)

• Efficacy of ATH008 cream in improving the quality of life of patients presenting PPES

  minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days

• Efficacy of ATH008 cream in improving signs and symptoms of PPES

  minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days

• Assessment of patient reported pain

  minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days

• Accumulated dose intensity of capecitabine before and during ATH008 cream treatment

  minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days

Study Arms (3)

ATH008 cream 3%

EXPERIMENTAL

ATH008 cream 3%

Drug: ATH008

ATH008 cream 8%

EXPERIMENTAL

ATH008 cream 8%

Drug: ATH008

ATH008 cream placebo

PLACEBO COMPARATOR

ATH008 cream placebo

Drug: ATH008

Interventions

ATH008 DRUG

The subject will be incorporated in the study and randomised to ATH008 cream 3% or 8% or ATH008 cream placebo

Also known as: ATH008 cream

ATH008 cream 3%; ATH008 cream 8%; ATH008 cream placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are under capecitabine monotherapy 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.
• In Part I, subjects still have to undergo at least 1 planned cycle with capecitabine monotherapy.
• In Part II, subjects still have to undergo at least 2 planned cycles with capecitabine monotherapy.

You may not qualify if:

• Are younger than 18 years.
• Use of other chemotherapies for the treatment of cancer except trastuzumab (Herceptin®) or bevacizumab (Avastin®).
• 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 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.
• The above is not a complete list of eligibility criteria. Please see your study doctor for more information.

Sponsors & Collaborators

• Advancell - Advanced In Vitro Cell Technologies, S.A.: lead
• Cromsource: collaborator

Study Sites (26)

Imelda

Bonheiden, 2820, Belgium

Location

Institute Jules Bordet

Brussels, 1000, Belgium

Location

AZ Maria Middelares

St-Niklaas, 9100, Belgium

Location

Iniversitätsklinikum Hamburg Eppendorf

Hamburg, Germany

Location

OncoResearch Lerchenfeld UG

Hamburg, Germany

Location

Klinikum Offenbach GmbH

Offenbach, Germany

Location

Prosper Hospital

Recklinghausen, Germany

Location

IRCCS - Istituto Europeo di Oncologia (IEO) di Milano

Milan, Dr. Franco Nolè, 20141, Italy

Location

A.O. Universitaria Policlinico S.Orsola-Malpighi di Bologna

Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria "Maggiore Della Carità" di Novara

Novara, 28100, Italy

Location

Azienda Ospedaliero Universitaria di Sassari

Sassari, 07100, Italy

Location

Institut Català d'Oncología

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

HGU Alicante

Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, 08033, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Complejo Hospitalario Regional Reina Sofia

Córdoba, 14004, Spain

Location

Hospital General de Elche

Elche, 03203, Spain

Location

Hospital Clínic i Provincial

Madrid, 08036, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

HGU La Paz

Madrid, 28046, Spain

Location

Hospital Ramón y Cajal

Madrid, 28049, Spain

Location

Hospital de Navarra

Pamplona, 31008, Spain

Location

Hospital de Torrevieja

Torrevieja, 03186, Spain

Location

Institut Valencià d'Oncologia

Valencia, 46009, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Dr. A. Awada

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 16, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

BE (3); ES (15); IT (4); DE (4)