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

PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Palmar-Plantar Erythrodysesthesia Syndrome
Interventions
DRUG

ATH008

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

Trial Locations (26)

1000

Institute Jules Bordet, Brussels

2820

Imelda, Bonheiden

9100

AZ Maria Middelares, St-Niklaas

14004

Complejo Hospitalario Regional Reina Sofia, Córdoba

20141

IRCCS - Istituto Europeo di Oncologia (IEO) di Milano, Milan

28007

Hospital Gregorio Marañón, Madrid

28046

HGU La Paz, Madrid

28049

Hospital Ramón y Cajal, Madrid

28100

"Azienda Ospedaliero Universitaria Maggiore Della Carità di Novara", Novara

28222

Hospital Puerta de Hierro, Majadahonda

31008

Hospital de Navarra, Pamplona

40138

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

46009

Institut Valencià d'Oncologia, Valencia

50009

Hospital Miguel Servet, Zaragoza

Unknown

Iniversitätsklinikum Hamburg Eppendorf, Hamburg

OncoResearch Lerchenfeld UG, Hamburg

Klinikum Offenbach GmbH, Offenbach

Prosper Hospital, Recklinghausen

07100

Azienda Ospedaliero Universitaria di Sassari, Sassari

08907

Institut Català d'Oncología, L'Hospitalet de Llobregat

03010

HGU Alicante, Alicante

08033

Hospital del Mar, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

03203

Hospital General de Elche, Elche

08036

Hospital Clínic i Provincial, Madrid

03186

Hospital de Torrevieja, Torrevieja

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cromsource

INDUSTRY

lead

Advancell - Advanced In Vitro Cell Technologies, S.A.

INDUSTRY

NCT01316406 - Safety and Efficacy Placebo Controlled Study of ATH008 Cream in PPES Patients Secondary to Capecitabine | Biotech Hunter | Biotech Hunter