Spots Global Cancer Trial Database for Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
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Trial Identification
Brief Title: Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
Official Title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in Pediatric Participants
Study ID: NCT03934372
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to \< 18 years with advanced leukemias, lymphomas, and solid tumors.
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Ghent University Hospital, Ghent, , Belgium
Universitair Ziekenhuis (Uz) Leuven, Leuven, , Belgium
The Finsen Centre National Hospital, Copenhagen, , Denmark
Hopital Robert Debre, Paris, , France
Armand Trousseau Hospital, Paris, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Chu de Rennes - Hospital Sud, Rennes, , France
Universitaetsklinikum Erlangen - Medizinische Klinik 5, Erlangen, , Germany
Universitatsklinikum Essen, Essen, , Germany
Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia, , Italy
Ospedale Pediatrico G. Gaslini, Genova, , Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milan, , Italy
Ospedale San Gerardo - Asst Monza, Monza, , Italy
University of Milano Bicocca, Monza, , Italy
Aorn Santobono Pausilipon, Naples, , Italy
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo, Pavia, , Italy
Ospedale Pediatrico Bambino Gesu Irccs, Rome, , Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza, Torino, , Italy
Princess Maxima Center For Pediatric Oncology, Utrecht, , Netherlands
Hospital General Universitario Vall D Hebron, Barcelona, , Spain
Hospital Sant Joan de Deu de Manresa, Barcelona, , Spain
Hospital Infantil Unversitario Nino Jesus, Madrid, , Spain
Hospital Universitario de La Paz, Madrid, , Spain
Hospital Universitari I Politecnic La Fe, Valencia, , Spain
Karolinska Universitetssjukhuset Solna, Solna, , Sweden
Karolinska University Hospital Solna, Stockholm, , Sweden
University Hospital Birmingham, Birmingham, , United Kingdom
Royal Hospital For Sick Children Yorkhill Glasgow, Glasgow, , United Kingdom
Alder Hey Childrens Nhs Foundation Trust, Liverpool, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton, Sutton, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Mohammed-El-Amine Bensmaine, MD
Affiliation: Incyte Biosciences International Sàrl
Role: STUDY_DIRECTOR
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