48
Participants
Start Date
October 31, 2013
Primary Completion Date
June 26, 2017
Study Completion Date
September 25, 2017
Givinostat
"In Part A patients will treated in dose levels at the following daily doses of Givinostat:~* 50 mg b.i.d.,~* 100 mg b.i.d.;~* 150 mg b.i.d.,~* 200 mg b.i.d.;~* 150 mg t.i.d.;~* 200 mg t.i.d.. Intermediate dose levels and, consequently, additionally dose levels may be used to establish the Maximum Tolerated Dose.~In Part B patients will be treated at the Maximum Tolerated Dose established in Part A. The product will be supplied as hard gelatine capsules for oral administration at the strength of 50 mg, 75 mg and/or 100 mg each."
Charite Research Organisation GmbH, Berlin
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
Fondazione IRCCS Policlinico San Matteo, Pavia
Hôpital Morvan - CHRU de Brest, Brest
Ospedale San Bortolo di Vicenza, Vicenza
Azienda Ospedaliero-Universitaria Careggi, Florence, Florence
Universitaetsklinikum Koeln, Cologne
Azienda Ospedaliero Universitaria Pisana, Pisa
Hopital Saint Vincent de Paul - GHICL Lille, Lille
Azienda ospedaliero universitaria Consorziale Policlinico di Bari, Bari
Istituto Tumori Giovanni Paolo II - IRCCS Ospedale Oncologico di Bari, Bari
Hôpital Saint-Louis (AP-HP), Centre Investigations Cliniques, Paris
Universitaetsklinikum Freiburg, Freiburg im Breisgau
CHU Amiens - Hôpital Sud, Amiens
Università degli Studi di Napoli Federico II, Facoltà di Medicina e Chirurgia, Napoli
"Azienda Ospedaliera Bianchi-Melacrino-Morelli", Reggio Calabria
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan
Ospedale Civile dello Spirito Santo, Pescara
Università Campus Bio-Medico di Roma, Rome
SP ZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzów
Uniwersyteckie Centrum Kliniczne, Gdansk
Belfast City Hospital, Belfast
Royal London Hospital, London
Royal Cornwall Hospital, Truro
Lead Sponsor
Italfarmaco
INDUSTRY