31
Participants
Start Date
July 12, 2017
Primary Completion Date
May 16, 2019
Study Completion Date
June 20, 2019
Milciclib maleate
100 mg/day once daily, for 4 consecutive days a week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3 cycles) unless patient refusal, consent withdrawal, Investigator's decision, unacceptable toxicity or death whichever occurs earlier. After the completion of three cycles, patients who, in the Investigator's judgment, are benefiting from treatment with milciclib, will resume treatment and will remain on study up to Day 180 from treatment start, unless withdrawal criteria are met earlier.
Ippokrateio General Hospital of Athens, Athens
Laiko General Hospital of Athens, Athens
Istituto Clinico Humanitas, Rozzano
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan
Rambam Health Corporation, Haifa
AOU S. Orsola Malpighi Bologna, Bologna
General University Hospital of Larissa, Larissa
Azienda Ospedaliera Universitaria Policlinico di Modena, Modena
University General Hospital of Thessaloniki - AHEPA, Thessaloniki
Tel Aviv Sourasky Medical Center, Tel Aviv
A.O.U. Federico II, Napoli
A.O. U. Policlinico Paolo Giaccone, Palermo
Rabin Medical Center - Beilinson Hospital, Petah Tikva
The Sheba Academic Medical Center Hospital - Tel Hashomer, Ramat Gan
Tiziana Life Sciences LTD
INDUSTRY