188
Participants
Start Date
October 31, 2016
Primary Completion Date
December 31, 2019
Study Completion Date
January 31, 2020
Thymalfasin (Thymosin alpha 1, Ta1)
In Phase I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II.
SoC (tyrosine kinase inhibitor)
In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months.
Azienda Sanitaria Locale Frosinone, Frosinone
Istituto Nazionale dei Tumori, Milan
Roma_Campus Bio-Medico, Rome
Sant'Andrea Hospital, Rome
Presidio Sanitario San Camillo, Torino
Lead Sponsor
SciClone Pharmaceuticals
INDUSTRY