17
Participants
Start Date
February 17, 2021
Primary Completion Date
August 25, 2023
Study Completion Date
August 25, 2023
S 64315 (also referred as MIK665) and azacitidine
"The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.~During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days."
Victorian Comprehensive Cancer Centre, Melbourne
The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services, Melbourne
H. Universitario La Fe Servicio de Hematologia, Valencia
Hôpital Saint Antoine, Paris
University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine, Houston
Institut Paoli-Calmettes, Marseille
H. Universitario Valle de Hebrón Servicio de Hematología, Barcelona
ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER