Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

February 17, 2021

Primary Completion Date

August 25, 2023

Study Completion Date

August 25, 2023

Conditions
Acute Myeloid Leukaemia
Interventions
DRUG

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."

Trial Locations (7)

3002

Victorian Comprehensive Cancer Centre, Melbourne

3004

The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services, Melbourne

46026

H. Universitario La Fe Servicio de Hematologia, Valencia

75012

Hôpital Saint Antoine, Paris

77030

University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine, Houston

Unknown

Institut Paoli-Calmettes, Marseille

08035

H. Universitario Valle de Hebrón Servicio de Hematología, Barcelona

All Listed Sponsors
collaborator

ADIR, a Servier Group company

INDUSTRY

lead

Institut de Recherches Internationales Servier

OTHER

NCT04629443 - Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia | Biotech Hunter | Biotech Hunter