Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

March 15, 2017

Primary Completion Date

May 11, 2020

Study Completion Date

May 11, 2020

Conditions
Acute Myeloid Leukaemia (AML)Myelodysplastic Syndrome (MDS)
Interventions
DRUG

S64315 once a week

S64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours once every week (21- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.

DRUG

S64315 twice a week

S64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours twice every week (28- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.

Trial Locations (9)

3004

The Alfred Hospital Department of Haematology, Melbourne

3050

Royal Melbourne Hospital, Department of Clinical Haematology and BMT Service, Melbourne

13009

Institut Paoli-Calmettes Departement d'Hématologie, Marseille

46026

Hospital Universitario La Fe Hematology Department, Valencia

75012

Hôpital Saint-Antoine Département d'Hematologie Clinique et de Thérapie cellulaire, Paris

77030

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

06511

Patient Care Location: Smilow Cancer Hospital at Yale, New Haven

31059 Cedex9

Institut Universitaire du Cancer Toulouse Oncopole, Toulouse

08035

Hospital Universitario Vall d' Hebron/VHIO Hematology Department, Barcelona

All Listed Sponsors
collaborator

ADIR, a Servier Group company

INDUSTRY

lead

Institut de Recherches Internationales Servier

OTHER

NCT02979366 - Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter