NCT02979366

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

Phase I, International, Multicentre, Open-label, Non-randomised, Non-comparative Study of Intravenously Administered S64315, a Mcl-1 Inhibitor, in Patients With Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion.

Conditions

• Acute Myeloid Leukaemia (AML)
• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-15
• Primary completion: 2020-05-11
• Completion: 2020-05-11
• First posted: 2016-12-01
• Last updated: 2022-05-18

Locations

9 sites across 4 countries: United States, Australia, France, Spain

Regulatory

• FDA-regulated drug study