NCT04629443

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

Phase I/II, International, Multicentre, Open-label, Non-randomised, Non-comparative, Study Evaluating the Safety, Tolerability and Clinical Activity of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Azacitidine in Patients With Acute Myeloid Leukaemia (AML)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.

Conditions

• Acute Myeloid Leukaemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-17
• Primary completion: 2023-08-25
• Completion: 2023-08-25
• First posted: 2020-11-16
• Last updated: 2024-06-06
• Results posted: 2024-06-06

Locations

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

Regulatory

• FDA-regulated drug study