Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study is designed in two parts: A single arm dose escalation phase I part and dose expansion phase II part. During dose escalation of S65487 in combination with azacitidine, only S65487 agent dose will escalate and a DDI (Drug-Drug interaction) assessment between S65487 and posaconazole (antifun...
The study is designed in two parts: A single arm dose escalation phase I part and dose expansion phase II part. During dose escalation of S65487 in combination with azacitidine, only S65487 agent dose will escalate and a DDI (Drug-Drug interaction) assessment between S65487 and posaconazole (antifungal drug) will be performed. For the expansion phase, Ramp up dose and full dose will be the RP2D (Recommended Phase 2 Dose) determined during phase I part
Tracking Information
- NCT #
- NCT04742101
- Collaborators
- ADIR, a Servier Group company
- Investigators
- Not Provided
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