A Study Evaluating Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Official Title

A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Summary:

This is a Phase 1b, open-label, non-randomized, multicentre, dose-finding study evaluating venetoclax in combination with azacitidine in subjects with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.

Trial Description

Primary Outcome:

• AUCt for azacitidine
• Cmax of venetoclax
• AUCt for venetoclax
• Tmax of venetoclax
• AUC[0 to infinity] for azacitidine
• Recommended Phase 2 dose (RPTD) and dosing schedule of venetoclax in combination with azacitidine
• Half-life (t[1/2]) for azacitidine
• Cmax for azacitidine
• AUC[0-24] for venetoclax
• Clearance (CL) for azacitidine
• Tmax for azacitidine

• Duration of Response (DOR)
• Rate of red blood cell (RBC) transfusion independence
• Progression-Free Survival (PFS)
• Overall Survival (OS)
• Hematologic Improvement (HI) rate
• Rate of platelet (PLT) transfusion independence
• Event-Free Survival (EFS)
• Time to transformation to acute myeloid leukemia (AML)
• Rate of bone marrow blast response
• Complete Remission (CR) rate
• Overall Response Rate (ORR)
• Rate of cytogenetic response
• Time to next treatment (TTNT)
• Marrow Complete Remission (mCR) Rate

View this trial on ClinicalTrials.gov