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
Secondary Outcome:
  • 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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society