A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

Official Title

An Open-label Phase 1b Study Of Pf-04449913 (Glasdegib) In Combination With Azacitidine In Patients With Previously Untreated Higher-risk Myelodysplastic Syndrome, Acute Myeloid Leukemia, Or Chronic Myelomonocytic Leukemia

Summary:

This multi centre open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.

Trial Description

Primary Outcome:

  • Complete remission (CR) rate
  • Adverse events (Safety lead-in phase)
Secondary Outcome:
  • Response Rate
  • Hematologic Improvement
  • Marrow Complete Response (mCR)
  • Cytogenetic Response
  • Stable Disease
  • QTc interval
  • Duration of CR
  • Time to CR
  • Overall Survival (OS)
  • Complete remission with partial hematologic recovery (AML Expansion cohort)
  • Adverse events (Expansion cohorts)
  • AUC for PF-04449913
  • Cmax for PF-04449913
  • Tmax for PF-04449913
  • AUC for Azacitidine
  • Cmax for Azacitidine
  • Tmax for Azacitidine
  • Ctrough for PF-04449913
  • Complete remission with incomplete hematologic recovery (AML Expansion cohort)
  • Morphologic leukemia free state (AML Expansion cohort)
  • Partial remission (AML Expansion cohort)
  • Stable disease (AML Expansion cohort)
  • Marrow complete remission (MDS Expansion cohort)
  • Partial remission (MDS Expansion cohort)
  • Stable disease (MDS Expansion cohort)
  • Partial or complete cytogenetic response (MDS Expansion cohort)
  • Hematologic improvement (MDS Expansion cohort)

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