Participant flow

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients · Source last updated 2024-01-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received subcutaneous (SC) administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg once daily (QD). In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit drug-drug interaction (DDI) evaluation.

   id

   FG000

   title

   Lead-in Cohort

2. description

   Participants received SC or intravenous (IV) administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.

   id

   FG001

   title

   AML Cohort

3. description

   Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.

   id

   FG002

   title

   MDS Cohort

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         24

      3. group Id

         FG002

         num Subjects

         17

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         9

      type

      Other reason

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      type

      Study Participation Terminated by Sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         30

      3. group Id

         FG002

         num Subjects

         30

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         30

      3. group Id

         FG002

         num Subjects

         30

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

12 participants were enrolled and received combination therapy of glasdegib and azacitidine in the Lead-in Cohort (LIC). 31 participants were enrolled in the acute myeloid leukemia (AML) cohort, and 30 received glasdegib + azacitidine (1 participant withdrew consent before receiving treatment). 30 participants were enrolled and received glasdegib + azacitidine in the myelodysplastic syndrome (MDS) cohort.

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Preserved source evidence · Not medical advice