Participant flow

A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS · Source last updated 2023-11-09

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

groups

1. description

   Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 20mg/m2 (4 hr IVI)

   id

   FG000

   title

   ALV-DEC: Cohort 1

2. description

   Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 30mg/m2 (4 hr IVI)

   id

   FG001

   title

   ALV-DEC: Cohort 2

3. description

   Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 45mg/m2 (4 hr IVI)

   id

   FG002

   title

   ALV-DEC: Cohort 3

4. description

   Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 60mg/m2 (4 hr IVI)

   id

   FG003

   title

   ALV-DEC: Cohort 4

5. description

   Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 75mg/m2 as a 30-60 minute IVI.

   id

   FG004

   title

   ALV-AZA: Cohort 5

6. description

   Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 90mg/m2 as a 30-60 minute IVI.

   id

   FG005

   title

   ALV-AZA: Cohort 6

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         4

      comment

      Any patient who received at least 1 dose of study drug.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         3

      comment

      Completed Cycle 1

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

In phase 1b, patients were enrolled in cohorts of 3-6 patients. Escalation of alvocidib (ALV) dose followed standard 3+3 dosing with sequential cohorts of 3 patients treated at incrementally higher doses of alvocidib administered in sequence after fixed doses of decitabine (DEC) or azacitadine (AZA) until MTD is reached.

recruitment Details

Twenty subjects were enrolled between August 2018 and August 2021

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Preserved source evidence · Not medical advice