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NCT01546038 · OUTCOME

Time to Cmax (Tmax) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03

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

Measure
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
Time frame
Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21

Analysis population: Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the "dose compliant" group.

Groups in this outcome

Phase 1B: Glasdegib 100 mg + LDAC

Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.

Phase 1B: Glasdegib 200 mg + LDAC

Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1B: Glasdegib 100 mg + LDAC17
Phase 1B: Glasdegib 200 mg + LDAC6

Reported measurements

Cycle 1/Day 10

Analysis denominator · Participants

GroupSource count
Phase 1B: Glasdegib 100 mg + LDAC13
Phase 1B: Glasdegib 200 mg + LDAC6
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib 100 mg + LDAC1.75Not reported0.75024.0Not reported
Phase 1B: Glasdegib 200 mg + LDAC4.00Not reported1.0224.0Not reported
Cycle 1/Day 21

Analysis denominator · Participants

GroupSource count
Phase 1B: Glasdegib 100 mg + LDAC8
Phase 1B: Glasdegib 200 mg + LDAC5
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib 100 mg + LDAC1.34Not reported0.5332.00Not reported
Phase 1B: Glasdegib 200 mg + LDAC4.00Not reported1.006.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.750
        upper Limit
        24.0
        value
        1.75
      2. group Id
        OG001
        lower Limit
        1.02
        upper Limit
        24.0
        value
        4.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Cycle 1/Day 10
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.533
        upper Limit
        2.00
        value
        1.34
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        6.00
        value
        4.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 1/Day 21
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      6
    units
    Participants
dispersion Type
Full Range
groups
  1. description
    Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.
    id
    OG000
    title
    Phase 1B: Glasdegib 100 mg + LDAC
  2. description
    Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
    id
    OG001
    title
    Phase 1B: Glasdegib 200 mg + LDAC
param Type
MEDIAN
population Description
Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the "dose compliant" group.
reporting Status
POSTED
time Frame
Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21
title
Time to Cmax (Tmax) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21
type
SECONDARY
unit Of Measure
Hours

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Preserved source evidence · Not medical advice