NCT01546038 · OUTCOME

Cmax of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10

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: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, 0.5, 1, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10

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 + Cytarabine/Daunorubicin

Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.

Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin

Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.

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

Analysis denominator · Participants

Group	Source count
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin	16
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin	6

Reported measurements

Induction Cycle 1/Day 3

Analysis denominator · Participants

Group	Source count
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin	14
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin	6

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin	674.2	45	Not reported	Not reported	Not reported
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin	1622	25	Not reported	Not reported	Not reported

Induction Cycle 1/Day 10

Analysis denominator · Participants

Group	Source count
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin	15
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin	6

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin	1135	43	Not reported	Not reported	Not reported
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin	2371	43	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
45
value
674.2
group Id
OG001
spread
25
value
1622
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
6
units
Participants
title
Induction Cycle 1/Day 3
categories
measurements
group Id
OG000
spread
43
value
1135
group Id
OG001
spread
43
value
2371
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
6
units
Participants
title
Induction Cycle 1/Day 10

denoms

counts
group Id
OG000
value
16
group Id
OG001
value
6
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
id
OG000
title
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin
description
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
id
OG001
title
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin

param Type

GEOMETRIC_MEAN

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, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10

title

Cmax of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10

type

SECONDARY

unit Of Measure

ng/mL

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