NCT01546038 · OUTCOME

AUCtau of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/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*hr/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10

Analysis population: Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.

Groups in this outcome

Phase 2 Unfit: Glasdegib 100 mg + LDAC

Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.

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 2 Unfit: Glasdegib 100 mg + LDAC	37

Reported measurements

Source class 1

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 Unfit: Glasdegib 100 mg + LDAC	17210	54	0.667	5.83	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.667
spread
54
upper Limit
5.83
value
17210

denoms

counts
group Id
OG000
value
37
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
id
OG000
title
Phase 2 Unfit: Glasdegib 100 mg + LDAC

param Type

GEOMETRIC_MEAN

population Description

Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.

reporting Status

POSTED

time Frame

Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10

title

AUCtau of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/Day 10

type

SECONDARY

unit Of Measure

ng*hr/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice