NCT01546038 · OUTCOME

Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Fit

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: Normalized expression units
Interval / dispersion: Full Range
Time frame: Baseline (Induction Cycle 1/Day -3 pre-dose)

What was measured

Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Baseline mRNA level showing statistically significant correlation with clinical response are reported. Baseline mRNA levels statistically significant associated with best overall response was only seen for CCND2 (G1/S-Specific Cyclin D2).

Analysis population: PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.

Groups in this outcome

Phase 2 Fit (Biomarker, Responder)

AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).

Phase 2 Fit (Biomarker, Non-Responder)

AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.

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 Fit (Biomarker, Responder)	39
Phase 2 Fit (Biomarker, Non-Responder)	22

Reported measurements

Source class 1

Values in Normalized expression units · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 2 Fit (Biomarker, Responder)	10.9	Not reported	1.61	25.26	Not reported
Phase 2 Fit (Biomarker, Non-Responder)	14.80	Not reported	5.03	23.74	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.61
upper Limit
25.26
value
10.9
group Id
OG001
lower Limit
5.03
upper Limit
23.74
value
14.80

denoms

counts
group Id
OG000
value
39
group Id
OG001
value
22
units
Participants

description

dispersion Type

Full Range

groups

description
AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
id
OG000
title
Phase 2 Fit (Biomarker, Responder)
description
AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
id
OG001
title
Phase 2 Fit (Biomarker, Non-Responder)

param Type

MEDIAN

population Description

PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.

reporting Status

POSTED

time Frame

Baseline (Induction Cycle 1/Day -3 pre-dose)

title

Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Fit

type

SECONDARY

unit Of Measure

Normalized expression units

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

Preserved source evidence · Not medical advice