NCT01546038 · OUTCOME

Ratios of mRNA Levels Associated With Best Overall Response at Phase 2 Unfit

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: ratio
Interval / dispersion: Full Range
Time frame: Baseline (Cycle 1/Day 1 pre-dose); Cycle 1/Day 1, 1 Hour Post 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. Ratios of mRNA level to baseline showing statistically significant correlation with clinical response are reported. Ratios of mRNA levels to baseline statistically significant associated with best overall response was only seen for MYCN (Neuroblastoma Myc oncogene) at Cycle 1/Day 1.

Analysis population: PD analysis set: all enrolled participants in the Phase 2 Unfit 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 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)

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

Phase 2 Unfit: Glasdegib 100 mg+LDAC(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 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)	33
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)	55

Reported measurements

Source class 1

Values in ratio · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)	1.60	Not reported	0.50	40.25	Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)	0.50	Not reported	0.03	20.60	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.50
upper Limit
40.25
value
1.60
group Id
OG001
lower Limit
0.03
upper Limit
20.60
value
0.50

denoms

counts
group Id
OG000
value
33
group Id
OG001
value
55
units
Participants

description

dispersion Type

Full Range

groups

description
AML participants who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS participants who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
id
OG000
title
Phase 2 Unfit: Glasdegib 100 mg + LDAC (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 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)

param Type

MEDIAN

population Description

PD analysis set: all enrolled participants in the Phase 2 Unfit 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 (Cycle 1/Day 1 pre-dose); Cycle 1/Day 1, 1 Hour Post dose

title

Ratios of mRNA Levels Associated With Best Overall Response at Phase 2 Unfit

type

SECONDARY

unit Of Measure

ratio

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Preserved source evidence · Not medical advice