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NCT01546038 · OUTCOME

Ratios of mRNA Levels to Baseline 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
ratio
Interval / dispersion
Full Range
Time frame
Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)

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.

Analysis population: PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter 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

GroupSource count
Phase 2 Fit (Biomarker, Responder)45
Phase 2 Fit (Biomarker, Non-Responder)26

Reported measurements

CCNE1

Analysis denominator · Participants

GroupSource count
Phase 2 Fit (Biomarker, Responder)26
Phase 2 Fit (Biomarker, Non-Responder)13
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit (Biomarker, Responder)0.60Not reported0.211.65Not reported
Phase 2 Fit (Biomarker, Non-Responder)1.10Not reported0.283.82Not reported
MSI2

Analysis denominator · Participants

GroupSource count
Phase 2 Fit (Biomarker, Responder)28
Phase 2 Fit (Biomarker, Non-Responder)14
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit (Biomarker, Responder)0.90Not reported0.314.58Not reported
Phase 2 Fit (Biomarker, Non-Responder)0.50Not reported0.331.86Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.21
        upper Limit
        1.65
        value
        0.60
      2. group Id
        OG001
        lower Limit
        0.28
        upper Limit
        3.82
        value
        1.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    CCNE1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.31
        upper Limit
        4.58
        value
        0.90
      2. group Id
        OG001
        lower Limit
        0.33
        upper Limit
        1.86
        value
        0.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    MSI2
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      26
    units
    Participants
description
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.
dispersion Type
Full Range
groups
  1. 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)
  2. 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 Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.
reporting Status
POSTED
time Frame
Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)
title
Ratios of mRNA Levels to Baseline Associated With Best Overall Response at Phase 2 Fit
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice