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NCT01546038 · OUTCOME

Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - End of Treatment

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
pg/mL
Interval / dispersion
Full Range
Time frame
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. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.

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

GroupSource count
Phase 2 Fit (Biomarker, Responder)27
Phase 2 Fit (Biomarker, Non-Responder)15

Reported measurements

IL-1β
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit (Biomarker, Responder)9.70Not reported0.0020.00Not reported
Phase 2 Fit (Biomarker, Non-Responder)6.70Not reported0.0020.00Not reported
IL-15 (Interleukin-15)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit (Biomarker, Responder)700Not reported01300Not reported
Phase 2 Fit (Biomarker, Non-Responder)600Not reported0850Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        20.00
        value
        9.70
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        20.00
        value
        6.70
    title
    IL-1β
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1300
        value
        700
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        850
        value
        600
    title
    IL-15 (Interleukin-15)
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      15
    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. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed 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 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
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
Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - End of Treatment
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice