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NCT01546038 · OUTCOME

Serum Levels of Circulating Protein Analytes at Phase 1B - Baseline

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

What was measured

Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here.

Analysis population: Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B 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 1B: Glasdegib + Cytarabine/Daunorubicin

Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.

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 1B: Glasdegib + Cytarabine/Daunorubicin22

Reported measurements

MMP-3 (Matrix metalloproteinase-3)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin10200Not reported170044000Not reported
IL-8 (Interleukin-8)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin10.7Not reported0.0071.00Not reported
BDNF (Brain-derived neurotrophic factor)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin1200Not reported0.0022000Not reported
IL-5 (Interleukin-5)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin0.00Not reported0.000.00Not reported
VEGF (Vascular endothelial growth factor)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin88.00Not reported32.002000.00Not reported
MCP-1 (Monocyte chemotactic protein-1)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin180.5Not reported0.001850.00Not reported
ITAC:Interferon-inducible T-cell α chemoattractant
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin0.00Not reported0.001900.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1700
        upper Limit
        44000
        value
        10200
    title
    MMP-3 (Matrix metalloproteinase-3)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        71.00
        value
        10.7
    title
    IL-8 (Interleukin-8)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        22000
        value
        1200
    title
    BDNF (Brain-derived neurotrophic factor)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.00
    title
    IL-5 (Interleukin-5)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.00
        upper Limit
        2000.00
        value
        88.00
    title
    VEGF (Vascular endothelial growth factor)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        1850.00
        value
        180.5
    title
    MCP-1 (Monocyte chemotactic protein-1)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        1900.00
        value
        0.00
    title
    ITAC:Interferon-inducible T-cell α chemoattractant
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here.
dispersion Type
Full Range
groups
  1. description
    Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.
    id
    OG000
    title
    Phase 1B: Glasdegib + Cytarabine/Daunorubicin
param Type
MEDIAN
population Description
Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B 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
Serum Levels of Circulating Protein Analytes at Phase 1B - Baseline
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice