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NCT01546038 · OUTCOME

Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 10

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
Induction Cycle 1/Day 10, 1 Hour Post 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: 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/Daunorubicin21

Reported measurements

IL-8
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin37.00Not reported7.90128.00Not reported
BDNF
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin200Not reported0.002800Not reported
IL-5
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin99.00Not reported0.002440.00Not reported
VEGF
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin51.00Not reported0.00149.00Not reported
MCP-1
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin684.00Not reported368.009780.00Not reported
ITAC
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1B: Glasdegib + Cytarabine/Daunorubicin0.00Not reported0.00218.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.90
        upper Limit
        128.00
        value
        37.00
    title
    IL-8
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        2800
        value
        200
    title
    BDNF
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        2440.00
        value
        99.00
    title
    IL-5
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        149.00
        value
        51.00
    title
    VEGF
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        368.00
        upper Limit
        9780.00
        value
        684.00
    title
    MCP-1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        218.00
        value
        0.00
    title
    ITAC
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    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
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
Induction Cycle 1/Day 10, 1 Hour Post dose
title
Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 10
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice