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NCT01546038 · OUTCOME

Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Consolidation 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
Consolidation Cycle 1/Day 10, Pre-dose

What was measured

Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.

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: Glasdegib 100 mg + Cytarabine/Daunorubicin

Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.

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: Glasdegib 100 mg + Cytarabine/Daunorubicin20

Reported measurements

MIP-1β
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin239.50Not reported0.006560.00Not reported
MCP-1
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin581.00Not reported192.003880.00Not reported
MMP-3
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin12000Not reported270048000Not reported
IL-8
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin11.00Not reported0.0074.00Not reported
ITAC
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin4.10Not reported0.0027.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        6560.00
        value
        239.50
    title
    MIP-1β
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        192.00
        upper Limit
        3880.00
        value
        581.00
    title
    MCP-1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2700
        upper Limit
        48000
        value
        12000
    title
    MMP-3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        74.00
        value
        11.00
    title
    IL-8
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        27.00
        value
        4.10
    title
    ITAC
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.
dispersion Type
Full Range
groups
  1. description
    Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
    id
    OG000
    title
    Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
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
Consolidation Cycle 1/Day 10, Pre-dose
title
Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Consolidation 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