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NCT01546038 · OUTCOME

Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction Cycle 1/Day 3

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 3, 1 Hour Post 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/Daunorubicin57

Reported measurements

Factor VII(activated blood coagulation factor VII)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin318000Not reported56000620000Not reported
BDNF
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin700Not reported06200Not reported
MMP-3
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin21000Not reported1700107000Not reported
IL-8
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin28.00Not reported0.00139.00Not reported
ITAC
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin14.00Not reported0.00535.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56000
        upper Limit
        620000
        value
        318000
    title
    Factor VII(activated blood coagulation factor VII)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        6200
        value
        700
    title
    BDNF
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1700
        upper Limit
        107000
        value
        21000
    title
    MMP-3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        139.00
        value
        28.00
    title
    IL-8
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        535.00
        value
        14.00
    title
    ITAC
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    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
Induction Cycle 1/Day 3, 1 Hour Post dose
title
Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction Cycle 1/Day 3
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice