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NCT01546038 · OUTCOME

Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 1

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
Cycle 1/Day 1, 1 Hour Post dose

What was measured

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

Analysis population: PD analysis set: all enrolled participants in the Phase 2 Unfit 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 Unfit: Glasdegib 100 mg + LDAC

Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.

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 Unfit: Glasdegib 100 mg + LDAC18

Reported measurements

Source class 1
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC483.00Not reported40.001230.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.00
        upper Limit
        1230.00
        value
        483.00
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Serum levels were determined for 38 circulating proteins. Selected value showing statistically significant difference compared with baseline is reported here.
dispersion Type
Full Range
groups
  1. description
    Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
    id
    OG000
    title
    Phase 2 Unfit: Glasdegib 100 mg + LDAC
param Type
MEDIAN
population Description
PD analysis set: all enrolled participants in the Phase 2 Unfit 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
Cycle 1/Day 1, 1 Hour Post dose
title
Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 1
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice