Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01546038 · OUTCOME

Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit

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 (Cycle 1/Day 1 pre-dose)

What was measured

Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.

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 (Biomarker, Responder)

AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).

Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)

AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.

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 + LDAC (Biomarker, Responder)28
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)44

Reported measurements

BDNF
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)2000Not reported17022000Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)900Not reported012000Not reported
ICAM-1 (Intercellular cell adhesion molecule-1)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)128000Not reported37000287000Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)161000Not reported82000580000Not reported
6CKINE
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)223.50Not reported53.00679.00Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)318.00Not reported128.00911.00Not reported
BAFF (B-cell activating factor)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)704.50Not reported116.003000.00Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)1295.00Not reported199.006190.00Not reported
MIP-3β
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)275.00Not reported86.002060.00Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)414.50Not reported109.002130.00Not reported
Eotaxin-1 (C-C motif chemokine 11)
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)169.00Not reported0.00333.00Not reported
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)0.00Not reported0.00260.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        170
        upper Limit
        22000
        value
        2000
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        12000
        value
        900
    title
    BDNF
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37000
        upper Limit
        287000
        value
        128000
      2. group Id
        OG001
        lower Limit
        82000
        upper Limit
        580000
        value
        161000
    title
    ICAM-1 (Intercellular cell adhesion molecule-1)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.00
        upper Limit
        679.00
        value
        223.50
      2. group Id
        OG001
        lower Limit
        128.00
        upper Limit
        911.00
        value
        318.00
    title
    6CKINE
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        116.00
        upper Limit
        3000.00
        value
        704.50
      2. group Id
        OG001
        lower Limit
        199.00
        upper Limit
        6190.00
        value
        1295.00
    title
    BAFF (B-cell activating factor)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.00
        upper Limit
        2060.00
        value
        275.00
      2. group Id
        OG001
        lower Limit
        109.00
        upper Limit
        2130.00
        value
        414.50
    title
    MIP-3β
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        333.00
        value
        169.00
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        260.00
        value
        0.00
    title
    Eotaxin-1 (C-C motif chemokine 11)
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      44
    units
    Participants
description
Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.
dispersion Type
Full Range
groups
  1. description
    AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response).
    id
    OG000
    title
    Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)
  2. description
    AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
    id
    OG001
    title
    Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)
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
Baseline (Cycle 1/Day 1 pre-dose)
title
Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice