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NCT02487095 · OUTCOME

Percentage of Peripheral Blood Mononuclear Cells (PBMCs): Cluster of Differentiation 14 (CD14)+ Monocytes Among Viable Cells, and Regulatory T Cells Among Cluster of Differentiation 4 (CD4)+ T Cells At Baseline and Post-Treatment

Trial of Topotecan With VX-970 (M6620), an ATR Kinase Inhibitor, in Small Cell Cancers and Extrapulmonary Small Cell Cancers · Source last updated 2025-04-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
percentage of PBMCs
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline and 3 weeks post-treatment

What was measured

Blood samples were collected via venipuncture and immunophenotyping of PBMCs were performed by multiparameter flow cytometry for CD14+ monocytes among viable cells, and regulatory T cells among CD4+ T cells.

Analysis population: Only one participant had a post treatment sample in phase 1 DL3.

Groups in this outcome

Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5

Phase I Dose Level (DL) 1 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 5

Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 2 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5

Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 3 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5

Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5

Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose

Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose. Small cell lung cancer (SCLC) participants only.

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 I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 56
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 56
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 53
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 56
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose41

Reported measurements

Baseline CD14+ monocytes among viable cells

Analysis denominator · Participants

GroupSource count
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 56
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 56
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 53
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 56
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose41
Values in percentage of PBMCs · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 533.30Not reported31.4341.40Not reported
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 535.4Not reported22.1046.83Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 538.20Not reported25.7550.45Not reported
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 522.50Not reported18.0536.93Not reported
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose34.25Not reported25.7342.65Not reported
Post-Treatment CD14+ monocytes among viable cells

Analysis denominator · Participants

GroupSource count
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 56
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 56
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 51
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 56
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose41
Values in percentage of PBMCs · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 531.50Not reported29.4534.18Not reported
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 534.95Not reported28.4040.45Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 523.70Not reportedNANAThere was only 1 sample.
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 533.25Not reported25.8346.20Not reported
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose32.75Not reported27.8047.85Not reported
Baseline regulatory T cells among CD4+ T cells

Analysis denominator · Participants

GroupSource count
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 56
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 56
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 53
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 56
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose41
Values in percentage of PBMCs · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 53.19Not reported2.665.04Not reported
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 53.80Not reported2.664.18Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 53.32Not reported2.584.44Not reported
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 53.92Not reported3.144.30Not reported
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose3.50Not reported1.955.65Not reported
Post-Treatment regulatory T cells among CD4+ T cells

Analysis denominator · Participants

GroupSource count
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 56
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 56
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 51
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 56
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose41
Values in percentage of PBMCs · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 51.87Not reported1.783.04Not reported
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 54.42Not reported4.175.50Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 51.79Not reportedNANAThere was only 1 sample.
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 53.11Not reported2.443.20Not reported
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose2.53Not reported1.683.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.43
        upper Limit
        41.40
        value
        33.30
      2. group Id
        OG001
        lower Limit
        22.10
        upper Limit
        46.83
        value
        35.4
      3. group Id
        OG002
        lower Limit
        25.75
        upper Limit
        50.45
        value
        38.20
      4. group Id
        OG003
        lower Limit
        18.05
        upper Limit
        36.93
        value
        22.50
      5. group Id
        OG004
        lower Limit
        25.73
        upper Limit
        42.65
        value
        34.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        41
      units
      Participants
    title
    Baseline CD14+ monocytes among viable cells
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.45
        upper Limit
        34.18
        value
        31.50
      2. group Id
        OG001
        lower Limit
        28.40
        upper Limit
        40.45
        value
        34.95
      3. comment
        There was only 1 sample.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        23.70
      4. group Id
        OG003
        lower Limit
        25.83
        upper Limit
        46.20
        value
        33.25
      5. group Id
        OG004
        lower Limit
        27.80
        upper Limit
        47.85
        value
        32.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        41
      units
      Participants
    title
    Post-Treatment CD14+ monocytes among viable cells
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.66
        upper Limit
        5.04
        value
        3.19
      2. group Id
        OG001
        lower Limit
        2.66
        upper Limit
        4.18
        value
        3.80
      3. group Id
        OG002
        lower Limit
        2.58
        upper Limit
        4.44
        value
        3.32
      4. group Id
        OG003
        lower Limit
        3.14
        upper Limit
        4.30
        value
        3.92
      5. group Id
        OG004
        lower Limit
        1.95
        upper Limit
        5.65
        value
        3.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        41
      units
      Participants
    title
    Baseline regulatory T cells among CD4+ T cells
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.78
        upper Limit
        3.04
        value
        1.87
      2. group Id
        OG001
        lower Limit
        4.17
        upper Limit
        5.50
        value
        4.42
      3. comment
        There was only 1 sample.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        1.79
      4. group Id
        OG003
        lower Limit
        2.44
        upper Limit
        3.20
        value
        3.11
      5. group Id
        OG004
        lower Limit
        1.68
        upper Limit
        3.37
        value
        2.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        41
      units
      Participants
    title
    Post-Treatment regulatory T cells among CD4+ T cells
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      41
    units
    Participants
description
Blood samples were collected via venipuncture and immunophenotyping of PBMCs were performed by multiparameter flow cytometry for CD14+ monocytes among viable cells, and regulatory T cells among CD4+ T cells.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Phase I Dose Level (DL) 1 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 5
    id
    OG000
    title
    Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5
  2. description
    Phase I Dose Level (DL) 2 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5
    id
    OG001
    title
    Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5
  3. description
    Phase I Dose Level (DL) 3 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5
    id
    OG002
    title
    Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5
  4. description
    Phase I Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5
    id
    OG003
    title
    Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5
  5. description
    Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose. Small cell lung cancer (SCLC) participants only.
    id
    OG004
    title
    Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose
param Type
MEDIAN
population Description
Only one participant had a post treatment sample in phase 1 DL3.
reporting Status
POSTED
time Frame
Baseline and 3 weeks post-treatment
title
Percentage of Peripheral Blood Mononuclear Cells (PBMCs): Cluster of Differentiation 14 (CD14)+ Monocytes Among Viable Cells, and Regulatory T Cells Among Cluster of Differentiation 4 (CD4)+ T Cells At Baseline and Post-Treatment
type
SECONDARY
unit Of Measure
percentage of PBMCs

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Preserved source evidence · Not medical advice