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NCT02487095 · OUTCOME

Ratio of Peripheral Blood Mononuclear Cells (PBMCs): Cluster of Differentiation 8 (CD8)/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
Ratio
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 CD8/CD4 T cell ratio.

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 DL 2 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 DL 2 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 CD8/CD4 T cell ratio

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 DL 2 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 Ratio · 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 50.55Not reported0.480.96Not reported
Phase I DL 2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 51.12Not reported1.011.25Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 50.86Not reported0.640.87Not reported
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 51.10Not reported0.881.34Not reported
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose0.63Not reported0.360.97Not reported
Post treatment CD8/CD4 T cell ratio

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 DL 2 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 Ratio · 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 50.64Not reported0.390.88Not reported
Phase I DL 2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 51.11Not reported0.881.26Not reported
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 50.29Not reportedNANAThere was only one sample.
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 50.99Not reported0.541.41Not reported
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose0.58Not reported0.330.95Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.48
        upper Limit
        0.96
        value
        0.55
      2. group Id
        OG001
        lower Limit
        1.01
        upper Limit
        1.25
        value
        1.12
      3. group Id
        OG002
        lower Limit
        0.64
        upper Limit
        0.87
        value
        0.86
      4. group Id
        OG003
        lower Limit
        0.88
        upper Limit
        1.34
        value
        1.10
      5. group Id
        OG004
        lower Limit
        0.36
        upper Limit
        0.97
        value
        0.63
    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 CD8/CD4 T cell ratio
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.39
        upper Limit
        0.88
        value
        0.64
      2. group Id
        OG001
        lower Limit
        0.88
        upper Limit
        1.26
        value
        1.11
      3. comment
        There was only one sample.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        0.29
      4. group Id
        OG003
        lower Limit
        0.54
        upper Limit
        1.41
        value
        0.99
      5. group Id
        OG004
        lower Limit
        0.33
        upper Limit
        0.95
        value
        0.58
    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 CD8/CD4 T cell ratio
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 CD8/CD4 T cell ratio.
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 DL 2 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
Ratio of Peripheral Blood Mononuclear Cells (PBMCs): Cluster of Differentiation 8 (CD8)/Cluster of Differentiation 4 (CD4) T Cells at Baseline and Post-Treatment
type
SECONDARY
unit Of Measure
Ratio

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice