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NCT03345485 · OUTCOME

Clearance of Tinostamustine and Metabolites in Phase 2 and Substudies

Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21

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

Measure
GEOMETRIC_MEAN
Unit
mL/h/m^2
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Blood samples were collected over a period of 24hr (phase 2 and sub-study 1) and 30hr (sub-study 2) on Cycle 1 Day 1 and Day 15.

Analysis population: All enrolled subjects in the Safety Population with at least 1 quantifiable pre-dose and 1 quantifiable post-dose PK plasma concentration in Cycle 1 were included in the PK Population. PK analyses were performed using the PK population. 48 subjects of the Safety Population were included in the PK Population.

Groups in this outcome

Tinostamustine (EDO-S101) - Sub Study 1 (SS1)

A dose of 60 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles

Tinostamustine (EDO-S101) - Sub Study 2 (SS2)

A dose of 80 mg/m2 administered over 80 minutes on D1 and D15 of 4-week cycles.

Phase 2 All Cohorts

A dose of 80 mg/m2 administered over 60 minutes on D1 and D15 of 4-week 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
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)7
Phase 2 All Cohorts35

Reported measurements

EDO-S101 concentration, Cycle 1 D1

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)4
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)3
Phase 2 All Cohorts28
Values in mL/h/m^2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)6980048.7Not reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)5600023.9Not reportedNot reportedNot reported
Phase 2 All Cohorts5080041.1Not reportedNot reportedNot reported
EDO-S101 concentration, Cycle 1 D15

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)3
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)2
Phase 2 All Cohorts21
Values in mL/h/m^2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)8960019.5Not reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)4960058.3Not reportedNot reportedNot reported
Phase 2 All Cohorts5360045.2Not reportedNot reportedNot reported
M2 metabolite concentration, Cycle 1 D1

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)7
Phase 2 All Cohorts35
Values in mL/h/m^2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)NANANot reportedNot reportedM2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)NANANot reportedNot reportedM2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
Phase 2 All CohortsNANANot reportedNot reportedM2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
M2 metabolite concentration, Cycle 1 D15

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)7
Phase 2 All Cohorts35
Values in mL/h/m^2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)NANANot reportedNot reportedM2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)NANANot reportedNot reportedM2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
Phase 2 All CohortsNANANot reportedNot reportedM2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
M8 metabolite concentration, Cycle 1 D1

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)3
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)3
Phase 2 All Cohorts35
Values in mL/h/m^2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)241000054.2Not reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)227000022.4Not reportedNot reportedNot reported
Phase 2 All CohortsNANANot reportedNot reportedM8 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
M8 metabolite concentration, Cycle 1 D15

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)2
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)3
Phase 2 All Cohorts35
Values in mL/h/m^2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)124000014.8Not reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)174000040.8Not reportedNot reportedNot reported
Phase 2 All CohortsNANANot reportedNot reportedM8 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.7
        value
        69800
      2. group Id
        OG001
        spread
        23.9
        value
        56000
      3. group Id
        OG002
        spread
        41.1
        value
        50800
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        28
      units
      Participants
    title
    EDO-S101 concentration, Cycle 1 D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.5
        value
        89600
      2. group Id
        OG001
        spread
        58.3
        value
        49600
      3. group Id
        OG002
        spread
        45.2
        value
        53600
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        21
      units
      Participants
    title
    EDO-S101 concentration, Cycle 1 D15
  3. categories
    1. measurements
      1. comment
        M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG002
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    M2 metabolite concentration, Cycle 1 D1
  4. categories
    1. measurements
      1. comment
        M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG002
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    M2 metabolite concentration, Cycle 1 D15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.2
        value
        2410000
      2. group Id
        OG001
        spread
        22.4
        value
        2270000
      3. comment
        M8 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG002
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    M8 metabolite concentration, Cycle 1 D1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.8
        value
        1240000
      2. group Id
        OG001
        spread
        40.8
        value
        1740000
      3. comment
        M8 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.
        group Id
        OG002
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    M8 metabolite concentration, Cycle 1 D15
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      35
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    A dose of 60 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles
    id
    OG000
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
  2. description
    A dose of 80 mg/m2 administered over 80 minutes on D1 and D15 of 4-week cycles.
    id
    OG001
    title
    Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
  3. description
    A dose of 80 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles.
    id
    OG002
    title
    Phase 2 All Cohorts
param Type
GEOMETRIC_MEAN
population Description
All enrolled subjects in the Safety Population with at least 1 quantifiable pre-dose and 1 quantifiable post-dose PK plasma concentration in Cycle 1 were included in the PK Population. PK analyses were performed using the PK population. 48 subjects of the Safety Population were included in the PK Population.
reporting Status
POSTED
time Frame
Blood samples were collected over a period of 24hr (phase 2 and sub-study 1) and 30hr (sub-study 2) on Cycle 1 Day 1 and Day 15.
title
Clearance of Tinostamustine and Metabolites in Phase 2 and Substudies
type
SECONDARY
unit Of Measure
mL/h/m^2

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Preserved source evidence · Not medical advice