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NCT03345485 · OUTCOME

Summary of Tmax in in Phase 2 and Sub Studies.

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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
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)6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)7
Phase 2 All Cohorts35
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0.750Not reported0.2500.750Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1Not reported0.7501.33Not reported
Phase 2 All Cohorts0.750Not reported0.2501.25Not reported
EDO-S101 concentration, Cycle 1 D15

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)5
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)6
Phase 2 All Cohorts35
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0.750Not reported0.50.750Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0.875Not reported0.1671.33Not reported
Phase 2 All Cohorts0.750Not reported01.25Not reported
M2 metabolite concentration, Cycle 1 D1

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)5
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)5
Phase 2 All Cohorts35
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)1Not reported0.2506Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1.58Not reported0.75024Not reported
Phase 2 All Cohorts1.00Not reported0.252.00Not reported
M2 metabolite concentration, Cycle 1 D15

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)3
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1
Phase 2 All Cohorts35
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)1Not reported0.25024Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)3.50Not reported3.503.50Not reported
Phase 2 All Cohorts1.00Not reported06Not reported
M8 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 hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0.750Not reported0.2501Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1Not reported11.33Not reported
Phase 2 All Cohorts0.750Not reported0.2501.50Not reported
M8 metabolite concentration, Cycle 1 D15

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)5
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)6
Phase 2 All Cohorts35
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0.750Not reported0.5000.750Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1.33Not reported11.33Not reported
Phase 2 All Cohorts0.750Not reported01.25Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.250
        upper Limit
        0.750
        value
        0.750
      2. group Id
        OG001
        lower Limit
        0.750
        upper Limit
        1.33
        value
        1
      3. group Id
        OG002
        lower Limit
        0.250
        upper Limit
        1.25
        value
        0.750
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    EDO-S101 concentration, Cycle 1 D1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        0.750
        value
        0.750
      2. group Id
        OG001
        lower Limit
        0.167
        upper Limit
        1.33
        value
        0.875
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        1.25
        value
        0.750
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    EDO-S101 concentration, Cycle 1 D15
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.250
        upper Limit
        6
        value
        1
      2. group Id
        OG001
        lower Limit
        0.750
        upper Limit
        24
        value
        1.58
      3. group Id
        OG002
        lower Limit
        0.25
        upper Limit
        2.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    M2 metabolite concentration, Cycle 1 D1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.250
        upper Limit
        24
        value
        1
      2. group Id
        OG001
        lower Limit
        3.50
        upper Limit
        3.50
        value
        3.50
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        6
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    M2 metabolite concentration, Cycle 1 D15
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.250
        upper Limit
        1
        value
        0.750
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        1.33
        value
        1
      3. group Id
        OG002
        lower Limit
        0.250
        upper Limit
        1.50
        value
        0.750
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        35
      units
      Participants
    title
    M8 metabolite concentration, Cycle 1 D1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.500
        upper Limit
        0.750
        value
        0.750
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        1.33
        value
        1.33
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        1.25
        value
        0.750
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      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
Full Range
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
MEDIAN
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
Summary of Tmax in in Phase 2 and Sub Studies.
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice