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NCT03687125 · OUTCOME

Phase 1 and 2: Time to Reach Maximum Plasma Concentration (Tmax) of Tinostamustine and Its Metabolites

Tinostamustine Conditioning and Autologous Stem Cell · Source last updated 2021-06-18

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
Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion

What was measured

Tmax was defined as time to reach maximum plasma concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.

Analysis population: Pharmacokinetic (PK) population included all participants in the safety population with at least one quantifiable pre-dose and one quantifiable post-dose PK plasma concentration. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2.

Groups in this outcome

Tinostamustine 180 mg/m^2

Participants received single dose of tinostamustine 180 mg/m\^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.

Tinostamustine 220 mg/m^2

Participants received single dose of tinostamustine 220 mg/m\^2 IV injection followed by ASCT on Day 1.

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 180 mg/m^23
Tinostamustine 220 mg/m^23

Reported measurements

EDO-S101
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine 180 mg/m^20.75Not reported0.500.75Not reported
Tinostamustine 220 mg/m^20.75Not reported0.500.75Not reported
M2-EDO-S101
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine 180 mg/m^21.00Not reported1.001.00Not reported
Tinostamustine 220 mg/m^21.00Not reported0.753.00Not reported
M8-EDO-S101
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tinostamustine 180 mg/m^20.75Not reported0.500.75Not reported
Tinostamustine 220 mg/m^21.00Not reported0.501.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.50
        upper Limit
        0.75
        value
        0.75
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        0.75
        value
        0.75
    title
    EDO-S101
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        1.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        0.75
        upper Limit
        3.00
        value
        1.00
    title
    M2-EDO-S101
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.50
        upper Limit
        0.75
        value
        0.75
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        1.00
        value
        1.00
    title
    M8-EDO-S101
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Tmax was defined as time to reach maximum plasma concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
dispersion Type
Full Range
groups
  1. description
    Participants received single dose of tinostamustine 180 mg/m\^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.
    id
    OG000
    title
    Tinostamustine 180 mg/m^2
  2. description
    Participants received single dose of tinostamustine 220 mg/m\^2 IV injection followed by ASCT on Day 1.
    id
    OG001
    title
    Tinostamustine 220 mg/m^2
param Type
MEDIAN
population Description
Pharmacokinetic (PK) population included all participants in the safety population with at least one quantifiable pre-dose and one quantifiable post-dose PK plasma concentration. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2.
reporting Status
POSTED
time Frame
Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion
title
Phase 1 and 2: Time to Reach Maximum Plasma Concentration (Tmax) of Tinostamustine and Its Metabolites
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice