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NCT03687125 · OUTCOME

Phase 1 and 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC0-12h) 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
MEAN
Unit
h*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-infusion, 0.50, 0.75, 1, 3, 6 hours post-infusion

What was measured

AUC0-12h was defined as area under the concentration-time curve from time zero to 12 hours. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.

Analysis population: 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. Here, number analyzed refers to the number of participants with available data for each specified category.

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^22
Tinostamustine 220 mg/m^23

Reported measurements

EDO-S101

Analysis denominator · Participants

GroupSource count
Tinostamustine 180 mg/m^22
Tinostamustine 220 mg/m^23
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tinostamustine 180 mg/m^2NANANot reportedNot reportedMean and SD was not calculated as data were available for only two participants.
Tinostamustine 220 mg/m^24887.162052.21Not reportedNot reportedNot reported
M2-EDO-S101

Analysis denominator · Participants

GroupSource count
Tinostamustine 180 mg/m^20
Tinostamustine 220 mg/m^20
M8-EDO-S101

Analysis denominator · Participants

GroupSource count
Tinostamustine 180 mg/m^20
Tinostamustine 220 mg/m^20
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Mean and SD was not calculated as data were available for only two participants.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        2052.21
        value
        4887.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    EDO-S101
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M2-EDO-S101
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M8-EDO-S101
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    units
    Participants
description
AUC0-12h was defined as area under the concentration-time curve from time zero to 12 hours. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
dispersion Type
Standard Deviation
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
MEAN
population Description
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. Here, number analyzed refers to the number of participants with available data for each specified category.
reporting Status
POSTED
time Frame
Pre-infusion, 0.50, 0.75, 1, 3, 6 hours post-infusion
title
Phase 1 and 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC0-12h) of Tinostamustine and Its Metabolites
type
SECONDARY
unit Of Measure
h*ng/mL

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

Preserved source evidence · Not medical advice