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NCT01456039 · OUTCOME

Cmax Accumulation Ratio of Romidepsin in Phase 1, Cycle 1

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

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

Measure
GEOMETRIC_MEAN
Unit
ratio
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at end of administration) hours after the start of administration, 0.25, 0.5, 1, 2, 4, 6, 20, and 44 hours after the end of administration. Day 8, Cycle 1, samples collected at 0 hour

What was measured

Cmax of Romidepsin: accumulation ratio based on Cmax calculated as Cmax,ss/Cmax

Analysis population: PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.

Groups in this outcome

Phase 1: Cohort 1: Romidepsin 9mg/m^2

Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle

Phase 1: Cohort 2: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

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 1: Cohort 1: Romidepsin 9mg/m^23
Phase 1: Cohort 2: Romidepsin 14mg/m^26

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Cohort 1: Romidepsin 9mg/m^20.9315.3Not reportedNot reportedNot reported
Phase 1: Cohort 2: Romidepsin 14mg/m^20.8622.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.3
        value
        0.93
      2. group Id
        OG001
        spread
        22.2
        value
        0.86
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Cmax of Romidepsin: accumulation ratio based on Cmax calculated as Cmax,ss/Cmax
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
    id
    OG000
    title
    Phase 1: Cohort 1: Romidepsin 9mg/m^2
  2. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG001
    title
    Phase 1: Cohort 2: Romidepsin 14mg/m^2
param Type
GEOMETRIC_MEAN
population Description
PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.
reporting Status
POSTED
time Frame
Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at end of administration) hours after the start of administration, 0.25, 0.5, 1, 2, 4, 6, 20, and 44 hours after the end of administration. Day 8, Cycle 1, samples collected at 0 hour
title
Cmax Accumulation Ratio of Romidepsin in Phase 1, Cycle 1
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice