NCT01456039 · OUTCOME

Cmax, ss of Romidepsin in Phase 1 at Cycle 1, Day 15

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: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration

What was measured

Maximum observed concentration in plasma at steady state

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

Group	Source count
Phase 1: Cohort 1: Romidepsin 9mg/m^2	3
Phase 1: Cohort 2: Romidepsin 14mg/m^2	6

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Cohort 1: Romidepsin 9mg/m^2	250.05	63.3	Not reported	Not reported	Not reported
Phase 1: Cohort 2: Romidepsin 14mg/m^2	489.47	31.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
63.3
value
250.05
group Id
OG001
spread
31.2
value
489.47

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
units
Participants

description

Maximum observed concentration in plasma at steady state

dispersion Type

Geometric Coefficient of Variation

groups

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
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 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration

title

Cmax, ss of Romidepsin in Phase 1 at Cycle 1, Day 15

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice