NCT00765102 · OUTCOME

Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

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

Measure: GEOMETRIC_MEAN
Unit: ng*hr/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion

What was measured

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.

Analysis population: A subset of participants from the lead investigator's site had PK samples taken.

Groups in this outcome

Romidepsin 8 mg/m^2 + Bortezomib

Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m\^2.

Romidepsin 10 mg/m^2 + Bortezomib

Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.

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
Romidepsin 8 mg/m^2 + Bortezomib	6
Romidepsin 10 mg/m^2 + Bortezomib	5

Reported measurements

Source class 1

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Romidepsin 8 mg/m^2 + Bortezomib	1209.1	29.4	Not reported	Not reported	Not reported
Romidepsin 10 mg/m^2 + Bortezomib	1149.5	22.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
29.4
value
1209.1
group Id
OG001
spread
22.2
value
1149.5

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
5
units
Participants

description

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.

dispersion Type

Geometric Coefficient of Variation

groups

description
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m\^2.
id
OG000
title
Romidepsin 8 mg/m^2 + Bortezomib
description
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
id
OG001
title
Romidepsin 10 mg/m^2 + Bortezomib

param Type

GEOMETRIC_MEAN

population Description

A subset of participants from the lead investigator's site had PK samples taken.

reporting Status

POSTED

time Frame

Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion

title

Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)

type

SECONDARY

unit Of Measure

ng*hr/mL

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

Preserved source evidence · Not medical advice