NCT01177397 · OUTCOME

Area Under the Concentration Time-Curve From 0-24 Hours After a Dose (AUC0-24) for Metabolite M1

Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2022-12-13

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

Measure: GEOMETRIC_MEAN
Unit: ng*h/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 0 to 24 hours post-dose on Day -1 and Day 15

What was measured

AUC0-24 is defined as the area under the concentration-time curve from Time 0 to 24 hours after a dose. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.

Analysis population: All treated participants with available pharmacokinetic data in Part A.

Groups in this outcome

Part A: CC-223 7.5 mg

Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

Part A: CC-223 15 mg

Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

Part A: CC-223 30 mg

Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

Part A: CC-223 45 mg

Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

Part A: CC-223 60 mg

Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.

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
Part A: CC-223 7.5 mg	1
Part A: CC-223 15 mg	2
Part A: CC-223 30 mg	8
Part A: CC-223 45 mg	9
Part A: CC-223 60 mg	7

Reported measurements

Day 1

Analysis denominator · Participants

Group	Source count
Part A: CC-223 7.5 mg	1
Part A: CC-223 15 mg	2
Part A: CC-223 30 mg	8
Part A: CC-223 45 mg	9
Part A: CC-223 60 mg	7

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	2712	NA	Not reported	Not reported	Insufficient data values to calculate coefficient of variation.
Part A: CC-223 15 mg	3207	82.5	Not reported	Not reported	Not reported
Part A: CC-223 30 mg	12328	39.4	Not reported	Not reported	Not reported
Part A: CC-223 45 mg	14107	26.9	Not reported	Not reported	Not reported
Part A: CC-223 60 mg	16926	89.2	Not reported	Not reported	Not reported

Day 15

Analysis denominator · Participants

Group	Source count
Part A: CC-223 7.5 mg	1
Part A: CC-223 15 mg	2
Part A: CC-223 30 mg	6
Part A: CC-223 45 mg	7
Part A: CC-223 60 mg	5

Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	6401	NA	Not reported	Not reported	Insufficient data values to calculate coefficient of variation.
Part A: CC-223 15 mg	4388	133.8	Not reported	Not reported	Not reported
Part A: CC-223 30 mg	27389	48.5	Not reported	Not reported	Not reported
Part A: CC-223 45 mg	30823	38.3	Not reported	Not reported	Not reported
Part A: CC-223 60 mg	33070	101.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Insufficient data values to calculate coefficient of variation.
group Id
OG000
spread
NA
value
2712
group Id
OG001
spread
82.5
value
3207
group Id
OG002
spread
39.4
value
12328
group Id
OG003
spread
26.9
value
14107
group Id
OG004
spread
89.2
value
16926
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
8
group Id
OG003
value
9
group Id
OG004
value
7
units
Participants
title
Day 1
categories
measurements
comment
Insufficient data values to calculate coefficient of variation.
group Id
OG000
spread
NA
value
6401
group Id
OG001
spread
133.8
value
4388
group Id
OG002
spread
48.5
value
27389
group Id
OG003
spread
38.3
value
30823
group Id
OG004
spread
101.6
value
33070
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
7
group Id
OG004
value
5
units
Participants
title
Day 15

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
8
group Id
OG003
value
9
group Id
OG004
value
7
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
OG000
title
Part A: CC-223 7.5 mg
description
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
OG001
title
Part A: CC-223 15 mg
description
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
OG002
title
Part A: CC-223 30 mg
description
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
OG003
title
Part A: CC-223 45 mg
description
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
id
OG004
title
Part A: CC-223 60 mg

param Type

GEOMETRIC_MEAN

population Description

All treated participants with available pharmacokinetic data in Part A.

reporting Status

POSTED

time Frame

0 to 24 hours post-dose on Day -1 and Day 15

title

Area Under the Concentration Time-Curve From 0-24 Hours After a Dose (AUC0-24) for Metabolite M1

type

SECONDARY

unit Of Measure

ng*h/mL

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Preserved source evidence · Not medical advice