NCT01177397 · OUTCOME

Maximum Observed Concentration (Cmax) of 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/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose

What was measured

Cmax is defined as the maximum observed concentration (in plasma), obtained directly from the observed concentration versus time data. 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/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	143	NA	Not reported	Not reported	Insufficient data values to calculate coefficient of variation.
Part A: CC-223 15 mg	284	64.6	Not reported	Not reported	Not reported
Part A: CC-223 30 mg	729	40.3	Not reported	Not reported	Not reported
Part A: CC-223 45 mg	1002	37.2	Not reported	Not reported	Not reported
Part A: CC-223 60 mg	1174	86.0	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/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	363	NA	Not reported	Not reported	Insufficient data values to calculate coefficient of variation.
Part A: CC-223 15 mg	357	139.8	Not reported	Not reported	Not reported
Part A: CC-223 30 mg	1681	34.5	Not reported	Not reported	Not reported
Part A: CC-223 45 mg	2061	23.1	Not reported	Not reported	Not reported
Part A: CC-223 60 mg	1946	78.9	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
143
group Id
OG001
spread
64.6
value
284
group Id
OG002
spread
40.3
value
729
group Id
OG003
spread
37.2
value
1002
group Id
OG004
spread
86.0
value
1174
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
363
group Id
OG001
spread
139.8
value
357
group Id
OG002
spread
34.5
value
1681
group Id
OG003
spread
23.1
value
2061
group Id
OG004
spread
78.9
value
1946
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

Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose

title

Maximum Observed Concentration (Cmax) of Metabolite M1

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice