NCT01177397 · OUTCOME

Time to Maximum Concentration (Tmax) 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: MEDIAN
Unit: Hours
Interval / dispersion: Full Range
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

Tmax is defined as the time to Cmax, 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 Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	8.00	Not reported	8.00	8.00	Not reported
Part A: CC-223 15 mg	2.28	Not reported	1.50	3.05	Not reported
Part A: CC-223 30 mg	6.51	Not reported	1.50	8.00	Not reported
Part A: CC-223 45 mg	5.00	Not reported	1.60	8.00	Not reported
Part A: CC-223 60 mg	5.00	Not reported	1.67	8.00	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 Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	1.50	Not reported	1.50	1.50	Not reported
Part A: CC-223 15 mg	3.25	Not reported	1.50	5.00	Not reported
Part A: CC-223 30 mg	1.58	Not reported	1.00	3.03	Not reported
Part A: CC-223 45 mg	1.71	Not reported	0.00	3.20	Not reported
Part A: CC-223 60 mg	3.00	Not reported	0.00	5.00	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
8.00
upper Limit
8.00
value
8.00
group Id
OG001
lower Limit
1.50
upper Limit
3.05
value
2.28
group Id
OG002
lower Limit
1.50
upper Limit
8.00
value
6.51
group Id
OG003
lower Limit
1.60
upper Limit
8.00
value
5.00
group Id
OG004
lower Limit
1.67
upper Limit
8.00
value
5.00
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
group Id
OG000
lower Limit
1.50
upper Limit
1.50
value
1.50
group Id
OG001
lower Limit
1.50
upper Limit
5.00
value
3.25
group Id
OG002
lower Limit
1.00
upper Limit
3.03
value
1.58
group Id
OG003
lower Limit
0.00
upper Limit
3.20
value
1.71
group Id
OG004
lower Limit
0.00
upper Limit
5.00
value
3.00
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

Full Range

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

MEDIAN

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

Time to Maximum Concentration (Tmax) of Metabolite M1

type

SECONDARY

unit Of Measure

Hours

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Preserved source evidence · Not medical advice