NCT01177397 · OUTCOME

Apparent Total Body Clearance (CL/F) of CC-223

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: L/h
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

CL/F is defined as the apparent total body clearance when dosed orally, calculated as Dose/AUCinf. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 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	8
Part A: CC-223 60 mg	6

Reported measurements

Day -1/1

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	8
Part A: CC-223 60 mg	6

Values in L/h · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	21.2	NA	Not reported	Not reported	Insufficient data values to calculate coefficient of variation.
Part A: CC-223 15 mg	39.7	49.7	Not reported	Not reported	Not reported
Part A: CC-223 30 mg	24.3	38.9	Not reported	Not reported	Not reported
Part A: CC-223 45 mg	26.6	41.8	Not reported	Not reported	Not reported
Part A: CC-223 60 mg	28.9	111.4	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	6
Part A: CC-223 60 mg	4

Values in L/h · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part A: CC-223 7.5 mg	25.1	NA	Not reported	Not reported	Insufficient data values to calculate coefficient of variation.
Part A: CC-223 15 mg	39.2	88.8	Not reported	Not reported	Not reported
Part A: CC-223 30 mg	20.8	41.4	Not reported	Not reported	Not reported
Part A: CC-223 45 mg	21.6	29.3	Not reported	Not reported	Not reported
Part A: CC-223 60 mg	20.3	106.2	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
21.2
group Id
OG001
spread
49.7
value
39.7
group Id
OG002
spread
38.9
value
24.3
group Id
OG003
spread
41.8
value
26.6
group Id
OG004
spread
111.4
value
28.9
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
8
group Id
OG003
value
8
group Id
OG004
value
6
units
Participants
title
Day -1/1
categories
measurements
comment
Insufficient data values to calculate coefficient of variation.
group Id
OG000
spread
NA
value
25.1
group Id
OG001
spread
88.8
value
39.2
group Id
OG002
spread
41.4
value
20.8
group Id
OG003
spread
29.3
value
21.6
group Id
OG004
spread
106.2
value
20.3
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
6
group Id
OG004
value
4
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
8
group Id
OG004
value
6
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

Apparent Total Body Clearance (CL/F) of CC-223

type

PRIMARY

unit Of Measure

L/h

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Preserved source evidence · Not medical advice