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NCT01177397 · OUTCOME

Apparent Volume of Distribution (Vz/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
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

What was measured

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. VZ/F was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.

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

GroupSource count
Part A: CC-223 7.5 mg1
Part A: CC-223 15 mg2
Part A: CC-223 30 mg8
Part A: CC-223 45 mg8
Part A: CC-223 60 mg6

Reported measurements

Source class 1
Values in L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part A: CC-223 7.5 mg235NANot reportedNot reportedInsufficient data values to calculate coefficient of variation.
Part A: CC-223 15 mg1923.70Not reportedNot reportedNot reported
Part A: CC-223 30 mg19536.7Not reportedNot reportedNot reported
Part A: CC-223 45 mg18627.1Not reportedNot reportedNot reported
Part A: CC-223 60 mg236107.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient data values to calculate coefficient of variation.
        group Id
        OG000
        spread
        NA
        value
        235
      2. group Id
        OG001
        spread
        3.70
        value
        192
      3. group Id
        OG002
        spread
        36.7
        value
        195
      4. group Id
        OG003
        spread
        27.1
        value
        186
      5. group Id
        OG004
        spread
        107.5
        value
        236
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      6
    units
    Participants
description
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. VZ/F was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
title
Apparent Volume of Distribution (Vz/F) of CC-223
type
PRIMARY
unit Of Measure
L

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Preserved source evidence · Not medical advice