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NCT00150462 · OUTCOME

Maximum Observed Plasma Concentration of Carfilzomib (Cmax)

Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies · Source last updated 2017-05-02

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.

Analysis population: Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Groups in this outcome

CFZ 1.2 mg/m²

Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 2.4 mg/m²

Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 4.0 mg/m²

Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 6.0 mg/m²

Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 8.4 mg/m²

Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 11.0 mg/m²

Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 15.0 mg/m²

Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 20.0 mg/m²

Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 27.0 mg/m²

Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 20/27 mg/m² (±DEX)

Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
CFZ 1.2 mg/m²0
CFZ 2.4 mg/m²0
CFZ 4.0 mg/m²0
CFZ 6.0 mg/m²0
CFZ 8.4 mg/m²0
CFZ 11.0 mg/m²3
CFZ 15.0 mg/m²3
CFZ 20.0 mg/m²8
CFZ 27.0 mg/m²5
CFZ 20/27 mg/m² (±DEX)8

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CFZ 11.0 mg/m²505.17485.12Not reportedNot reportedNot reported
CFZ 15.0 mg/m²142.6797.22Not reportedNot reportedNot reported
CFZ 20.0 mg/m²527.50405.59Not reportedNot reportedNot reported
CFZ 27.0 mg/m²406.08517.29Not reportedNot reportedNot reported
CFZ 20/27 mg/m² (±DEX)390.66492.92Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG005
        spread
        485.12
        value
        505.17
      2. group Id
        OG006
        spread
        97.22
        value
        142.67
      3. group Id
        OG007
        spread
        405.59
        value
        527.50
      4. group Id
        OG008
        spread
        517.29
        value
        406.08
      5. group Id
        OG009
        spread
        492.92
        value
        390.66
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      8
    9. group Id
      OG008
      value
      5
    10. group Id
      OG009
      value
      8
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG000
    title
    CFZ 1.2 mg/m²
  2. description
    Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG001
    title
    CFZ 2.4 mg/m²
  3. description
    Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG002
    title
    CFZ 4.0 mg/m²
  4. description
    Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG003
    title
    CFZ 6.0 mg/m²
  5. description
    Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG004
    title
    CFZ 8.4 mg/m²
  6. description
    Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG005
    title
    CFZ 11.0 mg/m²
  7. description
    Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG006
    title
    CFZ 15.0 mg/m²
  8. description
    Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG007
    title
    CFZ 20.0 mg/m²
  9. description
    Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    OG008
    title
    CFZ 27.0 mg/m²
  10. description
    Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
    id
    OG009
    title
    CFZ 20/27 mg/m² (±DEX)
param Type
MEAN
population Description
Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.
reporting Status
POSTED
time Frame
Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
title
Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
type
PRIMARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice