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NCT00150462 · OUTCOME

Duration of Response

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
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.

What was measured

Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median duration of response was calculated using the Kaplan-Meier method.

Analysis population: Biologic response-evaluable participants with an objective response

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

Participants 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.

CFZ 20/27 mg/m² + DEX

Participants 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. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).

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/m²0
CFZ 15.0 mg/m²1
CFZ 20.0 mg/m²1
CFZ 27.0 mg/m²3
CFZ 20/27 mg/m²2
CFZ 20/27 mg/m² + DEX1

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CFZ 15.0 mg/m²308.0Not reported308.0308.0Not reported
CFZ 20.0 mg/m²176.0Not reported176.0176.0Not reported
CFZ 27.0 mg/m²225.0Not reported94.0316.0Not reported
CFZ 20/27 mg/m²NANot reportedNANACould not be calculated due to the low number of events
CFZ 20/27 mg/m² + DEXNANot reportedNANACould not be calculated due to the low number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG006
        lower Limit
        308.0
        upper Limit
        308.0
        value
        308.0
      2. group Id
        OG007
        lower Limit
        176.0
        upper Limit
        176.0
        value
        176.0
      3. group Id
        OG008
        lower Limit
        94.0
        upper Limit
        316.0
        value
        225.0
      4. comment
        Could not be calculated due to the low number of events
        group Id
        OG009
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        Could not be calculated due to the low number of events
        group Id
        OG010
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
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
      0
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      1
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      2
    11. group Id
      OG010
      value
      1
    units
    Participants
description
Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median duration of response was calculated using the Kaplan-Meier method.
dispersion Type
Full Range
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 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
  11. description
    Participants 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. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
    id
    OG010
    title
    CFZ 20/27 mg/m² + DEX
param Type
MEDIAN
population Description
Biologic response-evaluable participants with an objective response
reporting Status
POSTED
time Frame
From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
title
Duration of Response
type
SECONDARY
unit Of Measure
days

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice