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NCT00531284 · OUTCOME

Duration of Response

Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma · Source last updated 2017-08-15

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.

What was measured

Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.

Analysis population: Safety Population with a partial response or better

Groups in this outcome

P1B ST: CFZ 20 mg/m² Bolus

Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B ST: CFZ 20/27 mg/m² Bolus

Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B ST: CFZ 20/36 mg/m² Bolus

Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P2 ST: CFZ 20/36 mg/m² Bolus

Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B ST: CFZ 36 mg/m²

Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B ST: CFZ 45 mg/m²

Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B ST: CFZ 20/45 mg/m²

Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B ST: CFZ 20/56 mg/m²

Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B ST: CFZ 20/70 mg/m²

Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B MM: CFZ 20/36 mg/m²

Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B MM: CFZ 20/45 mg/m²

Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1b MM: CFZ 20/56 mg/m²

Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B MM: CFZ 20/70 mg/m²

Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B NHL: CFZ 20/56 mg/m²

Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B NHL: CFZ 20/70 mg/m²

Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B WM: CFZ 20/56 mg/m²

Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B WM: CFZ 20/70 mg/m²

Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B MM: CFZ 20/45 mg/m² + Dex

Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

P1B MM: CFZ 20/56 mg/m² + Dex

Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
P1B ST: CFZ 20 mg/m² Bolus0
P1B ST: CFZ 20/27 mg/m² Bolus0
P1B ST: CFZ 20/36 mg/m² Bolus2
P2 ST: CFZ 20/36 mg/m² Bolus0
P1B ST: CFZ 36 mg/m²0
P1B ST: CFZ 45 mg/m²0
P1B ST: CFZ 20/45 mg/m²0
P1B ST: CFZ 20/56 mg/m²0
P1B ST: CFZ 20/70 mg/m²0
P1B MM: CFZ 20/36 mg/m²2
P1B MM: CFZ 20/45 mg/m²1
P1b MM: CFZ 20/56 mg/m²12
P1B MM: CFZ 20/70 mg/m²1
P1B NHL: CFZ 20/56 mg/m²0
P1B NHL: CFZ 20/70 mg/m²0
P1B WM: CFZ 20/56 mg/m²1
P1B WM: CFZ 20/70 mg/m²4
P1B MM: CFZ 20/45 mg/m² + Dex9
P1B MM: CFZ 20/56 mg/m² + Dex3

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
P1B ST: CFZ 20/36 mg/m² Bolus6.2Not reportedNANANot estimable due to the low number of progression events
P1B MM: CFZ 20/36 mg/m²9.3Not reported3.914.7Not reported
P1B MM: CFZ 20/45 mg/m²5.5Not reportedNANACould not be calculated since there was only 1 participant with a response
P1b MM: CFZ 20/56 mg/m²8.0Not reported4.132.5Not reported
P1B MM: CFZ 20/70 mg/m²14.8Not reportedNANACould not be calculated since there was only 1 participant with a response
P1B WM: CFZ 20/56 mg/m²NANot reportedNANANot estimable due to the low number of progression events
P1B WM: CFZ 20/70 mg/m²NANot reportedNANANot estimable due to the low number of progression events
P1B MM: CFZ 20/45 mg/m² + Dex9.0Not reported1.9NANot estimable due to the low number of progression events
P1B MM: CFZ 20/56 mg/m² + Dex22.6Not reported17.527.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to the low number of progression events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        6.2
      2. group Id
        OG009
        lower Limit
        3.9
        upper Limit
        14.7
        value
        9.3
      3. comment
        Could not be calculated since there was only 1 participant with a response
        group Id
        OG010
        lower Limit
        NA
        upper Limit
        NA
        value
        5.5
      4. group Id
        OG011
        lower Limit
        4.1
        upper Limit
        32.5
        value
        8.0
      5. comment
        Could not be calculated since there was only 1 participant with a response
        group Id
        OG012
        lower Limit
        NA
        upper Limit
        NA
        value
        14.8
      6. comment
        Not estimable due to the low number of progression events
        group Id
        OG015
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      7. comment
        Not estimable due to the low number of progression events
        group Id
        OG016
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      8. comment
        Not estimable due to the low number of progression events
        group Id
        OG017
        lower Limit
        1.9
        upper Limit
        NA
        value
        9.0
      9. group Id
        OG018
        lower Limit
        17.5
        upper Limit
        27.6
        value
        22.6
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      2
    11. group Id
      OG010
      value
      1
    12. group Id
      OG011
      value
      12
    units
    Participants
description
Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG000
    title
    P1B ST: CFZ 20 mg/m² Bolus
  2. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG001
    title
    P1B ST: CFZ 20/27 mg/m² Bolus
  3. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG002
    title
    P1B ST: CFZ 20/36 mg/m² Bolus
  4. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG003
    title
    P2 ST: CFZ 20/36 mg/m² Bolus
  5. description
    Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG004
    title
    P1B ST: CFZ 36 mg/m²
  6. description
    Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG005
    title
    P1B ST: CFZ 45 mg/m²
  7. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG006
    title
    P1B ST: CFZ 20/45 mg/m²
  8. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG007
    title
    P1B ST: CFZ 20/56 mg/m²
  9. description
    Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG008
    title
    P1B ST: CFZ 20/70 mg/m²
  10. description
    Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG009
    title
    P1B MM: CFZ 20/36 mg/m²
  11. description
    Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG010
    title
    P1B MM: CFZ 20/45 mg/m²
  12. description
    Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
    id
    OG011
    title
    P1b MM: CFZ 20/56 mg/m²
param Type
MEDIAN
population Description
Safety Population with a partial response or better
reporting Status
POSTED
time Frame
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
title
Duration of Response
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice