Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00531284 · OUTCOME

Time to Progression

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

Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.

Analysis population: Safety population.

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 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 20/45 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 Bolus3
P1B ST: CFZ 20/27 mg/m² Bolus4
P1B ST: CFZ 20/36 mg/m² Bolus7
P2 ST: CFZ 20/36 mg/m² Bolus65
P1B ST: CFZ 36 mg/m²6
P1B ST: CFZ 45 mg/m²7
P1B ST: CFZ 20/45 mg/m²6
P1B ST: CFZ 20/56 mg/m²10
P1B ST: CFZ 20/70 mg/m²11
P1B MM: CFZ 20/36 mg/m²4
P1B MM: CFZ 20/45 mg/m²3
P1b MM: CFZ 20/56 mg/m²24
P1B MM: CFZ 20/70 mg/m²2
P1B NHL: CFZ 20/56 mg/m²2
P1B NHL: CFZ 20/70 mg/m²3
P1B WM: CFZ 20/56 mg/m²1
P1B WM: CFZ 20/70 mg/m²4
P1B MM: CFZ 20/45 mg/m² + Dex14
P1B MM: CFZ 20/56 mg/m² + Dex8

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
P1B ST: CFZ 20 mg/m² Bolus5.1Not reportedNANACould not be estimated due to the low number of events
P1B ST: CFZ 20/27 mg/m² Bolus1.8Not reported1.61.9Not reported
P1B ST: CFZ 20/36 mg/m² Bolus1.8Not reported1.6NACould not be estimated due to the low number of events
P2 ST: CFZ 20/36 mg/m² Bolus1.8Not reported1.72.1Not reported
P1B ST: CFZ 36 mg/m²1.7Not reported1.1NACould not be estimated due to the low number of events
P1B ST: CFZ 45 mg/m²1.6Not reported0.94.1Not reported
P1B ST: CFZ 20/45 mg/m²1.6Not reported1.1NACould not be estimated due to the low number of events
P1B ST: CFZ 20/56 mg/m²1.6Not reported0.52.0Not reported
P1B ST: CFZ 20/70 mg/m²1.6Not reported0.35.6Not reported
P1B MM: CFZ 20/36 mg/m²5.2Not reported4.415.1Not reported
P1B MM: CFZ 20/45 mg/m²4.6Not reported1.45.9Not reported
P1b MM: CFZ 20/56 mg/m²6.9Not reported1.28.4Not reported
P1B MM: CFZ 20/70 mg/m²9.4Not reported1.916.8Not reported
P1B NHL: CFZ 20/56 mg/m²NANot reported1.6NACould not be estimated due to the low number of events
P1B NHL: CFZ 20/70 mg/m²1.0Not reported0.6NACould not be estimated due to the low number of events
P1B WM: CFZ 20/56 mg/m²NANot reportedNANACould not be estimated due to the low number of events
P1B WM: CFZ 20/70 mg/m²NANot reportedNANACould not be estimated due to the low number of events
P1B MM: CFZ 20/45 mg/m² + Dex4.6Not reported1.912.7Not reported
P1B MM: CFZ 20/56 mg/m² + Dex11.5Not reported1.828.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Could not be estimated due to the low number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        5.1
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        1.9
        value
        1.8
      3. comment
        Could not be estimated due to the low number of events
        group Id
        OG002
        lower Limit
        1.6
        upper Limit
        NA
        value
        1.8
      4. group Id
        OG003
        lower Limit
        1.7
        upper Limit
        2.1
        value
        1.8
      5. comment
        Could not be estimated due to the low number of events
        group Id
        OG004
        lower Limit
        1.1
        upper Limit
        NA
        value
        1.7
      6. group Id
        OG005
        lower Limit
        0.9
        upper Limit
        4.1
        value
        1.6
      7. comment
        Could not be estimated due to the low number of events
        group Id
        OG006
        lower Limit
        1.1
        upper Limit
        NA
        value
        1.6
      8. group Id
        OG007
        lower Limit
        0.5
        upper Limit
        2.0
        value
        1.6
      9. group Id
        OG008
        lower Limit
        0.3
        upper Limit
        5.6
        value
        1.6
      10. group Id
        OG009
        lower Limit
        4.4
        upper Limit
        15.1
        value
        5.2
      11. group Id
        OG010
        lower Limit
        1.4
        upper Limit
        5.9
        value
        4.6
      12. group Id
        OG011
        lower Limit
        1.2
        upper Limit
        8.4
        value
        6.9
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      65
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      7
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      10
    9. group Id
      OG008
      value
      11
    10. group Id
      OG009
      value
      4
    11. group Id
      OG010
      value
      3
    12. group Id
      OG011
      value
      24
    units
    Participants
description
Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.
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.
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
Time to Progression
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice