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NCT00531284 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    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
    FG008
    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
    FG009
    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
    FG010
    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
    FG011
    title
    P1b MM: CFZ 20/56 mg/m²
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        42
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        14
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        5
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        65
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        11
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG000
        num Subjects
        0
      2. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG001
        num Subjects
        0
      3. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG002
        num Subjects
        1
      4. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG003
        num Subjects
        2
      5. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG004
        num Subjects
        0
      6. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG005
        num Subjects
        0
      7. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG006
        num Subjects
        0
      8. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG007
        num Subjects
        0
      9. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG008
        num Subjects
        0
      10. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG009
        num Subjects
        0
      11. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG010
        num Subjects
        0
      12. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        11
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Phase 1b followed a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD). For Phase 2 (bolus), a Simon 2-stage design was planned using the MTD from phase 1b. The first stage of the Simon's 2-stage design was carried out; however, the study did not progress to the second stage.
recruitment Details
Patients with relapsed solid tumors (non-small and small cell lung, ovarian, renal, any other solid tumor type), multiple myeloma or lymphoma were enrolled at 7 sites in the US. Under the original protocol patients received a bolus intravenous (IV) infusion of carfilzomib; patients enrolled under Amendments 2 to 4 received a 30-minute IV infusion.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    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
    FG008
    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
    FG009
    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
    FG010
    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
    FG011
    title
    P1b MM: CFZ 20/56 mg/m²
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        42
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        14
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        5
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        65
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        11
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG000
        num Subjects
        0
      2. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG001
        num Subjects
        0
      3. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG002
        num Subjects
        1
      4. comment
        Indicates participants who completed 12 cycles of study drug
        group Id
        FG003
        num Subjects
        2
      5. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG004
        num Subjects
        0
      6. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG005
        num Subjects
        0
      7. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG006
        num Subjects
        0
      8. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG007
        num Subjects
        0
      9. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG008
        num Subjects
        0
      10. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG009
        num Subjects
        0
      11. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG010
        num Subjects
        0
      12. comment
        Indicates participants receiving treatment as of the data cut-off date of 07 October 2014
        group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        11
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Phase 1b followed a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD). For Phase 2 (bolus), a Simon 2-stage design was planned using the MTD from phase 1b. The first stage of the Simon's 2-stage design was carried out; however, the study did not progress to the second stage.
recruitment Details
Patients with relapsed solid tumors (non-small and small cell lung, ovarian, renal, any other solid tumor type), multiple myeloma or lymphoma were enrolled at 7 sites in the US. Under the original protocol patients received a bolus intravenous (IV) infusion of carfilzomib; patients enrolled under Amendments 2 to 4 received a 30-minute IV infusion.

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