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NCT01063907 · OUTCOME

Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-04-25

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

Measure
MEAN
Unit
hr*ng/mL
Interval / dispersion
Standard Deviation
Time frame
PK collected Day 11 of 21-day cycle

What was measured

Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.

Analysis population: The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.

Groups in this outcome

Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2

Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.

Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2

Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.

Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2

Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.

Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2

Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.

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

Analysis denominator · Participants

GroupSource count
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^23
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^23
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^23
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^26

Reported measurements

Source class 1
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^279402580Not reportedNot reportedNot reported
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^22620036700Not reportedNot reportedNot reported
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^271902150Not reportedNot reportedNot reported
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^260402280Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2580
        value
        7940
      2. group Id
        OG001
        spread
        36700
        value
        26200
      3. group Id
        OG002
        spread
        2150
        value
        7190
      4. group Id
        OG003
        spread
        2280
        value
        6040
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
dispersion Type
Standard Deviation
groups
  1. description
    Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
    id
    OG000
    title
    Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
  2. description
    Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
    id
    OG001
    title
    Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
  3. description
    Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
    id
    OG002
    title
    Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
  4. description
    Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
    id
    OG003
    title
    Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
param Type
MEAN
population Description
The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.
reporting Status
POSTED
time Frame
PK collected Day 11 of 21-day cycle
title
Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11
type
SECONDARY
unit Of Measure
hr*ng/mL

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Preserved source evidence · Not medical advice