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NCT02303821 · OUTCOME

Phase 2: AUCinf of Carfilzomib

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia · Source last updated 2025-06-04

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
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)

What was measured

AUCinf represents the total drug exposure over time, extrapolated from the time of administration until the drug is completely eliminated from the body.

Analysis population: Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.

Groups in this outcome

Carfilzomib - Day 8 Induction Cycle

Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 8 of the induction cycle.

Carfilzomib - Day 1 Consolidation Cycle

Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib - Day 8 Induction Cycle46
Carfilzomib - Day 1 Consolidation Cycle23

Reported measurements

Source class 1
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib - Day 8 Induction Cycle407011000Not reportedNot reportedNot reported
Carfilzomib - Day 1 Consolidation Cycle12002480Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        11000
        value
        4070
      2. group Id
        OG001
        spread
        2480
        value
        1200
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      23
    units
    Participants
description
AUCinf represents the total drug exposure over time, extrapolated from the time of administration until the drug is completely eliminated from the body.
dispersion Type
Standard Deviation
groups
  1. description
    Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 8 of the induction cycle.
    id
    OG000
    title
    Carfilzomib - Day 8 Induction Cycle
  2. description
    Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.
    id
    OG001
    title
    Carfilzomib - Day 1 Consolidation Cycle
param Type
MEAN
population Description
Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.
reporting Status
POSTED
time Frame
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
title
Phase 2: AUCinf of Carfilzomib
type
SECONDARY
unit Of Measure
hr*ng/mL

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

Preserved source evidence · Not medical advice