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NCT01962103 · OUTCOME

Phase 1: Area Under the Plasma Concentration-Time Curve (AUC)

Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors · Source last updated 2019-12-27

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

Measure
GEOMETRIC_MEAN
Unit
ng*h/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)

What was measured

Measurements include: AUC from time zero to the last measurable concentration (AUCt), AUC from time zero to 24 hours (AUC24), and AUC from time zero to infinity (AUCinf).

Analysis population: PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data for given measure.

Groups in this outcome

Phase 1: Nab-Paclitaxel 120 mg/m^2

nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).

Phase 1: Nab-Paclitaxel 150 mg/m^2

nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 180 mg/m^2

nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 210 mg/m^2

nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 240 mg/m^2

nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

Phase 1: Nab-Paclitaxel 270 mg/m^2

nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

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: Nab-Paclitaxel 120 mg/m^213
Phase 1: Nab-Paclitaxel 150 mg/m^27
Phase 1: Nab-Paclitaxel 180 mg/m^212
Phase 1: Nab-Paclitaxel 210 mg/m^29
Phase 1: Nab-Paclitaxel 240 mg/m^27
Phase 1: Nab-Paclitaxel 270 mg/m^26

Reported measurements

AUCt

Analysis denominator · Participants

GroupSource count
Phase 1: Nab-Paclitaxel 120 mg/m^213
Phase 1: Nab-Paclitaxel 150 mg/m^27
Phase 1: Nab-Paclitaxel 180 mg/m^212
Phase 1: Nab-Paclitaxel 210 mg/m^29
Phase 1: Nab-Paclitaxel 240 mg/m^27
Phase 1: Nab-Paclitaxel 270 mg/m^26
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^2784473.4Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^21037491.8Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^2969037.1Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^21181764.0Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^21270629.2Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^21124522.6Not reportedNot reportedNot reported
AUC24

Analysis denominator · Participants

GroupSource count
Phase 1: Nab-Paclitaxel 120 mg/m^213
Phase 1: Nab-Paclitaxel 150 mg/m^27
Phase 1: Nab-Paclitaxel 180 mg/m^212
Phase 1: Nab-Paclitaxel 210 mg/m^28
Phase 1: Nab-Paclitaxel 240 mg/m^27
Phase 1: Nab-Paclitaxel 270 mg/m^26
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^2639279.0Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^2894485.9Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^2836537.7Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^21093266.3Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^21116727.4Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^2976820.7Not reportedNot reportedNot reported
AUCinf

Analysis denominator · Participants

GroupSource count
Phase 1: Nab-Paclitaxel 120 mg/m^29
Phase 1: Nab-Paclitaxel 150 mg/m^26
Phase 1: Nab-Paclitaxel 180 mg/m^210
Phase 1: Nab-Paclitaxel 210 mg/m^26
Phase 1: Nab-Paclitaxel 240 mg/m^26
Phase 1: Nab-Paclitaxel 270 mg/m^25
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^2886785.4Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 150 mg/m^21199299.8Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 180 mg/m^21008738.4Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 210 mg/m^21436172.1Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 240 mg/m^21424229.2Not reportedNot reportedNot reported
Phase 1: Nab-Paclitaxel 270 mg/m^21242428.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        73.4
        value
        7844
      2. group Id
        OG001
        spread
        91.8
        value
        10374
      3. group Id
        OG002
        spread
        37.1
        value
        9690
      4. group Id
        OG003
        spread
        64.0
        value
        11817
      5. group Id
        OG004
        spread
        29.2
        value
        12706
      6. group Id
        OG005
        spread
        22.6
        value
        11245
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        6
      units
      Participants
    title
    AUCt
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        79.0
        value
        6392
      2. group Id
        OG001
        spread
        85.9
        value
        8944
      3. group Id
        OG002
        spread
        37.7
        value
        8365
      4. group Id
        OG003
        spread
        66.3
        value
        10932
      5. group Id
        OG004
        spread
        27.4
        value
        11167
      6. group Id
        OG005
        spread
        20.7
        value
        9768
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        6
      units
      Participants
    title
    AUC24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        85.4
        value
        8867
      2. group Id
        OG001
        spread
        99.8
        value
        11992
      3. group Id
        OG002
        spread
        38.4
        value
        10087
      4. group Id
        OG003
        spread
        72.1
        value
        14361
      5. group Id
        OG004
        spread
        29.2
        value
        14242
      6. group Id
        OG005
        spread
        28.5
        value
        12424
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        5
      units
      Participants
    title
    AUCinf
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      6
    units
    Participants
description
Measurements include: AUC from time zero to the last measurable concentration (AUCt), AUC from time zero to 24 hours (AUC24), and AUC from time zero to infinity (AUCinf).
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
    id
    OG000
    title
    Phase 1: Nab-Paclitaxel 120 mg/m^2
  2. description
    nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG001
    title
    Phase 1: Nab-Paclitaxel 150 mg/m^2
  3. description
    nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG002
    title
    Phase 1: Nab-Paclitaxel 180 mg/m^2
  4. description
    nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG003
    title
    Phase 1: Nab-Paclitaxel 210 mg/m^2
  5. description
    nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG004
    title
    Phase 1: Nab-Paclitaxel 240 mg/m^2
  6. description
    nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    OG005
    title
    Phase 1: Nab-Paclitaxel 270 mg/m^2
param Type
GEOMETRIC_MEAN
population Description
PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data for given measure.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)
title
Phase 1: Area Under the Plasma Concentration-Time Curve (AUC)
type
SECONDARY
unit Of Measure
ng*h/mL

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Preserved source evidence · Not medical advice