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NCT01962103 · OUTCOME

Phase 1: ORR

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively.

What was measured

Overall response rate was defined as the percentage of participants who achieved a complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) confirmed no less than 4 weeks after the criteria for response were first met) using RECIST version 1.1 guidelines over the total number of participants available for the analysis. Confidence interval was obtained using the Clopper-Pearson method.

Analysis population: Efficacy Evaluable Population: participants who met eligibility criteria for Phase 1, completed at least 1 dose of study drug, and had baseline and at least 1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.

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^214
Phase 1: Nab-Paclitaxel 150 mg/m^28
Phase 1: Nab-Paclitaxel 180 mg/m^212
Phase 1: Nab-Paclitaxel 210 mg/m^210
Phase 1: Nab-Paclitaxel 240 mg/m^28
Phase 1: Nab-Paclitaxel 270 mg/m^27

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: Nab-Paclitaxel 120 mg/m^20Not reported0.023.2Not reported
Phase 1: Nab-Paclitaxel 150 mg/m^20Not reported0.036.9Not reported
Phase 1: Nab-Paclitaxel 180 mg/m^20Not reported0.026.5Not reported
Phase 1: Nab-Paclitaxel 210 mg/m^20Not reported0.030.8Not reported
Phase 1: Nab-Paclitaxel 240 mg/m^212.5Not reported0.352.7Not reported
Phase 1: Nab-Paclitaxel 270 mg/m^214.3Not reported0.457.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        23.2
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        36.9
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        26.5
        value
        0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        30.8
        value
        0
      5. group Id
        OG004
        lower Limit
        0.3
        upper Limit
        52.7
        value
        12.5
      6. group Id
        OG005
        lower Limit
        0.4
        upper Limit
        57.9
        value
        14.3
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      7
    units
    Participants
description
Overall response rate was defined as the percentage of participants who achieved a complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) confirmed no less than 4 weeks after the criteria for response were first met) using RECIST version 1.1 guidelines over the total number of participants available for the analysis. Confidence interval was obtained using the Clopper-Pearson method.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Efficacy Evaluable Population: participants who met eligibility criteria for Phase 1, completed at least 1 dose of study drug, and had baseline and at least 1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.
reporting Status
POSTED
time Frame
Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively.
title
Phase 1: ORR
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice