Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01962103 · OUTCOME

Phase 1 and 2 Population PK: Maximum Elimination Rate From the Central Compartment (VMEL)

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
μg/h
Interval / dispersion
Not reported
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

Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for VMEL was 1.12.

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

Groups in this outcome

PK Population

The PK population included all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.

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

Analysis denominator · Participants

GroupSource count
PK Population106

Reported measurements

Source class 1
Values in μg/h · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PK Population31983Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31983
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    units
    Participants
description
Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for VMEL was 1.12.
groups
  1. description
    The PK population included all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.
    id
    OG000
    title
    PK Population
param Type
NUMBER
population Description
PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data
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 and 2 Population PK: Maximum Elimination Rate From the Central Compartment (VMEL)
type
SECONDARY
unit Of Measure
μg/h

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

Preserved source evidence · Not medical advice