NCT01962103 · OUTCOME

Phase 1 and 2 Population PK: Volume of Distribution of the Second Peripheral Compartment (V3)

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: liters
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 V3 was 0.888.

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

Phase 1: nab-paclitaxel 120-270 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. Phase 2: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.

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

Analysis denominator · Participants

Group	Source count
PK Population	106

Reported measurements

Source class 1

Values in liters · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PK Population	45.3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
45.3

denoms

counts
group Id
OG000
value
106
units
Participants

description

Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for V3 was 0.888.

groups

description
Phase 1: nab-paclitaxel 120-270 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. Phase 2: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
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: Volume of Distribution of the Second Peripheral Compartment (V3)

type

SECONDARY

unit Of Measure

liters

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

Preserved source evidence · Not medical advice