NCT04380753 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Sotorasib

AMG 510 Ethnic Sensitivity Study (CodeBreaK 105). · Source last updated 2026-05-06

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

Measure: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8

What was measured

Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.

Analysis population: PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected.

Groups in this outcome

Sotorasib

Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.

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
Sotorasib	12

Reported measurements

Day 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sotorasib	9010	5200	Not reported	Not reported	Not reported

Day 8

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Sotorasib	6330	3030	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5200
value
9010
title
Day 1
categories
measurements
group Id
OG000
spread
3030
value
6330
title
Day 8

denoms

counts
group Id
OG000
value
12
units
Participants

description

Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.

dispersion Type

Standard Deviation

groups

description
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
id
OG000
title
Sotorasib

param Type

MEAN

population Description

PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected.

reporting Status

POSTED

time Frame

Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8

title

Maximum Observed Plasma Concentration (Cmax) of Sotorasib

type

PRIMARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice