NCT04380753 · OUTCOME

Time to Achieve Cmax (Tmax) 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: MEDIAN
Unit: hours
Interval / dispersion: Full Range
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

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 hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Sotorasib	0.85	Not reported	0.50	6.00	Not reported

Day 8

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Sotorasib	0.96	Not reported	0.47	5.90	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.50
upper Limit
6.00
value
0.85
title
Day 1
categories
measurements
group Id
OG000
lower Limit
0.47
upper Limit
5.90
value
0.96
title
Day 8

denoms

counts
group Id
OG000
value
12
units
Participants

description

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

Full Range

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

MEDIAN

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

Time to Achieve Cmax (Tmax) of Sotorasib

type

PRIMARY

unit Of Measure

hours

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

Preserved source evidence · Not medical advice