NCT02499770 · OUTCOME

Time of Maximum Observed Concentration (Tmax) of Trilaciclib in Cycle 1, Part 1

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) · Source last updated 2020-08-21

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: Days 1 and 3 of Cycle 1 for a 21-day cycle

What was measured

Tmax of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.

Analysis population: PK analysis set - included all participants with evaluable PK profiles for both treatments and analytes

Groups in this outcome

Part 1: Cohort 1 Trilaciclib 200 mg/m^2

Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

Part 1: Cohort 2 Trilaciclib 240mg/m^2

Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

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
Part 1: Cohort 1 Trilaciclib 200 mg/m^2	8
Part 1: Cohort 2 Trilaciclib 240mg/m^2	1

Reported measurements

Day 1 Cycle 1

Values in Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Part 1: Cohort 1 Trilaciclib 200 mg/m^2	0.57	Not reported	0.45	0.98	Not reported
Part 1: Cohort 2 Trilaciclib 240mg/m^2	0.50	Not reported	NA	NA	Not calculable (n=1)

Day 3 Cycle 1

Values in Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Part 1: Cohort 1 Trilaciclib 200 mg/m^2	0.52	Not reported	0.47	1.00	Not reported
Part 1: Cohort 2 Trilaciclib 240mg/m^2	0.45	Not reported	NA	NA	Not calculable (n=1)

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.45
upper Limit
0.98
value
0.57
comment
Not calculable (n=1)
group Id
OG001
lower Limit
NA
upper Limit
NA
value
0.50
title
Day 1 Cycle 1
categories
measurements
group Id
OG000
lower Limit
0.47
upper Limit
1.00
value
0.52
comment
Not calculable (n=1)
group Id
OG001
lower Limit
NA
upper Limit
NA
value
0.45
title
Day 3 Cycle 1

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
1
units
Participants

description

Tmax of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.

dispersion Type

Full Range

groups

description
Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
id
OG000
title
Part 1: Cohort 1 Trilaciclib 200 mg/m^2
description
Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
id
OG001
title
Part 1: Cohort 2 Trilaciclib 240mg/m^2

param Type

MEDIAN

population Description

PK analysis set - included all participants with evaluable PK profiles for both treatments and analytes

reporting Status

POSTED

time Frame

Days 1 and 3 of Cycle 1 for a 21-day cycle

title

Time of Maximum Observed Concentration (Tmax) of Trilaciclib in Cycle 1, Part 1

type

SECONDARY

unit Of Measure

Hours

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

Preserved source evidence · Not medical advice