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NCT04322539 · OUTCOME

Observed Plasma Concentrations of Fruquintinib and Metabolite M11

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer · Source last updated 2025-04-04

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

Measure: MEAN
Unit: nanogram/milliliter (ng/mL)
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 (Day 21): Predose and 2 hours, Cycle 3 (Day 1): Pre-dose, Cycle 3 (Day 21): Pre-dose and 2 hours, Cycle 5, 7, 9, 11, 13, 15 and 17 (Day 1): Pre-dose (Each cycle = 28 days)

What was measured

Plasma samples were collected from the participants at the defined time points. Plasma concentrations were measured using a validated, specific, and sensitive liquid chromatography tandem mass spectrometry method. M11 is the active metabolite for the study drug.

Analysis population: PK population was used for tabulation of fruquintinib and M11 concentrations from PK plasma samples collected from the Fruquintinib + BSC Group. PK samples for the Placebo + BSC Group were not analyzed. Here, "Overall Number of Participants Analyzed" signifies those participants in the Fruquintinib + BSC Group who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.

Groups in this outcome

Fruquintinib + BSC Group

Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

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
Fruquintinib + BSC Group	312

Reported measurements

Cycle 1 Day 1 - Pre-dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	312

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	2.90	19.9	Not reported	Not reported	Not reported

Cycle 1 Day 1 - Pre-dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	312

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	0.585	6.61	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 1 hour (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	171

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	59.9	51.0	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 1 hour (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	171

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	1.06	8.36	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 2 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	304

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	91.5	48.2	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 2 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	304

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	1.03	6.81	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 3 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	171

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	98.5	47.1	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 3 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	171

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	1.96	9.51	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 4 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	171

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	99.7	44.6	Not reported	Not reported	Not reported

Cycle 1 Day 1 - 4 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	171

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	2.71	10.7	Not reported	Not reported	Not reported

Cycle 1 Day 21 - Pre-dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	227

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	219	82.6	Not reported	Not reported	Not reported

Cycle 1 Day 21 - Pre-dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	227

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	94.5	52.6	Not reported	Not reported	Not reported

Cycle 1 Day 21 - 1 hour (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	112

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	255	101	Not reported	Not reported	Not reported

Cycle 1 Day 21 - 1 hour (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	112

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	92.0	54.3	Not reported	Not reported	Not reported

Cycle 1 Day 21 - 2 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	214

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	279	91.6	Not reported	Not reported	Not reported

Cycle 1 Day 21 - 2 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	214

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	89.9	49.5	Not reported	Not reported	Not reported

Cycle 1 Day 21 -3 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	113

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	293	95.2	Not reported	Not reported	Not reported

Cycle 1 Day 21 - 3 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	113

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	88.0	50.4	Not reported	Not reported	Not reported

Cycle 1 Day 21 - 4 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	114

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	294	88.0	Not reported	Not reported	Not reported

Cycle 1 Day 21 - 4 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	114

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	89.2	49.0	Not reported	Not reported	Not reported

Cycle 2 Day 21 - Predose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	204

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	222	82.0	Not reported	Not reported	Not reported

Cycle 2 Day 21 - Predose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	204

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	97.6	53.7	Not reported	Not reported	Not reported

Cycle 2 Day 21 - 2 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	193

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	284	95.2	Not reported	Not reported	Not reported

Cycle 2 Day 21 - 2 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	193

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	94.2	52.8	Not reported	Not reported	Not reported

Cycle 3 Day 1 - Pre-dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	177

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	16.7	18.9	Not reported	Not reported	Not reported

Cycle 3 Day 1 - Pre-dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	177

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	22.6	18.2	Not reported	Not reported	Not reported

Cycle 3 Day 21 - Pre-dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	137

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	212	74.6	Not reported	Not reported	Not reported

Cycle 3 Day 21 - Pre-dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	137

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	90.6	54.1	Not reported	Not reported	Not reported

Cycle 3 Day 21 - 2 hours (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	123

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	275	78.6	Not reported	Not reported	Not reported

Cycle 3 Day 21 - 2 hours (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	123

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	92.8	54.2	Not reported	Not reported	Not reported

Cycle 5 Day 1 - Pre-Dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	103

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	16.9	20.5	Not reported	Not reported	Not reported

Cycle 5 Day 1 - Pre-Dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	103

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	23.2	20.9	Not reported	Not reported	Not reported

Cycle 7 Day 1 - Pre-Dose (Plasma Concentrations of Fruquintinib

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	46

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	18.2	33.0	Not reported	Not reported	Not reported

Cycle 7 Day 1 - Pre-Dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	46

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	20.1	12.1	Not reported	Not reported	Not reported

Cycle 9 Day 1 - Pre-Dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	13

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	12.2	12.6	Not reported	Not reported	Not reported

Cycle 9 Day 1 - Pre-Dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	13

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	19.1	17.1	Not reported	Not reported	Not reported

Cycle 11 Day 1 - Pre-Dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	6

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	13.4	13.4	Not reported	Not reported	Not reported

Cycle 11 Day 1 - Pre-Dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	6

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	17.1	15.3	Not reported	Not reported	Not reported

Cycle 13 Day 1 - Pre-Dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	1

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	15.4	Not reported	Not reported	Not reported	Not reported

Cycle 13 Day 1 - Pre-Dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	1

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	23.1	Not reported	Not reported	Not reported	Not reported

Cycle 15 Day 1 - Pre-Dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	1

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	10.8	Not reported	Not reported	Not reported	Not reported

Cycle 15 Day 1 - Pre-Dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	1

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	19.2	Not reported	Not reported	Not reported	Not reported

Cycle 17 Day 1 - Pre-Dose (Plasma Concentrations of Fruquintinib)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	1

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	10.6	Not reported	Not reported	Not reported	Not reported

Cycle 17 Day 1 - Pre-Dose (Plasma Concentrations of M11)

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	1

Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	15.2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
19.9
value
2.90
denoms
counts
group Id
OG000
value
312
units
Participants
title
Cycle 1 Day 1 - Pre-dose (Plasma Concentrations of Fruquintinib)
categories
measurements
group Id
OG000
spread
6.61
value
0.585
denoms
counts
group Id
OG000
value
312
units
Participants
title
Cycle 1 Day 1 - Pre-dose (Plasma Concentrations of M11)
categories
measurements
group Id
OG000
spread
51.0
value
59.9
denoms
counts
group Id
OG000
value
171
units
Participants
title
Cycle 1 Day 1 - 1 hour (Plasma Concentrations of Fruquintinib)
categories
measurements
group Id
OG000
spread
8.36
value
1.06
denoms
counts
group Id
OG000
value
171
units
Participants
title
Cycle 1 Day 1 - 1 hour (Plasma Concentrations of M11)
categories
measurements
group Id
OG000
spread
48.2
value
91.5
denoms
counts
group Id
OG000
value
304
units
Participants
title
Cycle 1 Day 1 - 2 hours (Plasma Concentrations of Fruquintinib)
categories
measurements
group Id
OG000
spread
6.81
value
1.03
denoms
counts
group Id
OG000
value
304
units
Participants
title
Cycle 1 Day 1 - 2 hours (Plasma Concentrations of M11)
categories
measurements
group Id
OG000
spread
47.1
value
98.5
denoms
counts
group Id
OG000
value
171
units
Participants
title
Cycle 1 Day 1 - 3 hours (Plasma Concentrations of Fruquintinib)
categories
measurements
group Id
OG000
spread
9.51
value
1.96
denoms
counts
group Id
OG000
value
171
units
Participants
title
Cycle 1 Day 1 - 3 hours (Plasma Concentrations of M11)
categories
measurements
group Id
OG000
spread
44.6
value
99.7
denoms
counts
group Id
OG000
value
171
units
Participants
title
Cycle 1 Day 1 - 4 hours (Plasma Concentrations of Fruquintinib)
categories
measurements
group Id
OG000
spread
10.7
value
2.71
denoms
counts
group Id
OG000
value
171
units
Participants
title
Cycle 1 Day 1 - 4 hours (Plasma Concentrations of M11)
categories
measurements
group Id
OG000
spread
82.6
value
219
denoms
counts
group Id
OG000
value
227
units
Participants
title
Cycle 1 Day 21 - Pre-dose (Plasma Concentrations of Fruquintinib)
categories
measurements
group Id
OG000
spread
52.6
value
94.5
denoms
counts
group Id
OG000
value
227
units
Participants
title
Cycle 1 Day 21 - Pre-dose (Plasma Concentrations of M11)

denoms

counts
group Id
OG000
value
312
units
Participants

description

Plasma samples were collected from the participants at the defined time points. Plasma concentrations were measured using a validated, specific, and sensitive liquid chromatography tandem mass spectrometry method. M11 is the active metabolite for the study drug.

dispersion Type

Standard Deviation

groups

description
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
id
OG000
title
Fruquintinib + BSC Group

param Type

MEAN

population Description

PK population was used for tabulation of fruquintinib and M11 concentrations from PK plasma samples collected from the Fruquintinib + BSC Group. PK samples for the Placebo + BSC Group were not analyzed. Here, "Overall Number of Participants Analyzed" signifies those participants in the Fruquintinib + BSC Group who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.

reporting Status

POSTED

time Frame

Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 (Day 21): Predose and 2 hours, Cycle 3 (Day 1): Pre-dose, Cycle 3 (Day 21): Pre-dose and 2 hours, Cycle 5, 7, 9, 11, 13, 15 and 17 (Day 1): Pre-dose (Each cycle = 28 days)

title

Observed Plasma Concentrations of Fruquintinib and Metabolite M11

type

SECONDARY

unit Of Measure

nanogram/milliliter (ng/mL)

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

Preserved source evidence · Independent clinical review pending · Not medical advice