NCT03261947 · OUTCOME

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931

A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors · Source last updated 2021-09-20

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

Measure: MEAN
Unit: h*ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Analysis population: PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Groups in this outcome

Western Safety Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.

Pancreatic Cancer Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.

Metastatic CRC Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.

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
Western Safety Cohort	12
Pancreatic Cancer Cohort	15
Metastatic CRC Cohort	34

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Western Safety Cohort	12
Pancreatic Cancer Cohort	12
Metastatic CRC Cohort	13

Values in h*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Western Safety Cohort	1165.52	552.287	Not reported	Not reported	Not reported
Pancreatic Cancer Cohort	1114.23	388.844	Not reported	Not reported	Not reported
Metastatic CRC Cohort	1311.41	388.557	Not reported	Not reported	Not reported

Cycle 1 Day 8

Analysis denominator · Participants

Group	Source count
Western Safety Cohort	12
Pancreatic Cancer Cohort	10
Metastatic CRC Cohort	11

Values in h*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Western Safety Cohort	1426.70	774.257	Not reported	Not reported	Not reported
Pancreatic Cancer Cohort	1289.33	616.737	Not reported	Not reported	Not reported
Metastatic CRC Cohort	1551.57	497.856	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
552.287
value
1165.52
group Id
OG001
spread
388.844
value
1114.23
group Id
OG002
spread
388.557
value
1311.41
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
12
group Id
OG002
value
13
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
774.257
value
1426.70
group Id
OG001
spread
616.737
value
1289.33
group Id
OG002
spread
497.856
value
1551.57
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
10
group Id
OG002
value
11
units
Participants
title
Cycle 1 Day 8

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
15
group Id
OG002
value
34
units
Participants

dispersion Type

Standard Deviation

groups

description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
id
OG000
title
Western Safety Cohort
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
id
OG001
title
Pancreatic Cancer Cohort
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
id
OG002
title
Metastatic CRC Cohort

param Type

MEAN

population Description

PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

reporting Status

POSTED

time Frame

Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

title

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931

type

SECONDARY

unit Of Measure

h*ng/mL

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Preserved source evidence · Not medical advice