Skip to content

TriangleGet started

← Full study record

NCT02347917 · OUTCOME

Phase 1 Part: Area Under the Concentration-time Curve

A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma · Source last updated 2022-04-12

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: Full Range
Time frame: Cycle 1 Day 1 and Day 23

What was measured

AUC0-12: Area under the concentration-time curve from time zero to 12 hours, AUC0-24: Area under the concentration-time curve from time zero to 24 hours, AUC0-inf: Area under the concentration-time curve from time zero to infinity

Analysis population: Pharmacokinetic (PK) analysis population 1 participant with MPM of 4 participants in the pharmacokinetic analysis population completed BBI608 administration on Day 14 in Cycle 1 and therefore was not included in the analysis for Cmax and AUC on Day 23.

Groups in this outcome

MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 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
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	4

Reported measurements

Day 1: AUC0-12

Analysis denominator · Participants

Group	Source count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	4

Values in h*ng/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	1814.3	Not reported	900	2443	Not reported

Day 1: AUC0-24

Analysis denominator · Participants

Group	Source count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	4

Values in h*ng/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2223.8	Not reported	1005	3060	Not reported

Day 1: AUC0-inf

Analysis denominator · Participants

Group	Source count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	4

Values in h*ng/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2413.5	Not reported	1141	3536	Not reported

Day 23: AUC0-12

Analysis denominator · Participants

Group	Source count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3

Values in h*ng/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3797.0	Not reported	1788	5725	Not reported

Day 23: AUC0-24

Analysis denominator · Participants

Group	Source count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3

Values in h*ng/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	6103.7	Not reported	1936	9948	Not reported

Day 23: AUC0-inf

Analysis denominator · Participants

Group	Source count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3

Values in h*ng/mL · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	10762.7	Not reported	1962	20834	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
900
upper Limit
2443
value
1814.3
denoms
counts
group Id
OG000
value
4
units
Participants
title
Day 1: AUC0-12
categories
measurements
group Id
OG000
lower Limit
1005
upper Limit
3060
value
2223.8
denoms
counts
group Id
OG000
value
4
units
Participants
title
Day 1: AUC0-24
categories
measurements
group Id
OG000
lower Limit
1141
upper Limit
3536
value
2413.5
denoms
counts
group Id
OG000
value
4
units
Participants
title
Day 1: AUC0-inf
categories
measurements
group Id
OG000
lower Limit
1788
upper Limit
5725
value
3797.0
denoms
counts
group Id
OG000
value
3
units
Participants
title
Day 23: AUC0-12
categories
measurements
group Id
OG000
lower Limit
1936
upper Limit
9948
value
6103.7
denoms
counts
group Id
OG000
value
3
units
Participants
title
Day 23: AUC0-24
categories
measurements
group Id
OG000
lower Limit
1962
upper Limit
20834
value
10762.7
denoms
counts
group Id
OG000
value
3
units
Participants
title
Day 23: AUC0-inf

denoms

counts
group Id
OG000
value
4
units
Participants

description

AUC0-12: Area under the concentration-time curve from time zero to 12 hours, AUC0-24: Area under the concentration-time curve from time zero to 24 hours, AUC0-inf: Area under the concentration-time curve from time zero to infinity

dispersion Type

Full Range

groups

description
Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
id
OG000
title
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)

param Type

MEAN

population Description

Pharmacokinetic (PK) analysis population 1 participant with MPM of 4 participants in the pharmacokinetic analysis population completed BBI608 administration on Day 14 in Cycle 1 and therefore was not included in the analysis for Cmax and AUC on Day 23.

reporting Status

POSTED

time Frame

Cycle 1 Day 1 and Day 23

title

Phase 1 Part: Area Under the Concentration-time Curve

type

PRIMARY

unit Of Measure

h*ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice