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NCT02347917 · OUTCOME

Respiratory Function Tests (Forced Expiratory Volume in the First Second [FEV1])

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: MEDIAN
Unit: L
Interval / dispersion: Full Range
Time frame: Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]

Analysis population: modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25). In respiratory function tests, data from 1 participant with MPM in Phase 1 part were not collected.

Groups in this outcome

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.

MPM: 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.

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.

MPM: BBI608 + Pem + CDDP (Phase 2 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.

MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in 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
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	4
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	24
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	25

Reported measurements

The change from baseline in FEV1: 6 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	20
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	20

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0.160	Not reported	-0.01	0.16	Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0.160	Not reported	-0.01	0.16	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	0.050	Not reported	-0.40	0.33	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	0.050	Not reported	-0.40	0.33	Not reported

The change from baseline in FEV1: 12 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	17
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	17

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0.070	Not reported	0.03	0.18	Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0.070	Not reported	0.03	0.18	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.130	Not reported	-0.33	0.52	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.130	Not reported	-0.33	0.52	Not reported

The change from baseline in FEV1: 18 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	3
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	4
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	13
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	13

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0.000	Not reported	-0.13	0.16	Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0.000	Not reported	-0.13	0.16	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.110	Not reported	-0.56	0.63	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.110	Not reported	-0.56	0.63	Not reported

The change from baseline in FEV1: 24 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	10
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	10

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	-0.010	Not reported	-0.16	0.14	Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	-0.010	Not reported	-0.16	0.14	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.040	Not reported	-0.45	0.78	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.040	Not reported	-0.45	0.78	Not reported

The change from baseline in FEV1: 30 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	7
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	7

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	-0.055	Not reported	-0.23	0.12	Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	-0.055	Not reported	-0.23	0.12	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.030	Not reported	-0.29	0.71	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.030	Not reported	-0.29	0.71	Not reported

The change from baseline in FEV1: 39 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	2
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	6
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	6

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	-0.140	Not reported	-0.28	0.00	Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	-0.140	Not reported	-0.28	0.00	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.050	Not reported	-0.37	0.26	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.050	Not reported	-0.37	0.26	Not reported

The change from baseline in FEV1: 48 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	1
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	1
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	4
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	4

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	NA	Not reported	-0.060	-0.060	because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	NA	Not reported	-0.060	-0.060	because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	0.115	Not reported	-0.12	0.39	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	0.115	Not reported	-0.12	0.39	Not reported

The change from baseline in FEV1: 57 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	1
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	1
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	3
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	3

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	NA	Not reported	-0.460	-0.460	because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	NA	Not reported	-0.460	-0.460	because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	0.010	Not reported	-0.07	0.31	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	0.010	Not reported	-0.07	0.31	Not reported

The change from baseline in FEV1: 66 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	1
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	1
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	2
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	2

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	NA	Not reported	-0.570	-0.570	because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	NA	Not reported	-0.570	-0.570	because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	0.085	Not reported	-0.16	0.33	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	0.085	Not reported	-0.16	0.33	Not reported

The change from baseline in FEV1: 75 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	2
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	2

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.045	Not reported	-0.42	0.33	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.045	Not reported	-0.42	0.33	Not reported

The change from baseline in FEV1: 84 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	2
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	2

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.130	Not reported	-0.44	0.18	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.130	Not reported	-0.44	0.18	Not reported

The change from baseline in FEV1: 93 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	2
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	2

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	-0.215	Not reported	-0.66	0.23	Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	-0.215	Not reported	-0.66	0.23	Not reported

The change from baseline in FEV1: 102 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	1
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	1

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	NA	Not reported	0.150	0.150	because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	NA	Not reported	0.150	0.150	because of 1 participant data only

The change from baseline in FEV1: 111 weeks

Analysis denominator · Participants

Group	Source count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem +CDDP (Phase 1 Part)	0
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	1
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	1

Values in L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	NA	Not reported	0.080	0.080	because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	NA	Not reported	0.080	0.080	because of 1 participant data only

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
-0.01
upper Limit
0.16
value
0.160
group Id
OG002
lower Limit
-0.01
upper Limit
0.16
value
0.160
group Id
OG003
lower Limit
-0.40
upper Limit
0.33
value
0.050
group Id
OG004
lower Limit
-0.40
upper Limit
0.33
value
0.050
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
20
group Id
OG004
value
20
units
Participants
title
The change from baseline in FEV1: 6 weeks
categories
measurements
group Id
OG000
lower Limit
0.03
upper Limit
0.18
value
0.070
group Id
OG002
lower Limit
0.03
upper Limit
0.18
value
0.070
group Id
OG003
lower Limit
-0.33
upper Limit
0.52
value
-0.130
group Id
OG004
lower Limit
-0.33
upper Limit
0.52
value
-0.130
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
17
group Id
OG004
value
17
units
Participants
title
The change from baseline in FEV1: 12 weeks
categories
measurements
group Id
OG000
lower Limit
-0.13
upper Limit
0.16
value
0.000
group Id
OG002
lower Limit
-0.13
upper Limit
0.16
value
0.000
group Id
OG003
lower Limit
-0.56
upper Limit
0.63
value
-0.110
group Id
OG004
lower Limit
-0.56
upper Limit
0.63
value
-0.110
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
4
group Id
OG003
value
13
group Id
OG004
value
13
units
Participants
title
The change from baseline in FEV1: 18 weeks
categories
measurements
group Id
OG000
lower Limit
-0.16
upper Limit
0.14
value
-0.010
group Id
OG002
lower Limit
-0.16
upper Limit
0.14
value
-0.010
group Id
OG003
lower Limit
-0.45
upper Limit
0.78
value
-0.040
group Id
OG004
lower Limit
-0.45
upper Limit
0.78
value
-0.040
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
10
group Id
OG004
value
10
units
Participants
title
The change from baseline in FEV1: 24 weeks
categories
measurements
group Id
OG000
lower Limit
-0.23
upper Limit
0.12
value
-0.055
group Id
OG002
lower Limit
-0.23
upper Limit
0.12
value
-0.055
group Id
OG003
lower Limit
-0.29
upper Limit
0.71
value
-0.030
group Id
OG004
lower Limit
-0.29
upper Limit
0.71
value
-0.030
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
7
group Id
OG004
value
7
units
Participants
title
The change from baseline in FEV1: 30 weeks
categories
measurements
group Id
OG000
lower Limit
-0.28
upper Limit
0.00
value
-0.140
group Id
OG002
lower Limit
-0.28
upper Limit
0.00
value
-0.140
group Id
OG003
lower Limit
-0.37
upper Limit
0.26
value
-0.050
group Id
OG004
lower Limit
-0.37
upper Limit
0.26
value
-0.050
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
6
group Id
OG004
value
6
units
Participants
title
The change from baseline in FEV1: 39 weeks
categories
measurements
comment
because of 1 participant data only
group Id
OG000
lower Limit
-0.060
upper Limit
-0.060
value
NA
comment
because of 1 participant data only
group Id
OG002
lower Limit
-0.060
upper Limit
-0.060
value
NA
group Id
OG003
lower Limit
-0.12
upper Limit
0.39
value
0.115
group Id
OG004
lower Limit
-0.12
upper Limit
0.39
value
0.115
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
4
group Id
OG004
value
4
units
Participants
title
The change from baseline in FEV1: 48 weeks
categories
measurements
comment
because of 1 participant data only
group Id
OG000
lower Limit
-0.460
upper Limit
-0.460
value
NA
comment
because of 1 participant data only
group Id
OG002
lower Limit
-0.460
upper Limit
-0.460
value
NA
group Id
OG003
lower Limit
-0.07
upper Limit
0.31
value
0.010
group Id
OG004
lower Limit
-0.07
upper Limit
0.31
value
0.010
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
3
units
Participants
title
The change from baseline in FEV1: 57 weeks
categories
measurements
comment
because of 1 participant data only
group Id
OG000
lower Limit
-0.570
upper Limit
-0.570
value
NA
comment
because of 1 participant data only
group Id
OG002
lower Limit
-0.570
upper Limit
-0.570
value
NA
group Id
OG003
lower Limit
-0.16
upper Limit
0.33
value
0.085
group Id
OG004
lower Limit
-0.16
upper Limit
0.33
value
0.085
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
2
units
Participants
title
The change from baseline in FEV1: 66 weeks
categories
measurements
group Id
OG003
lower Limit
-0.42
upper Limit
0.33
value
-0.045
group Id
OG004
lower Limit
-0.42
upper Limit
0.33
value
-0.045
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
2
units
Participants
title
The change from baseline in FEV1: 75 weeks
categories
measurements
group Id
OG003
lower Limit
-0.44
upper Limit
0.18
value
-0.130
group Id
OG004
lower Limit
-0.44
upper Limit
0.18
value
-0.130
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
2
units
Participants
title
The change from baseline in FEV1: 84 weeks
categories
measurements
group Id
OG003
lower Limit
-0.66
upper Limit
0.23
value
-0.215
group Id
OG004
lower Limit
-0.66
upper Limit
0.23
value
-0.215
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
2
units
Participants
title
The change from baseline in FEV1: 93 weeks

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
4
group Id
OG003
value
24
group Id
OG004
value
25
units
Participants

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
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
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
OG001
title
MPM: BBI608 + Pem +CDDP (Phase 1 Part)
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
OG002
title
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
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
OG003
title
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
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
OG004
title
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)

param Type

MEDIAN

population Description

modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25). In respiratory function tests, data from 1 participant with MPM in Phase 1 part were not collected.

reporting Status

POSTED

time Frame

Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]

title

Respiratory Function Tests (Forced Expiratory Volume in the First Second [FEV1])

type

SECONDARY

unit Of Measure

L

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Preserved source evidence · Not medical advice