Respiratory Function Tests (Vital Capacity [VC] and Forced Vital Capacity [FVC])
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
mL
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 VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
70.0
Not reported
-10
200
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
70.0
Not reported
-10
200
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
30.0
Not reported
-470
410
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
30.0
Not reported
-470
410
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
110.0
Not reported
-90
140
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
110.0
Not reported
-90
140
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
0.0
Not reported
-370
940
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
0.0
Not reported
-370
940
Not reported
The change from baseline in VC: 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)
3
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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-60.0
Not reported
-70
90
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-60.0
Not reported
-70
90
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-70.0
Not reported
-700
1250
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-70.0
Not reported
-700
1250
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-290.0
Not reported
-630
50
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-290.0
Not reported
-630
50
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-50.0
Not reported
-570
1480
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-50.0
Not reported
-570
1480
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-240.0
Not reported
-510
30
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-240.0
Not reported
-510
30
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
20.0
Not reported
-530
1410
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
20.0
Not reported
-530
1410
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-305.0
Not reported
-600
-10
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-305.0
Not reported
-600
-10
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
30.0
Not reported
-660
870
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
30.0
Not reported
-660
870
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-480
-480
because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-480
-480
because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
15.0
Not reported
-100
910
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
15.0
Not reported
-100
910
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-820
-820
because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-820
-820
because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-20.0
Not reported
-70
1090
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-20.0
Not reported
-70
1090
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-990
-990
because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-990
-990
because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
300.0
Not reported
-110
710
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
300.0
Not reported
-110
710
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
175.0
Not reported
-400
750
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
175.0
Not reported
-400
750
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
145.0
Not reported
-580
870
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
145.0
Not reported
-580
870
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-205.0
Not reported
-890
480
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-205.0
Not reported
-890
480
Not reported
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
NA
Not reported
480
480
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
480
480
because of 1 participant data only
The change from baseline in VC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
NA
Not reported
280
280
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
280
280
because of 1 participant data only
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
0.0
Not reported
-50
120
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
0.0
Not reported
-50
120
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
35.0
Not reported
-380
390
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
35.0
Not reported
-380
390
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
80.0
Not reported
-110
90
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
80.0
Not reported
-110
90
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
10.0
Not reported
-400
1030
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
10.0
Not reported
-400
1030
Not reported
The change from baseline in FVC: 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)
3
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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-20.0
Not reported
-110
0
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-20.0
Not reported
-110
0
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-140.0
Not reported
-860
1280
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-140.0
Not reported
-860
1280
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-155.0
Not reported
-390
80
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-155.0
Not reported
-390
80
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-50.0
Not reported
-610
1520
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-50.0
Not reported
-610
1520
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-265.0
Not reported
-570
40
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-265.0
Not reported
-570
40
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
150.0
Not reported
-430
1450
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
150.0
Not reported
-430
1450
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-345.0
Not reported
-530
-160
Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
-345.0
Not reported
-530
-160
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-35.0
Not reported
-530
770
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-35.0
Not reported
-530
770
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-480
-480
because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-480
-480
because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
70.0
Not reported
-160
800
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
70.0
Not reported
-160
800
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-800
-800
because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-800
-800
because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
60.0
Not reported
-70
880
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
60.0
Not reported
-70
880
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-880
-880
because of 1 participant data only
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
NA
Not reported
-880
-880
because of 1 participant data only
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
300.0
Not reported
-140
740
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
300.0
Not reported
-140
740
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
50.0
Not reported
-550
650
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
50.0
Not reported
-550
650
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
10.0
Not reported
-580
600
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
10.0
Not reported
-580
600
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
-230.0
Not reported
-900
440
Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
-230.0
Not reported
-900
440
Not reported
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
NA
Not reported
540
540
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
540
540
because of 1 participant data only
The change from baseline in FVC: 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 mL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
NA
Not reported
490
490
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
490
490
because of 1 participant data only
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
-10
upper Limit
200
value
70.0
group Id
OG002
lower Limit
-10
upper Limit
200
value
70.0
group Id
OG003
lower Limit
-470
upper Limit
410
value
30.0
group Id
OG004
lower Limit
-470
upper Limit
410
value
30.0
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 VC: 6 weeks
categories
measurements
group Id
OG000
lower Limit
-90
upper Limit
140
value
110.0
group Id
OG002
lower Limit
-90
upper Limit
140
value
110.0
group Id
OG003
lower Limit
-370
upper Limit
940
value
0.0
group Id
OG004
lower Limit
-370
upper Limit
940
value
0.0
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 VC: 12 weeks
categories
measurements
group Id
OG000
lower Limit
-70
upper Limit
90
value
-60.0
group Id
OG002
lower Limit
-70
upper Limit
90
value
-60.0
group Id
OG003
lower Limit
-700
upper Limit
1250
value
-70.0
group Id
OG004
lower Limit
-700
upper Limit
1250
value
-70.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
13
group Id
OG004
value
13
units
Participants
title
The change from baseline in VC: 18 weeks
categories
measurements
group Id
OG000
lower Limit
-630
upper Limit
50
value
-290.0
group Id
OG002
lower Limit
-630
upper Limit
50
value
-290.0
group Id
OG003
lower Limit
-570
upper Limit
1480
value
-50.0
group Id
OG004
lower Limit
-570
upper Limit
1480
value
-50.0
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 VC: 24 weeks
categories
measurements
group Id
OG000
lower Limit
-510
upper Limit
30
value
-240.0
group Id
OG002
lower Limit
-510
upper Limit
30
value
-240.0
group Id
OG003
lower Limit
-530
upper Limit
1410
value
20.0
group Id
OG004
lower Limit
-530
upper Limit
1410
value
20.0
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 VC: 30 weeks
categories
measurements
group Id
OG000
lower Limit
-600
upper Limit
-10
value
-305.0
group Id
OG002
lower Limit
-600
upper Limit
-10
value
-305.0
group Id
OG003
lower Limit
-660
upper Limit
870
value
30.0
group Id
OG004
lower Limit
-660
upper Limit
870
value
30.0
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 VC: 39 weeks
categories
measurements
comment
because of 1 participant data only
group Id
OG000
lower Limit
-480
upper Limit
-480
value
NA
comment
because of 1 participant data only
group Id
OG002
lower Limit
-480
upper Limit
-480
value
NA
group Id
OG003
lower Limit
-100
upper Limit
910
value
15.0
group Id
OG004
lower Limit
-100
upper Limit
910
value
15.0
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 VC: 48 weeks
categories
measurements
comment
because of 1 participant data only
group Id
OG000
lower Limit
-820
upper Limit
-820
value
NA
comment
because of 1 participant data only
group Id
OG002
lower Limit
-820
upper Limit
-820
value
NA
group Id
OG003
lower Limit
-70
upper Limit
1090
value
-20.0
group Id
OG004
lower Limit
-70
upper Limit
1090
value
-20.0
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 VC: 57 weeks
categories
measurements
comment
because of 1 participant data only
group Id
OG000
lower Limit
-990
upper Limit
-990
value
NA
comment
because of 1 participant data only
group Id
OG002
lower Limit
-990
upper Limit
-990
value
NA
group Id
OG003
lower Limit
-110
upper Limit
710
value
300.0
group Id
OG004
lower Limit
-110
upper Limit
710
value
300.0
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 VC: 66 weeks
categories
measurements
group Id
OG003
lower Limit
-400
upper Limit
750
value
175.0
group Id
OG004
lower Limit
-400
upper Limit
750
value
175.0
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 VC: 75 weeks
categories
measurements
group Id
OG003
lower Limit
-580
upper Limit
870
value
145.0
group Id
OG004
lower Limit
-580
upper Limit
870
value
145.0
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 VC: 84 weeks
categories
measurements
group Id
OG003
lower Limit
-890
upper Limit
480
value
-205.0
group Id
OG004
lower Limit
-890
upper Limit
480
value
-205.0
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 VC: 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 (Vital Capacity [VC] and Forced Vital Capacity [FVC])
Triangle