NCT02347917 · BASELINE

Baseline characteristics

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.

denoms

counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants

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
BG000
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
BG001
title
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.00
value
64.5
group Id
BG001
spread
10.71
value
65.6
group Id
BG002
spread
9.854
value
65.5
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
22
group Id
BG002
value
25
title
Male
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
24
group Id
BG002
value
25
title
MPM
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
NSCLC
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Primary cancer
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.278
value
58.53
group Id
BG001
spread
7.661
value
63.11
group Id
BG002
spread
8.025
value
62.45
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
11
group Id
BG002
value
14
title
0
measurements
group Id
BG000
value
1
group Id
BG001
value
13
group Id
BG002
value
14
title
1
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
2<=
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
description
The Eastern Cooperative Oncology Group (ECOG) performance status measures patients' disease status on the following scale: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2=Ambulatory and capable of all selfcare, unable to carry out any work activities. Up and about \>50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Totally confined to bed or chair; 5=Dead
param Type
COUNT_OF_PARTICIPANTS
title
ECOG PS
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE I
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
STAGE II
measurements
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
5
title
STAGE III
measurements
group Id
BG000
value
1
group Id
BG001
value
17
group Id
BG002
value
18
title
STAGE IV
denoms
counts
group Id
BG000
value
1
group Id
BG001
value
24
group Id
BG002
value
25
units
Participants
title
MPM
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE I
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE II
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE III
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
STAGE IV
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
units
Participants
title
NSCLC
description
Most types of cancer have four stages: stages I (1) to IV (4). Some cancers also have a stage 0 (zero). Lower stages indicate that the disease is more localized, or contained, whereas higher stages refer to cancers that have spread into other areas of the body: Stage 0 = cancer in situ, which means "in place"; Stage I = a small cancer or tumor that has not grown deeply into nearby tissues; Stage II and III = larger cancers or tumors that have grown more deeply into nearby tissue; Stage IV = the cancer has spread to other organs or parts of the body.
param Type
COUNT_OF_PARTICIPANTS
population Description
Of 4 participants in Phase 1 part, 3 participants with NSCLC and 1 participant with MPM enrolled.
title
Disease classification
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
16
group Id
BG002
value
17
title
EPITHELIOID
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
SARCOMATOID
measurements
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
5
title
BIPHASIC
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
OTHER
denoms
counts
group Id
BG000
value
1
group Id
BG001
value
24
group Id
BG002
value
25
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Of 4 participants in Phase 1 part, 3 participants with NSCLC and 1 participant with MPM enrolled.
title
Tissue classification (MPM)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
ADENOCARCINOMA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
SQUAMOUS CELL CARCINOMA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
LARGE CELL CARCINOMA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
OTHER
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Of 4 participants in Phase 1 part, 3 participants with NSCLC and 1 participant with MPM enrolled.
title
Tissue classification (NSCLC)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
11
group Id
BG002
value
14
title
Yes
measurements
group Id
BG000
value
1
group Id
BG001
value
13
group Id
BG002
value
14
title
No
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Metastases
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
2.866
value
3.91
group Id
BG001
spread
0.726
value
0.91
group Id
BG002
spread
1.562
value
1.34
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Disease duration
unit Of Measure
month

population Description

Participants were NOT enrolled in Phase 1 and Phase 2 in duplicate.

Complete source fields

denoms

counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants

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
BG000
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
BG001
title
MPM: BBI608 + Pem + CDDP (Phase 2 Part)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.00
value
64.5
group Id
BG001
spread
10.71
value
65.6
group Id
BG002
spread
9.854
value
65.5
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
22
group Id
BG002
value
25
title
Male
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
24
group Id
BG002
value
25
title
MPM
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
NSCLC
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Primary cancer
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.278
value
58.53
group Id
BG001
spread
7.661
value
63.11
group Id
BG002
spread
8.025
value
62.45
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
11
group Id
BG002
value
14
title
0
measurements
group Id
BG000
value
1
group Id
BG001
value
13
group Id
BG002
value
14
title
1
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
2<=
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
description
The Eastern Cooperative Oncology Group (ECOG) performance status measures patients' disease status on the following scale: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2=Ambulatory and capable of all selfcare, unable to carry out any work activities. Up and about \>50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Totally confined to bed or chair; 5=Dead
param Type
COUNT_OF_PARTICIPANTS
title
ECOG PS
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE I
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
STAGE II
measurements
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
5
title
STAGE III
measurements
group Id
BG000
value
1
group Id
BG001
value
17
group Id
BG002
value
18
title
STAGE IV
denoms
counts
group Id
BG000
value
1
group Id
BG001
value
24
group Id
BG002
value
25
units
Participants
title
MPM
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE I
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE II
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
STAGE III
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
STAGE IV
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
units
Participants
title
NSCLC
description
Most types of cancer have four stages: stages I (1) to IV (4). Some cancers also have a stage 0 (zero). Lower stages indicate that the disease is more localized, or contained, whereas higher stages refer to cancers that have spread into other areas of the body: Stage 0 = cancer in situ, which means "in place"; Stage I = a small cancer or tumor that has not grown deeply into nearby tissues; Stage II and III = larger cancers or tumors that have grown more deeply into nearby tissue; Stage IV = the cancer has spread to other organs or parts of the body.
param Type
COUNT_OF_PARTICIPANTS
population Description
Of 4 participants in Phase 1 part, 3 participants with NSCLC and 1 participant with MPM enrolled.
title
Disease classification
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
16
group Id
BG002
value
17
title
EPITHELIOID
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
SARCOMATOID
measurements
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
5
title
BIPHASIC
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
OTHER
denoms
counts
group Id
BG000
value
1
group Id
BG001
value
24
group Id
BG002
value
25
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Of 4 participants in Phase 1 part, 3 participants with NSCLC and 1 participant with MPM enrolled.
title
Tissue classification (MPM)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
ADENOCARCINOMA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
SQUAMOUS CELL CARCINOMA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
LARGE CELL CARCINOMA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
OTHER
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Of 4 participants in Phase 1 part, 3 participants with NSCLC and 1 participant with MPM enrolled.
title
Tissue classification (NSCLC)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
11
group Id
BG002
value
14
title
Yes
measurements
group Id
BG000
value
1
group Id
BG001
value
13
group Id
BG002
value
14
title
No
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Metastases
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
2.866
value
3.91
group Id
BG001
spread
0.726
value
0.91
group Id
BG002
spread
1.562
value
1.34
denoms
counts
group Id
BG000
value
4
group Id
BG001
value
24
group Id
BG002
value
28
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Disease duration
unit Of Measure
month

population Description

Participants were NOT enrolled in Phase 1 and Phase 2 in duplicate.

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Preserved source evidence · Not medical advice