Trial Outcomes & Findings for Study of BMS-986158 in Subjects With Select Advanced Cancers (NCT NCT02419417)

NCT ID: NCT02419417

Last Updated: 2022-06-16

Results Overview

Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

83 participants

Primary outcome timeframe

From first dose to 30 days following last dose (up to approximately 29 months)

Results posted on

2022-06-16

Participant Flow

83 participants were treated.

Participant milestones

Participant milestones
Measure	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 0.75 mg Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
Overall Study STARTED	4	6	13	10	1	5	4	13	10	13	4
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	6	13	10	1	5	4	13	10	13	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 0.75 mg Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
Overall Study Disease progression	4	5	13	9	0	5	4	13	10	10	3
Overall Study Study drug toxicity	0	0	0	0	0	0	0	0	0	1	0
Overall Study Adverse event unrelated to study drug	0	1	0	0	0	0	0	0	0	2	1
Overall Study Participant request to discontinue	0	0	0	1	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	1	0	0	0	0	0	0

Baseline Characteristics

Study of BMS-986158 in Subjects With Select Advanced Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=4 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=13 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=10 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=13 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg n=4 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg n=4 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg n=6 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg n=13 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg n=10 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	10 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	6 Participants n=24 Participants	12 Participants n=42 Participants	7 Participants n=42 Participants	1 Participants n=42 Participants	63 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	20 Participants n=42 Participants
Age, Continuous	61.4 Years STANDARD_DEVIATION 7.2 • n=5 Participants	45.0 Years STANDARD_DEVIATION 9.4 • n=7 Participants	63.2 Years STANDARD_DEVIATION 12.1 • n=5 Participants	54.3 Years STANDARD_DEVIATION 16.4 • n=4 Participants	55.5 Years STANDARD_DEVIATION 15.4 • n=21 Participants	61.3 Years STANDARD_DEVIATION 3.0 • n=8 Participants	68.5 Years STANDARD_DEVIATION 5.4 • n=8 Participants	58.8 Years STANDARD_DEVIATION 2.7 • n=24 Participants	53.6 Years STANDARD_DEVIATION 9.1 • n=42 Participants	58.1 Years STANDARD_DEVIATION 9.9 • n=42 Participants	30.0 Years STANDARD_DEVIATION NA • n=42 Participants	57.3 Years STANDARD_DEVIATION 12.2 • n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	9 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants	9 Participants n=42 Participants	9 Participants n=42 Participants	0 Participants n=42 Participants	64 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	19 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	1 Participants n=42 Participants	37 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	8 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	43 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	6 Participants n=24 Participants	8 Participants n=42 Participants	8 Participants n=42 Participants	0 Participants n=42 Participants	69 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days following last dose (up to approximately 29 months)

Population: All treated participants

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=4 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=13 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=10 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=13 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg n=4 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg n=4 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg n=6 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg n=13 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg n=10 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Number of Participants Experiencing Adverse Events Adverse Events (AEs)	5 Participants	4 Participants	13 Participants	10 Participants	13 Participants	4 Participants	4 Participants	6 Participants	13 Participants	9 Participants	1 Participants
Number of Participants Experiencing Adverse Events Serious Adverse Events (SAEs)	3 Participants	3 Participants	7 Participants	7 Participants	9 Participants	2 Participants	2 Participants	4 Participants	5 Participants	3 Participants	0 Participants
Number of Participants Experiencing Adverse Events AEs leading to discontinuation	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events Deaths	0 Participants	1 Participants	2 Participants	4 Participants	3 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days following last dose (up to approximately 29 months)

Population: All treated participants

Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=4 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=13 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=10 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=13 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg n=4 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg n=4 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg n=6 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg n=13 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg n=10 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Number of Participants With Abnormal Hepatic Test Values ALT OR AST > 10XULN	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Values ALT OR AST > 20XULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Values TOTAL BILIRUBIN > 2XULN	1 Participants	0 Participants	0 Participants	1 Participants	4 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hepatic Test Values CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Values CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Values ALT OR AST > 3XULN	2 Participants	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Hepatic Test Values ALT OR AST > 5XULN	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

Population: All treated participants

BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=4 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=13 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=10 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=13 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg n=4 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg n=4 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg n=6 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg n=13 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg n=10 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Best Overall Response (BOR) Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response (BOR) Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Best Overall Response (BOR) Stable Disease	1 Participants	1 Participants	2 Participants	1 Participants	7 Participants	2 Participants	1 Participants	1 Participants	4 Participants	4 Participants	0 Participants
Best Overall Response (BOR) Progressive Disease	4 Participants	2 Participants	8 Participants	7 Participants	3 Participants	2 Participants	2 Participants	2 Participants	9 Participants	4 Participants	0 Participants
Best Overall Response (BOR) Unable to determine	0 Participants	1 Participants	3 Participants	2 Participants	2 Participants	0 Participants	1 Participants	3 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

Population: All treated participants

ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=4 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=13 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=10 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=13 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg n=4 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg n=4 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg n=6 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg n=13 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg n=10 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Objective Response Rate (ORR)	0 Percent of Participants Interval 0.0 to 52.2	0 Percent of Participants Interval 0.0 to 60.2	0 Percent of Participants Interval 0.0 to 24.7	0 Percent of Participants Interval 0.0 to 30.8	7.7 Percent of Participants Interval 0.2 to 36.0	0 Percent of Participants Interval 0.0 to 60.2	0 Percent of Participants Interval 0.0 to 60.2	0 Percent of Participants Interval 0.0 to 45.9	0 Percent of Participants Interval 0.0 to 24.7	0 Percent of Participants Interval 0.0 to 30.8	100.0 Percent of Participants Interval 2.5 to 100.0

SECONDARY outcome

Timeframe: From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)

Population: All participants who achieved a Complete Response (CR) or Partial Response (PR)

DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer \[CRPC or NEPC\]), or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=1 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Duration of Response (DOR)	—	—	—	—	22.3 Weeks Standard Deviation NA Only 1 participant was analyzed in this cohort	—	—	—	—	—	42.4 Weeks Standard Deviation NA Only 1 participant was analyzed in this cohort

SECONDARY outcome

Timeframe: From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)

Population: All treated participants.

PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=4 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=13 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=10 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=13 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg n=4 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg n=4 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg n=6 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg n=13 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg n=10 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Progression Free Survival (PFS)	4.57 Weeks Interval 2.86 to 14.43	9.71 Weeks Interval 6.57 to 25.43	7.57 Weeks Interval 3.57 to 15.86	7.43 Weeks Interval 2.57 to 8.43	13.79 Weeks Interval 5.14 to 24.57	24.29 Weeks Interval 6.29 to 120.14	6.57 Weeks Interval 5.57 to 40.14	8.29 Weeks Interval 5.29 to Insufficient number of events	8.43 Weeks Interval 7.43 to 13.29	9.14 Weeks Interval 4.57 to 18.14	NA Weeks Insufficient number of events

SECONDARY outcome

Timeframe: From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose

Population: All treated participants.

PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks). Reported values are estimates derived from Kaplan-Meier analyses

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=4 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=13 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=10 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=13 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg n=4 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg n=4 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg n=6 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg n=13 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg n=10 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A n=1 Participants BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Progression Free Survival Rate (PFSR) 12 weeks	20.0 Percent of participants Interval 0.8 to 58.2	33.3 Percent of participants Interval 0.9 to 77.4	27.3 Percent of participants Interval 6.5 to 53.9	11.1 Percent of participants Interval 0.6 to 38.8	50.0 Percent of participants Interval 18.4 to 75.3	50.0 Percent of participants Interval 5.8 to 84.5	33.3 Percent of participants Interval 0.9 to 77.4	20.0 Percent of participants Interval 0.8 to 58.2	27.5 Percent of participants Interval 6.6 to 54.2	45.7 Percent of participants Interval 11.0 to 75.7	100.0 Percent of participants Interval 100.0 to 100.0
Progression Free Survival Rate (PFSR) 24 weeks	0.0 Percent of participants Insufficient number of events	33.3 Percent of participants Interval 0.9 to 77.4	9.1 Percent of participants Interval 0.5 to 33.3	11.1 Percent of participants Interval 0.6 to 38.8	30.0 Percent of participants Interval 7.1 to 57.8	50.0 Percent of participants Interval 5.8 to 84.5	33.3 Percent of participants Interval 0.9 to 77.4	0.0 Percent of participants Insufficient number of events	18.3 Percent of participants Interval 2.9 to 44.4	0.0 Percent of participants Insufficient number of events	100.0 Percent of participants Interval 100.0 to 100.0
Progression Free Survival Rate (PFSR) 48 weeks	0.0 Percent of participants Insufficient number of events	0.0 Percent of participants Insufficient number of events	0.0 Percent of participants Insufficient number of events	0.0 Percent of participants Insufficient number of events	0.0 Percent of participants Insufficient number of events	25.0 Percent of participants Interval 0.9 to 66.5	0.0 Percent of participants Insufficient number of events	0.0 Percent of participants Insufficient number of events	9.2 Percent of participants Interval 0.5 to 33.5	0.0 Percent of participants Insufficient number of events	100.0 Percent of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=3 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=16 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=25 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=17 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration Parent BMS-986158	68.8 ng/mL Geometric Coefficient of Variation 23	175 ng/mL Geometric Coefficient of Variation 36	269 ng/mL Geometric Coefficient of Variation 25	368 ng/mL Geometric Coefficient of Variation 30	513 ng/mL Geometric Coefficient of Variation 25	—	—	—	—	—	—
Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration Metabolite BMT-161485	5.00 ng/mL Geometric Coefficient of Variation 30	10.0 ng/mL Geometric Coefficient of Variation 29	18.2 ng/mL Geometric Coefficient of Variation 36	21.6 ng/mL Geometric Coefficient of Variation 47	35.6 ng/mL Geometric Coefficient of Variation 41	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=3 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=16 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=25 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=17 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration Parent BMS-986158	4.00 Hours Interval 2.0 to 4.02	1.00 Hours Interval 1.0 to 2.0	1.04 Hours Interval 0.5 to 4.03	1.02 Hours Interval 0.5 to 6.15	2.02 Hours Interval 1.0 to 4.03	—	—	—	—	—	—
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration Metabolite BMT-161485	24.0 Hours Interval 2.55 to 24.2	2.00 Hours Interval 2.0 to 24.0	6.00 Hours Interval 1.0 to 72.0	3.03 Hours Interval 0.983 to 48.0	6.27 Hours Interval 1.0 to 48.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=3 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=16 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=25 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=17 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration Parent BMS-986158	1027 hr*ng/mL Geometric Coefficient of Variation 16	2309 hr*ng/mL Geometric Coefficient of Variation 13	3533 hr*ng/mL Geometric Coefficient of Variation 25	4989 hr*ng/mL Geometric Coefficient of Variation 38	7039 hr*ng/mL Geometric Coefficient of Variation 34	—	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration Metabolite BMT-161485	98.2 hr*ng/mL Geometric Coefficient of Variation 34	188 hr*ng/mL Geometric Coefficient of Variation 11	310 hr*ng/mL Geometric Coefficient of Variation 35	377 hr*ng/mL Geometric Coefficient of Variation 44	629 hr*ng/mL Geometric Coefficient of Variation 41	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=4 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=3 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=11 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=18 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=14 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration Parent BMS-986158	33.7 hr Standard Deviation 1.41	48.7 hr Standard Deviation 6.66	54.3 hr Standard Deviation 19.87	42.7 hr Standard Deviation 19.56	43.8 hr Standard Deviation 15.75	—	—	—	—	—	—
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration Metabolite BMT-161485	35.3 hr Standard Deviation NA Only 1 participants analyzed in this cohort	50.8 hr Standard Deviation 6.26	48.8 hr Standard Deviation 18.78	39.4 hr Standard Deviation 13.80	38.7 hr Standard Deviation 13.66	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=4 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=3 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=11 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=18 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=14 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration Parent BMS-986158	2479 hr*ng/mL Geometric Coefficient of Variation 18	7013 hr*ng/mL Geometric Coefficient of Variation 17	9775 hr*ng/mL Geometric Coefficient of Variation 56	11677 hr*ng/mL Geometric Coefficient of Variation 44	18974 hr*ng/mL Geometric Coefficient of Variation 40	—	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration Metabolite BMT-161485	409 hr*ng/mL Geometric Coefficient of Variation NA Only 1 participants analyzed in this cohort	892 hr*ng/mL Geometric Coefficient of Variation 13	944 hr*ng/mL Geometric Coefficient of Variation 73	1128 hr*ng/mL Geometric Coefficient of Variation 46	2231 hr*ng/mL Geometric Coefficient of Variation 67	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

Values are reported only for the parent BMS-986158

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=5 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=3 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=16 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=25 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=17 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Apparent Total Body Clearance (CLT/F) - Single Dose Administration	5.04 mL/min Geometric Coefficient of Variation 17	2.97 mL/min Geometric Coefficient of Variation 18	3.41 mL/min Geometric Coefficient of Variation 56	4.28 mL/min Geometric Coefficient of Variation 62	3.95 mL/min Geometric Coefficient of Variation 33	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

Values are reported only for the parent BMS-986158

Outcome measures

Outcome measures
Measure	Part 1 Schedule A - BMS-986158 0.75 mg n=4 Participants Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 1.25 mg n=3 Participants Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 2 mg n=11 Participants Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 3 mg n=18 Participants Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule A - BMS-986158 4.5 mg n=14 Participants Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle	Part 1 Schedule B - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule B - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 2 mg Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 3 mg Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 1 Schedule C - BMS-986158 4.5 mg Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle	Part 2 Schedule A BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration	14.7 Liters Geometric Coefficient of Variation 21	12.5 Liters Geometric Coefficient of Variation 18	14.8 Liters Geometric Coefficient of Variation 27	14.4 Liters Geometric Coefficient of Variation 28	14.1 Liters Geometric Coefficient of Variation 31	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)