Trial Outcomes & Findings for A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029) (NCT NCT00127127)

Last Updated: 2022-09-13

Results Overview

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Up to approximately 4 years

Results posted on

2022-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Vorinostat 100 mg During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.)
Overall Study STARTED	3	6	3	6
Overall Study COMPLETED	2	1	3	3
Overall Study NOT COMPLETED	1	5	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vorinostat 100 mg During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.)
Overall Study Adverse Event	0	2	0	1
Overall Study Lack of Efficacy	1	3	0	2

Baseline Characteristics

A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.)	Total n=18 Participants Total of all reporting groups
Age, Continuous	59.7 Years STANDARD_DEVIATION 6.7 • n=93 Participants	60.5 Years STANDARD_DEVIATION 6.3 • n=4 Participants	49.3 Years STANDARD_DEVIATION 21.5 • n=27 Participants	57.7 Years STANDARD_DEVIATION 8.3 • n=483 Participants	57.6 Years STANDARD_DEVIATION 10.4 • n=36 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	15 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	6 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	18 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: Up to approximately 4 years

Population: All participants who received at least one dose of study drug. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=4 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Number of Participants Who Experienced One or More Adverse Events	4 Participants	6 Participants	3 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to approximately 4 years

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=4 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 26 days

Population: All participants who received at least one dose of study drug

A DLT was defined as an event considered to be related to study treatment and included: 1) Grade 4 neutropenia refractory to treatments persisting more than 5 days; 2) Grade 3 or more severe neutropenic fever; 3) Grade 3 thrombocytopenia requiring blood transfusions or Grade 4 thrombocytopenia; 4) Grade 4 hemoglobin decrease; 5) Grade 3 or more severe non-hematological toxicities other than anorexia, nausea/vomiting, and fatigue. (For the diarrhea, it was defined as not to use the frequency for the grading. For the alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\]), it was defined as the case of over 300 IU/L; 6) Grade 3 or more severe anorexia, nausea/vomiting, and fatigue refractory to treatments; and 7) compliance of the study drug, while administrating 14 consecutive days, was less than 50% due to the drug-related adverse experience.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1	0 Participants	3 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 1 pharmacokinetic (PK) data for AUC0-inf.

AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of Vorinostat After a Single Oral Dose in a Fasted State	1.20 μM·hours Standard Deviation 0.27	2.31 μM·hours Standard Deviation 0.96	3.96 μM·hours Standard Deviation 1.62	3.47 μM·hours Standard Deviation 2.21

SECONDARY outcome

Timeframe: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 3 PK data for AUC0-inf.

AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
AUC0-Inf of Vorinostat After a Single Oral Dose in a Fed State	0.98 μM·hours Standard Deviation 0.07	2.22 μM·hours Standard Deviation 0.89	4.30 μM·hours Standard Deviation 0.37	5.93 μM·hours Standard Deviation 1.78

SECONDARY outcome

Timeframe: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had up to Day 19 PK data for AUC0-inf

AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
AUC0-inf of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	1.33 μM·hours Standard Deviation 0.23	2.76 μM·hours Standard Deviation 0.85	5.41 μM·hours Standard Deviation 2.18	6.33 μM·hours Standard Deviation 1.53

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 1 PK data for Cmax

Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Maximum Concentration (Cmax) of Vorinostat After a Single Oral Dose in a Fasted State	0.49 μM Standard Deviation 0.15	0.77 μM Standard Deviation 0.13	1.19 μM Standard Deviation 0.20	1.06 μM Standard Deviation 0.52

SECONDARY outcome

Timeframe: Day 3: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 3 PK data for Cmax

Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Cmax of Vorinostat After a Single Oral Dose in a Fed State	0.21 μM Standard Deviation 0.14	0.59 μM Standard Deviation 0.22	0.93 μM Standard Deviation 0.12	1.35 μM Standard Deviation 0.39

SECONDARY outcome

Timeframe: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had up to Day 19 PK data for Cmax

Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Cmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	0.29 μM Standard Deviation 0.25	0.84 μM Standard Deviation 0.56	0.86 μM Standard Deviation 0.61	1.09 μM Standard Deviation 0.30

SECONDARY outcome

Timeframe: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 1 PK data for Tmax

Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Time to Maximum Concentration (Tmax) of Vorinostat After a Single Oral Dose in a Fasted State	0.84 Hours Standard Deviation 0.30	1.59 Hours Standard Deviation 0.74	2.49 Hours Standard Deviation 0.86	1.91 Hours Standard Deviation 0.91

SECONDARY outcome

Timeframe: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 3 PK data for Tmax

Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Tmax of Vorinostat After a Single Oral Dose in a Fed State	5.66 Hours Standard Deviation 3.79	3.00 Hours Standard Deviation 0.89	3.53 Hours Standard Deviation 2.33	3.17 Hours Standard Deviation 1.17

SECONDARY outcome

Timeframe: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had up to Day 19 PK data for Tmax

Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Tmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	4.66 Hours Standard Deviation 1.16	3.30 Hours Standard Deviation 1.10	4.34 Hours Standard Deviation 1.53	4.61 Hours Standard Deviation 1.95

SECONDARY outcome

Timeframe: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 1 PK data for t½

t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Apparent Terminal Half-Life (t½) of Vorinostat After a Single Oral Dose in a Fasted State	1.08 Hours Standard Deviation 0.30	1.83 Hours Standard Deviation 0.53	1.90 Hours Standard Deviation 0.72	1.93 Hours Standard Deviation 0.67

SECONDARY outcome

Timeframe: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had Day 3 PK data for t½

t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=2 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
t½ of Vorinostat After a Single Oral Dose in a Fed State	1.62 Hours Standard Deviation 0.45	1.36 Hours Standard Deviation 0.28	2.01 Hours Standard Deviation 1.47	1.60 Hours Standard Deviation 0.66

SECONDARY outcome

Timeframe: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

Population: All participants who complied with the protocol and had up to Day 19 PK data for t½

t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate.

Outcome measures

Outcome measures
Measure	Vorinostat 100 mg n=3 Participants During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=2 Participants During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=5 Participants During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
t½ of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	1.95 Hours Standard Deviation 0.54	1.42 Hours Standard Deviation 0.50	1.98 Hours Standard Deviation 1.56	1.30 Hours Standard Deviation 0.41

Adverse Events

Vorinostat 100 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Vorinostat 200 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Vorinostat 400 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Vorinostat 500 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vorinostat 100 mg n=4 participants at risk During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 200 mg n=6 participants at risk During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 400 mg n=3 participants at risk During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)	Vorinostat 500 mg n=6 participants at risk During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)
Cardiac disorders Pericardial effusion	0.00% 0/4 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/6 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	33.3% 1/3 • Number of events 1 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/6 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/4 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/6 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	33.3% 1/3 • Number of events 1 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/6 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)
Infections and infestations Pneumonia	0.00% 0/4 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	16.7% 1/6 • Number of events 1 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/3 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/6 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)
Renal and urinary disorders Renal impairment	0.00% 0/4 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/6 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	33.3% 1/3 • Number of events 1 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)	0.00% 0/6 • Up to approximately 4 years Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER