Trial Outcomes & Findings for Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED) (NCT NCT00880568)
NCT ID: NCT00880568
Last Updated: 2015-02-19
Results Overview
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Cycle 1 (up to 21 or 28 days, depending on treatment arm)
Results posted on
2015-02-19
Participant Flow
Participant milestones
| Measure |
MK-1496 20 mg (21-Day Cycle)
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
1
|
3
|
3
|
6
|
2
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
1
|
3
|
3
|
6
|
2
|
3
|
Reasons for withdrawal
| Measure |
MK-1496 20 mg (21-Day Cycle)
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
3
|
3
|
3
|
1
|
3
|
3
|
5
|
0
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=1 Participants
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
n=6 Participants
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
n=2 Participants
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.0 Years
n=5 Participants
|
57.0 Years
n=7 Participants
|
61.0 Years
n=5 Participants
|
56.0 Years
n=4 Participants
|
52.0 Years
n=21 Participants
|
51.0 Years
n=10 Participants
|
62.5 Years
n=115 Participants
|
57.5 Years
n=6 Participants
|
68.0 Years
n=6 Participants
|
61.0 Years
n=64 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
14 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
13 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (up to 21 or 28 days, depending on treatment arm)Population: All participants in the first cycle of each dosing schedule (21 or 28 days)
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=1 Participants
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
n=6 Participants
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
n=2 Participants
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: First dose up to 30 days after last dose (up to 2 years)Population: All participants on study
This is a measure of the number of participants who experienced any adverse event (AE) while on study.
Outcome measures
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=1 Participants
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
n=6 Participants
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
n=2 Participants
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Clinical or Laboratory Adverse Event
|
3 participants
|
3 participants
|
2 participants
|
1 participants
|
3 participants
|
3 participants
|
6 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 (Hour 0 through Hour 24)Population: All participants on the 21-day dosing schedule
AUC\[0-24\] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle. AUC\[0-24\] for the 28-day cycle is reported as Outcome Measures 4 and 5.
Outcome measures
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=1 Participants
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)
|
305 hr*nmol/L
Standard Deviation 246
|
434 hr*nmol/L
Standard Deviation 82.6
|
295 hr*nmol/L
Standard Deviation 193
|
1460 hr*nmol/L
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 (Hour 0 through Hour 24)Population: All participants in the first cycle of the 28-day dosing schedule
AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC\[0-24\] for the Day 3 doses is reported as Outcome Measure 5.
Outcome measures
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=6 Participants
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=2 Participants
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)
|
122 hr*nmol/L
Standard Deviation 85.3
|
302 hr*nmol/L
Standard Deviation 47.7
|
936 hr*nmol/L
Standard Deviation 364
|
2530 hr*nmol/L
Standard Deviation 81.2
|
2320 hr*nmol/L
Standard Deviation 673
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 3 (Hour 0 through Hour 24)Population: All participants in the first 28-day cycle
AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC\[0-24\] for the Day 1 doses is reported as Outcome Measure 4.
Outcome measures
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 Participants
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=6 Participants
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=2 Participants
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
n=2 Participants
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)
|
141 hr*nmol/L
Standard Deviation 114
|
366 hr*nmol/L
Standard Deviation 31.1
|
1300 hr*nmol/L
Standard Deviation 379
|
3090 hr*nmol/L
Standard Deviation 222
|
3470 hr*nmol/L
Standard Deviation 1560
|
—
|
—
|
—
|
—
|
Adverse Events
MK-1496 20 mg (21-Day Cycle)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1496 40 mg (21-Day Cycle)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1496 80 mg (21-Day Cycle)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-1496 120 mg (21-Day Cycle)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1496 20 mg (28-Day Cycle)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1496 40 mg (28-Day Cycle)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1496 80 mg (28-Day Cycle)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-1496 100 mg (28-Day Cycle)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-1496 120 mg (28-Day Cycle)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=1 participants at risk
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
n=6 participants at risk
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
n=2 participants at risk
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Disease progression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
MK-1496 20 mg (21-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
|
MK-1496 40 mg (21-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
|
MK-1496 80 mg (21-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
|
MK-1496 120 mg (21-Day Cycle)
n=1 participants at risk
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
|
MK-1496 20 mg (28-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 40 mg (28-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 80 mg (28-Day Cycle)
n=6 participants at risk
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 100 mg (28-Day Cycle)
n=2 participants at risk
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
MK-1496 120 mg (28-Day Cycle)
n=3 participants at risk
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
100.0%
3/3 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
100.0%
3/3 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
100.0%
3/3 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
100.0%
3/3 • Number of events 3
|
|
Eye disorders
Keratitis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 4
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
1/1 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
100.0%
2/2 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Bactaermia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
1/1 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
|
Vascular disorders
Orthostatic hypotension
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/3
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme
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. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER