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Trial record 37 of 42 for:    Malignant Hyperthermia 5

Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00880568
Recruitment Status : Completed
First Posted : April 14, 2009
Results First Posted : October 26, 2012
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplasms
Malignant
Intervention Drug: MK-1496
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Hide Arm/Group Description Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Period Title: Overall Study
Started 3 3 3 1 3 3 6 2 3
Completed 0 0 0 0 0 0 0 0 0
Not Completed 3 3 3 1 3 3 6 2 3
Reason Not Completed
Disease progression             3             3             3             1             3             3             5             0             3
Adverse Event             0             0             0             0             0             0             1             1             0
Withdrawal by Subject             0             0             0             0             0             0             0             1             0
Arm/Group Title MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle) Total
Hide Arm/Group Description Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 1 3 3 6 2 3 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 1 participants 3 participants 3 participants 6 participants 2 participants 3 participants 27 participants
65.0
(64 to 69)
57.0
(54 to 71)
61.0
(53 to 75)
56.0
(56 to 56)
52.0
(48 to 63)
51.0
(43 to 58)
62.5
(56 to 71)
57.5
(42 to 73)
68.0
(59 to 68)
61.0
(42 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 1 participants 3 participants 3 participants 6 participants 2 participants 3 participants 27 participants
Female
1
  33.3%
2
  66.7%
1
  33.3%
0
   0.0%
2
  66.7%
2
  66.7%
3
  50.0%
2
 100.0%
1
  33.3%
14
  51.9%
Male
2
  66.7%
1
  33.3%
2
  66.7%
1
 100.0%
1
  33.3%
1
  33.3%
3
  50.0%
0
   0.0%
2
  66.7%
13
  48.1%
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLTs)
Hide Description 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.
Time Frame Cycle 1 (up to 21 or 28 days, depending on treatment arm)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the first cycle of each dosing schedule (21 or 28 days)
Arm/Group Title MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Hide Arm/Group Description:
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Overall Number of Participants Analyzed 3 3 3 1 3 3 6 2 3
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0 2 2
2.Primary Outcome
Title Number of Participants With Any Clinical or Laboratory Adverse Event
Hide Description This is a measure of the number of participants who experienced any adverse event (AE) while on study.
Time Frame First dose up to 30 days after last dose (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants on study
Arm/Group Title MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Hide Arm/Group Description:
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Overall Number of Participants Analyzed 3 3 3 1 3 3 6 2 3
Measure Type: Number
Unit of Measure: participants
3 3 2 1 3 3 6 2 3
3.Secondary Outcome
Title Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)
Hide Description

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.

Time Frame Cycle 1, Day 1 (Hour 0 through Hour 24)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants on the 21-day dosing schedule
Arm/Group Title MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle)
Hide Arm/Group Description:
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
Overall Number of Participants Analyzed 3 3 3 1
Mean (Standard Deviation)
Unit of Measure: hr*nmol/L
305  (246) 434  (82.6) 295  (193) 1460
4.Secondary Outcome
Title Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)
Hide Description

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.

Time Frame Cycle 1, Day 1 (Hour 0 through Hour 24)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the first cycle of the 28-day dosing schedule
Arm/Group Title MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Hide Arm/Group Description:
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Overall Number of Participants Analyzed 3 3 6 2 3
Mean (Standard Deviation)
Unit of Measure: hr*nmol/L
122  (85.3) 302  (47.7) 936  (364) 2530  (81.2) 2320  (673)
5.Secondary Outcome
Title Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)
Hide Description

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.

Time Frame Cycle 1, Day 3 (Hour 0 through Hour 24)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the first 28-day cycle
Arm/Group Title MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Hide Arm/Group Description:
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
Overall Number of Participants Analyzed 3 3 6 2 2
Mean (Standard Deviation)
Unit of Measure: hr*nmol/L
141  (114) 366  (31.1) 1300  (379) 3090  (222) 3470  (1560)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Hide Arm/Group Description Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
All-Cause Mortality
MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      1/1 (100.00%)      1/3 (33.33%)      0/3 (0.00%)      2/6 (33.33%)      2/2 (100.00%)      1/3 (33.33%)    
Blood and lymphatic system disorders                   
Febrile neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Thrombocytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders                   
Vomiting  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Dysphagia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
General disorders                   
Disease progression  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Hepatobiliary disorders                   
Jaundice cholestatic  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations                   
Bacteraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders                   
Hypercalcaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-1496 20 mg (21-Day Cycle) MK-1496 40 mg (21-Day Cycle) MK-1496 80 mg (21-Day Cycle) MK-1496 120 mg (21-Day Cycle) MK-1496 20 mg (28-Day Cycle) MK-1496 40 mg (28-Day Cycle) MK-1496 80 mg (28-Day Cycle) MK-1496 100 mg (28-Day Cycle) MK-1496 120 mg (28-Day Cycle)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      2/3 (66.67%)      1/1 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      2/2 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders                   
Anaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 2/2 (100.00%)  2 3/3 (100.00%)  3
Febrile neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 1/3 (33.33%)  1
Leukopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  3 2/2 (100.00%)  2 3/3 (100.00%)  3
Lymphopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 2/2 (100.00%)  2 2/3 (66.67%)  2
Neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 2/2 (100.00%)  2 3/3 (100.00%)  3
Thrombocytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  3 2/2 (100.00%)  2 3/3 (100.00%)  3
Eye disorders                   
Keratitis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Vision blurred  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Gastrointestinal disorders                   
Abdominal distension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Abdominal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Cheilitis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Constipation  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 0/2 (0.00%)  0 0/3 (0.00%)  0
Diarrhoea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  3 1/3 (33.33%)  1
Dysphagia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Intestinal obstruction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  4 0/2 (0.00%)  0 0/3 (0.00%)  0
Stomatitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Vomiting  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
General disorders                   
Chest pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Fatigue  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 0/2 (0.00%)  0 1/3 (33.33%)  1
Malaise  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/2 (100.00%)  2 1/3 (33.33%)  1
Mucosal inflammation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Oedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  2
Pyrexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  2 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hepatobiliary disorders                   
Cholangitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations                   
Bactaermia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Cystitis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Nasopharyngitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Investigations                   
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 1/3 (33.33%)  3
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
C-reactive protein increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Electrocardiogram QT prolonged  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Weight decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders                   
Decreased appetite  1  2/3 (66.67%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 1/6 (16.67%)  1 1/2 (50.00%)  3 1/3 (33.33%)  1
Hypercreatininaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hyperglycaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/2 (0.00%)  0 0/3 (0.00%)  0
Hyperlipasaemia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  2
Hypermagnesaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hyperphosphatasaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hypoalbuminaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/2 (50.00%)  1 0/3 (0.00%)  0
Hypophosphataemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Arthralgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/2 (50.00%)  1 0/3 (0.00%)  0
Back pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 1/3 (33.33%)  1
Musculoskeletal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Cancer pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Tumour pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders                   
Dizziness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Headache  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Psychiatric disorders                   
Insomnia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders                   
Hydronephrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Ketonuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Urinary incontinence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Cough  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Epistaxis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Productive cough  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Upper respiratory tract inflammation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Skin and subcutaneous tissue disorders                   
Alopecia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Rash  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1 2/3 (66.67%)  3
Urticaria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders                   
Hypertension  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hypotension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Orthostatic hypotension  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00880568     History of Changes
Other Study ID Numbers: 1496-002
2009_575
First Submitted: April 10, 2009
First Posted: April 14, 2009
Results First Submitted: September 25, 2012
Results First Posted: October 26, 2012
Last Update Posted: February 19, 2015