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Trial record 56 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

A Study to Determine the Activity of Robatumumab (SCH 717454, MK-7454) in Participants With Relapsed or Recurrent Colorectal Cancer (P04721, MK-7454-003)

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: NCT00551213
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : December 15, 2015
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: Robatumumab
Drug: Irinotecan
Biological: Cetuximab
Drug: Capecitabine
Drug: FOLFOX
Drug: CAPEOX/XELOX
Drug: FOLFIRI
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab
Hide Arm/Group Description Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Period Title: Overall Study
Started 50 17
Treated 49 15
Completed 0 0
Not Completed 50 17
Reason Not Completed
Adverse Event             6             3
Progressive Disease             41             12
Withdrawal by Subject             2             0
Not Treated             1             2
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab Total
Hide Arm/Group Description Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. Total of all reporting groups
Overall Number of Baseline Participants 50 17 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 17 participants 67 participants
64.7  (10.8) 61.9  (10.6) 64.0  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 17 participants 67 participants
Female
30
  60.0%
9
  52.9%
39
  58.2%
Male
20
  40.0%
8
  47.1%
28
  41.8%
1.Primary Outcome
Title Number of Participants With a >20% Decrease in Positron Emission Tomography (PET)-Assessed Tumor Glucose Metabolism: Fluorodeoxyglucose (FDG) Standardized Uptake Value (SUV) in the Target Lesion
Hide Description FDG-PET was used in this study to detect the biological activity of modulation of the target within the tumor. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 was used to select the target lesion. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were identified as target lesions and recorded and measured at Baseline. The changes in SUVmax were calculated using the formula: (endpoint SUVmax – baseline SUVmax)/baseline SUVmax as a percentage. If multiple lesions had been measured at a visit, percentages calculated for all target lesions were averaged to find the decrease during the treatment period per participant. FDG SUVmax responder was defined as participants with >20% decrease in SUVmax after the first cycle of robatumumab in Period 2.
Time Frame After the first robatumumab dose in Period 2 (Up to approximately 4 weeks after first robatumumab dose in Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of robatumumab in Periods 1 and 2 and had SUV data before and after the first dose of robatumumab in Period 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab
Hide Arm/Group Description:
Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Overall Number of Participants Analyzed 41 0
Measure Type: Number
Unit of Measure: Participants
7
2.Secondary Outcome
Title Number of Participants Who Experienced One or More Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
Time Frame Up to 30 days after last dose of study drug (Up to approximately 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of study drug were included in the analysis.
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab
Hide Arm/Group Description:
Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Overall Number of Participants Analyzed 49 15
Measure Type: Number
Unit of Measure: Participants
49 15
3.Secondary Outcome
Title Best Overall Tumor Response Per Investigator Review
Hide Description Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST v 1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Up to 30 days after last dose of study drug (Up to approximately 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of robatumumab were included in the analysis.
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab
Hide Arm/Group Description:
Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Overall Number of Participants Analyzed 49 15
Measure Type: Number
Unit of Measure: Participants
Partial Response 1 0
Stable Disease 10 7
Progressive Disease 33 6
No post-Baseline assessment 5 2
4.Secondary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an AE
Hide Description An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
Time Frame Up to last dose of study drug (Up to approximately 18 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of study drug were included in the analysis.
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab
Hide Arm/Group Description:
Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Overall Number of Participants Analyzed 49 15
Measure Type: Number
Unit of Measure: Participants
6 3
5.Secondary Outcome
Title Best Overall Tumor Response Per Central Review
Hide Description Tumor response was assessed by CT or MRI scan using RECIST v1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the LD for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Up to 30 days after last dose of study drug (Up to approximately 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of robatumumab were included in the analysis.
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab
Hide Arm/Group Description:
Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Overall Number of Participants Analyzed 49 15
Measure Type: Number
Unit of Measure: Participants
Partial Response 0 0
Stable Disease 10 5
Progressive Disease 31 9
No post-Baseline assessment 8 1
6.Secondary Outcome
Title Change From Baseline in Tumor Growth Rate
Hide Description Tumor growth rate was assessed by CT or MRI scans using RECIST criteria at Screening, at every 8 weeks of robatumumab treatment and at post study. For Pre Baseline 1, tumor growth rate=(sum of longest diameter of target lesions at Baseline – the most recent prior to Baseline)/duration between Baseline and Pre Baseline. For all other cycles, tumor growth rate=(sum of longest diameter of target lesions at a cycle – Baseline)/ duration between Baseline and the cycle. The cycles presented below are relative to the first dose of robatumumab in Period 1.
Time Frame Baseline and up to approximately 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of robatumumab in Periods 1 and 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.
Arm/Group Title Robatumumab→Robatumumab Chemotherapy→Robatumumab
Hide Arm/Group Description:
Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
Overall Number of Participants Analyzed 49 0
Mean (Standard Deviation)
Unit of Measure: mm/day
Pre Baseline 1 (n=46) 0.49  (0.48)
Cycle 1 (n=24) 0.07  (0.67)
Cycle 2 (n=25) 0.41  (0.57)
Cycle 5 (n=25) 0.53  (0.63)
Cycle 9 (n=7) 0.19  (0.26)
Time Frame Up to approximately 22 weeks
Adverse Event Reporting Description All participants who received ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
 
Arm/Group Title Chemotherapy→Robatumumab Robatumumab→Robatumumab
Hide Arm/Group Description Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
All-Cause Mortality
Chemotherapy→Robatumumab Robatumumab→Robatumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy→Robatumumab Robatumumab→Robatumumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/15 (40.00%)      14/49 (28.57%)    
Cardiac disorders     
ATRIAL FIBRILLATION  1  0/15 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
ABDOMINAL PAIN  1  0/15 (0.00%)  0 3/49 (6.12%)  4
CONSTIPATION  1  0/15 (0.00%)  0 1/49 (2.04%)  1
DIARRHOEA  1  1/15 (6.67%)  1 1/49 (2.04%)  2
INTESTINAL OBSTRUCTION  1  0/15 (0.00%)  0 1/49 (2.04%)  1
NAUSEA  1  0/15 (0.00%)  0 3/49 (6.12%)  4
SMALL INTESTINAL OBSTRUCTION  1  1/15 (6.67%)  2 0/49 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/15 (0.00%)  0 1/49 (2.04%)  1
VOMITING  1  0/15 (0.00%)  0 3/49 (6.12%)  4
General disorders     
ASTHENIA  1  0/15 (0.00%)  0 1/49 (2.04%)  1
CATHETER RELATED COMPLICATION  1  0/15 (0.00%)  0 1/49 (2.04%)  1
CHEST PAIN  1  0/15 (0.00%)  0 1/49 (2.04%)  1
MALAISE  1  0/15 (0.00%)  0 1/49 (2.04%)  2
PAIN  1  0/15 (0.00%)  0 1/49 (2.04%)  2
CHILLS  1  1/15 (6.67%)  1 0/49 (0.00%)  0
PYREXIA  1  1/15 (6.67%)  2 0/49 (0.00%)  0
Hepatobiliary disorders     
CHOLECYSTITIS ACUTE  1  0/15 (0.00%)  0 1/49 (2.04%)  1
CHOLELITHIASIS  1  0/15 (0.00%)  0 1/49 (2.04%)  1
HEPATIC FUNCTION ABNORMAL  1  0/15 (0.00%)  0 1/49 (2.04%)  1
HYPERBILIRUBINAEMIA  1  1/15 (6.67%)  2 0/49 (0.00%)  0
Infections and infestations     
BACTERAEMIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
CELLULITIS  1  0/15 (0.00%)  0 1/49 (2.04%)  1
KLEBSIELLA BACTERAEMIA  1  0/15 (0.00%)  0 1/49 (2.04%)  1
PERIHEPATIC ABSCESS  1  0/15 (0.00%)  0 1/49 (2.04%)  1
PNEUMONIA  1  0/15 (0.00%)  0 1/49 (2.04%)  1
SEPSIS  1  0/15 (0.00%)  0 1/49 (2.04%)  1
TOOTH INFECTION  1  0/15 (0.00%)  0 1/49 (2.04%)  1
Metabolism and nutrition disorders     
DEHYDRATION  1  2/15 (13.33%)  2 1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  0/15 (0.00%)  0 1/49 (2.04%)  1
MUSCULOSKELETAL CHEST PAIN  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Nervous system disorders     
DIZZINESS  1  0/15 (0.00%)  0 1/49 (2.04%)  1
Psychiatric disorders     
MENTAL STATUS CHANGES  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Renal and urinary disorders     
RENAL FAILURE ACUTE  1  0/15 (0.00%)  0 1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  1/15 (6.67%)  1 1/49 (2.04%)  1
HYPOXIA  1  0/15 (0.00%)  0 1/49 (2.04%)  1
ACUTE RESPIRATORY FAILURE  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Vascular disorders     
DEEP VEIN THROMBOSIS  1  0/15 (0.00%)  0 1/49 (2.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy→Robatumumab Robatumumab→Robatumumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      48/49 (97.96%)    
Blood and lymphatic system disorders     
ANAEMIA  1  1/15 (6.67%)  1 2/49 (4.08%)  11
LEUKOPENIA  1  1/15 (6.67%)  4 0/49 (0.00%)  0
LYMPHOPENIA  1  1/15 (6.67%)  1 1/49 (2.04%)  1
NEUTROPENIA  1  1/15 (6.67%)  10 1/49 (2.04%)  1
Cardiac disorders     
SINUS TACHYCARDIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
VENTRICULAR EXTRASYSTOLES  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Ear and labyrinth disorders     
EAR HAEMORRHAGE  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Eye disorders     
LACRIMATION INCREASED  1  1/15 (6.67%)  1 1/49 (2.04%)  1
MYODESOPSIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
PHOTOPSIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN  1  5/15 (33.33%)  6 15/49 (30.61%)  23
ABDOMINAL PAIN UPPER  1  1/15 (6.67%)  1 4/49 (8.16%)  5
ASCITES  1  1/15 (6.67%)  1 1/49 (2.04%)  1
CONSTIPATION  1  6/15 (40.00%)  7 16/49 (32.65%)  22
DIARRHOEA  1  8/15 (53.33%)  12 14/49 (28.57%)  19
DRY MOUTH  1  1/15 (6.67%)  1 5/49 (10.20%)  5
DYSPHAGIA  1  1/15 (6.67%)  1 1/49 (2.04%)  1
ERUCTATION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
FLATULENCE  1  1/15 (6.67%)  1 0/49 (0.00%)  0
FREQUENT BOWEL MOVEMENTS  1  1/15 (6.67%)  1 0/49 (0.00%)  0
GASTROINTESTINAL PAIN  1  1/15 (6.67%)  1 1/49 (2.04%)  1
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/15 (6.67%)  1 1/49 (2.04%)  1
HAEMATOCHEZIA  1  1/15 (6.67%)  1 1/49 (2.04%)  1
NAUSEA  1  9/15 (60.00%)  12 24/49 (48.98%)  31
ODYNOPHAGIA  1  1/15 (6.67%)  1 1/49 (2.04%)  1
PROCTALGIA  1  0/15 (0.00%)  0 3/49 (6.12%)  5
RECTAL HAEMORRHAGE  1  1/15 (6.67%)  1 2/49 (4.08%)  2
RECTAL TENESMUS  1  1/15 (6.67%)  1 0/49 (0.00%)  0
SALIVARY HYPERSECRETION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
STOMATITIS  1  3/15 (20.00%)  3 2/49 (4.08%)  2
TOOTHACHE  1  1/15 (6.67%)  1 2/49 (4.08%)  2
VOMITING  1  7/15 (46.67%)  9 16/49 (32.65%)  20
ABDOMINAL DISTENSION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
General disorders     
ASTHENIA  1  5/15 (33.33%)  6 8/49 (16.33%)  10
CATHETER RELATED COMPLICATION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
CATHETER SITE RASH  1  1/15 (6.67%)  1 1/49 (2.04%)  1
CHILLS  1  1/15 (6.67%)  1 1/49 (2.04%)  1
EARLY SATIETY  1  1/15 (6.67%)  1 2/49 (4.08%)  2
FATIGUE  1  9/15 (60.00%)  11 26/49 (53.06%)  36
GAIT DISTURBANCE  1  2/15 (13.33%)  2 1/49 (2.04%)  1
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/15 (0.00%)  0 3/49 (6.12%)  3
MUCOSAL INFLAMMATION  1  1/15 (6.67%)  1 4/49 (8.16%)  4
OEDEMA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
OEDEMA PERIPHERAL  1  3/15 (20.00%)  4 6/49 (12.24%)  8
PAIN  1  0/15 (0.00%)  0 3/49 (6.12%)  3
PERFORMANCE STATUS DECREASED  1  1/15 (6.67%)  1 0/49 (0.00%)  0
PYREXIA  1  2/15 (13.33%)  2 0/49 (0.00%)  0
PITTING OEDEMA  1  1/15 (6.67%)  1 1/49 (2.04%)  1
Hepatobiliary disorders     
BILE DUCT STENOSIS  1  1/15 (6.67%)  1 0/49 (0.00%)  0
JAUNDICE  1  1/15 (6.67%)  1 1/49 (2.04%)  3
Infections and infestations     
ORAL HERPES  1  2/15 (13.33%)  2 0/49 (0.00%)  0
TOOTH ABSCESS  1  1/15 (6.67%)  1 0/49 (0.00%)  0
URINARY TRACT INFECTION  1  2/15 (13.33%)  3 2/49 (4.08%)  2
TINEA INFECTION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Injury, poisoning and procedural complications     
CONTUSION  1  1/15 (6.67%)  1 3/49 (6.12%)  3
INCISIONAL HERNIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
THERMAL BURN  1  1/15 (6.67%)  1 0/49 (0.00%)  0
WRIST FRACTURE  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Investigations     
BLOOD CALCIUM DECREASED  1  1/15 (6.67%)  1 0/49 (0.00%)  0
BLOOD CREATININE INCREASED  1  0/15 (0.00%)  0 3/49 (6.12%)  4
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/15 (0.00%)  0 4/49 (8.16%)  4
HAEMOGLOBIN DECREASED  1  1/15 (6.67%)  1 1/49 (2.04%)  1
INTERNATIONAL NORMALISED RATIO INCREASED  1  1/15 (6.67%)  1 1/49 (2.04%)  1
WEIGHT DECREASED  1  4/15 (26.67%)  9 6/49 (12.24%)  10
Metabolism and nutrition disorders     
ANOREXIA  1  8/15 (53.33%)  10 15/49 (30.61%)  18
DECREASED APPETITE  1  4/15 (26.67%)  4 3/49 (6.12%)  3
DEHYDRATION  1  4/15 (26.67%)  4 11/49 (22.45%)  14
HYPERGLYCAEMIA  1  2/15 (13.33%)  7 7/49 (14.29%)  9
HYPOKALAEMIA  1  2/15 (13.33%)  3 1/49 (2.04%)  1
HYPOMAGNESAEMIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  0/15 (0.00%)  0 4/49 (8.16%)  4
BACK PAIN  1  2/15 (13.33%)  2 3/49 (6.12%)  3
GROIN PAIN  1  1/15 (6.67%)  1 0/49 (0.00%)  0
MUSCLE SPASMS  1  1/15 (6.67%)  1 5/49 (10.20%)  6
MUSCULAR WEAKNESS  1  2/15 (13.33%)  2 0/49 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN  1  1/15 (6.67%)  1 1/49 (2.04%)  2
MUSCULOSKELETAL PAIN  1  3/15 (20.00%)  3 3/49 (6.12%)  4
MYALGIA  1  1/15 (6.67%)  1 3/49 (6.12%)  3
PAIN IN EXTREMITY  1  0/15 (0.00%)  0 5/49 (10.20%)  7
FLANK PAIN  1  1/15 (6.67%)  1 1/49 (2.04%)  1
Nervous system disorders     
COGNITIVE DISORDER  1  0/15 (0.00%)  0 3/49 (6.12%)  3
DIZZINESS  1  1/15 (6.67%)  1 4/49 (8.16%)  4
DYSGEUSIA  1  2/15 (13.33%)  2 3/49 (6.12%)  3
HEADACHE  1  2/15 (13.33%)  2 9/49 (18.37%)  11
MEMORY IMPAIRMENT  1  1/15 (6.67%)  1 2/49 (4.08%)  2
NEUROPATHY PERIPHERAL  1  2/15 (13.33%)  2 4/49 (8.16%)  5
PERIPHERAL SENSORY NEUROPATHY  1  2/15 (13.33%)  2 3/49 (6.12%)  3
SCIATICA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Psychiatric disorders     
ANXIETY  1  0/15 (0.00%)  0 6/49 (12.24%)  6
CONFUSIONAL STATE  1  1/15 (6.67%)  1 4/49 (8.16%)  5
DEPRESSION  1  0/15 (0.00%)  0 5/49 (10.20%)  5
DISORIENTATION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
INSOMNIA  1  2/15 (13.33%)  2 6/49 (12.24%)  8
MENTAL STATUS CHANGES  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Renal and urinary disorders     
HAEMATURIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
MICTURITION URGENCY  1  1/15 (6.67%)  1 0/49 (0.00%)  0
NOCTURIA  1  0/15 (0.00%)  0 3/49 (6.12%)  3
POLLAKIURIA  1  1/15 (6.67%)  1 0/49 (0.00%)  0
RENAL VEIN THROMBOSIS  1  1/15 (6.67%)  1 0/49 (0.00%)  0
URETHRAL OBSTRUCTION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
COUGH  1  4/15 (26.67%)  4 8/49 (16.33%)  8
DYSPNOEA  1  6/15 (40.00%)  6 6/49 (12.24%)  6
EPISTAXIS  1  2/15 (13.33%)  2 2/49 (4.08%)  2
HAEMOPTYSIS  1  1/15 (6.67%)  1 0/49 (0.00%)  0
OROPHARYNGEAL PAIN  1  2/15 (13.33%)  3 1/49 (2.04%)  1
PARANASAL SINUS HYPERSECRETION  1  1/15 (6.67%)  2 0/49 (0.00%)  0
RHINORRHOEA  1  1/15 (6.67%)  1 1/49 (2.04%)  1
SINUS CONGESTION  1  1/15 (6.67%)  1 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders     
ALOPECIA  1  4/15 (26.67%)  5 3/49 (6.12%)  3
DERMATITIS ACNEIFORM  1  1/15 (6.67%)  1 0/49 (0.00%)  0
DRY SKIN  1  3/15 (20.00%)  3 3/49 (6.12%)  3
ERYTHEMA  1  2/15 (13.33%)  2 0/49 (0.00%)  0
NAIL DISCOLOURATION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
PRURITUS GENERALISED  1  1/15 (6.67%)  1 0/49 (0.00%)  0
RASH  1  4/15 (26.67%)  4 3/49 (6.12%)  3
SKIN DISCOLOURATION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
SKIN DISORDER  1  1/15 (6.67%)  1 1/49 (2.04%)  2
SKIN LESION  1  1/15 (6.67%)  1 0/49 (0.00%)  0
FACIAL WASTING  1  1/15 (6.67%)  1 0/49 (0.00%)  0
PRURITUS  1  1/15 (6.67%)  1 1/49 (2.04%)  1
Vascular disorders     
FLUSHING  1  1/15 (6.67%)  2 0/49 (0.00%)  0
HYPERTENSION  1  1/15 (6.67%)  1 3/49 (6.12%)  3
HYPOTENSION  1  2/15 (13.33%)  2 1/49 (2.04%)  1
DEEP VEIN THROMBOSIS  1  1/15 (6.67%)  1 1/49 (2.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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 Investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00551213     History of Changes
Other Study ID Numbers: P04721
MK-7454-003 ( Other Identifier: Merck Protocol Number )
First Submitted: October 29, 2007
First Posted: October 30, 2007
Results First Submitted: November 10, 2015
Results First Posted: December 15, 2015
Last Update Posted: August 24, 2018