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Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

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: NCT00334802
Recruitment Status : Completed
First Posted : June 8, 2006
Results First Posted : July 20, 2009
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: gemcitabine
Drug: paclitaxel
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Period Title: Overall Study
Started 6 56
Completed 0 16
Not Completed 6 40
Reason Not Completed
Progressive Disease             2             24
Toxicity             1             5
Lack of Efficacy             1             3
Patient Condition Aggrevated             1             0
Physician Decision             1             0
Withdrawal by Subject             0             4
Adverse Event             0             3
Criteria for Starting Next Cycle Not Met             0             1
Arm/Group Title Dose Level 1 Dose Level 2 Total
Hide Arm/Group Description Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Total of all reporting groups
Overall Number of Baseline Participants 6 56 62
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 56 participants 62 participants
58.2  (4.49) 54.4  (8.73) 54.7  (8.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 56 participants 62 participants
Female
6
 100.0%
56
 100.0%
62
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 6 participants 56 participants 62 participants
6 56 62
Age at Primary Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 56 participants 62 participants
<30 years old 0 0 0
30 to <40 years old 0 3 3
40 to <50 years old 1 20 21
50 to <60 years old 3 24 27
60 to <70 years old 2 8 10
≥70 years old 0 1 1
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 56 participants 62 participants
0 - Fully Active 4 50 54
1 - Ambulatory, Restricted Strenuous Activity 2 6 8
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 6 participants 56 participants 62 participants
57.18  (15.313) 55.76  (8.715) 55.90  (9.375)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 6 participants 56 participants 62 participants
153.53  (7.987) 154.71  (6.184) 154.60  (6.312)
1.Primary Outcome
Title Tumor Response
Hide Description Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response.
Time Frame baseline to measured progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Overall Number of Participants Analyzed 6 56
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0
Partial Response 3 25
Stable Disease 1 17
Progressive Disease 1 11
Not Evaluable 1 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose Level 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments P-value for Dose Level 1 Responders (Complete Response + Partial Response)
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dose Level 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value for Dose Level 2 Responders (Complete Response + Partial Response)
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Duration of Response
Hide Description The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time Frame time of response to progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 2
Hide Arm/Group Description:
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Overall Number of Participants Analyzed 56
Median (Full Range)
Unit of Measure: months
4.70
(1.2 to 7.3)
3.Secondary Outcome
Title Time to Progressive Disease
Hide Description Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time Frame baseline to measured progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Overall Number of Participants Analyzed 6 56
Median (Full Range)
Unit of Measure: days
310.5
(42 to 455)
194.0
(29 to 265)
4.Secondary Outcome
Title Number of Participants Alive at One Year (1-Year Survival)
Hide Description [Not Specified]
Time Frame baseline to date of death from any cause, evaluated at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Overall Number of Participants Analyzed 6 56
Measure Type: Number
Unit of Measure: participants
5 45
5.Secondary Outcome
Title Pharmacokinetics - Maximum Plasma Concentration (Cmax)
Hide Description Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.
Time Frame cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.
Arm/Group Title Gemcitabine + Paclitaxcel Gemcitabine
Hide Arm/Group Description:
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
Overall Number of Participants Analyzed 12 12
Geometric Mean (Full Range)
Unit of Measure: nanograms per milliliter (ng/mL)
25800
(12800 to 43600)
25400
(20000 to 33100)
6.Secondary Outcome
Title Pharmacokinetics - Area Under the Concentration Curve (AUC)
Hide Description Area under the concentration curve from time zero to infinity.
Time Frame cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.
Arm/Group Title Gemcitabine + Paclitaxcel Gemcitabine
Hide Arm/Group Description:
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
Overall Number of Participants Analyzed 12 12
Geometric Mean (Full Range)
Unit of Measure: nanograms*hour per milliliter (ng*hr/mL)
16300
(11700 to 25500)
14700
(11500 to 21000)
7.Secondary Outcome
Title Pharmacokinetics - Half Life (t½)
Hide Description Apparent elimination half-life.
Time Frame cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.
Arm/Group Title Gemcitabine + Paclitaxcel Gemcitabine
Hide Arm/Group Description:
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
Overall Number of Participants Analyzed 12 12
Geometric Mean (Full Range)
Unit of Measure: hours
0.282
(0.192 to 1.00)
0.258
(0.162 to 0.969)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
All-Cause Mortality
Dose Level 1 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 Dose Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1      3    
Infections and infestations     
Pneumonia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Investigations     
Haemoglobin decreased  1  1/6 (16.67%)  1 0/56 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Psychiatric disorders     
Panic disorder  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 Dose Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6      56    
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Cardiac disorders     
Palpitations  1  2/6 (33.33%)  2 2/56 (3.57%)  2
Arrhythmia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Atrial fibrillation  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Tachycardia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Ventricular extrasystoles  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Ear and labyrinth disorders     
Tinnitus  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Vertigo  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Eye disorders     
Eye discharge  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Ocular hyperaemia  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Conjunctival haemorrhage  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Diplopia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Eyelid oedema  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Lacrimation increased  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Vision blurred  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Gastrointestinal disorders     
Nausea  1  3/6 (50.00%)  10 29/56 (51.79%)  105
Constipation  1  1/6 (16.67%)  3 13/56 (23.21%)  63
Vomiting  1  1/6 (16.67%)  2 16/56 (28.57%)  38
Diarrhoea  1  0/6 (0.00%)  0 13/56 (23.21%)  27
Stomach discomfort  1  0/6 (0.00%)  0 5/56 (8.93%)  8
Abdominal distension  1  0/6 (0.00%)  0 4/56 (7.14%)  4
Abdominal pain  1  0/6 (0.00%)  0 3/56 (5.36%)  5
Cheilitis  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Haemorrhoids  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Abdominal pain upper  1  0/6 (0.00%)  0 2/56 (3.57%)  3
Dyspepsia  1  0/6 (0.00%)  0 2/56 (3.57%)  5
Gastritis  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Stomatitis  1  0/6 (0.00%)  0 2/56 (3.57%)  4
Gingival bleeding  1  0/6 (0.00%)  0 1/56 (1.79%)  5
Gingival pain  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Gingival swelling  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Gingivitis  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Hypoaesthesia oral  1  0/6 (0.00%)  0 1/56 (1.79%)  1
General disorders     
Malaise  1  5/6 (83.33%)  22 34/56 (60.71%)  116
Oedema peripheral  1  2/6 (33.33%)  4 6/56 (10.71%)  10
Pyrexia  1  2/6 (33.33%)  3 16/56 (28.57%)  47
Chills  1  1/6 (16.67%)  2 4/56 (7.14%)  7
Localised oedema  1  1/6 (16.67%)  2 0/56 (0.00%)  0
Fatigue  1  0/6 (0.00%)  0 7/56 (12.50%)  15
Face oedema  1  0/6 (0.00%)  0 5/56 (8.93%)  9
Pain  1  0/6 (0.00%)  0 5/56 (8.93%)  8
Chest discomfort  1  0/6 (0.00%)  0 4/56 (7.14%)  4
Oedema  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Thirst  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Asthenia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Chest pain  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Feeling abnormal  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Feeling drunk  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Generalised oedema  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Hangover  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Injection site reaction  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Local swelling  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Immune system disorders     
Seasonal allergy  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Infections and infestations     
Bronchitis  1  1/6 (16.67%)  1 0/56 (0.00%)  0
Cystitis  1  1/6 (16.67%)  1 2/56 (3.57%)  2
Folliculitis  1  1/6 (16.67%)  1 0/56 (0.00%)  0
Nasopharyngitis  1  1/6 (16.67%)  2 17/56 (30.36%)  26
Tinea infection  1  1/6 (16.67%)  1 0/56 (0.00%)  0
Cellulitis  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Hordeolum  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Gastroenteritis  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Genital herpes  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Infection  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Pulpitis dental  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Injury, poisoning and procedural complications     
Joint sprain  1  1/6 (16.67%)  1 0/56 (0.00%)  0
Contusion  1  0/6 (0.00%)  0 2/56 (3.57%)  3
Wound  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Alcohol poisoning  1  0/6 (0.00%)  0 1/56 (1.79%)  3
Animal bite  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Hand fracture  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Head injury  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Investigations     
Alanine amiontransferase increased  1  6/6 (100.00%)  26 44/56 (78.57%)  155
Haemoglobin decreased  1  6/6 (100.00%)  23 42/56 (75.00%)  130
White blood cell count decreased  1  5/6 (83.33%)  40 52/56 (92.86%)  370
Aspartate aminotransferase increased  1  4/6 (66.67%)  24 38/56 (67.86%)  133
Lymphocyte count decreased  1  4/6 (66.67%)  22 28/56 (50.00%)  101
Neutrophil count decreased  1  4/6 (66.67%)  39 54/56 (96.43%)  368
Platelet count decreased  1  4/6 (66.67%)  22 39/56 (69.64%)  164
Blood alkaline phosphatase increased  1  4/6 (66.67%)  7 14/56 (25.00%)  23
Red blood cell count decreased  1  3/6 (50.00%)  8 37/56 (66.07%)  112
Platelet count increased  1  3/6 (50.00%)  17 10/56 (17.86%)  33
Gamma-glutamyltransferase increased  1  2/6 (33.33%)  3 18/56 (32.14%)  23
Glucose urine present  1  2/6 (33.33%)  2 4/56 (7.14%)  11
Haematocrit decreased  1  2/6 (33.33%)  11 32/56 (57.14%)  116
Blood urine present  1  2/6 (33.33%)  3 8/56 (14.29%)  13
Weight decreased  1  2/6 (33.33%)  3 3/56 (5.36%)  3
Protein urine present  1  2/6 (33.33%)  5 8/56 (14.29%)  15
Blood albumin decreased  1  1/6 (16.67%)  4 13/56 (23.21%)  25
Blood bilirubin increased  1  1/6 (16.67%)  1 6/56 (10.71%)  10
Blood calcium decreased  1  1/6 (16.67%)  4 2/56 (3.57%)  2
Blood calcium increased  1  1/6 (16.67%)  2 2/56 (3.57%)  6
Blood pressure increased  1  1/6 (16.67%)  1 4/56 (7.14%)  14
Blood sodium decreased  1  1/6 (16.67%)  1 5/56 (8.93%)  9
Leucine aminopeptidase increased  1  1/6 (16.67%)  1 0/56 (0.00%)  0
Neutrophil count increased  1  1/6 (16.67%)  1 7/56 (12.50%)  10
Weight increased  1  1/6 (16.67%)  1 1/56 (1.79%)  1
White blood cell count increased  1  1/6 (16.67%)  1 7/56 (12.50%)  13
Blood potassium decreased  1  0/6 (0.00%)  0 10/56 (17.86%)  23
Protein total decreased  1  0/6 (0.00%)  0 9/56 (16.07%)  21
Blood lactate dehydrogenase increased  1  0/6 (0.00%)  0 7/56 (12.50%)  24
Blood creatinine increased  1  0/6 (0.00%)  0 6/56 (10.71%)  7
Blood urea decreased  1  0/6 (0.00%)  0 6/56 (10.71%)  10
C-reactive protein increased  1  0/6 (0.00%)  0 4/56 (7.14%)  8
Blood chloride decreased  1  0/6 (0.00%)  0 3/56 (5.36%)  4
Blood triglycerides increased  1  0/6 (0.00%)  0 3/56 (5.36%)  6
White blood cells urine positive  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Blood cholesterol increased  1  0/6 (0.00%)  0 2/56 (3.57%)  7
Blood glucose increased  1  0/6 (0.00%)  0 2/56 (3.57%)  7
Blood potassium increased  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Blood urea increased  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Creatine phosphokinase decreased  1  0/6 (0.00%)  0 2/56 (3.57%)  4
Alanine aminotransferase decreased  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Aspartate aminotransferase decreased  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Blood cholinesterase increased  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Blood creatinine decreased  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Blood pressure decreased  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Blood sodium increased  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Glycosylated haemoglobin increased  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Haematocrit increased  1  0/6 (0.00%)  0 1/56 (1.79%)  1
High density lipoprotein increased  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Low density lipoprotein increased  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Lymphocyte count increased  1  0/6 (0.00%)  0 1/56 (1.79%)  3
Urobilin urine present  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Metabolism and nutrition disorders     
Anorexia  1  3/6 (50.00%)  5 27/56 (48.21%)  54
Diabetes mellitus  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Decreased appetite  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Hyperlipidaemia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/6 (16.67%)  1 23/56 (41.07%)  69
Arthritis  1  1/6 (16.67%)  2 0/56 (0.00%)  0
Back pain  1  1/6 (16.67%)  2 6/56 (10.71%)  8
Myalgia  1  1/6 (16.67%)  11 19/56 (33.93%)  62
Pain in extremity  1  1/6 (16.67%)  1 12/56 (21.43%)  31
Muscular weakness  1  0/6 (0.00%)  0 4/56 (7.14%)  8
Musculoskeletal pain  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Musculoskeletal stiffness  1  0/6 (0.00%)  0 3/56 (5.36%)  4
Sensation of heaviness  1  0/6 (0.00%)  0 2/56 (3.57%)  6
Bone pain  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Spinal osteoarthritis  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Torticollis  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Intervertebral disc protrusion  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/6 (16.67%)  1 7/56 (12.50%)  10
Lentigo  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Tumour haemorrhage  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Nervous system disorders     
Dysgeusia  1  2/6 (33.33%)  5 19/56 (33.93%)  57
Headache  1  2/6 (33.33%)  5 15/56 (26.79%)  36
Hypoaesthesia  1  2/6 (33.33%)  3 20/56 (35.71%)  42
Dizziness  1  1/6 (16.67%)  1 5/56 (8.93%)  7
Neuropathy peripheral  1  1/6 (16.67%)  1 13/56 (23.21%)  18
Sensory disturbance  1  1/6 (16.67%)  1 13/56 (23.21%)  13
Hyperaesthesia  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Peripheral motor neuropathy  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Dizziness postural  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Neuralgia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Neurotoxicity  1  0/6 (0.00%)  0 1/56 (1.79%)  6
Parosmia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Sciatica  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Somnolence  1  0/6 (0.00%)  0 1/56 (1.79%)  7
Syncope vasovagal  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Vocal cord paralysis  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Olfactory nerve disorder  1  0/6 (0.00%)  0 1/56 (1.79%)  4
Psychiatric disorders     
Insomnia  1  1/6 (16.67%)  1 13/56 (23.21%)  17
Agitation  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Anxiety  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Renal and urinary disorders     
Residual urine  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Dysuria  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Cystitis-like symptom  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Reproductive system and breast disorders     
Breast discharge  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Dysmenorrhoea  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/6 (16.67%)  1 10/56 (17.86%)  16
Epistaxis  1  1/6 (16.67%)  2 4/56 (7.14%)  6
Pharyngolaryngeal pain  1  0/6 (0.00%)  0 9/56 (16.07%)  11
Rhinorrhoea  1  0/6 (0.00%)  0 4/56 (7.14%)  4
Dyspnoea  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Haemoptysis  1  0/6 (0.00%)  0 2/56 (3.57%)  3
Upper respiratory tract inflammation  1  0/6 (0.00%)  0 2/56 (3.57%)  3
Dysphonia  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Hiccups  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Pleural effusion  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Productive cough  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  4/6 (66.67%)  4 34/56 (60.71%)  34
Erythema  1  2/6 (33.33%)  2 9/56 (16.07%)  11
Pruritus  1  2/6 (33.33%)  2 10/56 (17.86%)  25
Eczema  1  1/6 (16.67%)  1 12/56 (21.43%)  22
Palmar-plantar erythrodysaesthesia syndrome  1  1/6 (16.67%)  1 3/56 (5.36%)  3
Rash papular  1  1/6 (16.67%)  1 1/56 (1.79%)  1
Rash  1  0/6 (0.00%)  0 16/56 (28.57%)  26
Pruritus generalized  1  0/6 (0.00%)  0 4/56 (7.14%)  4
Hyperhidrosis  1  0/6 (0.00%)  0 2/56 (3.57%)  5
Skin exfoliation  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Urticaria  1  0/6 (0.00%)  0 2/56 (3.57%)  3
Toxic skin eruption  1  0/6 (0.00%)  0 2/56 (3.57%)  2
Blister  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Drug eruption  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Erythema multiforme  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Nail disorder  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Skin erosion  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Swelling face  1  0/6 (0.00%)  0 1/56 (1.79%)  2
Surgical and medical procedures     
Cautery to nose  1  1/6 (16.67%)  2 0/56 (0.00%)  0
Central venous catheterisation  1  0/6 (0.00%)  0 4/56 (7.14%)  4
Catheterisation venous  1  0/6 (0.00%)  0 1/56 (1.79%)  1
Vascular disorders     
Angiopathy  1  2/6 (33.33%)  3 25/56 (44.64%)  73
Flushing  1  1/6 (16.67%)  1 5/56 (8.93%)  11
Hypertension  1  1/6 (16.67%)  2 1/56 (1.79%)  2
Hot flush  1  0/6 (0.00%)  0 6/56 (10.71%)  13
Vasculitis  1  0/6 (0.00%)  0 3/56 (5.36%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00334802     History of Changes
Other Study ID Numbers: 9066
B9E-JE-MB22 ( Other Identifier: Eli Lilly and Company )
First Submitted: June 6, 2006
First Posted: June 8, 2006
Results First Submitted: May 29, 2009
Results First Posted: July 20, 2009
Last Update Posted: March 16, 2010