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A Study of LY2510924 and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01391130
Recruitment Status : Terminated (Study Terminated due to Insufficient Efficacy)
First Posted : July 11, 2011
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Clear Cell Renal Cell Carcinoma
Interventions Drug: LY2510924
Drug: Sunitinib
Enrollment 110
Recruitment Details  
Pre-assignment Details Participants who died (any cause) or had disease progression at the time the primary analysis were considered to be study completers.
Arm/Group Title LY2510924 + Sunitinib Sunitinib
Hide Arm/Group Description LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met. 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Period Title: Overall Study
Started 73 37
Received At Least One Dose of Study Drug 72 36
Completed 67 31
Not Completed 6 6
Reason Not Completed
Withdrawal by Subject             3             2
Physician Decision             2             3
Did not Receive Drug             1             1
Arm/Group Title LY2510924 + Sunitinib Sunitinib Total
Hide Arm/Group Description LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met. 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met. Total of all reporting groups
Overall Number of Baseline Participants 72 36 108
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 36 participants 108 participants
64.51  (11.332) 64.21  (9.474) 64.41  (10.705)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 36 participants 108 participants
Female 24 12 36
Male 48 24 72
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 36 participants 108 participants
Hispanic or Latino 0 2 2
Not Hispanic or Latino 71 34 105
Unknown or Not Reported 1 0 1
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 36 participants 108 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 4 2 6
White 68 34 102
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 72 participants 36 participants 108 participants
72 36 108
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS is defined as the time from date of study Randomization to the first date of objectively determined progressive disease(PD) or death from any cause defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0).PD was defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study(including the baseline sum if that is the smallest).In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions was also considered PD.For participants still alive at the time of analysis and without evidence of tumor progression,PFS would be censored at the date of the most recent objective progression-free observation.For participants who receive subsequent anticancer therapy prior to objective disease progression or death,PFS was censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.
Time Frame Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib = 16 and Sunitinib=12.
Arm/Group Title LY2510924 + Sunitinib Sunitinib
Hide Arm/Group Description:
LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Overall Number of Participants Analyzed 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
8.08
(5.52 to 10.64)
12.25
(2.66 to 20.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2510924 + Sunitinib, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4318
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.2149
Confidence Interval (2-Sided) 95%
0.7462 to 1.9779
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
Hide Description ORR is defined as the number of participants with a best response of CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.
Time Frame Baseline to Date of Tumor Response or Measured Progressive Disease or Date of Death from any Cause ((Up to 67 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title LY2510924 + Sunitinib Sunitinib
Hide Arm/Group Description:
LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Overall Number of Participants Analyzed 72 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.9
(21.17 to 42.71)
38.9
(22.96 to 54.81)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from the date of study randomization to the date of death from any cause. For participants who were still alive as of the data cut-off date, OS time will be censored on the date of the participant's last contact (last contact for participants in post-discontinuation = last known alive date in mortality status).
Time Frame Randomization to Date of Death from Any Cause (Up to 67 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib=19 and Sunitinib=10.
Arm/Group Title LY2510924 + Sunitinib Sunitinib
Hide Arm/Group Description:
LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Overall Number of Participants Analyzed 72 36
Median (95% Confidence Interval)
Unit of Measure: months
24.18
(13.90 to 35.19)
23.82
(11.60 to 43.86)
4.Secondary Outcome
Title Duration of Overall Response (DOR)
Hide Description DOR 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. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame Date of First Response to Date of Progressive Disease (Up to 67 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib=7 and Sunitinib=7.
Arm/Group Title LY2510924 + Sunitinib Sunitinib
Hide Arm/Group Description:
LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Overall Number of Participants Analyzed 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
11.30
(5.36 to 16.99)
12.42 [1] 
(3.15 to NA)
[1]
The data were not evaluable for the upper confidence interval.
5.Secondary Outcome
Title Duration of Complete Response
Hide Description Duration of complete response is defined as the time from the date when the measurement criteria are met for complete response until the date of first observation of objective disease progression (taking as reference for PD the smallest measurements recorded since the treatment started). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame Date of Complete Response to the Date of Progressive Disease (Up to 67 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug who had CR.
Arm/Group Title LY2510924 + Sunitinib Sunitinib
Hide Arm/Group Description:
LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Overall Number of Participants Analyzed 0 1
Median (95% Confidence Interval)
Unit of Measure: months
10 [1] 
(NA to NA)
[1]
Only one participant had CR.
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title LY2510924 + Sunitinib Sunitinib
Hide Arm/Group Description LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met. 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
All-Cause Mortality
LY2510924 + Sunitinib Sunitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2510924 + Sunitinib Sunitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/72 (43.06%)      10/36 (27.78%)    
Blood and lymphatic system disorders     
Coagulopathy  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Febrile neutropenia  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Idiopathic thrombocytopenic purpura  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Cardiac disorders     
Cardiac arrest  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Cardiac failure congestive  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Myocardial infarction  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Pericardial effusion  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Gastrointestinal haemorrhage  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Lower gastrointestinal haemorrhage  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Small intestinal obstruction  1  1/72 (1.39%)  1 0/36 (0.00%)  0
General disorders     
Asthenia  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Disease progression  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Fatigue  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Pain  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Pyrexia  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Infections and infestations     
Bacteraemia  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Cellulitis  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Clostridial infection  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Pancreas infection  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Peridiverticular abscess  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Pneumonia  1  1/72 (1.39%)  1 1/36 (2.78%)  1
Post procedural infection  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Urinary tract infection  1  1/72 (1.39%)  2 0/36 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  2/72 (2.78%)  3 2/36 (5.56%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Haemarthrosis  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Intracranial tumour haemorrhage  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Metastatic renal cell carcinoma  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Squamous cell carcinoma  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders     
Brain oedema  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Central nervous system lesion  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Convulsion  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Dizziness  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Syncope  1  2/72 (2.78%)  2 1/36 (2.78%)  2
Psychiatric disorders     
Delirium  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Mental status changes  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Renal and urinary disorders     
Cystitis haemorrhagic  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Haematuria  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Renal failure  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Renal failure acute  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/72 (4.17%)  3 0/36 (0.00%)  0
Haemoptysis  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Pleural effusion  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Pulmonary embolism  1  1/72 (1.39%)  1 1/36 (2.78%)  1
Pulmonary oedema  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Respiratory arrest  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Surgical and medical procedures     
Spinal operation  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Vascular disorders     
Deep vein thrombosis  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Embolism  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2510924 + Sunitinib Sunitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/72 (97.22%)      35/36 (97.22%)    
Blood and lymphatic system disorders     
Anaemia  1  26/72 (36.11%)  95 7/36 (19.44%)  10
Leukocytosis  1  5/72 (6.94%)  6 1/36 (2.78%)  1
Leukopenia  1  3/72 (4.17%)  4 5/36 (13.89%)  8
Neutropenia  1  6/72 (8.33%)  22 4/36 (11.11%)  18
Thrombocytopenia  1  20/72 (27.78%)  57 9/36 (25.00%)  12
Endocrine disorders     
Hypothyroidism  1  11/72 (15.28%)  11 3/36 (8.33%)  3
Eye disorders     
Vision blurred  1  5/72 (6.94%)  5 0/36 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  6/72 (8.33%)  9 1/36 (2.78%)  2
Abdominal pain upper  1  5/72 (6.94%)  5 1/36 (2.78%)  1
Constipation  1  16/72 (22.22%)  19 6/36 (16.67%)  10
Diarrhoea  1  28/72 (38.89%)  55 18/36 (50.00%)  39
Dry mouth  1  6/72 (8.33%)  7 3/36 (8.33%)  3
Dyspepsia  1  8/72 (11.11%)  8 4/36 (11.11%)  6
Dysphagia  1  2/72 (2.78%)  2 2/36 (5.56%)  3
Flatulence  1  4/72 (5.56%)  5 0/36 (0.00%)  0
Gastrooesophageal reflux disease  1  6/72 (8.33%)  8 2/36 (5.56%)  4
Glossodynia  1  2/72 (2.78%)  2 2/36 (5.56%)  2
Haemorrhoids  1  5/72 (6.94%)  9 1/36 (2.78%)  1
Nausea  1  35/72 (48.61%)  50 18/36 (50.00%)  33
Oral pain  1  6/72 (8.33%)  6 4/36 (11.11%)  4
Stomatitis  1  15/72 (20.83%)  19 7/36 (19.44%)  11
Vomiting  1  18/72 (25.00%)  32 8/36 (22.22%)  14
General disorders     
Asthenia  1  9/72 (12.50%)  10 0/36 (0.00%)  0
Chest pain  1  5/72 (6.94%)  5 1/36 (2.78%)  1
Chills  1  6/72 (8.33%)  7 0/36 (0.00%)  0
Fatigue  1  50/72 (69.44%)  96 20/36 (55.56%)  37
Injection site pruritus  1  6/72 (8.33%)  6 0/36 (0.00%)  0
Injection site reaction  1  6/72 (8.33%)  6 0/36 (0.00%)  0
Mucosal inflammation  1  17/72 (23.61%)  25 10/36 (27.78%)  15
Oedema  1  3/72 (4.17%)  3 2/36 (5.56%)  2
Oedema peripheral  1  17/72 (23.61%)  27 6/36 (16.67%)  8
Pain  1  3/72 (4.17%)  3 2/36 (5.56%)  13
Pyrexia  1  10/72 (13.89%)  10 2/36 (5.56%)  2
Infections and infestations     
Herpes zoster  1  0/72 (0.00%)  0 2/36 (5.56%)  2
Oral candidiasis  1  0/72 (0.00%)  0 2/36 (5.56%)  2
Sinusitis  1  9/72 (12.50%)  11 2/36 (5.56%)  2
Upper respiratory tract infection  1  6/72 (8.33%)  6 2/36 (5.56%)  2
Urinary tract infection  1  8/72 (11.11%)  16 1/36 (2.78%)  1
Injury, poisoning and procedural complications     
Contusion  1  6/72 (8.33%)  7 2/36 (5.56%)  3
Excoriation  1  1/72 (1.39%)  1 2/36 (5.56%)  2
Fall  1  4/72 (5.56%)  4 0/36 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  5/72 (6.94%)  5 0/36 (0.00%)  0
Aspartate aminotransferase increased  1  7/72 (9.72%)  8 0/36 (0.00%)  0
Blood alkaline phosphatase increased  1  5/72 (6.94%)  5 2/36 (5.56%)  2
Blood creatinine increased  1  5/72 (6.94%)  6 5/36 (13.89%)  7
Weight decreased  1  12/72 (16.67%)  15 9/36 (25.00%)  13
Weight increased  1  2/72 (2.78%)  4 2/36 (5.56%)  3
Metabolism and nutrition disorders     
Decreased appetite  1  17/72 (23.61%)  26 8/36 (22.22%)  14
Dehydration  1  12/72 (16.67%)  19 5/36 (13.89%)  12
Hypercalcaemia  1  3/72 (4.17%)  4 3/36 (8.33%)  4
Hypoalbuminaemia  1  2/72 (2.78%)  2 3/36 (8.33%)  3
Hypocalcaemia  1  2/72 (2.78%)  2 3/36 (8.33%)  6
Hypokalaemia  1  3/72 (4.17%)  3 2/36 (5.56%)  2
Hyponatraemia  1  5/72 (6.94%)  8 1/36 (2.78%)  1
Vitamin b12 deficiency  1  1/72 (1.39%)  1 2/36 (5.56%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/72 (12.50%)  23 2/36 (5.56%)  9
Back pain  1  8/72 (11.11%)  9 2/36 (5.56%)  3
Bone pain  1  4/72 (5.56%)  6 0/36 (0.00%)  0
Muscle spasms  1  4/72 (5.56%)  4 1/36 (2.78%)  1
Muscular weakness  1  6/72 (8.33%)  8 3/36 (8.33%)  4
Musculoskeletal pain  1  5/72 (6.94%)  5 1/36 (2.78%)  2
Myalgia  1  7/72 (9.72%)  8 2/36 (5.56%)  2
Pain in extremity  1  7/72 (9.72%)  9 4/36 (11.11%)  4
Pain in jaw  1  0/72 (0.00%)  0 2/36 (5.56%)  3
Nervous system disorders     
Dizziness  1  17/72 (23.61%)  20 7/36 (19.44%)  11
Dysgeusia  1  23/72 (31.94%)  27 11/36 (30.56%)  14
Headache  1  10/72 (13.89%)  14 6/36 (16.67%)  6
Psychiatric disorders     
Anxiety  1  9/72 (12.50%)  11 3/36 (8.33%)  4
Confusional state  1  4/72 (5.56%)  6 1/36 (2.78%)  3
Depression  1  7/72 (9.72%)  7 2/36 (5.56%)  2
Insomnia  1  7/72 (9.72%)  9 5/36 (13.89%)  7
Renal and urinary disorders     
Dysuria  1  4/72 (5.56%)  4 1/36 (2.78%)  1
Haematuria  1  8/72 (11.11%)  9 1/36 (2.78%)  1
Reproductive system and breast disorders     
Vaginal discharge  1  0/24 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  14/72 (19.44%)  19 7/36 (19.44%)  10
Dyspnoea  1  13/72 (18.06%)  16 2/36 (5.56%)  2
Epistaxis  1  13/72 (18.06%)  16 0/36 (0.00%)  0
Pleuritic pain  1  1/72 (1.39%)  2 2/36 (5.56%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  4/72 (5.56%)  4 0/36 (0.00%)  0
Dermatitis  1  0/72 (0.00%)  0 2/36 (5.56%)  4
Dermatitis acneiform  1  5/72 (6.94%)  6 1/36 (2.78%)  1
Dry skin  1  9/72 (12.50%)  9 3/36 (8.33%)  4
Palmar-plantar erythrodysaesthesia syndrome  1  12/72 (16.67%)  38 6/36 (16.67%)  6
Pruritus  1  5/72 (6.94%)  5 2/36 (5.56%)  5
Rash  1  19/72 (26.39%)  28 4/36 (11.11%)  6
Skin lesion  1  5/72 (6.94%)  7 1/36 (2.78%)  1
Vascular disorders     
Hypertension  1  17/72 (23.61%)  26 12/36 (33.33%)  18
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V14.0
Study Terminated due to Insufficient Efficacy.
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
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01391130     History of Changes
Other Study ID Numbers: 14241
I2V-MC-CXAB ( Other Identifier: Eli Lilly and Company )
First Submitted: July 7, 2011
First Posted: July 11, 2011
Results First Submitted: June 28, 2019
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019