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A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer

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ClinicalTrials.gov Identifier: NCT00781911
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : April 18, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma
Neuroendocrine Tumors
Interventions Biological: Cixutumumab
Drug: depot octreotide
Enrollment 43
Recruitment Details  
Pre-assignment Details Participants who completed the study include those who died and had progressive disease.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description

Participants with carcinoid tumor received cixutumumab 10 mg/kg intravenously (IV) over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Period Title: Overall Study
Started 31 12
Received at Least 1 Dose of Study Drug 31 12
Completed 25 4
Not Completed 6 8
Reason Not Completed
Adverse Event             4             4
Withdrawal by Subject             1             2
Physician Decision             0             2
Sponsor Decision             1             0
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma Total
Hide Arm/Group Description

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Total of all reporting groups
Overall Number of Baseline Participants 31 12 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 12 participants 43 participants
60.3  (9.65) 61.3  (9.85) 60.6  (9.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 12 participants 43 participants
Female
17
  54.8%
4
  33.3%
21
  48.8%
Male
14
  45.2%
8
  66.7%
22
  51.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 12 participants 43 participants
Hispanic or Latino
2
   6.5%
3
  25.0%
5
  11.6%
Not Hispanic or Latino
29
  93.5%
9
  75.0%
38
  88.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 12 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.2%
0
   0.0%
1
   2.3%
White
30
  96.8%
12
 100.0%
42
  97.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants 12 participants 43 participants
31
 100.0%
12
 100.0%
43
 100.0%
1.Primary Outcome
Title Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months
Hide Description Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.
Time Frame From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. Participants censored in the carcinoid tumor arm were 8 and in the islet cell carcinoma arm were 4.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
Overall Number of Participants Analyzed 31 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Binomial Distribution; Primary Analysis
45.2
(27.3 to 64.0)
41.7
(15.2 to 72.3)
Kaplan-Meier Method; Secondary Analysis
54.1
(34.2 to 70.3)
61.4
(26.6 to 83.5)
2.Secondary Outcome
Title Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)
Hide Description Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.
Time Frame From Start of Treatment Baseline to Disease Progression (Up to 18 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 31 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.2
(0.1 to 16.7)
0
(0 to 26.5)
3.Secondary Outcome
Title Percentage of Participants With a Biochemical Response Rate
Hide Description Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.
Time Frame From Start of Treatment Up to 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post-baseline Chromogranin A and Gastrin data.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 31 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Chromogranin A Number Analyzed 25 participants 9 participants
0.0
(0.0 to 13.7)
22.2
(2.8 to 60)
Gastrin Number Analyzed 6 participants 2 participants
0.0
(0.0 to 45.9)
0.0
(0.0 to 84.2)
4.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Hide Description Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study drug.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study.

Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 31 12
Measure Type: Count of Participants
Unit of Measure: Participants
31 12
5.Secondary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1
Hide Description [Not Specified]
Time Frame Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study.

Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title PK: Half-life (t 1/2) Cycle 1
Hide Description [Not Specified]
Time Frame Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title PK: Area Under Concentration (AUCinf) Cycle 1
Hide Description [Not Specified]
Time Frame Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title PK: Clearance (CL) Cycle 1
Hide Description [Not Specified]
Time Frame Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title PK: Volume at Steady State (Vss) Cycle 1
Hide Description [Not Specified]
Time Frame Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Serum Anti-Cixutumumab Antibody Assessment
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to no data collection due to low number of clinical responses observed.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to no data collection due to low number of clinical responses observed.
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description:

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carcinoid Tumor Islet Cell Carcinoma
Hide Arm/Group Description

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

All-Cause Mortality
Carcinoid Tumor Islet Cell Carcinoma
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Carcinoid Tumor Islet Cell Carcinoma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/31 (38.71%)      6/12 (50.00%)    
Ear and labyrinth disorders     
Deafness  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Abdominal pain upper  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Diarrhea  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Gastritis  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Gastrointestinal hemorrhage  1  1/31 (3.23%)  2 0/12 (0.00%)  0
Ileus  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Nausea  1  1/31 (3.23%)  2 0/12 (0.00%)  0
Pancreatitis  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Pancreatitis acute  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Vomiting  1  1/31 (3.23%)  2 0/12 (0.00%)  0
General disorders     
Disease progression  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Non-cardiac chest pain  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Oedema peripheral  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Pyrexia  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Cholangitis  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
Bacteraemia  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Investigations     
Weight decreased  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Hyperglycaemia  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Carcinoid syndrome  1  1/31 (3.23%)  2 0/12 (0.00%)  0
Nervous system disorders     
Ataxia  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Syncope  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Psychiatric disorders     
Anxiety  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders     
Renal failure acute  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Vascular disorders     
Flushing  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Shock haemorrhagic  1  1/31 (3.23%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carcinoid Tumor Islet Cell Carcinoma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/31 (100.00%)      12/12 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Lymphadenopathy  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Thrombocytopenia  1  2/31 (6.45%)  2 2/12 (16.67%)  3
Ear and labyrinth disorders     
Deafness  1  2/31 (6.45%)  2 2/12 (16.67%)  2
Ear discomfort  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Ear pain  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Vertigo  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Eye disorders     
Eyelids pruritus  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Metamorphopsia  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Photopsia  1  5/31 (16.13%)  5 1/12 (8.33%)  1
Vision blurred  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Visual impairment  1  0/31 (0.00%)  0 2/12 (16.67%)  2
Gastrointestinal disorders     
Abdominal distension  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Abdominal pain  1  9/31 (29.03%)  20 2/12 (16.67%)  2
Abdominal pain lower  1  3/31 (9.68%)  3 0/12 (0.00%)  0
Abdominal pain upper  1  5/31 (16.13%)  5 3/12 (25.00%)  3
Ascites  1  3/31 (9.68%)  5 0/12 (0.00%)  0
Constipation  1  5/31 (16.13%)  7 3/12 (25.00%)  3
Diarrhoea  1  20/31 (64.52%)  47 1/12 (8.33%)  1
Dry mouth  1  6/31 (19.35%)  6 2/12 (16.67%)  2
Flatulence  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Gingival bleeding  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Haemorrhoids  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Impaired gastric emptying  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Malabsorption  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Nausea  1  14/31 (45.16%)  23 3/12 (25.00%)  4
Oral pain  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Stomatitis  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Vomiting  1  9/31 (29.03%)  20 2/12 (16.67%)  2
General disorders     
Asthenia  1  5/31 (16.13%)  8 0/12 (0.00%)  0
Catheter site erosion  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Chest pain  1  3/31 (9.68%)  4 0/12 (0.00%)  0
Early satiety  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Fatigue  1  20/31 (64.52%)  36 9/12 (75.00%)  10
Feeling cold  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Inflammation  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Influenza like illness  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Mucosal inflammation  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Non-cardiac chest pain  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Oedema  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Oedema peripheral  1  5/31 (16.13%)  6 2/12 (16.67%)  2
Pain  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Pyrexia  1  4/31 (12.90%)  5 3/12 (25.00%)  3
Hepatobiliary disorders     
Hyperbilirubinaemia  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Infections and infestations     
Bronchitis  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Candidiasis  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Cystitis  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Nasopharyngitis  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Sinusitis  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Upper respiratory tract infection  1  0/31 (0.00%)  0 2/12 (16.67%)  2
Urinary tract infection  1  2/31 (6.45%)  3 0/12 (0.00%)  0
Vulval abscess  1  1/17 (5.88%)  1 0/4 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  6/31 (19.35%)  8 0/12 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  2/31 (6.45%)  6 2/12 (16.67%)  2
Aspartate aminotransferase increased  1  2/31 (6.45%)  6 3/12 (25.00%)  3
Blood alkaline phosphatase increased  1  2/31 (6.45%)  2 3/12 (25.00%)  3
Blood creatinine increased  1  6/31 (19.35%)  7 3/12 (25.00%)  4
Blood pressure increased  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Breath sounds abnormal  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Clostridium test positive  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Haemoglobin decreased  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Platelet count decreased  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Urine output decreased  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Weight decreased  1  18/31 (58.06%)  24 4/12 (33.33%)  5
White blood cell count decreased  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  10/31 (32.26%)  15 2/12 (16.67%)  2
Decreased appetite  1  3/31 (9.68%)  3 2/12 (16.67%)  2
Dehydration  1  6/31 (19.35%)  7 2/12 (16.67%)  2
Failure to thrive  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Hyperglycaemia  1  8/31 (25.81%)  13 6/12 (50.00%)  11
Hyperkalaemia  1  1/31 (3.23%)  2 1/12 (8.33%)  1
Hypoalbuminaemia  1  2/31 (6.45%)  3 0/12 (0.00%)  0
Hypocalcaemia  1  2/31 (6.45%)  3 0/12 (0.00%)  0
Hypoglycaemia  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Hypokalaemia  1  4/31 (12.90%)  7 0/12 (0.00%)  0
Hypomagnesaemia  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Hyponatraemia  1  4/31 (12.90%)  5 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Back pain  1  9/31 (29.03%)  12 3/12 (25.00%)  3
Flank pain  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Muscle spasms  1  5/31 (16.13%)  6 5/12 (41.67%)  7
Musculoskeletal chest pain  1  3/31 (9.68%)  5 1/12 (8.33%)  1
Musculoskeletal pain  1  4/31 (12.90%)  7 0/12 (0.00%)  0
Myalgia  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Neck pain  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Nervous system disorders     
Convulsion  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Disturbance in attention  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Dizziness  1  12/31 (38.71%)  14 2/12 (16.67%)  3
Dysgeusia  1  4/31 (12.90%)  5 1/12 (8.33%)  1
Headache  1  6/31 (19.35%)  13 1/12 (8.33%)  1
Tremor  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Psychiatric disorders     
Depression  1  4/31 (12.90%)  5 0/12 (0.00%)  0
Insomnia  1  3/31 (9.68%)  5 0/12 (0.00%)  0
Renal and urinary disorders     
Nocturia  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Pollakiuria  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Renal failure acute  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Urinary hesitation  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Reproductive system and breast disorders     
Penile haematoma  1  0/14 (0.00%)  0 1/8 (12.50%)  1
Prostatitis  1  1/14 (7.14%)  1 0/8 (0.00%)  0
Vulvovaginal burning sensation  1  1/17 (5.88%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Dysphonia  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Dyspnoea  1  7/31 (22.58%)  9 1/12 (8.33%)  1
Dyspnoea exertional  1  3/31 (9.68%)  3 1/12 (8.33%)  1
Nasal congestion  1  3/31 (9.68%)  5 0/12 (0.00%)  0
Oropharyngeal pain  1  1/31 (3.23%)  1 2/12 (16.67%)  2
Sinus congestion  1  2/31 (6.45%)  2 1/12 (8.33%)  1
Throat irritation  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Dry skin  1  4/31 (12.90%)  4 0/12 (0.00%)  0
Erythema  1  3/31 (9.68%)  3 0/12 (0.00%)  0
Hair texture abnormal  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Increased tendency to bruise  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Nail discolouration  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Nail disorder  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Onychoclasis  1  4/31 (12.90%)  4 1/12 (8.33%)  1
Pruritus  1  1/31 (3.23%)  1 1/12 (8.33%)  1
Psoriasis  1  0/31 (0.00%)  0 1/12 (8.33%)  1
Rash  1  6/31 (19.35%)  8 2/12 (16.67%)  3
Vascular disorders     
Hypertension  1  5/31 (16.13%)  6 0/12 (0.00%)  0
Hypotension  1  2/31 (6.45%)  2 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00781911     History of Changes
Other Study ID Numbers: 13929
CP13-0710 ( Other Identifier: ImClone Systems )
I5A-IE-JAEE ( Other Identifier: Eli Lilly and Company )
First Submitted: October 27, 2008
First Posted: October 29, 2008
Results First Submitted: March 17, 2018
Results First Posted: April 18, 2018
Last Update Posted: September 20, 2019