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Trial record 81 of 827 for:    Advanced | Neuroendocrine Tumors

Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy

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ClinicalTrials.gov Identifier: NCT00363051
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : March 30, 2012
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Islet Cell Carcinoma
Neuroendocrine Carcinoma
Neuroendocrine Tumor
Pancreatic Neoplasms
Interventions Drug: Everolimus 10 mg
Drug: Octreotide Depot
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stratum 1: Everolimus 10 mg Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Period Title: Overall Study
Started 115 45
Completed 77 [1] 23
Not Completed 38 22
Reason Not Completed
Adminstrative problems             1             1
Adverse Event             21             12
New Cancer Therapy             2             1
Withdrawal by Subject             11             3
Lost to Follow-up             0             1
Protocol Violation             0             2
Death             3             2
[1]
Patients with documented disease progression per RECIST criteria
Arm/Group Title Stratum 1: Everolimus 10 mg Stratum 2: Everolimus 10 mg + Octreotide Depot Total
Hide Arm/Group Description Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. Total of all reporting groups
Overall Number of Baseline Participants 115 45 160
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 45 participants 160 participants
55.1  (11.8) 53.64  (12.478) 54.33  (11.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 45 participants 160 participants
Female
49
  42.6%
21
  46.7%
70
  43.8%
Male
66
  57.4%
24
  53.3%
90
  56.3%
1.Primary Outcome
Title Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
Time Frame from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.
Arm/Group Title Stratum 1: Everolimus 10 mg
Hide Arm/Group Description:
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
Overall Number of Participants Analyzed 115
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.6
(4.9 to 16.5)
2.Secondary Outcome
Title Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Hide Description

Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):

  • Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.
  • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.

Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions

Time Frame from date of first documented confirmed response to time to progression, at least 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis.
Arm/Group Title Stratum 1: Everolimus 10 mg
Hide Arm/Group Description:
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: Months
10.64 [1] 
(9.79 to NA)
[1]
The upper limit was not estimable in the study as it is longer than duration of study.
3.Secondary Outcome
Title Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Hide Description

Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):

  • Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.
  • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.

Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions

Time Frame from date of first documented confirmed response to time to progression, at least 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated.
Arm/Group Title Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description:

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
Time Frame from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus.
Arm/Group Title Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description:

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.4
(0.5 to 15.1)
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
Hide Description Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time Frame on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.
Arm/Group Title Stratum 1: Everolimus 10 mg
Hide Arm/Group Description:
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
Overall Number of Participants Analyzed 115
Measure Type: Number
Unit of Measure: Participants
Adverse Events 115
Death 10
Serious Adverse Events 63
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
Hide Description Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time Frame on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.
Arm/Group Title Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description:
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Participants
Adverse Events 45
Death 2
Serious Adverse Events 27
7.Secondary Outcome
Title Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
Hide Description

Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.

Median PFS was obtained and displayed along with 95% confidence intervals.

Time Frame from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.
Arm/Group Title Stratum 1: Everolimus 10 mg
Hide Arm/Group Description:
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
Overall Number of Participants Analyzed 115
Median (95% Confidence Interval)
Unit of Measure: Months
9.69
(8.25 to 13.31)
8.Secondary Outcome
Title Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
Hide Description

Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.

Median PFS was obtained and displayed along with 95% confidence intervals.

Time Frame from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.
Arm/Group Title Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description:
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: Months
16.69 [1] 
(11.07 to NA)
[1]
The upper limit was not estimable in the study as it is longer than duration of study.
9.Secondary Outcome
Title Time to Overall Survival (OS)(Stratum 1)
Hide Description

Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.

If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.

Time Frame from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consisted of all patients who received at least one dose of everolimus.
Arm/Group Title Stratum 1: Everolimus 10 mg
Hide Arm/Group Description:
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
Overall Number of Participants Analyzed 115
Median (95% Confidence Interval)
Unit of Measure: months
28.78
(20.24 to 36.37)
10.Secondary Outcome
Title Time to Overall Survival (OS) (Stratum 2)
Hide Description

Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.

If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.

Time Frame from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consisted of all patients who received at least one dose of everolimus.
Arm/Group Title Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description:

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: months
38.77 [1] 
(29.08 to NA)
[1]
The upper limit was not estimable in the study as it is longer than duration of study.
11.Secondary Outcome
Title Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
Hide Description For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.
Time Frame Cycle 1 Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included
Arm/Group Title Stratum 1: Everolimus 10 mg Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description:
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Overall Number of Participants Analyzed 92 30
Mean (Standard Deviation)
Unit of Measure: ng/ml
15.7  (15.82) 17.3  (18.08)
12.Secondary Outcome
Title Effect of Octreotide Depot on the Trough Concentrations of Everolimus
Hide Description The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.
Time Frame Cycle 1 Day 1, Cycle 2 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included.
Arm/Group Title Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description:

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: ng/ml
Cycle 1 Day 1 (pre-treatment baseline) (n=37) 3.2  (2.81)
Cycle 2 Day 1 (n= 38) 3.7  (3.47)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stratum 1: Everolimus 10 mg Stratum 2: Everolimus 10 mg + Octreotide Depot
Hide Arm/Group Description Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
All-Cause Mortality
Stratum 1: Everolimus 10 mg Stratum 2: Everolimus 10 mg + Octreotide Depot
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stratum 1: Everolimus 10 mg Stratum 2: Everolimus 10 mg + Octreotide Depot
Affected / at Risk (%) Affected / at Risk (%)
Total   63/115 (54.78%)   27/45 (60.00%) 
Blood and lymphatic system disorders     
Anaemia  1  3/115 (2.61%)  0/45 (0.00%) 
Lymphopenia  1  1/115 (0.87%)  0/45 (0.00%) 
Neutropenia  1  0/115 (0.00%)  1/45 (2.22%) 
Thrombocytopenia  1  0/115 (0.00%)  3/45 (6.67%) 
Cardiac disorders     
Acute myocardial infarction  1  0/115 (0.00%)  1/45 (2.22%) 
Cardiac failure  1  1/115 (0.87%)  3/45 (6.67%) 
Cardiac failure congestive  1  0/115 (0.00%)  2/45 (4.44%) 
Cardio-respiratory arrest  1  1/115 (0.87%)  0/45 (0.00%) 
Myocardial infarction  1  0/115 (0.00%)  1/45 (2.22%) 
Tachycardia  1  0/115 (0.00%)  1/45 (2.22%) 
Congenital, familial and genetic disorders     
Gastrointestinal angiodysplasia  1  1/115 (0.87%)  0/45 (0.00%) 
Eye disorders     
Optic ischaemic neuropathy  1  1/115 (0.87%)  0/45 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  0/115 (0.00%)  1/45 (2.22%) 
Abdominal pain  1  10/115 (8.70%)  4/45 (8.89%) 
Abdominal pain upper  1  2/115 (1.74%)  0/45 (0.00%) 
Ascites  1  1/115 (0.87%)  0/45 (0.00%) 
Colitis  1  1/115 (0.87%)  0/45 (0.00%) 
Diarrhoea  1  1/115 (0.87%)  0/45 (0.00%) 
Gastritis  1  1/115 (0.87%)  1/45 (2.22%) 
Gastrointestinal haemorrhage  1  2/115 (1.74%)  0/45 (0.00%) 
Inguinal hernia  1  1/115 (0.87%)  0/45 (0.00%) 
Intestinal ischaemia  1  1/115 (0.87%)  0/45 (0.00%) 
Intestinal obstruction  1  0/115 (0.00%)  1/45 (2.22%) 
Nausea  1  3/115 (2.61%)  2/45 (4.44%) 
Small intestinal obstruction  1  2/115 (1.74%)  0/45 (0.00%) 
Subileus  1  2/115 (1.74%)  0/45 (0.00%) 
Swollen tongue  1  1/115 (0.87%)  0/45 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/115 (0.87%)  0/45 (0.00%) 
Vomiting  1  4/115 (3.48%)  3/45 (6.67%) 
General disorders     
Asthenia  1  6/115 (5.22%)  0/45 (0.00%) 
Device dislocation  1  1/115 (0.87%)  0/45 (0.00%) 
Device occlusion  1  1/115 (0.87%)  0/45 (0.00%) 
Fatigue  1  4/115 (3.48%)  0/45 (0.00%) 
General physical health deterioration  1  2/115 (1.74%)  0/45 (0.00%) 
Hyperthermia  1  1/115 (0.87%)  1/45 (2.22%) 
Hypothermia  1  1/115 (0.87%)  0/45 (0.00%) 
Local swelling  1  1/115 (0.87%)  0/45 (0.00%) 
Multi-organ failure  1  1/115 (0.87%)  1/45 (2.22%) 
Non-cardiac chest pain  1  1/115 (0.87%)  1/45 (2.22%) 
Oedema peripheral  1  0/115 (0.00%)  2/45 (4.44%) 
Performance status decreased  1  2/115 (1.74%)  0/45 (0.00%) 
Pyrexia  1  6/115 (5.22%)  2/45 (4.44%) 
Systemic inflammatory response syndrome  1  1/115 (0.87%)  0/45 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/115 (0.87%)  1/45 (2.22%) 
Cholangitis  1  4/115 (3.48%)  0/45 (0.00%) 
Cholelithiasis  1  1/115 (0.87%)  0/45 (0.00%) 
Hepatic failure  1  1/115 (0.87%)  0/45 (0.00%) 
Jaundice  1  1/115 (0.87%)  0/45 (0.00%) 
Jaundice cholestatic  1  1/115 (0.87%)  0/45 (0.00%) 
Portal vein thrombosis  1  2/115 (1.74%)  0/45 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/115 (0.00%)  1/45 (2.22%) 
Infections and infestations     
Abscess soft tissue  1  1/115 (0.87%)  0/45 (0.00%) 
Bacteraemia  1  1/115 (0.87%)  0/45 (0.00%) 
Bacterial infection  1  1/115 (0.87%)  0/45 (0.00%) 
Biliary tract infection  1  0/115 (0.00%)  1/45 (2.22%) 
Bronchitis  1  1/115 (0.87%)  1/45 (2.22%) 
Cellulitis  1  0/115 (0.00%)  1/45 (2.22%) 
Device related infection  1  1/115 (0.87%)  1/45 (2.22%) 
Diverticulitis  1  1/115 (0.87%)  0/45 (0.00%) 
Escherichia infection  1  0/115 (0.00%)  1/45 (2.22%) 
Folliculitis  1  1/115 (0.87%)  0/45 (0.00%) 
Gastroenteritis  1  1/115 (0.87%)  0/45 (0.00%) 
Gastroenteritis viral  1  1/115 (0.87%)  0/45 (0.00%) 
Infection  1  1/115 (0.87%)  0/45 (0.00%) 
Influenza  1  1/115 (0.87%)  0/45 (0.00%) 
Liver abscess  1  1/115 (0.87%)  0/45 (0.00%) 
Lobar pneumonia  1  2/115 (1.74%)  0/45 (0.00%) 
Lung infection  1  1/115 (0.87%)  0/45 (0.00%) 
Peritonitis bacterial  1  1/115 (0.87%)  0/45 (0.00%) 
Pharyngitis streptococcal  1  1/115 (0.87%)  0/45 (0.00%) 
Pneumocystis jiroveci pneumonia  1  1/115 (0.87%)  0/45 (0.00%) 
Pneumonia  1  5/115 (4.35%)  1/45 (2.22%) 
Post procedural infection  1  0/115 (0.00%)  1/45 (2.22%) 
Pyelonephritis  1  1/115 (0.87%)  0/45 (0.00%) 
Sepsis  1  3/115 (2.61%)  1/45 (2.22%) 
Sepsis syndrome  1  1/115 (0.87%)  0/45 (0.00%) 
Serratia infection  1  0/115 (0.00%)  1/45 (2.22%) 
Sinusitis  1  1/115 (0.87%)  0/45 (0.00%) 
Soft tissue infection  1  1/115 (0.87%)  0/45 (0.00%) 
Staphylococcal infection  1  1/115 (0.87%)  0/45 (0.00%) 
Subcutaneous abscess  1  0/115 (0.00%)  1/45 (2.22%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/115 (0.87%)  0/45 (0.00%) 
Lumbar vertebral fracture  1  1/115 (0.87%)  0/45 (0.00%) 
Radiation oesophagitis  1  0/115 (0.00%)  1/45 (2.22%) 
Investigations     
Ammonia increased  1  1/115 (0.87%)  0/45 (0.00%) 
Blood creatinine increased  1  0/115 (0.00%)  1/45 (2.22%) 
Haematocrit decreased  1  0/115 (0.00%)  1/45 (2.22%) 
Metabolism and nutrition disorders     
Cachexia  1  1/115 (0.87%)  0/45 (0.00%) 
Decreased appetite  1  4/115 (3.48%)  0/45 (0.00%) 
Dehydration  1  3/115 (2.61%)  2/45 (4.44%) 
Diabetes mellitus  1  1/115 (0.87%)  0/45 (0.00%) 
Hypercalcaemia  1  0/115 (0.00%)  1/45 (2.22%) 
Hypoglycaemia  1  1/115 (0.87%)  1/45 (2.22%) 
Hyponatraemia  1  1/115 (0.87%)  1/45 (2.22%) 
Malnutrition  1  3/115 (2.61%)  0/45 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/115 (0.87%)  0/45 (0.00%) 
Back pain  1  0/115 (0.00%)  1/45 (2.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder transitional cell carcinoma  1  0/115 (0.00%)  1/45 (2.22%) 
Breast cancer  1  0/115 (0.00%)  1/45 (2.22%) 
Colon adenoma  1  1/115 (0.87%)  0/45 (0.00%) 
Colon cancer  1  1/115 (0.87%)  0/45 (0.00%) 
Metastases to liver  1  1/115 (0.87%)  0/45 (0.00%) 
Metastases to small intestine  1  1/115 (0.87%)  0/45 (0.00%) 
Metastases to spine  1  1/115 (0.87%)  0/45 (0.00%) 
Tumour necrosis  1  1/115 (0.87%)  0/45 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  1/115 (0.87%)  0/45 (0.00%) 
Cerebral haemorrhage  1  1/115 (0.87%)  0/45 (0.00%) 
Cerebrovascular accident  1  2/115 (1.74%)  0/45 (0.00%) 
Coma hepatic  1  1/115 (0.87%)  0/45 (0.00%) 
Hepatic encephalopathy  1  0/115 (0.00%)  1/45 (2.22%) 
Hyperaesthesia  1  1/115 (0.87%)  0/45 (0.00%) 
Loss of consciousness  1  0/115 (0.00%)  1/45 (2.22%) 
Metabolic encephalopathy  1  1/115 (0.87%)  0/45 (0.00%) 
Unresponsive to stimuli  1  0/115 (0.00%)  1/45 (2.22%) 
Visual field defect  1  1/115 (0.87%)  0/45 (0.00%) 
Psychiatric disorders     
Confusional state  1  2/115 (1.74%)  1/45 (2.22%) 
Depression  1  1/115 (0.87%)  0/45 (0.00%) 
Insomnia  1  1/115 (0.87%)  0/45 (0.00%) 
Mental status changes  1  1/115 (0.87%)  0/45 (0.00%) 
Renal and urinary disorders     
Dysuria  1  0/115 (0.00%)  1/45 (2.22%) 
Pollakiuria  1  0/115 (0.00%)  1/45 (2.22%) 
Renal failure  1  2/115 (1.74%)  3/45 (6.67%) 
Renal failure acute  1  0/115 (0.00%)  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/115 (0.87%)  0/45 (0.00%) 
Aspiration  1  1/115 (0.87%)  0/45 (0.00%) 
Cough  1  1/115 (0.87%)  0/45 (0.00%) 
Dyspnoea  1  4/115 (3.48%)  3/45 (6.67%) 
Dyspnoea exertional  1  1/115 (0.87%)  1/45 (2.22%) 
Hydropneumothorax  1  1/115 (0.87%)  0/45 (0.00%) 
Interstitial lung disease  1  1/115 (0.87%)  0/45 (0.00%) 
Lung consolidation  1  0/115 (0.00%)  1/45 (2.22%) 
Lung disorder  1  1/115 (0.87%)  0/45 (0.00%) 
Pleural effusion  1  0/115 (0.00%)  2/45 (4.44%) 
Pleuritic pain  1  1/115 (0.87%)  0/45 (0.00%) 
Pneumonitis  1  2/115 (1.74%)  0/45 (0.00%) 
Pulmonary embolism  1  1/115 (0.87%)  2/45 (4.44%) 
Pulmonary hypertension  1  0/115 (0.00%)  1/45 (2.22%) 
Pulmonary infarction  1  0/115 (0.00%)  1/45 (2.22%) 
Pulmonary oedema  1  1/115 (0.87%)  1/45 (2.22%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/115 (0.87%)  0/45 (0.00%) 
Swelling face  1  0/115 (0.00%)  1/45 (2.22%) 
Vascular disorders     
Deep vein thrombosis  1  0/115 (0.00%)  1/45 (2.22%) 
Hypotension  1  1/115 (0.87%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stratum 1: Everolimus 10 mg Stratum 2: Everolimus 10 mg + Octreotide Depot
Affected / at Risk (%) Affected / at Risk (%)
Total   115/115 (100.00%)   44/45 (97.78%) 
Blood and lymphatic system disorders     
Anaemia  1  22/115 (19.13%)  11/45 (24.44%) 
Leukopenia  1  10/115 (8.70%)  2/45 (4.44%) 
Lymphopenia  1  10/115 (8.70%)  0/45 (0.00%) 
Neutropenia  1  10/115 (8.70%)  5/45 (11.11%) 
Thrombocytopenia  1  11/115 (9.57%)  6/45 (13.33%) 
Eye disorders     
Conjunctivitis  1  4/115 (3.48%)  4/45 (8.89%) 
Vision blurred  1  0/115 (0.00%)  4/45 (8.89%) 
Gastrointestinal disorders     
Abdominal distension  1  9/115 (7.83%)  5/45 (11.11%) 
Abdominal pain  1  38/115 (33.04%)  9/45 (20.00%) 
Abdominal pain upper  1  25/115 (21.74%)  7/45 (15.56%) 
Aphthous stomatitis  1  24/115 (20.87%)  6/45 (13.33%) 
Ascites  1  9/115 (7.83%)  0/45 (0.00%) 
Constipation  1  30/115 (26.09%)  8/45 (17.78%) 
Diarrhoea  1  63/115 (54.78%)  25/45 (55.56%) 
Dry mouth  1  7/115 (6.09%)  2/45 (4.44%) 
Dyspepsia  1  6/115 (5.22%)  1/45 (2.22%) 
Flatulence  1  6/115 (5.22%)  4/45 (8.89%) 
Haemorrhoids  1  2/115 (1.74%)  3/45 (6.67%) 
Mouth ulceration  1  7/115 (6.09%)  2/45 (4.44%) 
Nausea  1  54/115 (46.96%)  22/45 (48.89%) 
Steatorrhoea  1  1/115 (0.87%)  3/45 (6.67%) 
Stomatitis  1  57/115 (49.57%)  24/45 (53.33%) 
Toothache  1  7/115 (6.09%)  2/45 (4.44%) 
Vomiting  1  40/115 (34.78%)  12/45 (26.67%) 
General disorders     
Asthenia  1  38/115 (33.04%)  9/45 (20.00%) 
Chills  1  10/115 (8.70%)  4/45 (8.89%) 
Fatigue  1  53/115 (46.09%)  20/45 (44.44%) 
Non-cardiac chest pain  1  6/115 (5.22%)  1/45 (2.22%) 
Oedema peripheral  1  34/115 (29.57%)  14/45 (31.11%) 
Pain  1  7/115 (6.09%)  3/45 (6.67%) 
Pyrexia  1  41/115 (35.65%)  14/45 (31.11%) 
Infections and infestations     
Bronchitis  1  4/115 (3.48%)  4/45 (8.89%) 
Influenza  1  7/115 (6.09%)  4/45 (8.89%) 
Nasopharyngitis  1  18/115 (15.65%)  5/45 (11.11%) 
Pneumonia  1  4/115 (3.48%)  3/45 (6.67%) 
Rhinitis  1  7/115 (6.09%)  2/45 (4.44%) 
Sinusitis  1  12/115 (10.43%)  4/45 (8.89%) 
Upper respiratory tract infection  1  11/115 (9.57%)  4/45 (8.89%) 
Urinary tract infection  1  11/115 (9.57%)  5/45 (11.11%) 
Injury, poisoning and procedural complications     
Fall  1  0/115 (0.00%)  4/45 (8.89%) 
Investigations     
Alanine aminotransferase increased  1  7/115 (6.09%)  1/45 (2.22%) 
Aspartate aminotransferase increased  1  7/115 (6.09%)  0/45 (0.00%) 
Blood alkaline phosphatase increased  1  9/115 (7.83%)  1/45 (2.22%) 
Blood creatinine increased  1  1/115 (0.87%)  6/45 (13.33%) 
Haemoglobin decreased  1  4/115 (3.48%)  3/45 (6.67%) 
International normalised ratio increased  1  1/115 (0.87%)  3/45 (6.67%) 
Weight decreased  1  32/115 (27.83%)  12/45 (26.67%) 
Metabolism and nutrition disorders     
Decreased appetite  1  27/115 (23.48%)  10/45 (22.22%) 
Dehydration  1  5/115 (4.35%)  6/45 (13.33%) 
Diabetes mellitus  1  11/115 (9.57%)  1/45 (2.22%) 
Hypercholesterolaemia  1  14/115 (12.17%)  2/45 (4.44%) 
Hyperglycaemia  1  21/115 (18.26%)  9/45 (20.00%) 
Hypoglycaemia  1  9/115 (7.83%)  3/45 (6.67%) 
Hypokalaemia  1  15/115 (13.04%)  5/45 (11.11%) 
Hyponatraemia  1  7/115 (6.09%)  1/45 (2.22%) 
Hypophosphataemia  1  11/115 (9.57%)  4/45 (8.89%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  15/115 (13.04%)  12/45 (26.67%) 
Back pain  1  28/115 (24.35%)  9/45 (20.00%) 
Muscle spasms  1  6/115 (5.22%)  2/45 (4.44%) 
Musculoskeletal pain  1  8/115 (6.96%)  2/45 (4.44%) 
Myalgia  1  12/115 (10.43%)  4/45 (8.89%) 
Neck pain  1  8/115 (6.96%)  3/45 (6.67%) 
Pain in extremity  1  5/115 (4.35%)  6/45 (13.33%) 
Nervous system disorders     
Dizziness  1  5/115 (4.35%)  7/45 (15.56%) 
Dysgeusia  1  14/115 (12.17%)  7/45 (15.56%) 
Headache  1  40/115 (34.78%)  9/45 (20.00%) 
Psychiatric disorders     
Anxiety  1  8/115 (6.96%)  3/45 (6.67%) 
Confusional state  1  6/115 (5.22%)  2/45 (4.44%) 
Depression  1  10/115 (8.70%)  2/45 (4.44%) 
Insomnia  1  15/115 (13.04%)  5/45 (11.11%) 
Renal and urinary disorders     
Nocturia  1  2/115 (1.74%)  4/45 (8.89%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  31/115 (26.96%)  8/45 (17.78%) 
Dyspnoea  1  18/115 (15.65%)  11/45 (24.44%) 
Epistaxis  1  17/115 (14.78%)  5/45 (11.11%) 
Lung disorder  1  4/115 (3.48%)  3/45 (6.67%) 
Oropharyngeal pain  1  8/115 (6.96%)  9/45 (20.00%) 
Pleural effusion  1  4/115 (3.48%)  3/45 (6.67%) 
Pneumonitis  1  5/115 (4.35%)  4/45 (8.89%) 
Skin and subcutaneous tissue disorders     
Acne  1  7/115 (6.09%)  2/45 (4.44%) 
Dermatitis acneiform  1  2/115 (1.74%)  5/45 (11.11%) 
Dry skin  1  15/115 (13.04%)  7/45 (15.56%) 
Erythema  1  5/115 (4.35%)  5/45 (11.11%) 
Hyperhidrosis  1  6/115 (5.22%)  1/45 (2.22%) 
Nail disorder  1  9/115 (7.83%)  2/45 (4.44%) 
Pruritus  1  18/115 (15.65%)  7/45 (15.56%) 
Rash  1  54/115 (46.96%)  21/45 (46.67%) 
Vascular disorders     
Hypertension  1  13/115 (11.30%)  4/45 (8.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis's agreements with it's investigators vary. However, Novartis does not prohibit any investigator from publishing. Any publication from a single-center site is postponed until the publication of the pooled data ( i.e. data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Novartis Study Director
Organization: Novartis Pharmaceuticals
Phone: (862 778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00363051     History of Changes
Other Study ID Numbers: CRAD001C2239
First Submitted: August 2, 2006
First Posted: August 15, 2006
Results First Submitted: December 2, 2011
Results First Posted: March 30, 2012
Last Update Posted: May 10, 2013