Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00412061

First received: December 13, 2006

Last updated: June 4, 2013

Last verified: June 2013

History of Changes

Results First Received: October 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Carcinoid Tumor Malignant Carcinoid Syndrome
Interventions:	Drug: Everolimus Drug: Octreotide Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 429 patients were randomized to double blind phase of treatment.

Reporting Groups

Description

Octreotide+ Everolimus

Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.

Octreotide+ Placebo

Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Participant Flow: Overall Study

	Octreotide+ Everolimus	Octreotide+ Placebo
STARTED	216	213
Safety Population	215	211
COMPLETED	95 ^[1]	146
NOT COMPLETED	121	67
Ongoing, on study drug	37	34
Adverse Event	57	14
Withdrawn consent	17	11
Death	6	2
Protocol Violation	3	4
New cancer therapy	1	1
Lost to Follow-up	0	1

[1]	Patients listed as completed discontinued due to disease progression.

Baseline Characteristics

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Reporting Groups

	Description
Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
Octreotide+ Placebo	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
Total	Total of all reporting groups

Baseline Measures

	Octreotide+ Everolimus	Octreotide+ Placebo	Total
Number of Participants [units: participants]	216	213	429
Age [units: years] Mean ± Standard Deviation	60.1 ± 10.72	59.4 ± 11.13	59.8 ± 10.92
Gender [units: patients]
Female	119	89	208
Male	97	124	221

Outcome Measures

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1. Primary:

Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review [ Time Frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 ]

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2. Secondary:

Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 ]

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3. Secondary:

Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) [ Time Frame: From first day of treatment up to 28 days after last day of treatment in double blind (safety data collected till data cut off date i.e. 2nd April 2010) ]

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4. Secondary:

Progression Free Survival (PFS) as Per Adjudicated Central Review by Change From Baseline Chromogranin A (CgA) and 5-hydroxyindoleacetic Acid (5-HIAA) [ Time Frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle) ]

Results not yet posted. Anticipated Posting Date: 08/2013 Safety Issue: No

5. Secondary:

Overall Survival Using Kaplan-Meier Methodology [ Time Frame: The date of randomization to the date of death ]

Results not yet posted. Anticipated Posting Date: 08/2013 Safety Issue: No

6. Secondary:

Evaluation of Pharmacokinetics (PK)Parameters [ Time Frame: Day 1 of every cycle (28 days/cycle) throughout the study ]

Results not yet posted. Anticipated Posting Date: 08/2013 Safety Issue: No

Serious Adverse Events

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Time Frame	No text entered.
Additional Description	The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. The “other adverse events” table includes only non-serious adverse events.

Reporting Groups

Description

Octreotide+ Everolimus

Octreotide + Placebo

Serious Adverse Events

	Octreotide+ Everolimus	Octreotide + Placebo
Total, serious adverse events
# participants affected / at risk	122/215 (56.74%)	73/211 (34.60%)
Blood and lymphatic system disorders
Anaemia ^{† 1}
# participants affected / at risk	4/215 (1.86%)	2/211 (0.95%)
Disseminated intravascular coagulation ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Febrile neutropenia ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Haemorrhagic anaemia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Thrombocytopenia ^{† 1}
# participants affected / at risk	3/215 (1.40%)	0/211 (0.00%)
Cardiac disorders
Acute myocardial infarction ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Angina pectoris ^{† 1}
# participants affected / at risk	2/215 (0.93%)	3/211 (1.42%)
Aortic valve incompetence ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Arrhythmia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Atrial fibrillation ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Atrial flutter ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Carcinoid heart disease ^{† 1}
# participants affected / at risk	2/215 (0.93%)	2/211 (0.95%)
Cardiac failure ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Cardiac failure congestive ^{† 1}
# participants affected / at risk	2/215 (0.93%)	2/211 (0.95%)
Cardiac valve disease ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Cardio-respiratory arrest ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Cardiopulmonary failure ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Coronary artery disease ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Coronary artery occlusion ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Dilatation ventricular ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Left ventricular dysfunction ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Mitral valve stenosis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Myocardial infarction ^{† 1}
# participants affected / at risk	1/215 (0.47%)	2/211 (0.95%)
Myocardial ischaemia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Palpitations ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Pericardial effusion ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Pulmonary valve incompetence ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Pulmonary valve stenosis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Right ventricular failure ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Stress cardiomyopathy ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Tricuspid valve disease ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Tricuspid valve incompetence ^{† 1}
# participants affected / at risk	1/215 (0.47%)	2/211 (0.95%)
Tricuspid valve prolapse ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Tricuspid valve stenosis ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Congenital, familial and genetic disorders
Atrial septal defect ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Gastrointestinal angiodysplasia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Ear and labyrinth disorders
Vertigo ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Endocrine disorders
Adrenocortical insufficiency acute ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Carcinoid syndrome ^{† 1}
# participants affected / at risk	3/215 (1.40%)	1/211 (0.47%)
Eye disorders
Diplopia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Gastrointestinal disorders
Abdominal adhesions ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Abdominal distension ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Abdominal hernia ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Abdominal pain ^{† 1}
# participants affected / at risk	13/215 (6.05%)	11/211 (5.21%)
Abdominal pain lower ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Abdominal pain upper ^{† 1}
# participants affected / at risk	1/215 (0.47%)	2/211 (0.95%)
Ascites ^{† 1}
# participants affected / at risk	0/215 (0.00%)	5/211 (2.37%)
Colitis ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Diarrhoea ^{† 1}
# participants affected / at risk	8/215 (3.72%)	5/211 (2.37%)
Duodenal obstruction ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Duodenal stenosis ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Enteritis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Faeces discoloured ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Food poisoning ^{† 1}
# participants affected / at risk	0/215 (0.00%)	2/211 (0.95%)
Gastric haemorrhage ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Gastrointestinal fistula ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Gastrointestinal haemorrhage ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Gastrooesophageal reflux disease ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Haematemesis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Haematochezia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Haemorrhoids ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Ileus ^{† 1}
# participants affected / at risk	5/215 (2.33%)	1/211 (0.47%)
Inguinal hernia, obstructive ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Intestinal obstruction ^{† 1}
# participants affected / at risk	2/215 (0.93%)	4/211 (1.90%)
Lip oedema ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Melaena ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Nausea ^{† 1}
# participants affected / at risk	3/215 (1.40%)	4/211 (1.90%)
Oesophageal spasm ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Pancreatitis acute ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Pneumatosis intestinalis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Rectal haemorrhage ^{† 1}
# participants affected / at risk	3/215 (1.40%)	0/211 (0.00%)
Small intestinal haemorrhage ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Small intestinal obstruction ^{† 1}
# participants affected / at risk	7/215 (3.26%)	3/211 (1.42%)
Small intestinal stenosis ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Stomatitis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Subileus ^{† 1}
# participants affected / at risk	3/215 (1.40%)	2/211 (0.95%)
Upper gastrointestinal haemorrhage ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Vomiting ^{† 1}
# participants affected / at risk	5/215 (2.33%)	6/211 (2.84%)
General disorders
Asthenia ^{† 1}
# participants affected / at risk	2/215 (0.93%)	3/211 (1.42%)
Brain death ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Chest pain ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Chills ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Fatigue ^{† 1}
# participants affected / at risk	2/215 (0.93%)	1/211 (0.47%)
General physical health deterioration ^{† 1}
# participants affected / at risk	6/215 (2.79%)	2/211 (0.95%)
Generalised oedema ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Hypothermia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Malaise ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Non-cardiac chest pain ^{† 1}
# participants affected / at risk	3/215 (1.40%)	0/211 (0.00%)
Oedema peripheral ^{† 1}
# participants affected / at risk	3/215 (1.40%)	4/211 (1.90%)
Pain ^{† 1}
# participants affected / at risk	1/215 (0.47%)	2/211 (0.95%)
Pyrexia ^{† 1}
# participants affected / at risk	7/215 (3.26%)	3/211 (1.42%)
Hepatobiliary disorders
Cholangitis ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Cholangitis acute ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Cholecystitis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Cholecystitis acute ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Cholestasis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Cytolytic hepatitis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Hepatic failure ^{† 1}
# participants affected / at risk	2/215 (0.93%)	2/211 (0.95%)
Hepatic function abnormal ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Hyperbilirubinaemia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Jaundice ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Infections and infestations
Abdominal wall abscess ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Abscess intestinal ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Arthritis infective ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Bacteraemia ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Cellulitis ^{† 1}
# participants affected / at risk	3/215 (1.40%)	0/211 (0.00%)
Cholecystitis infective ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Clostridium difficile colitis ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Diverticulitis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Escherichia sepsis ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Gastroenteritis ^{† 1}
# participants affected / at risk	2/215 (0.93%)	1/211 (0.47%)
Gastroenteritis viral ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Herpes zoster ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Infected skin ulcer ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Influenza ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Lung infection ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Pneumonia ^{† 1}
# participants affected / at risk	9/215 (4.19%)	1/211 (0.47%)
Pneumonia viral ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Sepsis ^{† 1}
# participants affected / at risk	2/215 (0.93%)	1/211 (0.47%)
Sinusitis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Staphylococcal infection ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Urinary tract infection ^{† 1}
# participants affected / at risk	2/215 (0.93%)	2/211 (0.95%)
Urinary tract infection bacterial ^{† 1}
# participants affected / at risk	0/215 (0.00%)	2/211 (0.95%)
Urosepsis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Injury, poisoning and procedural complications
Femoral neck fracture ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Fractured sacrum ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Heat exhaustion ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Hip fracture ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Humerus fracture ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Joint injury ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Post procedural complication ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Post procedural haemorrhage ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Rib fracture ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Scapula fracture ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Seroma ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Traumatic lung injury ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Investigations
Alanine aminotransferase increased ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Aspartate aminotransferase increased ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Blood creatinine increased ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Blood urea increased ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Cardiac murmur ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Coagulation time shortened ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Heart rate increased ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Lipase increased ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Weight decreased ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Metabolism and nutrition disorders
Cachexia ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Decreased appetite ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Dehydration ^{† 1}
# participants affected / at risk	7/215 (3.26%)	1/211 (0.47%)
Failure to thrive ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Hypercalcaemia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Hyperglycaemia ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Hypocalcaemia ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Hypoglycaemia ^{† 1}
# participants affected / at risk	2/215 (0.93%)	1/211 (0.47%)
Hypokalaemia ^{† 1}
# participants affected / at risk	4/215 (1.86%)	0/211 (0.00%)
Hypomagnesaemia ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Hypophosphataemia ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Malnutrition ^{† 1}
# participants affected / at risk	1/215 (0.47%)	2/211 (0.95%)
Metabolic acidosis ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Type 2 diabetes mellitus ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Arthritis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Back pain ^{† 1}
# participants affected / at risk	0/215 (0.00%)	4/211 (1.90%)
Bone pain ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Flank pain ^{† 1}
# participants affected / at risk	2/215 (0.93%)	1/211 (0.47%)
Muscle spasms ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Musculoskeletal chest pain ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Neck pain ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Osteoarthritis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Osteoporosis ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Pain in extremity ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell type acute leukaemia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Brain neoplasm malignant ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Cancer pain ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Lung infiltration malignant ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Malignant pleural effusion ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Nervous system disorders
Cerebrovascular accident ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Depressed level of consciousness ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Dizziness postural ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Encephalopathy ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Facial paresis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Headache ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Hemicephalalgia ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Hypoaesthesia ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Intracranial haematoma ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Lethargy ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Mental impairment ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Metabolic encephalopathy ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Radiculopathy ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Sciatica ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Subarachnoid haemorrhage ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Syncope ^{† 1}
# participants affected / at risk	2/215 (0.93%)	1/211 (0.47%)
Psychiatric disorders
Confusional state ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Hallucination ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Renal and urinary disorders
Bladder tamponade ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Calculus ureteric ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Calculus urinary ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Haematuria ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Nephrolithiasis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Renal failure ^{† 1}
# participants affected / at risk	4/215 (1.86%)	0/211 (0.00%)
Renal failure acute ^{† 1}
# participants affected / at risk	3/215 (1.40%)	1/211 (0.47%)
Renal impairment ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Renal infarct ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Ureteric obstruction ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Urinary bladder haemorrhage ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Urinary retention ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Reproductive system and breast disorders
Testicular swelling ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Atelectasis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Cough ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Dyspnoea ^{† 1}
# participants affected / at risk	8/215 (3.72%)	2/211 (0.95%)
Hypoxia ^{† 1}
# participants affected / at risk	3/215 (1.40%)	1/211 (0.47%)
Interstitial lung disease ^{† 1}
# participants affected / at risk	3/215 (1.40%)	0/211 (0.00%)
Lung infiltration ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Organising pneumonia ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Pleural effusion ^{† 1}
# participants affected / at risk	3/215 (1.40%)	0/211 (0.00%)
Pneumonitis ^{† 1}
# participants affected / at risk	2/215 (0.93%)	0/211 (0.00%)
Pulmonary embolism ^{† 1}
# participants affected / at risk	6/215 (2.79%)	1/211 (0.47%)
Respiratory failure ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Tachypnoea ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Skin and subcutaneous tissue disorders
Angioedema ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Palmar-plantar erythrodysaesthesia syndrome ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Vascular disorders
Aortic dissection ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Deep vein thrombosis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Flushing ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Haematoma ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Hypertension ^{† 1}
# participants affected / at risk	1/215 (0.47%)	1/211 (0.47%)
Hypotension ^{† 1}
# participants affected / at risk	0/215 (0.00%)	1/211 (0.47%)
Jugular vein thrombosis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Orthostatic hypotension ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)
Phlebitis ^{† 1}
# participants affected / at risk	1/215 (0.47%)	0/211 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided by Novartis

Publications automatically indexed to this study:

Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled radiant-2 Study. Chest. 2013 Apr;143(4):955-62.

Pavel ME, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-12. Epub 2011 Nov 25.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00412061 History of Changes
Other Study ID Numbers:	CRAD001C2325
Study First Received:	December 13, 2006
Results First Received:	October 25, 2011
Last Updated:	June 4, 2013
Health Authority:	United States: Food and Drug Administration

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