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Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer (BOLERO-3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007942
First Posted: November 4, 2009
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: June 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: HER2/Neu Over-expressing Locally Advanced Breast Cancer
Metastatic Breast Cancer
Interventions: Drug: everolimus
Drug: Placebo
Drug: vinorelbine
Drug: trastuzumab

  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
DCO ( Data cut-off) for patient disposition is 1-Apr-2015. Each Cycle = 21 days

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
284 patients randomized to the Everolimus + trastuzumab + vinorelbine arm, 280 took drug. 285 patients randomized to the placebo + trastuzumab + vinorelbine arm, 282 too drug. A total of 569 were comprised to randomized total and 562 to safety.

Reporting Groups
  Description
Everolimus + Vinorelbine + Trastuzumab Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Placebo + Vinorelbine + Trastuzumab Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Participant Flow:   Overall Study
    Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab
STARTED   284   285 
COMPLETED   3 [1]   7 [1] 
NOT COMPLETED   281   278 
Adverse Event                29                14 
Abnormal test procedure                0                1 
Disease progression                217                242 
New cancer therapy                5                1 
Protocol Violation                1                1 
Withdrawal by Subject                19                14 
Lost to Follow-up                1                0 
Administrative problems                2                0 
Death                3                2 
Patients untreated                4                3 
[1] Pts completed= on treatment at time of DCO. Not Completed = ended treatment as per protocol.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) consisted of all randomized patients.

Reporting Groups
  Description
Everolimus + Vinorelbine + Trastuzumab Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Placebo + Vinorelbine + Trastuzumab Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Total Total of all reporting groups

Baseline Measures
   Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 284   285   569 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (10.98)   53.4  (11.00)   53.8  (10.99) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      284 100.0%      285 100.0%      569 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progressive-free Survival (PFS) Per Investigator Assessment   [ Time Frame: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Every 3 months until death up to 41 months ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months ]

4.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months ]

5.  Secondary:   Median Time to Deterioration of the ECOG Performance Status Score   [ Time Frame: baseline, until disease progression or death up to about 41 months ]

6.  Secondary:   PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)–Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)   [ Time Frame: Baseline, until disease progression or death up to about 41 months ]

7.  Secondary:   Everolimus Blood Concentrations by Leading Dose and Time Point   [ Time Frame: Cycle 2, Day 1 ]

8.  Secondary:   Vinorelbine Blood Concentrations by Leading Dose and Time Point   [ Time Frame: Cycle 2, Day 1 ]

9.  Secondary:   Trastuzumab Blood Concentrations by Leading Dose and Time Point   [ Time Frame: Cycle 3, Day 1 ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Everolimus + Trastuzumab + Vinorelbine Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Placebo + Trastuzumab + Vinorelbine Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Serious Adverse Events
    Everolimus + Trastuzumab + Vinorelbine   Placebo + Trastuzumab + Vinorelbine
Total, Serious Adverse Events     
# participants affected / at risk   122/280 (43.57%)   58/282 (20.57%) 
Blood and lymphatic system disorders     
Agranulocytosis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Anaemia † 1     
# participants affected / at risk   10/280 (3.57%)   2/282 (0.71%) 
Febrile neutropenia † 1     
# participants affected / at risk   30/280 (10.71%)   4/282 (1.42%) 
Immune thrombocytopenic purpura † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Leukopenia † 1     
# participants affected / at risk   3/280 (1.07%)   0/282 (0.00%) 
Neutropenia † 1     
# participants affected / at risk   12/280 (4.29%)   3/282 (1.06%) 
Thrombocytopenia † 1     
# participants affected / at risk   4/280 (1.43%)   1/282 (0.35%) 
Cardiac disorders     
Acute myocardial infarction † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Cardiac failure † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Eye disorders     
Cataract † 1     
# participants affected / at risk   2/280 (0.71%)   1/282 (0.35%) 
Cataract subcapsular † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Vision blurred † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Abdominal pain upper † 1     
# participants affected / at risk   2/280 (0.71%)   1/282 (0.35%) 
Ascites † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Constipation † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Diarrhoea † 1     
# participants affected / at risk   5/280 (1.79%)   2/282 (0.71%) 
Dysphagia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Gastric perforation † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Gastritis † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Gastrointestinal inflammation † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Haematemesis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Haematochezia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Ileus † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Intestinal obstruction † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Nausea † 1     
# participants affected / at risk   3/280 (1.07%)   1/282 (0.35%) 
Neutropenic colitis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Pancreatitis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Stomatitis † 1     
# participants affected / at risk   9/280 (3.21%)   1/282 (0.35%) 
Vomiting † 1     
# participants affected / at risk   5/280 (1.79%)   2/282 (0.71%) 
General disorders     
Asthenia † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Chills † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Device dislocation † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Extravasation † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
General physical health deterioration † 1     
# participants affected / at risk   3/280 (1.07%)   2/282 (0.71%) 
Hyperpyrexia † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Hyperthermia † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Inflammation † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Pyrexia † 1     
# participants affected / at risk   13/280 (4.64%)   5/282 (1.77%) 
Systemic inflammatory response syndrome † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction † 1     
# participants affected / at risk   0/280 (0.00%)   2/282 (0.71%) 
Cholecystitis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Hepatic mass † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Hepatocellular injury † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Infections and infestations     
Abscess jaw † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Aspergillus infection † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Bronchiolitis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Bronchitis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Cellulitis † 1     
# participants affected / at risk   4/280 (1.43%)   0/282 (0.00%) 
Clostridium difficile colitis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Conjunctivitis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Device related infection † 1     
# participants affected / at risk   3/280 (1.07%)   1/282 (0.35%) 
Device related sepsis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Escherichia sepsis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Escherichia urinary tract infection † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Furuncle † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Gastroenteritis † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Gastroenteritis clostridial † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Herpes zoster † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Influenza † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Klebsiella bacteraemia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Lobar pneumonia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Lung infection † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Neutropenic infection † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Neutropenic sepsis † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Osteomyelitis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Parainfluenzae virus infection † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Peritonitis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Peritonsillar abscess † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Pharyngitis † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Pneumocystis jirovecii infection † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Pneumonia † 1     
# participants affected / at risk   8/280 (2.86%)   1/282 (0.35%) 
Postoperative wound infection † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Pseudomonal sepsis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Sepsis † 1     
# participants affected / at risk   3/280 (1.07%)   0/282 (0.00%) 
Sinusitis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Soft tissue infection † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Tuberculosis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Urinary tract infection † 1     
# participants affected / at risk   1/280 (0.36%)   2/282 (0.71%) 
Viral upper respiratory tract infection † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Injury, poisoning and procedural complications     
Fall † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Femur fracture † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Fractured sacrum † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Hand fracture † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Humerus fracture † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Pelvic fracture † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Procedural pain † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Spinal compression fracture † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Subdural haematoma † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Thoracic vertebral fracture † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Wound dehiscence † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Investigations     
Neutrophil count decreased † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Metabolism and nutrition disorders     
Cachexia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Decreased appetite † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Dehydration † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Diabetes mellitus † 1     
# participants affected / at risk   2/280 (0.71%)   1/282 (0.35%) 
Hyperglycaemia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Hyperkalaemia † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Hypocalcaemia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Hypokalaemia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Hyponatraemia † 1     
# participants affected / at risk   2/280 (0.71%)   1/282 (0.35%) 
Type 2 diabetes mellitus † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain † 1     
# participants affected / at risk   2/280 (0.71%)   0/282 (0.00%) 
Flank pain † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Musculoskeletal pain † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Neck pain † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Paraneoplastic syndrome † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Thyroid cancer † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Nervous system disorders     
Brain oedema † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Disturbance in attention † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Dizziness † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Headache † 1     
# participants affected / at risk   2/280 (0.71%)   3/282 (1.06%) 
Hydrocephalus † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Migraine † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Neuralgia † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Neurological symptom † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Neuropathy peripheral † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Seizure † 1     
# participants affected / at risk   3/280 (1.07%)   1/282 (0.35%) 
Somnolence † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Syncope † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Psychiatric disorders     
Suicide attempt † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Renal and urinary disorders     
Acute kidney injury † 1     
# participants affected / at risk   3/280 (1.07%)   0/282 (0.00%) 
Dysuria † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Reproductive system and breast disorders     
Breast pain † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Ovarian cyst † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Pelvic pain † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Uterine haemorrhage † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Cough † 1     
# participants affected / at risk   1/280 (0.36%)   2/282 (0.71%) 
Dyspnoea † 1     
# participants affected / at risk   3/280 (1.07%)   3/282 (1.06%) 
Dyspnoea exertional † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Epistaxis † 1     
# participants affected / at risk   3/280 (1.07%)   0/282 (0.00%) 
Haemothorax † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Hypoxia † 1     
# participants affected / at risk   1/280 (0.36%)   1/282 (0.35%) 
Interstitial lung disease † 1     
# participants affected / at risk   3/280 (1.07%)   0/282 (0.00%) 
Oropharyngeal pain † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Pleural effusion † 1     
# participants affected / at risk   1/280 (0.36%)   5/282 (1.77%) 
Pneumonitis † 1     
# participants affected / at risk   2/280 (0.71%)   3/282 (1.06%) 
Pneumothorax † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Pulmonary arterial hypertension † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Pulmonary embolism † 1     
# participants affected / at risk   3/280 (1.07%)   5/282 (1.77%) 
Respiratory failure † 1     
# participants affected / at risk   0/280 (0.00%)   3/282 (1.06%) 
Tachypnoea † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Skin and subcutaneous tissue disorders     
Rash † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Skin ulcer † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Vascular disorders     
Deep vein thrombosis † 1     
# participants affected / at risk   1/280 (0.36%)   0/282 (0.00%) 
Haematoma † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Haemorrhage † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Hypotension † 1     
# participants affected / at risk   1/280 (0.36%)   2/282 (0.71%) 
Shock † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Thrombosis † 1     
# participants affected / at risk   0/280 (0.00%)   1/282 (0.35%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA V18.0




  Other Adverse Events


  Limitations and Caveats
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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
All randomized patients were included in the FAS. Seven patients (4 in the everolimus arm & 3 in the placebo arm) were randomized but never received treatment & were therefore excluded from the Safety Set.


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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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01007942     History of Changes
Other Study ID Numbers: CRAD001W2301
2008-008697-31 ( EudraCT Number )
First Submitted: November 2, 2009
First Posted: November 4, 2009
Results First Submitted: June 10, 2016
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017