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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
  Hide Participant Flow

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
  Hide 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 ]

Measure Type Primary
Measure Title Progressive-free Survival (PFS) Per Investigator Assessment
Measure Description PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Every 6 weeks until disease progression or death which ever occurred first up to about 41 months  

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)

Measured Values
   Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab 
Participants Analyzed 
[Units: Participants]
 284   285 
Progressive-free Survival (PFS) Per Investigator Assessment 
[Units: Months]
Median (95% Confidence Interval)
 7.00 
 (6.74 to 8.18) 
 5.78 
 (5.49 to 6.90) 


Statistical Analysis 1 for Progressive-free Survival (PFS) Per Investigator Assessment
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.0067
Hazard Ratio (HR) [5] 0.78
95% Confidence Interval 0.65 to 0.95
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Overall Survival (OS)
Measure Description OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.
Time Frame Every 3 months until death up to 41 months  

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)

Measured Values
   Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab 
Participants Analyzed 
[Units: Participants]
 284   285 
Overall Survival (OS) 
[Units: Months]
Median (95% Confidence Interval)
 23.46 
 (20.01 to 28.81) 
 24.08 
 (21.49 to 27.63) 

No statistical analysis provided for Overall Survival (OS)



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 ]

Measure Type Secondary
Measure Title Overall Response Rate (ORR)
Measure Description ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Every 6 weeks until disease progression or death which ever occurred first up to about 41 months  

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)

Measured Values
   Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab 
Participants Analyzed 
[Units: Participants]
 284   285 
Overall Response Rate (ORR) 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 40.8 
 (35.1 to 46.8) 
 37.2 
 (31.6 to 43.1) 

No statistical analysis provided for Overall Response Rate (ORR)



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 ]

Measure Type Secondary
Measure Title Clinical Benefit Rate (CBR)
Measure Description CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.
Time Frame Every 6 weeks until disease progression or death which ever occurred first up to about 41 months  

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)

Measured Values
   Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab 
Participants Analyzed 
[Units: Participants]
 284   285 
Clinical Benefit Rate (CBR) 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 59.2 
 (53.2 to 64.9) 
 53.3 
 (47.4 to 59.2) 

No statistical analysis provided for Clinical Benefit Rate (CBR)



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 ]

Measure Type Secondary
Measure Title Median Time to Deterioration of the ECOG Performance Status Score
Measure Description Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, & physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead
Time Frame baseline, until disease progression or death up to about 41 months  

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)

Measured Values
   Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab 
Participants Analyzed 
[Units: Participants]
 284   285 
Median Time to Deterioration of the ECOG Performance Status Score 
[Units: Months]
Median (95% Confidence Interval)
 32.66 
 (17.68 to 32.66) 
 21.55 [1] 
 (12.48 to N/A) 
[1] N/A = data could not be analyzed at later time points due to the low number of patients.

No statistical analysis provided for Median Time to Deterioration of the ECOG Performance Status Score



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 ]

Measure Type Secondary
Measure Title 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%)
Measure Description PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, & social functioning [EF, PF, & SF]). It contains 30 items & is composed of multi-item scales & single-item measures. These include 5 functional scales (physical, role, emotional, social & cognitive functioning), 3 symptom scales (fatigue, pain, nausea, & vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia & financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest & disclosed here.
Time Frame Baseline, until disease progression or death up to about 41 months  

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)

Measured Values
   Everolimus + Vinorelbine + Trastuzumab   Placebo + Vinorelbine + Trastuzumab 
Participants Analyzed 
[Units: Participants]
 284   285 
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%) 
[Units: Months]
Median (95% Confidence Interval)
   
Deterioration - global QoL domain by at least 10%   8.31 
 (6.93 to 11.53) 
 7.29 
 (5.55 to 10.38) 
Deterioration in the PF domain by at least 10%   11.96 
 (8.31 to 14.09) 
 12.48 
 (8.31 to 20.86) 
Deterioration in the EF domain by at least 10%   15.18 
 (9.20 to 17.28) 
 12.45 
 (9.69 to 16.36) 
Deterioration in the SF domain by at least 10%   11.33 
 (8.18 to 14.52) 
 13.11 
 (8.31 to 19.32) 

No statistical analysis provided for 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%)



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

Measure Type Secondary
Measure Title Everolimus Blood Concentrations by Leading Dose and Time Point
Measure Description Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.
Time Frame Cycle 2, Day 1  

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 Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.

Reporting Groups
  Description
Everolimus 2.5 mg Oral everolimus of 2.5 mg/day
Everolimus Oral everolimus of 5 mg/day

Measured Values
   Everolimus 2.5 mg   Everolimus 
Participants Analyzed 
[Units: Participants]
 10   43 
Everolimus Blood Concentrations by Leading Dose and Time Point 
[Units: Ng/ml]
Mean (Standard Deviation)
   
Pre-dose (Cmin) (n: 7, 32)   2.928  (2.6197)   5.652  (4.1006) 
2 hours post administration (C2h) (n:10, 43)   13.035  (6.6842)   22.005  (13.3800) 

No statistical analysis provided for Everolimus Blood Concentrations by Leading Dose and Time Point



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

Measure Type Secondary
Measure Title Vinorelbine Blood Concentrations by Leading Dose and Time Point
Measure Description Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses.
Time Frame Cycle 2, Day 1  

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 Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.

Reporting Groups
  Description
Everolimus Oral everolimus of 5 mg/day
Everolimus Placebo Oral placebo everolimus of 5 mg/day

Measured Values
   Everolimus   Everolimus Placebo 
Participants Analyzed 
[Units: Participants]
 76   64 
Vinorelbine Blood Concentrations by Leading Dose and Time Point 
[Units: Ng/ml]
Mean (Standard Deviation)
   
Pre-infusion - dose (Cmin) (n: 76, 64)   11.085  (66.8551)   0.061  (0.4888) 
End of infusion (Cmax) (n: 58, 49)   867.147  (971.3057)   1068.51  (1145.860) 

No statistical analysis provided for Vinorelbine Blood Concentrations by Leading Dose and Time Point



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

Measure Type Secondary
Measure Title Trastuzumab Blood Concentrations by Leading Dose and Time Point
Measure Description Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.
Time Frame Cycle 3, Day 1  

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 Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.

Reporting Groups
  Description
Everolimus Oral everolimus of 5 mg/day
Everolimus Placebo Oral placebo everolimus of 5 mg/day

Measured Values
   Everolimus   Everolimus Placebo 
Participants Analyzed 
[Units: Participants]
 74   59 
Trastuzumab Blood Concentrations by Leading Dose and Time Point 
[Units: Ng/ml]
Mean (Standard Deviation)
   
Pre-infusion - dose (Cmin) (n: 73, 57)   23.351  (6.3344)   24.526  (7.9960) 
End of infusion (Cmax) (n: 75, 59)   64.279  (27.8549)   60.576  (15.5198) 

No statistical analysis provided for Trastuzumab Blood Concentrations by Leading Dose and Time Point




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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.


  More Information
  Hide More Information

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