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Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer (ENCORE301)

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.
 
ClinicalTrials.gov Identifier: NCT00676663
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : October 24, 2019
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
Syndax Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Breast Cancer
Estrogen Receptor-Positive Breast Cancer
Breast Cancer, Estrogen Receptor-Positive
ER+ Breast Cancer
Interventions Drug: entinostat
Drug: exemestane
Drug: Placebo
Enrollment 130
Recruitment Details Participants took part in the study at 38 investigative sites in the United States, Canada, Czech Republic, Hungary and Russia from 13 June 2008 to 26 November 2012.
Pre-assignment Details Participants with a diagnosis of metastatic breast cancer were enrolled equally in one of two treatment arms: exemestane 25 mg plus entinostat 5 mg or exemestane 25 mg plus placebo.
Arm/Group Title Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Hide Arm/Group Description Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first. Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Period Title: Overall Study
Started 66 64
Completed 21 26
Not Completed 45 38
Reason Not Completed
Death             43             27
Withdrew Consent             1             8
Lost to Follow-up             1             3
Arm/Group Title Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg Total
Hide Arm/Group Description Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first. Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first. Total of all reporting groups
Overall Number of Baseline Participants 66 64 130
Hide Baseline Analysis Population Description
Full Analysis Set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 64 participants 130 participants
62.7  (10.06) 62.2  (11.72) 62.4  (10.87)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
18 to 44 years
2
   3.0%
3
   4.7%
5
   3.8%
45 to 64 years
38
  57.6%
32
  50.0%
70
  53.8%
65 to 74 years
19
  28.8%
19
  29.7%
38
  29.2%
≥75 years
7
  10.6%
10
  15.6%
17
  13.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
Female
66
 100.0%
64
 100.0%
130
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
Hispanic or Latino
1
   1.5%
3
   4.7%
4
   3.1%
Not Hispanic or Latino
65
  98.5%
61
  95.3%
126
  96.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
Black/African American
5
   7.6%
4
   6.3%
9
   6.9%
White
61
  92.4%
60
  93.8%
121
  93.1%
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 65 participants 63 participants 128 participants
164.9  (6.38) 162.7  (6.44) 163.8  (6.48)
[1]
Measure Analysis Population Description: Height data is only available for n= 65, 63 participants.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 66 participants 64 participants 130 participants
73.2  (17.47) 75.6  (16.66) 74.3  (17.05)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 64 participants 130 participants
Score=0
50
  75.8%
40
  62.5%
90
  69.2%
Score=1
16
  24.2%
24
  37.5%
40
  30.8%
[1]
Measure Description: ECOG Performance status is an assessment of a participant's general well-being and activities of daily of life. Scores range from 0=perfect health (asymptomatic; able to carry out activities without restriction) to 5=death.
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.
Time Frame From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants.
Arm/Group Title Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Hide Arm/Group Description:
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Overall Number of Participants Analyzed 66 64
Median (95% Confidence Interval)
Unit of Measure: months
2.27
(1.81 to 3.68)
4.28
(3.26 to 5.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane 25 mg + Placebo, Exemestane 25 mg + Entinostat 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Log Rank
Comments P-value is stratified by the randomization stratification factors and is 1-sided, with a 0.10 threshold for significance.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.49 to 1.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants with response during treatment classified as complete response (CR) or partial response (PR), as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame From date of randomization to discontinuation due to disease progression or intolerable Adverse Event (AE) up to primary completion date (Median follow-up 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants.
Arm/Group Title Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Hide Arm/Group Description:
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.6
(1.0 to 12.7)
4.7
(1.0 to 13.1)
3.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description CBR is defined as the percentage of participants with overall response (CR + PR) plus stable disease (SD) for 6 months as assessed by the investigator based on RECIST, version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame From date of randomization to discontinuation due to disease progression or intolerable AE up to primary completion date (Median follow-up 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants.
Arm/Group Title Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Hide Arm/Group Description:
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.8
(15.8 to 38.0)
26.6
(16.3 to 39.1)
4.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description

An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. Abnormal clinical laboratory findings determined by the investigator to be clinically significant were recorded as AEs. A TEAE is an AE that starts after the administration of study drug.

A SAE is any AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth effect or other significant medical hazard.

Time Frame First dose to within 30 days of last dose of study drug (Up to Approximately 2 Years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study drug.
Arm/Group Title Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Hide Arm/Group Description:
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Overall Number of Participants Analyzed 66 63
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
56
  84.8%
60
  95.2%
SAE
8
  12.1%
10
  15.9%
5.Other Pre-specified Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the number of months elapsed between the date of randomization and the date of death (whatever the cause).
Time Frame First dose of study drug to end of study (Median follow-up 24 months in the EE arm and 26.4 months in the EP arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants.
Arm/Group Title Exemestane 25 mg + Placebo (EP) Exemestane 25 mg + Entinostat 5 mg (EE)
Hide Arm/Group Description:
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Overall Number of Participants Analyzed 66 64
Median (95% Confidence Interval)
Unit of Measure: months
19.84
(17.04 to 26.71)
28.13 [1] 
(21.15 to NA)
[1]
Upper Confidence Interval was not estimable due to the low number of participants with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane 25 mg + Placebo (EP), Exemestane 25 mg + Entinostat 5 mg (EE)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments P-value is stratified by the randomization stratification factors and is 1-sided.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.36 to 0.97
Estimation Comments Hazard ratio was estimated from a Cox proportional hazards model. Placebo serves as the reference treatment group for the interpretation of the hazard ratio.
Time Frame First dose to within 30 days of last dose of study drug (Up to approximately 2 Years)
Adverse Event Reporting Description Safety population included all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Hide Arm/Group Description Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first. Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
All-Cause Mortality
Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   8/66 (12.12%)   10/63 (15.87%) 
Blood and lymphatic system disorders     
Anemia group  1  1/66 (1.52%)  1/63 (1.59%) 
Leukopenia group  1  1/66 (1.52%)  0/63 (0.00%) 
Thrombocytopenia group  1  1/66 (1.52%)  0/63 (0.00%) 
Cardiac disorders     
Atrial tachycardia  1  0/66 (0.00%)  1/63 (1.59%) 
Gastrointestinal disorders     
Constipation  1  1/66 (1.52%)  0/63 (0.00%) 
Enterocutaneous fistula  1  1/66 (1.52%)  0/63 (0.00%) 
Ileus  1  0/66 (0.00%)  1/63 (1.59%) 
Oesophagitis  1  0/66 (0.00%)  1/63 (1.59%) 
Pancreatic mass  1  1/66 (1.52%)  0/63 (0.00%) 
Pancreatitis acute  1  0/66 (0.00%)  1/63 (1.59%) 
General disorders     
Asthenia  1  1/66 (1.52%)  0/63 (0.00%) 
Pyrexia  1  1/66 (1.52%)  0/63 (0.00%) 
Infections and infestations     
Sepsis  1  1/66 (1.52%)  0/63 (0.00%) 
Injury, poisoning and procedural complications     
Overdose  1  0/66 (0.00%)  1/63 (1.59%) 
Procedural nausea  1  1/66 (1.52%)  0/63 (0.00%) 
Radiation pneumonitis  1  0/66 (0.00%)  1/63 (1.59%) 
Metabolism and nutrition disorders     
Hypercalcaemia  1  1/66 (1.52%)  0/63 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion  1  0/66 (0.00%)  1/63 (1.59%) 
Renal and urinary disorders     
Urinary tract infection  1  1/66 (1.52%)  0/63 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Lobar pneumonia  1  1/66 (1.52%)  1/63 (1.59%) 
Pneumonia  1  0/66 (0.00%)  2/63 (3.17%) 
Chronic obstructive pulmonary disease  1  1/66 (1.52%)  0/63 (0.00%) 
Pleural effusion  1  0/66 (0.00%)  1/63 (1.59%) 
Lung infiltration  1  0/66 (0.00%)  1/63 (1.59%) 
Pneumonitis  1  0/66 (0.00%)  1/63 (1.59%) 
Dyspnoea  1  0/66 (0.00%)  1/63 (1.59%) 
Vascular disorders     
Deep vein thrombosis  1  0/66 (0.00%)  1/63 (1.59%) 
Vena cava thrombosis  1  0/66 (0.00%)  1/63 (1.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exemestane 25 mg + Placebo Exemestane 25 mg + Entinostat 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   51/66 (77.27%)   58/63 (92.06%) 
Blood and lymphatic system disorders     
Anemia group  1  7/66 (10.61%)  12/63 (19.05%) 
Neutropenia group  1  1/66 (1.52%)  19/63 (30.16%) 
Thrombocytopenia group  1  3/66 (4.55%)  12/63 (19.05%) 
Leukopenia group  1  1/66 (1.52%)  9/63 (14.29%) 
Cardiac disorders     
Tachycardia  1  4/66 (6.06%)  3/63 (4.76%) 
Gastrointestinal disorders     
Nausea  1  10/66 (15.15%)  25/63 (39.68%) 
Diarrhoea  1  8/66 (12.12%)  11/63 (17.46%) 
Constipation  1  10/66 (15.15%)  6/63 (9.52%) 
Vomiting  1  3/66 (4.55%)  13/63 (20.63%) 
Abdominal pain upper  1  6/66 (9.09%)  5/63 (7.94%) 
Dyspepsia  1  2/66 (3.03%)  9/63 (14.29%) 
Pyrexia  1  3/66 (4.55%)  4/63 (6.35%) 
General disorders     
Fatigue  1  17/66 (25.76%)  30/63 (47.62%) 
Oedema peripheral  1  3/66 (4.55%)  13/63 (20.63%) 
Pain  1  4/66 (6.06%)  10/63 (15.87%) 
Hot flush  1  6/66 (9.09%)  5/63 (7.94%) 
Asthenia  1  4/66 (6.06%)  3/63 (4.76%) 
Chills  1  0/66 (0.00%)  4/63 (6.35%) 
Investigations     
Weight decreased  1  12/66 (18.18%)  13/63 (20.63%) 
Blood alkaline phosphatase increased  1  5/66 (7.58%)  5/63 (7.94%) 
Aspartate aminotransferase increased  1  7/66 (10.61%)  3/63 (4.76%) 
Alanine aminotransferase increased  1  6/66 (9.09%)  3/63 (4.76%) 
Electrocardiogram QT prolonged  1  6/66 (9.09%)  1/63 (1.59%) 
Blood lactate dehydrogenase increased  1  1/66 (1.52%)  4/63 (6.35%) 
Metabolism and nutrition disorders     
Anorexia  1  5/66 (7.58%)  8/63 (12.70%) 
Hypokalaemia  1  2/66 (3.03%)  6/63 (9.52%) 
Hypophosphataemia  1  3/66 (4.55%)  4/63 (6.35%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  11/66 (16.67%)  10/63 (15.87%) 
Arthralgia  1  11/66 (16.67%)  7/63 (11.11%) 
Pain in extremity  1  4/66 (6.06%)  10/63 (15.87%) 
Muscle spasms  1  2/66 (3.03%)  7/63 (11.11%) 
Musculoskeletal chest pain  1  3/66 (4.55%)  6/63 (9.52%) 
Bone pain  1  2/66 (3.03%)  5/63 (7.94%) 
Myalgia  1  5/66 (7.58%)  2/63 (3.17%) 
Muscular weakness  1  1/66 (1.52%)  4/63 (6.35%) 
Nervous system disorders     
Headache  1  7/66 (10.61%)  9/63 (14.29%) 
Insomnia  1  7/66 (10.61%)  7/63 (11.11%) 
Neuropathy  1  0/66 (0.00%)  4/63 (6.35%) 
Psychiatric disorders     
Anxiety  1  3/66 (4.55%)  6/63 (9.52%) 
Renal and urinary disorders     
Urinary tract infection  1  0/66 (0.00%)  5/63 (7.94%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  7/66 (10.61%)  12/63 (19.05%) 
Cough  1  3/66 (4.55%)  8/63 (12.70%) 
Upper respiratory tract infection  1  4/66 (6.06%)  2/63 (3.17%) 
Skin and subcutaneous tissue disorders     
Rash  1  2/66 (3.03%)  4/63 (6.35%) 
Vascular disorders     
Vascular disorders  1  3/66 (4.55%)  8/63 (12.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a period of 18 months until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kate Madigan, MD, Chief Medical Officer
Organization: Syndax Pharmaceuticals, Inc.
Phone: +1-858-888-3798
EMail: kmadigan@syndax.com
Layout table for additonal information
Responsible Party: Syndax Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00676663    
Other Study ID Numbers: SNDX-275-0301
2009-012623-28 ( EudraCT Number )
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: October 24, 2018
Results First Posted: October 24, 2019
Last Update Posted: May 11, 2022