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An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

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ClinicalTrials.gov Identifier: NCT01646125
Recruitment Status : Terminated (An interim analysis was conducted in May-2014. Upon review of the data, the committee recommended study termination due to futility.)
First Posted : July 20, 2012
Results First Posted : March 13, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Non Small Cell Lung Cancer (NSCLC)
Interventions Drug: AUY922
Drug: Docetaxel
Drug: Pemetrexed
Enrollment 59
Recruitment Details Patients were randomized in a ratio of 1:1 to receive either AUY922 or pemetrexed/docetaxel. A total of 59 participants were randomized in the study: 31 to the AUY922 arm and 28 to the chemotherapy arm. 2 patients from the AUY922 arm & 5 from the chemotherapy arm were not treated. Only 52 received at least 1 dose of study medication.
Pre-assignment Details  
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Period Title: Overall Study
Started 31 28
Completed 0 0
Not Completed 31 28
Reason Not Completed
Untreated             2             5
Adverse Event             2             1
Death             1             1
Physician Decision             1             3
Progressive disease             22             16
Study terminated by sponsor             2             1
Subject/Guardian decision             1             1
Arm/Group Title AUY922 Arm Chemotherapy Arm Total
Hide Arm/Group Description

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Total of all reporting groups
Overall Number of Baseline Participants 31 28 59
Hide Baseline Analysis Population Description
Full analysis set (FAS) comprised of all patients who were randomized to a study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 28 participants 59 participants
61.8  (10.10) 62.1  (10.34) 61.9  (10.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 28 participants 59 participants
Female
27
  87.1%
21
  75.0%
48
  81.4%
Male
4
  12.9%
7
  25.0%
11
  18.6%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set (EAS) compromised of a subset of patients in the FAS who received 2 lines of prior antineoplastic therapy consisting of a platinum-based treatment & an EGFR TKI treatment. The DMC recommendation at Interim analysis was to stop the study for futility. As a result, collection of all efficacy assessments was stopped.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 19 17
Median (90% Confidence Interval)
Unit of Measure: Months
1.5
(1.2 to 5.6)
2.3
(1.2 to 4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AUY922 Arm, Chemotherapy Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.76
Confidence Interval (2-Sided) 90%
0.35 to 1.63
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria 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.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time.
Time Frame 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee's (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 19 17
Measure Type: Number
Unit of Measure: Participants
Complete Response (CR) 0 0
Partial Response (PR) 3 2
ORR (CR + PR) 3 2
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive.
Time Frame from randomization until death up to death
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1
Time Frame baseline, until disease progression up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Response (TRR)
Hide Description TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1
Time Frame baseline, until disease progression up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Duration of Response (DOR)
Hide Description The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1
Time Frame baseline, until disease progression up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Rate of Adverse Events (AEs)
Hide Description To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
Time Frame baseline, until disease progression up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change in Laboratory Paramenters
Hide Description Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.
Time Frame baseline, until disease progression up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1
Time Frame baseline, until disease progression up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.
Arm/Group Title AUY922 Arm Chemotherapy Arm
Hide Arm/Group Description:

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Safety set: comprised of all participants who received at least one dose of study medication (AUY922, pemetrexed or docetaxel). In the safety set, patients were classified and analyzed according to the treatment received. Of the 59 participants randomized, only 52 received one dose of study medication.
 
Arm/Group Title AUY922 Arm Chemotherapy Arm Total
Hide Arm/Group Description

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Total
All-Cause Mortality
AUY922 Arm Chemotherapy Arm Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
AUY922 Arm Chemotherapy Arm Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/29 (34.48%)   6/23 (26.09%)   16/52 (30.77%) 
Cardiac disorders       
ATRIAL FIBRILLATION  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Eye disorders       
RETINAL DEGENERATION  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
VISION BLURRED  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Gastrointestinal disorders       
CONSTIPATION  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
STOMATITIS  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
General disorders       
ASTHENIA  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
DISCOMFORT  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
PYREXIA  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
SUDDEN DEATH  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Infections and infestations       
LOCALISED INFECTION  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
PNEUMONIA  1  1/29 (3.45%)  1/23 (4.35%)  2/52 (3.85%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
URINARY TRACT INFECTION  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Injury, poisoning and procedural complications       
FALL  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
METASTASES TO CENTRAL NERVOUS SYSTEM  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
Nervous system disorders       
DIZZINESS  1  0/29 (0.00%)  1/23 (4.35%)  1/52 (1.92%) 
EPILEPSY  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders       
HAEMOPTYSIS  1  1/29 (3.45%)  0/23 (0.00%)  1/52 (1.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AUY922 Arm Chemotherapy Arm Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/29 (96.55%)   21/23 (91.30%)   49/52 (94.23%) 
Blood and lymphatic system disorders       
ANAEMIA  1  5/29 (17.24%)  0/23 (0.00%)  5/52 (9.62%) 
LYMPHOPENIA  1  2/29 (6.90%)  1/23 (4.35%)  3/52 (5.77%) 
NEUTROPENIA  1  0/29 (0.00%)  3/23 (13.04%)  3/52 (5.77%) 
Eye disorders       
ACCOMMODATION DISORDER  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
NIGHT BLINDNESS  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
PHOTOPSIA  1  10/29 (34.48%)  0/23 (0.00%)  10/52 (19.23%) 
VISION BLURRED  1  6/29 (20.69%)  0/23 (0.00%)  6/52 (11.54%) 
VISUAL ACUITY REDUCED  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
VISUAL IMPAIRMENT  1  6/29 (20.69%)  0/23 (0.00%)  6/52 (11.54%) 
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER  1  2/29 (6.90%)  1/23 (4.35%)  3/52 (5.77%) 
CONSTIPATION  1  6/29 (20.69%)  2/23 (8.70%)  8/52 (15.38%) 
DIARRHOEA  1  21/29 (72.41%)  1/23 (4.35%)  22/52 (42.31%) 
DRY MOUTH  1  1/29 (3.45%)  2/23 (8.70%)  3/52 (5.77%) 
NAUSEA  1  10/29 (34.48%)  3/23 (13.04%)  13/52 (25.00%) 
STOMATITIS  1  1/29 (3.45%)  3/23 (13.04%)  4/52 (7.69%) 
VOMITING  1  3/29 (10.34%)  3/23 (13.04%)  6/52 (11.54%) 
General disorders       
ASTHENIA  1  8/29 (27.59%)  8/23 (34.78%)  16/52 (30.77%) 
AXILLARY PAIN  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
FATIGUE  1  10/29 (34.48%)  5/23 (21.74%)  15/52 (28.85%) 
NON-CARDIAC CHEST PAIN  1  2/29 (6.90%)  1/23 (4.35%)  3/52 (5.77%) 
OEDEMA PERIPHERAL  1  1/29 (3.45%)  2/23 (8.70%)  3/52 (5.77%) 
PYREXIA  1  2/29 (6.90%)  4/23 (17.39%)  6/52 (11.54%) 
Hepatobiliary disorders       
HEPATOCELLULAR INJURY  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
Infections and infestations       
CONJUNCTIVITIS  1  0/29 (0.00%)  3/23 (13.04%)  3/52 (5.77%) 
RHINITIS  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/29 (10.34%)  1/23 (4.35%)  4/52 (7.69%) 
URINARY TRACT INFECTION  1  1/29 (3.45%)  2/23 (8.70%)  3/52 (5.77%) 
Investigations       
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  3/29 (10.34%)  0/23 (0.00%)  3/52 (5.77%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  4/29 (13.79%)  3/23 (13.04%)  7/52 (13.46%) 
HYPERGLYCAEMIA  1  3/29 (10.34%)  0/23 (0.00%)  3/52 (5.77%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  6/29 (20.69%)  0/23 (0.00%)  6/52 (11.54%) 
BACK PAIN  1  5/29 (17.24%)  3/23 (13.04%)  8/52 (15.38%) 
MUSCULOSKELETAL CHEST PAIN  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
MUSCULOSKELETAL PAIN  1  5/29 (17.24%)  0/23 (0.00%)  5/52 (9.62%) 
MYALGIA  1  4/29 (13.79%)  3/23 (13.04%)  7/52 (13.46%) 
PAIN IN EXTREMITY  1  3/29 (10.34%)  2/23 (8.70%)  5/52 (9.62%) 
Nervous system disorders       
DIZZINESS  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
HEADACHE  1  9/29 (31.03%)  0/23 (0.00%)  9/52 (17.31%) 
PARAESTHESIA  1  2/29 (6.90%)  2/23 (8.70%)  4/52 (7.69%) 
PERIPHERAL SENSORY NEUROPATHY  1  2/29 (6.90%)  2/23 (8.70%)  4/52 (7.69%) 
VISUAL FIELD DEFECT  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
VISUAL PERSEVERATION  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
Psychiatric disorders       
DEPRESSION  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
INSOMNIA  1  3/29 (10.34%)  0/23 (0.00%)  3/52 (5.77%) 
Renal and urinary disorders       
POLLAKIURIA  1  2/29 (6.90%)  0/23 (0.00%)  2/52 (3.85%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  7/29 (24.14%)  2/23 (8.70%)  9/52 (17.31%) 
DYSPNOEA  1  2/29 (6.90%)  7/23 (30.43%)  9/52 (17.31%) 
HAEMOPTYSIS  1  0/29 (0.00%)  2/23 (8.70%)  2/52 (3.85%) 
OROPHARYNGEAL PAIN  1  0/29 (0.00%)  2/23 (8.70%)  2/52 (3.85%) 
Skin and subcutaneous tissue disorders       
ALOPECIA  1  0/29 (0.00%)  6/23 (26.09%)  6/52 (11.54%) 
NAIL DISORDER  1  0/29 (0.00%)  2/23 (8.70%)  2/52 (3.85%) 
PRURITUS  1  6/29 (20.69%)  2/23 (8.70%)  8/52 (15.38%) 
RASH  1  2/29 (6.90%)  4/23 (17.39%)  6/52 (11.54%) 
Vascular disorders       
HYPERTENSION  1  5/29 (17.24%)  0/23 (0.00%)  5/52 (9.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results to terminate the study early due to futility, data was not collected for this assessment on many of the secondary endpoints.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01646125    
Other Study ID Numbers: CAUY922A2207
2012-001050-25 ( EudraCT Number )
First Submitted: June 26, 2012
First Posted: July 20, 2012
Results First Submitted: November 3, 2016
Results First Posted: March 13, 2017
Last Update Posted: July 24, 2019