Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. (SOLAR-1)

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: NCT02437318
Recruitment Status : Active, not recruiting
First Posted : May 7, 2015
Results First Posted : August 13, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Fulvestrant
Drug: Alpelisib
Drug: Alpelisib placebo
Enrollment 572
Recruitment Details A total of 340 subjects were planned for the PIK3CA mutant cohort and 341 were analyzed. A total of 220 subjects were planned for the PIK3CA non-mutant cohort and 231 were analyzed.
Pre-assignment Details  
Arm/Group Title Alpelisib qd + Fulvestrant Placebo qd + Fulvestrant
Hide Arm/Group Description Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Period Title: Overall Study
Started 284 288
End of Treatment (Didn't Complete) 229 241
Untreated (Protocol Deviation) 0 1
Completed [1] 55 46
Not Completed 229 242
Reason Not Completed
Progressive disease             173             208
Subject/guardian decision             22             10
Physician Decision             11             10
Adverse Event             14             3
Death             4             4
Protocol Violation             5             6
Untreated             0             1
[1]
Completed = Subjects ongoing at the time of data cut-off: 12-Jun-2018
Arm/Group Title Alpelisib qd + Fulvestrant Placebo qd + Fulvestrant Total
Hide Arm/Group Description Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) Total of all reporting groups
Overall Number of Baseline Participants 284 288 572
Hide Baseline Analysis Population Description
The Full analysis set (FAS) comprised of all subjects who were randomized to study treatment (alpelisib plus fulvestrant or matching placebo plus fulvestrant).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 284 participants 288 participants 572 participants
62.6  (9.74) 63.3  (10.26) 63.0  (10.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 288 participants 572 participants
Female
283
  99.6%
288
 100.0%
571
  99.8%
Male
1
   0.4%
0
   0.0%
1
   0.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 284 participants 288 participants 572 participants
White 199 178 377
Asian 59 66 125
Unknown 14 17 31
Other 9 17 26
Black or African American 2 6 8
American Indian or Alaska 1 4 5
1.Primary Outcome
Title Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort
Hide Description PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1
Time Frame Once approximately 243 PFS events in this cohort had been observed, up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full analysis set (FAS) comprised of all subjects who were randomized to study treatment (alpelisib plus fulvestrant or matching placebo plus fulvestrant). Analysis comprised all subjects in the FAS with a PIK3CA mutation who were randomized to study treatment.
Arm/Group Title Alpelisib qd + Fulvestrant Placebo qd + Fulvestrant
Hide Arm/Group Description:
Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Overall Number of Participants Analyzed 169 172
Median (95% Confidence Interval)
Unit of Measure: Months
11.0
(7.49 to 14.52)
5.7
(3.65 to 7.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alpelisib qd + Fulvestrant, Placebo qd + Fulvestrant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00065
Comments (one-sided)
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.50 to 0.85
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS) for Patients With PI3KCA Mutant Status
Hide Description OS is defined as the time from date of randomization to date of death due to any cause.
Time Frame Up to approximatly 59 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator’s assessment according to RECIST 1.1.
Time Frame Up to approximatly 36 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Hide Description Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time Frame Baseline, Up to approximatly 36 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Safety and Tolerability of Alpelisib in Combination With Fulvestrant
Hide Description Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study.
Time Frame Up to approximatly 37 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30
Hide Description Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized
Time Frame Up to approximatly 36 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Plasma Concentration-time Profile of Alpelisib Given in Combinatio With Fulvestrant and Appropriate Pharmacokinetics (PK) Parameters
Hide Description Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples. PK parameters includes,but not limited to, Cmin, Cmax, t1/2, AUClast for alpelisib (and any relevant metabolites) and fulvestrant
Time Frame Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8
Outcome Measure Data Not Reported
8.Secondary Outcome
Title PFS Based on Radiology Assessments and Using RECIST 1.1 Criteria
Hide Description PFS in patients with PIK3CA mutant status and patients with PIK3CA non-mutant status as measured in ctDNA.
Time Frame Baseline, Up to approximatly 36 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description Clinical benefit rate is defined as the proportion of patients with a best overall response of CR or PR or SD or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment.
Time Frame Up to approximatly 36 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change in the Global Health Status/(QOL) Scale Score of the EORTC QLQ-C30
Hide Description Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized
Time Frame Baseline, Up to approximatly 36 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Summary Statistics of Fulvestrant and Alpelisib Plasma Concentrations
Hide Description Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples.
Time Frame Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8
Outcome Measure Data Not Reported
12.Secondary Outcome
Title PFS for Patients With PIK3CA Non-mutant Status
Hide Description PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA non-mutant cohort
Time Frame Up to approximatly 36 months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title OS for Patients With PIK3CA Non-mutant Status
Hide Description OS is defined as the time from date of randomization to date of death due to any cause.
Time Frame Up to approximatly 59 months
Outcome Measure Data Not Reported
Time Frame Adverse Events and Serious Adverse Events were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 30.8 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alpelisib qd + Fulvestrant Placebo qd + Fulvestrant
Hide Arm/Group Description Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
All-Cause Mortality
Alpelisib qd + Fulvestrant Placebo qd + Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   7/284 (2.46%)   12/287 (4.18%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alpelisib qd + Fulvestrant Placebo qd + Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   99/284 (34.86%)   48/287 (16.72%) 
Blood and lymphatic system disorders     
Anaemia  1  5/284 (1.76%)  0/287 (0.00%) 
Febrile neutropenia  1  1/284 (0.35%)  0/287 (0.00%) 
Thrombotic microangiopathy  1  1/284 (0.35%)  0/287 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/284 (0.00%)  1/287 (0.35%) 
Cardiac arrest  1  1/284 (0.35%)  0/287 (0.00%) 
Cardiac failure  1  0/284 (0.00%)  2/287 (0.70%) 
Myocardial infarction  1  0/284 (0.00%)  1/287 (0.35%) 
Pericardial effusion  1  0/284 (0.00%)  1/287 (0.35%) 
Sinus tachycardia  1  0/284 (0.00%)  1/287 (0.35%) 
Gastrointestinal disorders     
Abdominal pain  1  6/284 (2.11%)  2/287 (0.70%) 
Colitis  1  0/284 (0.00%)  1/287 (0.35%) 
Constipation  1  0/284 (0.00%)  1/287 (0.35%) 
Diarrhoea  1  8/284 (2.82%)  0/287 (0.00%) 
Dyspepsia  1  1/284 (0.35%)  0/287 (0.00%) 
Enterocolitis  1  1/284 (0.35%)  0/287 (0.00%) 
Gallstone ileus  1  0/284 (0.00%)  1/287 (0.35%) 
Gastrointestinal haemorrhage  1  0/284 (0.00%)  1/287 (0.35%) 
Ileus  1  1/284 (0.35%)  0/287 (0.00%) 
Intestinal obstruction  1  1/284 (0.35%)  0/287 (0.00%) 
Melaena  1  1/284 (0.35%)  0/287 (0.00%) 
Nausea  1  5/284 (1.76%)  2/287 (0.70%) 
Oesophagitis  1  1/284 (0.35%)  0/287 (0.00%) 
Pancreatitis  1  1/284 (0.35%)  0/287 (0.00%) 
Stomatitis  1  4/284 (1.41%)  0/287 (0.00%) 
Subileus  1  0/284 (0.00%)  1/287 (0.35%) 
Upper gastrointestinal haemorrhage  1  2/284 (0.70%)  0/287 (0.00%) 
Vomiting  1  5/284 (1.76%)  3/287 (1.05%) 
General disorders     
Asthenia  1  1/284 (0.35%)  0/287 (0.00%) 
Chest pain  1  1/284 (0.35%)  0/287 (0.00%) 
Fatigue  1  1/284 (0.35%)  0/287 (0.00%) 
General physical health deterioration  1  2/284 (0.70%)  0/287 (0.00%) 
Malaise  1  1/284 (0.35%)  0/287 (0.00%) 
Mucosal inflammation  1  3/284 (1.06%)  0/287 (0.00%) 
Multiple organ dysfunction syndrome  1  1/284 (0.35%)  0/287 (0.00%) 
Pyrexia  1  4/284 (1.41%)  0/287 (0.00%) 
Hepatobiliary disorders     
Hepatic failure  1  1/284 (0.35%)  0/287 (0.00%) 
Hepatitis acute  1  1/284 (0.35%)  0/287 (0.00%) 
Immune system disorders     
Hypersensitivity  1  3/284 (1.06%)  0/287 (0.00%) 
Infections and infestations     
Abscess jaw  1  1/284 (0.35%)  0/287 (0.00%) 
Appendicitis  1  0/284 (0.00%)  1/287 (0.35%) 
Bacteraemia  1  1/284 (0.35%)  0/287 (0.00%) 
Cellulitis  1  2/284 (0.70%)  2/287 (0.70%) 
Erysipelas  1  1/284 (0.35%)  0/287 (0.00%) 
Herpes zoster  1  1/284 (0.35%)  0/287 (0.00%) 
Mediastinitis  1  0/284 (0.00%)  1/287 (0.35%) 
Peritonsillar abscess  1  1/284 (0.35%)  0/287 (0.00%) 
Pneumonia  1  3/284 (1.06%)  5/287 (1.74%) 
Pulmonary tuberculosis  1  0/284 (0.00%)  1/287 (0.35%) 
Pyelonephritis  1  0/284 (0.00%)  1/287 (0.35%) 
Pyelonephritis acute  1  1/284 (0.35%)  0/287 (0.00%) 
Respiratory tract infection  1  0/284 (0.00%)  1/287 (0.35%) 
Septic shock  1  0/284 (0.00%)  1/287 (0.35%) 
Skin infection  1  0/284 (0.00%)  1/287 (0.35%) 
Urinary tract infection  1  2/284 (0.70%)  3/287 (1.05%) 
Urosepsis  1  1/284 (0.35%)  0/287 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  0/284 (0.00%)  1/287 (0.35%) 
Hip fracture  1  1/284 (0.35%)  1/287 (0.35%) 
Overdose  1  0/284 (0.00%)  1/287 (0.35%) 
Procedural complication  1  0/284 (0.00%)  1/287 (0.35%) 
Radiation proctitis  1  1/284 (0.35%)  0/287 (0.00%) 
Rib fracture  1  1/284 (0.35%)  0/287 (0.00%) 
Spinal compression fracture  1  1/284 (0.35%)  1/287 (0.35%) 
Ulna fracture  1  0/284 (0.00%)  1/287 (0.35%) 
Wrist fracture  1  1/284 (0.35%)  0/287 (0.00%) 
Investigations     
Blood bilirubin increased  1  0/284 (0.00%)  1/287 (0.35%) 
Blood creatinine increased  1  2/284 (0.70%)  0/287 (0.00%) 
Haemoglobin decreased  1  1/284 (0.35%)  0/287 (0.00%) 
Hepatic enzyme increased  1  1/284 (0.35%)  0/287 (0.00%) 
Lipase increased  1  1/284 (0.35%)  0/287 (0.00%) 
Weight decreased  1  1/284 (0.35%)  0/287 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/284 (0.70%)  0/287 (0.00%) 
Dehydration  1  3/284 (1.06%)  3/287 (1.05%) 
Diabetic ketoacidosis  1  1/284 (0.35%)  0/287 (0.00%) 
Hypercalcaemia  1  0/284 (0.00%)  2/287 (0.70%) 
Hyperglycaemia  1  28/284 (9.86%)  0/287 (0.00%) 
Hypochloraemia  1  1/284 (0.35%)  0/287 (0.00%) 
Hypokalaemia  1  3/284 (1.06%)  1/287 (0.35%) 
Hyponatraemia  1  2/284 (0.70%)  1/287 (0.35%) 
Ketoacidosis  1  1/284 (0.35%)  0/287 (0.00%) 
Type 2 diabetes mellitus  1  1/284 (0.35%)  0/287 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/284 (0.70%)  2/287 (0.70%) 
Bone pain  1  0/284 (0.00%)  1/287 (0.35%) 
Muscular weakness  1  2/284 (0.70%)  0/287 (0.00%) 
Musculoskeletal chest pain  1  1/284 (0.35%)  0/287 (0.00%) 
Osteitis  1  0/284 (0.00%)  1/287 (0.35%) 
Osteonecrosis of jaw  1  5/284 (1.76%)  1/287 (0.35%) 
Spinal column stenosis  1  1/284 (0.35%)  0/287 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  0/284 (0.00%)  1/287 (0.35%) 
Metastases to meninges  1  1/284 (0.35%)  0/287 (0.00%) 
Second primary malignancy  1  1/284 (0.35%)  0/287 (0.00%) 
Tumour pain  1  1/284 (0.35%)  0/287 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  0/284 (0.00%)  1/287 (0.35%) 
Brain oedema  1  2/284 (0.70%)  0/287 (0.00%) 
Cerebrovascular accident  1  0/284 (0.00%)  1/287 (0.35%) 
Headache  1  1/284 (0.35%)  0/287 (0.00%) 
Motor dysfunction  1  0/284 (0.00%)  1/287 (0.35%) 
Seizure  1  1/284 (0.35%)  0/287 (0.00%) 
Spinal cord compression  1  0/284 (0.00%)  2/287 (0.70%) 
Syncope  1  1/284 (0.35%)  0/287 (0.00%) 
Psychiatric disorders     
Bipolar disorder  1  1/284 (0.35%)  0/287 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  5/284 (1.76%)  1/287 (0.35%) 
Nephrolithiasis  1  1/284 (0.35%)  1/287 (0.35%) 
Renal failure  1  2/284 (0.70%)  0/287 (0.00%) 
Ureterolithiasis  1  1/284 (0.35%)  0/287 (0.00%) 
Reproductive system and breast disorders     
Pelvic pain  1  0/284 (0.00%)  1/287 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/284 (0.00%)  1/287 (0.35%) 
Aspiration  1  0/284 (0.00%)  1/287 (0.35%) 
Bronchostenosis  1  0/284 (0.00%)  1/287 (0.35%) 
Dyspnoea  1  2/284 (0.70%)  4/287 (1.39%) 
Interstitial lung disease  1  1/284 (0.35%)  1/287 (0.35%) 
Pleural effusion  1  3/284 (1.06%)  5/287 (1.74%) 
Pneumonitis  1  2/284 (0.70%)  0/287 (0.00%) 
Pulmonary embolism  1  2/284 (0.70%)  3/287 (1.05%) 
Pulmonary oedema  1  1/284 (0.35%)  0/287 (0.00%) 
Respiratory failure  1  1/284 (0.35%)  0/287 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  1/284 (0.35%)  0/287 (0.00%) 
Dermatitis allergic  1  1/284 (0.35%)  0/287 (0.00%) 
Erythema  1  1/284 (0.35%)  0/287 (0.00%) 
Erythema multiforme  1  3/284 (1.06%)  0/287 (0.00%) 
Rash  1  5/284 (1.76%)  0/287 (0.00%) 
Rash generalised  1  1/284 (0.35%)  0/287 (0.00%) 
Rash macular  1  1/284 (0.35%)  0/287 (0.00%) 
Rash maculo-papular  1  3/284 (1.06%)  0/287 (0.00%) 
Stevens-Johnson syndrome  1  1/284 (0.35%)  0/287 (0.00%) 
Urticaria  1  1/284 (0.35%)  0/287 (0.00%) 
Vascular disorders     
Hypertension  1  1/284 (0.35%)  0/287 (0.00%) 
Hypertensive crisis  1  1/284 (0.35%)  0/287 (0.00%) 
Thrombosis  1  0/284 (0.00%)  1/287 (0.35%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alpelisib qd + Fulvestrant Placebo qd + Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   279/284 (98.24%)   243/287 (84.67%) 
Blood and lymphatic system disorders     
Anaemia  1  22/284 (7.75%)  14/287 (4.88%) 
Gastrointestinal disorders     
Abdominal pain  1  30/284 (10.56%)  19/287 (6.62%) 
Abdominal pain upper  1  16/284 (5.63%)  11/287 (3.83%) 
Constipation  1  22/284 (7.75%)  36/287 (12.54%) 
Diarrhoea  1  161/284 (56.69%)  45/287 (15.68%) 
Dry mouth  1  27/284 (9.51%)  12/287 (4.18%) 
Dyspepsia  1  31/284 (10.92%)  16/287 (5.57%) 
Nausea  1  127/284 (44.72%)  63/287 (21.95%) 
Stomatitis  1  68/284 (23.94%)  18/287 (6.27%) 
Vomiting  1  73/284 (25.70%)  26/287 (9.06%) 
General disorders     
Asthenia  1  58/284 (20.42%)  37/287 (12.89%) 
Fatigue  1  69/284 (24.30%)  49/287 (17.07%) 
Mucosal inflammation  1  52/284 (18.31%)  3/287 (1.05%) 
Oedema peripheral  1  41/284 (14.44%)  13/287 (4.53%) 
Pyrexia  1  40/284 (14.08%)  14/287 (4.88%) 
Infections and infestations     
Nasopharyngitis  1  22/284 (7.75%)  24/287 (8.36%) 
Upper respiratory tract infection  1  12/284 (4.23%)  18/287 (6.27%) 
Urinary tract infection  1  28/284 (9.86%)  12/287 (4.18%) 
Investigations     
Alanine aminotransferase increased  1  23/284 (8.10%)  16/287 (5.57%) 
Aspartate aminotransferase increased  1  27/284 (9.51%)  15/287 (5.23%) 
Blood creatinine increased  1  29/284 (10.21%)  4/287 (1.39%) 
Gamma-glutamyltransferase increased  1  27/284 (9.51%)  20/287 (6.97%) 
Lipase increased  1  17/284 (5.99%)  11/287 (3.83%) 
Weight decreased  1  75/284 (26.41%)  6/287 (2.09%) 
Metabolism and nutrition disorders     
Decreased appetite  1  99/284 (34.86%)  30/287 (10.45%) 
Hyperglycaemia  1  177/284 (62.32%)  28/287 (9.76%) 
Hypokalaemia  1  23/284 (8.10%)  5/287 (1.74%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  32/284 (11.27%)  47/287 (16.38%) 
Back pain  1  39/284 (13.73%)  37/287 (12.89%) 
Bone pain  1  10/284 (3.52%)  16/287 (5.57%) 
Muscle spasms  1  19/284 (6.69%)  11/287 (3.83%) 
Musculoskeletal pain  1  14/284 (4.93%)  19/287 (6.62%) 
Myalgia  1  19/284 (6.69%)  8/287 (2.79%) 
Pain in extremity  1  22/284 (7.75%)  21/287 (7.32%) 
Nervous system disorders     
Dizziness  1  22/284 (7.75%)  20/287 (6.97%) 
Dysgeusia  1  47/284 (16.55%)  10/287 (3.48%) 
Headache  1  49/284 (17.25%)  38/287 (13.24%) 
Psychiatric disorders     
Insomnia  1  21/284 (7.39%)  12/287 (4.18%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  28/284 (9.86%)  27/287 (9.41%) 
Dyspnoea  1  23/284 (8.10%)  28/287 (9.76%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  56/284 (19.72%)  7/287 (2.44%) 
Dry skin  1  42/284 (14.79%)  10/287 (3.48%) 
Erythema  1  15/284 (5.28%)  2/287 (0.70%) 
Pruritus  1  51/284 (17.96%)  16/287 (5.57%) 
Rash  1  99/284 (34.86%)  17/287 (5.92%) 
Rash maculo-papular  1  38/284 (13.38%)  5/287 (1.74%) 
Vascular disorders     
Hot flush  1  9/284 (3.17%)  19/287 (6.62%) 
Hypertension  1  23/284 (8.10%)  14/287 (4.88%) 
Lymphoedema  1  15/284 (5.28%)  6/287 (2.09%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
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: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02437318     History of Changes
Other Study ID Numbers: CBYL719C2301
2015-000340-42 ( EudraCT Number )
First Submitted: April 22, 2015
First Posted: May 7, 2015
Results First Submitted: June 17, 2019
Results First Posted: August 13, 2019
Last Update Posted: November 20, 2019