EPIK-B3: Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: alpelisib + nab-paclitaxel Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Single arm Open label in Study Part B1 |
Drug: alpelisib
300 mg orally once per day (QD)
Other Names:
Drug: nab-paclitaxel
100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle
Other Names:
|
| Placebo Comparator: placebo + nab-paclitaxel Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Not applicable in Study Part B1 |
Drug: placebo
300 mg orally once per day (QD)
Other Names:
Drug: nab-paclitaxel
100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) Per Investigator Assessment in Study part A [Once approximately 192 PFS events in Study Part A had been observed, up to 35 months]
PFS, defined as 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
- Progression-free Survival (PFS) Per Investigator Assessment in Study part B2 [Once approximately 192 PFS events in Study Part B2 had been observed, up to 22 months]
PFS, defined as 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
- Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in study Part B1 [Up to 6 months]
ORR is defined as the proportion of subjects with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1
Secondary Outcome Measures
- Overall Survival (OS) in Study Part A [Up to 66 months]
OS is defined as the time from date of randomization to date of death due to any cause
- Overall Survival (OS) in Study Part B2 [Up to 41 months]
OS is defined as the time from date of randomization to date of death due to any cause
- Overall response rate (ORR) with confirmed response in Study Part A [Up to 35 months]
ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1
- Overall response rate (ORR) with confirmed response in Study Part B2 [Up to 22 months]
ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1
- Clinical benefit rate (CBR) with confirmed response in Study Part A [Up to 35 months]
Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1
- Clinical benefit rate (CBR) with confirmed response in Study Part B1 [Up to 6 months]
Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1
- Clinical benefit rate (CBR) with confirmed response in Study Part B2 [Up to 22 months]
Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1
- Time to response (TTR) in Study Part A [Up to 35 months]
Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1
- Time to response (TTR) in Study Part B1 [Up to 6 months]
Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1
- Time to response (TTR) in Study Part B2 [Up to 22 months]
Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1
- Duration of Response (DOR) with confirmed response in Study Part A [Up to 35 months]
Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer
- Duration of Response (DOR) with confirmed response in Study Part B1 [Up to 6 months]
Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer
- Duration of Response (DOR) with confirmed response in Study Part B2 [Up to 22 months]
Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer
- Overall Survival (OS) in Study Part B1 [Up to 6 months]
OS is defined as the time from date of enrolment to date of death due to any cause
- Progression-free Survival (PFS) Per Investigator Assessment in Study part B1 [Up to 6 months]
PFS, defined as time from the date of enrolment 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
- Plasma concentrations of alpelisib - Part A [Up to 35 months]
Summary statistics of plasma alpelisib concentrations by time point in study Part A
- Plasma concentrations of alpelisib - Part B1 [Up to 6 months]
Summary statistics of plasma alpelisib concentrations by time point in study Part B1
- Plasma concentrations of alpelisib -Part B2 [up to 22 months]
Summary statistics of plasma alpelisib concentrations by time point in study Part B2
- Plasma concentrations of paclitaxel - Part A [Up to 35 months]
Summary statistics of plasma paclitaxel concentrations by time point in study Part A
- Plasma concentrations of paclitaxel - Part B1 [up to 6 months]
Summary statistics of plasma paclitaxel concentrations by time point in study Part B1
- Change from baseline in the global health status/Quality of life (QoL) scale score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) in study Part A [Up to 35 months]
Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment
- Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in study Part B2 [Up to 22 months]
Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment
- Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in study Part A [Up to 35 months]
Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items & is composed of both multi-item scales & single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items & a global health status/QoL scale. The scales & single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems
- Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in study Part B2 [Up to 22 months]
Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items & is composed of both multi-item scales & single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items & a global health status/QoL scale. The scales & single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems
- PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in study Part A [Up to 35 months]
PFS in patients with PIK3CA mutation as measured in ctDNA
- PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in study Part B2 [Up to 22 months]
PFS in patients with PIK3CA mutation as measured in ctDNA
- Time to definitive deterioration of the Eastern Cooperative Oncology Group (ECOG) performance status (PS) from baseline in Study Part A [Up to 35 months]
Definitive deterioration of ECOG PS is defined as the time from the date of randomization to the date of event defined as a worsening of at least once category from baseline in ECOG PS with no later improvement above this threshold observed during the course of the treatment or until death due to any cause
- Time to definitive deterioration of the ECOG performance status from baseline in Study Part B2 [Up to 22 months]
Definitive deterioration of ECOG PS is defined as the time from the date of randomization to the date of event defined as a worsening of at least once category from baseline in ECOG PS with no later improvement above this threshold observed during the course of the treatment or until death due to any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC
-
Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: patients must have measurable disease
-
Participant has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation
-
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Participant has received no more than one line of therapy for metastatic disease.
-
Participant has adequate bone marrow and organ function
Exclusion Criteria:
-
Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
-
Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients
-
Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia
-
Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening
-
Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c
-
Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion
-
Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis
-
Participant has currently documented pneumonitis/interstitial lung disease
-
Participant has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS)
-
Participant with unresolved osteonecrosis of the jaw
Other protocol-defined inclusion/exclusion criteria apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Blood and Cancer Center Dept. of CBCC (2) | Bakersfield | California | United States | 93309 |
| 2 | Cancer and Blood Specialty Clinic | Los Alamitos | California | United States | 90720 |
| 3 | USC Norris Cancer Center | Los Angeles | California | United States | 90033 |
| 4 | UCLA Medical Center Santa Monica Location | Los Angeles | California | United States | 90095 |
| 5 | Cancer Care Associates Medical Group Center | Redondo Beach | California | United States | 90277 |
| 6 | Florida Cancer Specialists Dept of Oncology (2) | Fort Myers | Florida | United States | 33901 |
| 7 | Florida Cancer Specialists FL Cancer Specialists | Fort Myers | Florida | United States | 33901 |
| 8 | Florida Cancer Specialists Onc Dept | Fort Myers | Florida | United States | 33901 |
| 9 | Florida Cancer Affiliates of Ocala | Ocala | Florida | United States | 34471 |
| 10 | University of Illinois Cancer Center at Chicago | Chicago | Illinois | United States | 60612 |
| 11 | Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd | Fort Wayne | Indiana | United States | 46815 |
| 12 | University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2 | Kansas City | Kansas | United States | 66160 |
| 13 | Hematology and Oncology Clinic SC | Baton Rouge | Louisiana | United States | 70809 |
| 14 | Sinai Hospital of Baltimore Dept of Sinai Hospital - 2 | Baltimore | Maryland | United States | 21215 |
| 15 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 16 | Mayo Clinic Rochester Mayo - Roch. | Rochester | Minnesota | United States | 55905 |
| 17 | Park Nicollet Institute Dept Onc | Saint Louis Park | Minnesota | United States | 55416 |
| 18 | Research Medical Center HCA Midwest Division | Kansas City | Missouri | United States | 64132 |
| 19 | Comprehensive Cancer Centers of Nevada CCC of Nevada (1) | Henderson | Nevada | United States | 89052 |
| 20 | Meridian Health Systems | Neptune | New Jersey | United States | 07753 |
| 21 | New York Oncology Hematology, P.C. | Albany | New York | United States | 12206 |
| 22 | Cleveland Clinic Foundation Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 23 | University of Pittsburgh Cancer Institute Cancer Pavilion, 5th floor | Pittsburgh | Pennsylvania | United States | 15232 |
| 24 | Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga | Chattanooga | Tennessee | United States | 37404 |
| 25 | Tennessee Oncology Tennessee Oncology (3) | Nashville | Tennessee | United States | 37203 |
| 26 | Texas Oncology, P.A. Austin | Bedford | Texas | United States | 76022 |
| 27 | Texas Oncology PA Dallas Presbyterian Hospital SC | Dallas | Texas | United States | 75231 |
| 28 | Texas Oncology Texas Oncology - Denton | Dallas | Texas | United States | 75246 |
| 29 | US Oncology US Oncology Associates | Dallas | Texas | United States | 75246 |
| 30 | El Paso, Texas Oncology | El Paso | Texas | United States | 79902 |
| 31 | Texas Oncology Houston Memorial City SC | Houston | Texas | United States | 77024 |
| 32 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 33 | Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio | San Antonio | Texas | United States | 78229 |
| 34 | Texas Oncology Northeast Texas | Tyler | Texas | United States | 75702 |
| 35 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
| 36 | Northwest Medical Specialties Northwest Medical - Puyallup | Tacoma | Washington | United States | 98405 |
| 37 | Novartis Investigative Site | Caba | Buenos Aires | Argentina | C1125ABD |
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| 40 | Novartis Investigative Site | Buenos Aires | Caba | Argentina | C1431FWO |
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| 42 | Novartis Investigative Site | Rio Negro | Viedma | Argentina | 8500 |
| 43 | Novartis Investigative Site | Darlinghurst | New South Wales | Australia | 2010 |
| 44 | Novartis Investigative Site | Melbourne | Victoria | Australia | 3000 |
| 45 | Novartis Investigative Site | Murdoch | Western Australia | Australia | 6150 |
| 46 | Novartis Investigative Site | Nedlands | Western Australia | Australia | 6009 |
| 47 | Novartis Investigative Site | Innsbruck | Tyrol | Austria | 6020 |
| 48 | Novartis Investigative Site | Leoben | Austria | A 8700 | |
| 49 | Novartis Investigative Site | Salzburg | Austria | 5020 | |
| 50 | Novartis Investigative Site | Vienna | Austria | 1090 | |
| 51 | Novartis Investigative Site | Vienna | Austria | A-1090 | |
| 52 | Novartis Investigative Site | Caxias do Sul | RS | Brazil | 95070-560 |
| 53 | Novartis Investigative Site | Barretos | SP | Brazil | 14784 400 |
| 54 | Novartis Investigative Site | Sao Paulo | SP | Brazil | 01317-002 |
| 55 | Novartis Investigative Site | Sao Paulo | SP | Brazil | 03102-002 |
| 56 | Novartis Investigative Site | Plovdiv | Bulgaria | 4004 | |
| 57 | Novartis Investigative Site | Sofia | Bulgaria | 1407 | |
| 58 | Novartis Investigative Site | Sofia | Bulgaria | 1756 | |
| 59 | Novartis Investigative Site | Varna | Bulgaria | 9010 | |
| 60 | Novartis Investigative Site | Hefei | Anhui | China | 230001 |
| 61 | Novartis Investigative Site | Chongqing | Chongqing | China | 404100 |
| 62 | Novartis Investigative Site | Guangzhou | Guangdong | China | 510630 |
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| 65 | Novartis Investigative Site | Harbin | Heilongjiang | China | 150081 |
| 66 | Novartis Investigative Site | Wuhan | Hubei | China | 430022 |
| 67 | Novartis Investigative Site | Changsha | Hunan | China | 410013 |
| 68 | Novartis Investigative Site | Nanjing | Jiangsu | China | 210029 |
| 69 | Novartis Investigative Site | Nanchang | Jiangxi | China | 330009 |
| 70 | Novartis Investigative Site | Chang Chun | Jilin | China | 130021 |
| 71 | Novartis Investigative Site | Shengyang | Liaoning | China | 110042 |
| 72 | Novartis Investigative Site | Jinan | Shandong | China | 250117 |
| 73 | Novartis Investigative Site | Xian | Shanxi | China | 710061 |
| 74 | Novartis Investigative Site | Chengdu | Sichuan | China | 610041 |
| 75 | Novartis Investigative Site | Tianjin | Tianjin | China | 300060 |
| 76 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310016 |
| 77 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310022 |
| 78 | Novartis Investigative Site | Beijing | China | 100021 | |
| 79 | Novartis Investigative Site | Dalian | China | ||
| 80 | Novartis Investigative Site | Qingdao | China | 266000 | |
| 81 | Novartis Investigative Site | Shanghai | China | 200025 | |
| 82 | Novartis Investigative Site | Shenyang | China | 110001 | |
| 83 | Novartis Investigative Site | Rionegro | Antioquia | Colombia | 054047 |
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| 87 | Novartis Investigative Site | Split | HRV | Croatia | 21000 |
| 88 | Novartis Investigative Site | Zagreb | Croatia | 10000 | |
| 89 | Novartis Investigative Site | Saint-Cloud | Hauts De Seine | France | 92210 |
| 90 | Novartis Investigative Site | Angers Cedex 02 | France | 49055 | |
| 91 | Novartis Investigative Site | Besancon Cedex | France | 25030 | |
| 92 | Novartis Investigative Site | Clermont Ferrand | France | 63011 | |
| 93 | Novartis Investigative Site | Creteil | France | 94010 | |
| 94 | Novartis Investigative Site | Dijon | France | 21034 | |
| 95 | Novartis Investigative Site | Le Mans | France | 72000 | |
| 96 | Novartis Investigative Site | Metz | France | 57085 | |
| 97 | Novartis Investigative Site | Nimes Cedex 9 | France | 30029 | |
| 98 | Novartis Investigative Site | Paris Cedex 10 | France | 75475 | |
| 99 | Novartis Investigative Site | Poitiers | France | 86000 | |
| 100 | Novartis Investigative Site | Reims | France | 51100 | |
| 101 | Novartis Investigative Site | Saint-Herblain Cédex | France | 44805 | |
| 102 | Novartis Investigative Site | Villejuif Cedex | France | 94800 | |
| 103 | Novartis Investigative Site | Ravensburg | Baden-Wuerttemberg | Germany | 88212 |
| 104 | Novartis Investigative Site | Muenchen | Bavaria | Germany | 80637 |
| 105 | Novartis Investigative Site | Essen | Nordrhein-Westfalen | Germany | 45136 |
| 106 | Novartis Investigative Site | Velbert | North Rhine-westphalia | Germany | 42551 |
| 107 | Novartis Investigative Site | Luebeck | Schleswig-holstein | Germany | 23563 |
| 108 | Novartis Investigative Site | Berlin | Germany | 13581 | |
| 109 | Novartis Investigative Site | Bonn | Germany | 53111 | |
| 110 | Novartis Investigative Site | Dresden | Germany | 01307 | |
| 111 | Novartis Investigative Site | Erlangen | Germany | 91054 | |
| 112 | Novartis Investigative Site | Hamburg | Germany | 20357 | |
| 113 | Novartis Investigative Site | Heidelberg | Germany | 69120 | |
| 114 | Novartis Investigative Site | Leipzig | Germany | 04103 | |
| 115 | Novartis Investigative Site | Mannheim | Germany | 68167 | |
| 116 | Novartis Investigative Site | Rostock | Germany | 18059 | |
| 117 | Novartis Investigative Site | Tübingen | Germany | 72076 | |
| 118 | Novartis Investigative Site | Ulm | Germany | 89081 | |
| 119 | Novartis Investigative Site | Wuerzburg | Germany | 97080 | |
| 120 | Novartis Investigative Site | Hong Kong | Hong Kong | ||
| 121 | Novartis Investigative Site | Budapest | Hungary | 1062 | |
| 122 | Novartis Investigative Site | Budapest | Hungary | H 1122 | |
| 123 | Novartis Investigative Site | Debrecen | Hungary | 4032 | |
| 124 | Novartis Investigative Site | Kecskemet | Hungary | 6000 | |
| 125 | Novartis Investigative Site | Tatabanya | Hungary | H 2800 | |
| 126 | Novartis Investigative Site | Faridabad | Haryana | India | 121 001 |
| 127 | Novartis Investigative Site | Mumbai | Maharashtra | India | 400 053 |
| 128 | Novartis Investigative Site | Mumbai | Maharashtra | India | 400056 |
| 129 | Novartis Investigative Site | Vellore | Tamil Nadu | India | 632 004 |
| 130 | Novartis Investigative Site | Hyderabad | Telangana | India | 500034 |
| 131 | Novartis Investigative Site | Hyderabad | Telangana | India | 500082 |
| 132 | Novartis Investigative Site | Kolkata | West Bengal | India | 700160 |
| 133 | Novartis Investigative Site | Be'er Sheva | Israel | 8457108 | |
| 134 | Novartis Investigative Site | Ramat Gan | Israel | 52621 | |
| 135 | Novartis Investigative Site | Tel Aviv | Israel | 6423906 | |
| 136 | Novartis Investigative Site | Ancona | AN | Italy | 60126 |
| 137 | Novartis Investigative Site | Brindisi | BR | Italy | 72100 |
| 138 | Novartis Investigative Site | Meldola | FC | Italy | 47014 |
| 139 | Novartis Investigative Site | Genova | GE | Italy | 16132 |
| 140 | Novartis Investigative Site | Monza | MB | Italy | 20900 |
| 141 | Novartis Investigative Site | Messina | ME | Italy | 98158 |
| 142 | Novartis Investigative Site | Rionero in Vulture | PZ | Italy | 85028 |
| 143 | Novartis Investigative Site | Roma | RM | Italy | 00128 |
| 144 | Novartis Investigative Site | Roma | RM | Italy | 00168 |
| 145 | Novartis Investigative Site | Torino | TO | Italy | 10126 |
| 146 | Novartis Investigative Site | Napoli | Italy | 80131 | |
| 147 | Novartis Investigative Site | Amman | Jordan | 11941 | |
| 148 | Novartis Investigative Site | Seoul | Korea, Republic of | 03080 | |
| 149 | Novartis Investigative Site | Seoul | Korea, Republic of | 05505 | |
| 150 | Novartis Investigative Site | Seoul | Korea, Republic of | 06351 | |
| 151 | Novartis Investigative Site | El Chouf | LBN | Lebanon | 1503201002 |
| 152 | Novartis Investigative Site | Ashrafieh | Lebanon | 166830 | |
| 153 | Novartis Investigative Site | Beirut | Lebanon | 1107 2020 | |
| 154 | Novartis Investigative Site | Petaling Jaya | Selangor | Malaysia | 46050 |
| 155 | Novartis Investigative Site | Kuala Lumpur | Malaysia | 59100 | |
| 156 | Novartis Investigative Site | Pulau Pinang | Malaysia | 10990 | |
| 157 | Novartis Investigative Site | Tuxtla Gutierrez | Chiapas | Mexico | 29038 |
| 158 | Novartis Investigative Site | Ciudad De Mexico | Distrito Federal | Mexico | 04980 |
| 159 | Novartis Investigative Site | Monterrey | Nuevo Leon | Mexico | 64460 |
| 160 | Novartis Investigative Site | Oslo | Norway | NO 0450 | |
| 161 | Novartis Investigative Site | Stavanger | Norway | 4019 | |
| 162 | Novartis Investigative Site | Tromsoe | Norway | 9038 | |
| 163 | Novartis Investigative Site | Trujillo | La Libertad | Peru | |
| 164 | Novartis Investigative Site | Lima | Peru | 33 | |
| 165 | Novartis Investigative Site | Lima | Peru | Lima 31 | |
| 166 | Novartis Investigative Site | Gdynia | Poland | 81 519 | |
| 167 | Novartis Investigative Site | Opole | Poland | 45-061 | |
| 168 | Novartis Investigative Site | Poznan | Poland | 61 485 | |
| 169 | Novartis Investigative Site | Rzeszow | Poland | 35-021 | |
| 170 | Novartis Investigative Site | Bucharest | Romania | 022328 | |
| 171 | Novartis Investigative Site | Cluj Napoca | Romania | 400006 | |
| 172 | Novartis Investigative Site | Cluj-Napoca | Romania | 400124 | |
| 173 | Novartis Investigative Site | Constanta | Romania | 900591 | |
| 174 | Novartis Investigative Site | Craiova | Romania | 200347 | |
| 175 | Novartis Investigative Site | Ploiesti | Romania | 100337 | |
| 176 | Novartis Investigative Site | Arkhangelsk | Russian Federation | 163045 | |
| 177 | Novartis Investigative Site | Chelyabinsk | Russian Federation | 454048 | |
| 178 | Novartis Investigative Site | Moscow | Russian Federation | 117997 | |
| 179 | Novartis Investigative Site | Moscow | Russian Federation | 123056 | |
| 180 | Novartis Investigative Site | Moscow | Russian Federation | 143423 | |
| 181 | Novartis Investigative Site | Pushkin Saint Petersburg | Russian Federation | 196603 | |
| 182 | Novartis Investigative Site | Nis | Serbia | 18000 | |
| 183 | Novartis Investigative Site | Bratislava | Slovak Republic | Slovakia | 83310 |
| 184 | Novartis Investigative Site | Bratislava | Slovakia | 812 50 | |
| 185 | Novartis Investigative Site | Kosice | Slovakia | 041 91 | |
| 186 | Novartis Investigative Site | Ljubljana | Slovenia | 1000 | |
| 187 | Novartis Investigative Site | Port Elizabeth | Western Cape | South Africa | 6045 |
| 188 | Novartis Investigative Site | Johannesburg | South Africa | 2196 | |
| 189 | Novartis Investigative Site | Pretoria | South Africa | 0081 | |
| 190 | Novartis Investigative Site | Almeria | Andalucia | Spain | 04009 |
| 191 | Novartis Investigative Site | Sabadell | Barcelona | Spain | 08208 |
| 192 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08036 |
| 193 | Novartis Investigative Site | Alicante | Comunidad Valenciana | Spain | 03010 |
| 194 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46017 |
| 195 | Novartis Investigative Site | Badajoz | Extremadura | Spain | 06080 |
| 196 | Novartis Investigative Site | Palma De Mallorca | Islas Baleares | Spain | 07120 |
| 197 | Novartis Investigative Site | Ferrol | Spain | 15405 | |
| 198 | Novartis Investigative Site | Madrid | Spain | 28009 | |
| 199 | Novartis Investigative Site | Madrid | Spain | 28041 | |
| 200 | Novartis Investigative Site | Santa Cruz de Tenerife | Spain | 38009 | |
| 201 | Novartis Investigative Site | Valencia | Spain | 46026 | |
| 202 | Novartis Investigative Site | Aarau | Switzerland | 5000 | |
| 203 | Novartis Investigative Site | Bern | Switzerland | 3010 | |
| 204 | Novartis Investigative Site | Lausanne | Switzerland | 1011 | |
| 205 | Novartis Investigative Site | Zurich | Switzerland | 8008 | |
| 206 | Novartis Investigative Site | Kaoshiung | Taiwan | 83301 | |
| 207 | Novartis Investigative Site | Taichung | Taiwan | 40447 | |
| 208 | Novartis Investigative Site | Taipei | Taiwan | 10002 | |
| 209 | Novartis Investigative Site | Taipei | Taiwan | 10449 | |
| 210 | Novartis Investigative Site | Taoyuan | Taiwan | 33305 | |
| 211 | Novartis Investigative Site | Adana | Turkey | 01250 | |
| 212 | Novartis Investigative Site | Ankara | Turkey | 06100 | |
| 213 | Novartis Investigative Site | Istanbul | Turkey | 34722 | |
| 214 | Novartis Investigative Site | Istanbul | Turkey | 35100 | |
| 215 | Novartis Investigative Site | Izmir | Turkey | 35040 | |
| 216 | Novartis Investigative Site | Talas / Kayseri | Turkey | 38039 | |
| 217 | Novartis Investigative Site | Nottingham | United Kingdom | NG5 1PB | |
| 218 | Novartis Investigative Site | Oxford | United Kingdom | OX3 7LJ | |
| 219 | Novartis Investigative Site | Swansea | United Kingdom | SA2 8QA |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBYL719H12301
- 2019-002637-11