NAPOLI 3: A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Study Details
Study Description
Brief Summary
The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Irinotecan liposome injection + Oxaliplatin + 5-FU/LV Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity). |
Drug: Irinotecan Liposomal Injection
Irinotecan liposome injection is irinotecan in the form of the sucrosofate salt, encapsulated in liposomes for i.v. infusion. It is supplied in sterile, single-use vials containing 10 mL of irinotecan liposome injection at a concentration of 4.3 mg/mL free base equivalent (FBE).
Other Names:
Drug: Oxaliplatin
Oxaliplatin injection, USP is supplied in single-dose vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.
Other Names:
Drug: 5Fluorouracil
Fluorouracil injection, USP is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package. Each mL contains 50 mg fluorouracil in water for injection, USP.
Other Names:
Drug: Leucovorin
Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.
Other Names:
|
Active Comparator: Nab-paclitaxel + Gemcitabine Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity). |
Drug: Nab-paclitaxel
Nab-paclitaxel is a lyophilised powder containing 100 or 250 mg of paclitaxel formulated as albumin-bound particles in single-use vials for re-constitution. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.
Other Names:
Drug: Gemcitabine
Gemcitabine for injection is a lyophilised powder for solution for infusion, with each single use vial containing 200 mg, 1 g or 2 g of gemcitabine.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment)]
Secondary Outcome Measures
- Progression free survival (PFS) [From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment)]
- Overall Response Rate (ORR) [From study start until 543 OS events have occurred (approximately 15 months after last patient enrollment)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
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Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening.
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Subject has one or more metastatic lesions measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.
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Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal (ULN) (≤5x ULN is acceptable if liver metastases are present).
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Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.
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Adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xULN ).
Exclusion Criteria:
-
Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy
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Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.
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Subject has only localised advanced disease.
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Documented serum albumin <3 g/dL
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Known history of central nervous system (CNS) metastases.
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Clinically significant gastrointestinal disorder
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History of any second malignancy in the last 2 years
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Concurrent illnesses that would be a relative contraindication to trial participation
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Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1
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Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
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Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
2 | Banner Health- MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
3 | Mayo Clinic - Scottsdale | Phoenix | Arizona | United States | 85054 |
4 | Comprehensive Blood And Cancer Center | Bakersfield | California | United States | 93309 |
5 | University of California- Irvine Health Cancer Cente | Costa Mesa | California | United States | 92627 |
6 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
7 | University of California, Los Angeles (UCLA) | Los Angeles | California | United States | 90095 |
8 | St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare | Orange | California | United States | 92835 |
9 | University of California - Irvine Medical Center | Orange | California | United States | 92868 |
10 | Torrance Memorial Physician Network Cancer Care | Redondo Beach | California | United States | 90277 |
11 | Sutter Health Sacramento | Sacramento | California | United States | 95816 |
12 | Presbyterian Intercommunity Hospital (PIH) | Whittier | California | United States | 90602 |
13 | UC Health Memorial Hospital | Colorado Springs | Colorado | United States | 80909 |
14 | Rocky Mountain Cancer Center | Denver | Colorado | United States | 80218 |
15 | Mount Sinai Medical Center of Florida, Inc. | Miami Beach | Florida | United States | 33140 |
16 | Miami Cancer Institute | Miami | Florida | United States | 33176 |
17 | Florida Cancer Specialists - Fort Myers | Sarasota | Florida | United States | 34236 |
18 | Florida Cancer Specialists - Panhandle | Tallahassee | Florida | United States | 32308 |
19 | Florida Cancer Specialists - St. Petersburg | Tampa | Florida | United States | 33607 |
20 | Florida Cancer Specialists - East | West Palm Beach | Florida | United States | 33401 |
21 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
22 | Edward Hospital - Elmhurst | Elmhurst | Illinois | United States | 60540 |
23 | Edward Hospital | Naperville | Illinois | United States | 60540 |
24 | Illinois CancerCare - Peoria | Peoria | Illinois | United States | 61443 |
25 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
26 | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | United States | 46804 |
27 | Siouxland Hematology - Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
28 | University of Kentucky Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
29 | Pikeville Medical Center | Pikeville | Kentucky | United States | 41501 |
30 | Hematology Oncology Clinic | Baton Rouge | Louisiana | United States | 70809 |
31 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
32 | Willis-Knighton Cancer Center | Shreveport | Louisiana | United States | 71103 |
33 | Maine Center for Cancer Medicine | Scarborough | Maine | United States | 04074 |
34 | Maryland Oncology Hematology | Silver Spring | Maryland | United States | 20904 |
35 | Beth Israel Deaconess | Boston | Massachusetts | United States | 02215 |
36 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
37 | Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | United States | 49546 |
38 | Health Partners Institute | Minneapolis | Minnesota | United States | 55425 |
39 | Mayo Clinic - Rochester | Rochester | Minnesota | United States | 55902 |
40 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
41 | Washington University School of Medicine in St. Louis | Saint Louis | Missouri | United States | 63110 |
42 | Frontier Cancer Center | Billings | Montana | United States | 59102 |
43 | Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | United States | 68130 |
44 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
45 | Clinical Research Alliance, Inc | Lake Success | New York | United States | 10021 |
46 | David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
47 | University of Rochester | Rochester | New York | United States | 14642 |
48 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
49 | Messino Cancer Center | Asheville | North Carolina | United States | 28806 |
50 | The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James) | Columbus | Ohio | United States | 43210 |
51 | Toledo Clinic Cancer Center | Toledo | Ohio | United States | 43623 |
52 | Mercy Health - St. Elizabeth Youngstown Hospital | Youngstown | Ohio | United States | 44501 |
53 | University of Oklahoma - Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
54 | Oncology Associates of Oregon | Eugene | Oregon | United States | 97401 |
55 | Compass Oncology - Rose Quarter Cancer Center | Portland | Oregon | United States | 97227 |
56 | Kaiser Permanente - Northwest | Portland | Oregon | United States | 97227 |
57 | Oregon Health & Science University (OHSU) | Portland | Oregon | United States | 97239 |
58 | University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
59 | Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
60 | Chattanooga Oncology Hematology Care - Tennessee Oncology | Chattanooga | Tennessee | United States | 37404 |
61 | The West Cancer Center | Memphis | Tennessee | United States | 38138 |
62 | Sarah Cannon and HCA Research Institute | Nashville | Tennessee | United States | 37203 |
63 | Texas Oncology - Austin | Austin | Texas | United States | 78731 |
64 | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
65 | The Center for Cancer and Blood Disorders | Fort Worth | Texas | United States | 76104 |
66 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
67 | Houston Methodist Research Institute | Houston | Texas | United States | 77030 |
68 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
69 | Oncology Consultants | Houston | Texas | United States | 77030 |
70 | Texas Oncology - Tyler | Tyler | Texas | United States | 75702 |
71 | Texas Oncology - Wichita Falls | Wichita Falls | Texas | United States | 76310 |
72 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84106 |
73 | Virginia Cancer Specialists | Fairfax | Virginia | United States | 22031 |
74 | Blue Ridge Cancer Care | Wytheville | Virginia | United States | 24014 |
75 | Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
76 | ProHealth Care Medical Associates | Waukesha | Wisconsin | United States | 53188 |
77 | Bankstown-Lidcombe Hospital | Bankstown | Australia | 2200 | |
78 | Monash Medical Centre | Clayton | Australia | 3168 | |
79 | Fiona Stanley Hospital | Murdoch | Australia | 6150 | |
80 | Sir Charles Gairdner Hospital | Nedlands | Australia | 6009 | |
81 | St John of God Subiaco Hospital | Subiaco | Australia | 6008 | |
82 | Queen Elizabeth Hospital | Woodville South | Australia | 5011 | |
83 | Medizinische Universitaet Graz | Graz | Austria | 8036 | |
84 | Ordensklinikum Linz GmbH Barmherzige Schwestern | Linz | Austria | 4010 | |
85 | SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh | Salzburg | Austria | A-5020 | |
86 | Medical University of Vienna | Vienna | Austria | 1090 | |
87 | Onze-Lieve-Vrouwziekenhuis | Aalst | Belgium | 9300 | |
88 | ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame | Charleroi | Belgium | 6000 | |
89 | Universitair Ziekenhuis Antwerpen (UZA) | Edegem | Belgium | 2650 | |
90 | University Hospital Gent | Gent | Belgium | 9000 | |
91 | Hospital centre Jolimont | Haine-Saint-Paul | Belgium | 7100 | |
92 | University Hospital (UZ) Leuven | Leuven | Belgium | 3000 | |
93 | University Hospital Mont-Godinne | Yvoir | Belgium | 5530 | |
94 | Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | Brazil | 14784-400 | |
95 | Centro Regional Integrado de Oncologia (CRIO) | Ceara | Brazil | 60336-550 | |
96 | Instituto de Oncologia do Parana - IOP | Curitiba | Brazil | 80530-010 | |
97 | Centro de Pesquisas Oncológicas - CEPON | Florianópolis | Brazil | 88034-000 | |
98 | Hospital de Caridade de Ijui | Ijuí | Brazil | 98700 | |
99 | Clinica Neoplasias Litoral | Itajaí | Brazil | 88301-220 | |
100 | Hospital Bruno Born | Lajeado | Brazil | 95900 | |
101 | Centro de Pesquisas Clinicas de Natal - CPCLIN | Natal | Brazil | 59025-050 | |
102 | Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Brazil | ||
103 | Instituto Nacional Do Cancer (INCA) | Rio de Janeiro | Brazil | 20230-130 | |
104 | Instituto COI | Rio De Janeiro | Brazil | 22793-080 | |
105 | Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo) | San Paolo | Brazil | 03102-006 | |
106 | CIP Centro Integrado de Pesquisas do Hospital de Base | São José Do Rio Preto | Brazil | 5416 | |
107 | Hospital Alemão Oswaldo Cruz | São Paulo | Brazil | 01323-001 | |
108 | Instituto do Cancer do Estado de São Paulo (ICESP) | São Paulo | Brazil | ||
109 | Alberta Health Services Cross Cancer Institute | Edmonton | Canada | T6G 1Z2 | |
110 | Queen Elizabeth II Health Sciences Centre | Halifax | Canada | B3H 3A7 | |
111 | McGill University Faculty of Medicine - Royal Victoria Hospital | Montréal | Canada | H3G 1Y6 | |
112 | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Canada | J1H 5N4 | |
113 | Masarykuv onkologicky ustav | Brno | Czechia | 65653 | |
114 | Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | 50005 | |
115 | University Hospital Olomouc, Department of Oncology | Olomouc | Czechia | 77020 | |
116 | Thomayerova Nemocnice | Praha | Czechia | 14059 | |
117 | CHRU de Tours - Hôpital Trousseau | Chambray-lès-Tours | France | 37170 | |
118 | Centre Oscar Lambret | Lille | France | 59020 | |
119 | Hôpital Edouard Herriot | Lyon | France | 69003 | |
120 | Centre Leon Berard | Lyon | France | 69008 | |
121 | Hopital Prive Jean Mermoz | Lyon | France | 69008 | |
122 | Centre Antoine-Lacassagne | Nice | France | 06189 | |
123 | Hopital Saint Louis | Paris | France | 75010 | |
124 | CHU Bordeaux - Hopital Haut-Leveque | Pessac | France | 33604 | |
125 | Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital | Poitiers Cedex | France | 86021 | |
126 | Strasbourg Oncologie Liberale | Strasbourg | France | 67000 | |
127 | Charité - Universitaetsmedizin Berlin | Berlin | Germany | 10117 | |
128 | St. Josef-Hospital | Bochum | Germany | 44791 | |
129 | Klinikum Esslingen GmbH | Esslingen | Germany | 73730 | |
130 | Krankenhaus Nordwest | Frankfurt | Germany | 60488 | |
131 | Studiengesellschaft BSF | Halle | Germany | 06108 | |
132 | Martin Luther Universitat Halle-Wittenberg | Halle | Germany | 06120 | |
133 | Facharztzentrum Eppendorf | Hamburg | Germany | 20249 | |
134 | Marienkrankenhaus Hamburg | Hamburg | Germany | 22087 | |
135 | Asklepios Klinik Altona | Hamburg | Germany | 22763 | |
136 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
137 | Slk-Kliniken | Heilbronn | Germany | 74078 | |
138 | Klinikum Mannheim | Mannheim | Germany | 68167 | |
139 | Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH | Mönchengladbach | Germany | 41063 | |
140 | Universitaetsklinikum Tuebingen | Tuebingen | Germany | 72076 | |
141 | Universitaetsklinikum Ulm | Ulm | Germany | 89081 | |
142 | Agios Savvas Anticancer Hospital | Athens | Greece | 11522 | |
143 | General Hospital of Athens - Laiko | Athens | Greece | 11528 | |
144 | National and Kapodistrian University of Athens | Athens | Greece | 11528 | |
145 | University General Hospital of Ioannina | Ioánnina | Greece | 45500 | |
146 | Theagenion Hospital | Thessaloníki | Greece | 54007 | |
147 | Dél-pesti Centrumkórház - Szent László Kórház telephely | Budapest | Hungary | 1097 | |
148 | Országos Onkológiai Intézet | Budapest | Hungary | 1122 | |
149 | Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika | Budapest | Hungary | H-1089 | |
150 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | H-4032 | |
151 | Petz Aladar Megyei Oktato Korhaz | Győr | Hungary | 9023 | |
152 | Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvár | Hungary | 7400 | |
153 | Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet | Szolnok | Hungary | H-5000 | |
154 | Soroka Medical Center | Beer Sheva | Israel | Beer Sheva | |
155 | Rambam Health Care Campus | Haifa | Israel | 3109601 | |
156 | Policlinico S. Orsola-Malpighi | Bologna | Italy | 40138 | |
157 | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori | Meldola | Italy | 47014 | |
158 | Istituto Europeo di Oncologia | Milano | Italy | 20141 | |
159 | Azienda Ospedaliero-Universitaria di Modena | Modena | Italy | 41124 | |
160 | AUSL di Piacenza-Ospedale Guglielmo Da Saliceto | Piacenza | Italy | 29121 | |
161 | Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | 56126 | |
162 | AOU Ospedali Riuniti di Ancona | Torrette | Italy | 60126 | |
163 | Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma | Verona | Italy | 37134 | |
164 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | 48108 | |
165 | National Cancer Center | Goyang-si | Korea, Republic of | 10408 | |
166 | CHA Bundang Medical Center | Gyeonggi-do | Korea, Republic of | 13520 | |
167 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
168 | Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | Korea, Republic of | 06591 | |
169 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 | |
170 | Hospital de Braga | Braga | Portugal | 4710-243 | |
171 | Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria | Lisboa | Portugal | 1649-035 | |
172 | Champalimaud Cancer Center | Lisbon | Portugal | 1400-038 | |
173 | Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano | Senhora da Hora | Portugal | 4464-513 | |
174 | Centro Hospitalar de Vila Nova de Gaia/Espinho EPE | Vila Nova de Gaia | Portugal | 4434-502 | |
175 | Evimed LLC | Chelyabinsk | Russian Federation | 454048 | |
176 | Limited Liability Company- Clinica Druzhkovyh | Kazan | Russian Federation | 420126 | |
177 | Kursk Regional Clinical Oncology Dispensary | Kursk | Russian Federation | 305524 | |
178 | Main Military Clinical Hospital named after N.N. Burdenko | Moscow | Russian Federation | 105229 | |
179 | Volga District Medical Centre | Novgorod | Russian Federation | 603074 | |
180 | Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov | Saint-Petersburg | Russian Federation | ||
181 | Hospital General Universitario de Elche | Alicante | Spain | 03203 | |
182 | Hospital Universitario de Badajoz | Badajoz | Spain | 06080 | |
183 | Hospital Germans Trias i Pujol | Badalona | Spain | 08916 | |
184 | Hospital Quironsalud Barcelona | Barcelona | Spain | 08023 | |
185 | Hospital de la Santa Creu i Sant Pau Barcelona | Barcelona | Spain | 08026 | |
186 | Hospital Vall D Hebron | Barcelona | Spain | 08035 | |
187 | Hospital Clinic Barcelona | Barcelona | Spain | 08036 | |
188 | Corporacio Sanitaria Parc Tauli - Hospital de Sabadell | Barcelona | Spain | 08208 | |
189 | Institut Catala d'Oncologia - L'Hospitalet | Barcelona | Spain | 08908 | |
190 | Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves | Granada | Spain | 18014 | |
191 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
192 | Fundacion Jimenez Diaz | Madrid | Spain | 28040 | |
193 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
194 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
195 | Centro Integral Oncologico Clara Campal | Madrid | Spain | 28050 | |
196 | Hospital Regional Universitario de Malaga | Málaga | Spain | 29009 | |
197 | Complejo Hospitalario de Navarra | Pamplona | Spain | 31008 | |
198 | Hospital Universitario Marques de Valdecilla | Santander | Spain | 39008 | |
199 | Hospital Universitario Miguel Servet | Zaragoza | Spain | 50009 | |
200 | Guy's and St. Thomas' NHS Foundation Trust | London | United Kingdom | SE1 9RT | |
201 | Royal Marsden Foundation Trust | London | United Kingdom | SM2 5PT | |
202 | Royal Marsden Foundation Trust | London | United Kingdom | SW3 6JJ | |
203 | Imperial College Healthcare NHS Trust | London | United Kingdom | W12 0HS | |
204 | Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology | Manchester | United Kingdom | M20 4BX | |
205 | Nottingham City Hospital | Nottingham | United Kingdom | NG5 1PB |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D-US-60010-001
- 2018-003585-14