BRUIN CLL-321: Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Study Details
Study Description
Brief Summary
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed Description
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm
- in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm A (LOXO-305) Orally |
Drug: LOXO-305
Oral LOXO-305
Other Names:
|
Active Comparator: Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [BR]) Investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR). |
Drug: Idelalisib
Oral
Other Names:
Drug: Bendamustine
IV
Other Names:
Drug: Rituximab
IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B) [Up to approximately 36 months]
Assessed per iwCLL 2018
Secondary Outcome Measures
- To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR) [Up to approximately 36 months]
Assessed per iwCLL 2018
- To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS) [Up to approximately 36 months]
Assessed by survival
- To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT) [Up to approximately 36 months]
Defined as time from randomization to next systemic anticancer therapy for CLL/SLL
- Time to worsening (TTW) of CLL/SLL related symptoms [Up to approximately 36 months]
Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms
- Time to worsening (TTW) of physical function [Up to approximately 36 months]
Using the 5 physical function items identified from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) questionnaire (also known as the EORTC IL 19 questionnaire), physical function will be measured. The range of raw scores for these items could be from 0-20 with the highest score indicating worst function.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria
-
Previously treated with a covalent BTK inhibitor
-
Eastern Cooperative Oncology Group (ECOG) 0-2
-
Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support
-
Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 14 days of Cycle 1 Day 1
-
Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 14 days of C1D1. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ (75 × 109/L).
-
AST and ALT ≤ 3.0 x upper limit of normal (ULN).
-
Total bilirubin ≤ 1.5 x ULN.
-
Estimated creatinine clearance of ≥ 30 mL/min.
Exclusion Criteria:
-
Known or suspected Richter's transformation at any time preceding enrollment.
-
Known or suspected history of central nervous system (CNS) involvement by CLL/SLL
-
Ongoing drug-induced liver injury
-
Active uncontrolled auto-immune cytopenia
-
Significant cardiovascular disease
-
History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days
-
Active hepatitis B or hepatitis C
-
Known active cytomegalovirus (CMV) infection.
-
Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
-
Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
-
Clinically significant active malabsorption syndrome or inflammatory bowel disease
-
Prior exposure to non-covalent (reversible) BTK inhibitor.
-
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
-
Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors
-
Vaccination with a live vaccine within 28 days prior to randomization
-
Patients with the following hypersensitivity:
-
Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305, idelalisib, and bendamustine
-
Prior significant hypersensitivity to rituximab
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Southern Cancer Center, P.C. | Daphne | Alabama | United States | 36526 |
2 | Mitchell Cancer Institute -University of South Alabama | Mobile | Alabama | United States | 36604 |
3 | Palo Verde Hematology Oncology | Glendale | Arizona | United States | 85304 |
4 | Arizona Oncology Associates, P.C. - HOPE | Tucson | Arizona | United States | 85711 |
5 | Orange Coast Memorial Medical Center | Fountain Valley | California | United States | 92708 |
6 | California Research Institute | Los Angeles | California | United States | 90027 |
7 | Rocky Mountain Cancer Center | Aurora | Colorado | United States | 80012 |
8 | Medical Oncology Hematology Consultants, PA | Newark | Delaware | United States | 19713 |
9 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33486 |
10 | Cancer Specialists of North Florida -St Augustine | Jacksonville | Florida | United States | 32256 |
11 | Oncology-Hematology Associates of West Broward | Tamarac | Florida | United States | 33321 |
12 | WellStar Health System | Marietta | Georgia | United States | 30060 |
13 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
14 | Illinois Cancer Specialists-Niles | Niles | Illinois | United States | 60714 |
15 | Community Health Network | Indianapolis | Indiana | United States | 46250 |
16 | Arnett Cancer Center | Lafayette | Indiana | United States | 47904 |
17 | University of Kentucky Markey Cancer Center | Lexington | Kentucky | United States | 40563 |
18 | Norton Cancer Institute | Louisville | Kentucky | United States | 40207 |
19 | Mercy Health-Paducah Medical Oncology and Hematology | Paducah | Kentucky | United States | 42003 |
20 | Cancer Center Office of Clinical Research | New Orleans | Louisiana | United States | 70112 |
21 | Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | United States | 21201 |
22 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
23 | Ascension St. John Hospital | Grosse Pointe Woods | Michigan | United States | 48236 |
24 | Minnesota Oncology/Hematology PA | Saint Paul | Minnesota | United States | 55102 |
25 | St. Vincent Frontier Cancer Center | Billings | Montana | United States | 59102 |
26 | Nebraska Hematology-Oncology | Lincoln | Nebraska | United States | 68506 |
27 | New Jersey Center for Cancer Research | Brick | New Jersey | United States | 08724 |
28 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10021 |
29 | University of Rochester | Rochester | New York | United States | 14642 |
30 | Clinical Research Alliance, Inc. | Westbury | New York | United States | 11590 |
31 | Oncology Hematology Care Inc | Cincinnati | Ohio | United States | 45236 |
32 | Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | United States | 97401 |
33 | Texas Oncology - Amarillo | Amarillo | Texas | United States | 79106 |
34 | Texas Oncology Cancer Center | Austin | Texas | United States | 78705 |
35 | Texas Oncology - Medical City Dallas | Dallas | Texas | United States | 75230 |
36 | Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | United States | 75231 |
37 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
38 | Texas Oncology Fort Worth | Fort Worth | Texas | United States | 76104 |
39 | The Center for Cancer and Blood Disorders | Fort Worth | Texas | United States | 76104 |
40 | Texas Oncology - McAllen | McAllen | Texas | United States | 78503 |
41 | Texas Oncology - San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
42 | Texas Oncology - Tyler | Tyler | Texas | United States | 75702 |
43 | Virginia Cancer Specialists, PC | Gainesville | Virginia | United States | 20155 |
44 | Oncology and Hematology Associates of Southwest Virginia Inc | Roanoke | Virginia | United States | 24014 |
45 | Northwest Medical Specialties, PLLC | Tacoma | Washington | United States | 98405 |
46 | St Vincent's Hospital | Darlinghurst | New South Wales | Australia | 2010 |
47 | The St. George Hospital | Kogarah | New South Wales | Australia | 2217 |
48 | Ingham Institute of Medical Research | Liverpool | New South Wales | Australia | NSW2170 |
49 | Westmead Hospital | Wentworthville | New South Wales | Australia | 2145 |
50 | Royal Perth Hospital | Perth | Western Australia | Australia | 6000 |
51 | Ordensklinikum Linz GmbH Elisabethinen | Linz | Oberösterreich | Austria | 4020 |
52 | Uniklinikum Salzburg | Salzburg | Osterreich | Austria | 5020 |
53 | CHR Verviers-Onco | Verviers | Liege | Belgium | 4800 |
54 | VITAZ | Sint-Niklaas | Oost-Vlaanderen | Belgium | B-9100 |
55 | AZ Delta | Roeselare | West Flanders | Belgium | 8800 |
56 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
57 | Groupe Jolimont | Haine-Saint-Paul | Belgium | 7100 | |
58 | AZ St-Elisabeth | Herentals | Belgium | 2200 | |
59 | Clinique Saint Pierre Ottignies | Ottignies | Belgium | 1340 | |
60 | Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | Canada | B3H 1V7 |
61 | Southlake Regional Health Centre | Newmarket | Ontario | Canada | L3Y 2P9 |
62 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 1Z5 |
63 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
64 | Peking University Third Hospital | Beijing | Beijing | China | 100191 |
65 | Xuanwu Hospital Capital Medical University | Xicheng District | Beijing | China | 100053 |
66 | Southern Medical University Nanfang Hospital | Guangzhou | Guangdong | China | 510515 |
67 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450008 |
68 | The Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu | China | 221006 |
69 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | 330006 |
70 | The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | 330006 |
71 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China | |
72 | Affiliated Tumor Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China | 830002 |
73 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
74 | Zhejiang Provincial Taizhou Hospital | Linhai | Zhejiang | China | 317000 |
75 | Beijing Hospital | Beijing | China | 100730 | |
76 | Blood Institute of the Chinese Academy of Medical science | Tianjin | China | 300020 | |
77 | University Hospital Split | Split | Croatia | 21000 | |
78 | Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb | Zagreb | Croatia | ||
79 | Fakultni nemocnice Brno | Brno | Czechia | 62500 | |
80 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
81 | Vseobecna fakultni nemocnice v Praze | Praha 2 | Czechia | 12808 | |
82 | CHU De Grenoble Hopital Albert Michallon | Grenoble | Cedex 09 | France | 38043 |
83 | Hospital AVICENNE | Bobigny | Cedex | France | 93 009 |
84 | Centre Hospitalier Lyon Sud | Pierre Benite | Cedex | France | 69495 |
85 | CHD Vendee | La Roche-sur-Yon | La Roche Sur Yon | France | 85000 |
86 | Chu Nimes/Institut De Cancerologie Du Gard | Nîmes | Nimes | France | 30900 |
87 | Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen | Rouen | Seine-Maritime | France | 76038 |
88 | CHRU De Tours | Tours | Tours Cedex 9 | France | 37044 |
89 | Centre Hospitalier de la Côte Basque | Bayonne | France | 64109 | |
90 | Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | France | 33076 | |
91 | CHRU de Brest - Hôpital Morvan | Brest cedex | France | 29609 | |
92 | Centre Hospitalier du Mans | Le Mans | France | 72000 | |
93 | Hopital Saint Vincent De Paul | Lille cedex | France | 59020 | |
94 | Ch Perpignan | Perpignan | France | 66046 | |
95 | Pole Regionalde Cancérologie(CHU de Poitiers) | Politiers | France | 86021 | |
96 | Universitätsklinikum Heidelberg | Heidelberg | Baden-Württemberg | Germany | 69120 |
97 | Uniklinik Köln | Kerpener | Köln | Germany | 50937 |
98 | Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | Germany | 24105 |
99 | Lübecker Onkologische Schwerpunktpraxis | Lübeck | Schleswig-Holstein | Germany | 23562 |
100 | Mater Misericordiae Hospital | Dublin 7 | Ireland | ||
101 | St James's Hosptial | Dublin 8 | Ireland | D08 NHY1 | |
102 | Beaumont Hospital, Dublin | Dublin | Ireland | DUBLIN 9 | |
103 | Rabin Medical Center | Petah Tikva | HaMerkaz | Israel | |
104 | Soroka Medical Center | Beer Sheva | Israel | 8457108 | |
105 | Laniado Medical Center | Netanya | Israel | 4244916 | |
106 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 6423906 | |
107 | Carmel Hospital | Haifa | Ḥeifā | Israel | 3436212 |
108 | ASST-Monza -U.O Ematologia Adulti | Monza (MB) -Settore E | Piano 2 | Italy | 20900 |
109 | Azienda Ospedaliero Universitaria Pisana | Pisa | PI | Italy | 56126 |
110 | Irccs Crob | Rionero In Vulture | Potenza | Italy | 85028 |
111 | AULSS8 Berica-Ospedale S.Bortolo | Vicenza | Veneto | Italy | 36100 |
112 | Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | 15100 | |
113 | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | Italy | 24127 | |
114 | ASST Spedali Civili - Università degli Studi | Brescia | Italy | 25123 | |
115 | A.O.U. Policlinico G.Rodolico - S. Marco | Catania | Italy | 95123 | |
116 | Azienda Ospedaliera Pugliese Ciaccio | Catanzaro | Italy | 88100 | |
117 | Azienda Ospedaliera Universitaria Careggi | Firenze | Italy | 50134 | |
118 | IRCCS Ospedale Policlinico San Martino | Genova | Italy | 16132 | |
119 | Ospedale Papardo | Messina | Italy | 98158 | |
120 | IRCCS Ospedale San Raffaele | Milano | Italy | 20132 | |
121 | ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C | Milano | Italy | 20162 | |
122 | A.O.U. di Modena | Modena | Italy | 41224 | |
123 | Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | 27100 | |
124 | Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich) | Perugia | Italy | 06132 | |
125 | Ospedale Santa Maria delle Croci | Ravenna | Italy | 48020 | |
126 | Fondazione Policlinico Universitario Agostino Gemelli | Roma | Italy | 00168 | |
127 | Azienda Ospedaliera Santa Maria Terni | Terni | Italy | 05100 | |
128 | A.O.U. Citta' della Salute e della Scienza di Torino | Torino | Italy | 10126 | |
129 | Az. Osp. "Card G Panico" | Tricase | Italy | 4 - 73039 | |
130 | Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | Italy | 34125 | |
131 | Ospedale Policlinico Giambattista Rossi, Borgo Roma | Verona | Italy | 37134 | |
132 | Nagoya Medical Center | Nagoya | Aichi | Japan | 460-0001 |
133 | Aichi Cancer Center Hospital | Nagoya | Aichi | Japan | 464-8681 |
134 | Nagoya City University Hospital | Nagoya | Aichi | Japan | 467-8602 |
135 | Ogaki Municipal Hospital | Ogaki-shi | Gifu | Japan | 503-8502 |
136 | Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
137 | Kobe City Medical Center General Hospital | Kobe | Hyogo | Japan | 650-0047 |
138 | Tokai University Hospital- Isehara Campus | Isehara | Kanagawa | Japan | 259-1143 |
139 | Kochi Medical School Hospital | Nankoku | Kochi | Japan | 783-8505 |
140 | Tohoku University Hospital | Sendai-shi | Miyagi | Japan | 980-8574 |
141 | Kindai University Hospital | Osaka Sayama-shi | Osaka | Japan | 589 8511 |
142 | Saitama Medical Center | Kawagoe | Saitama | Japan | 350-8550 |
143 | Japanese Foundation for Cancer Research | Koto | Tokyo | Japan | 135-8550 |
144 | NTT Medical Center Tokyo | Shinagawa-Ku | Tokyo | Japan | 141-8625 |
145 | Kumamoto University Hospital | Kumamoto | Japan | 860-8556 | |
146 | Okayama University Hospital | Okayama | Japan | 700-8558 | |
147 | Osaka University Hospital | Osaka | Japan | 565-0871 | |
148 | Gachon University Gil Hospital | Namdong-gu | Incheon-gwangyeoksi [Incheon] | Korea, Republic of | 21565 |
149 | Pusan National University Hospital | Busan | Pusan-Kwangyǒkshi | Korea, Republic of | 49241 |
150 | Seoul National University Hospital | Seoul | Seoul, Korea | Korea, Republic of | 03080 |
151 | Severance Hospital, Yonsei University Health System | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 03722 |
152 | The Catholic University of Korea-Seoul St. Mary's Hospital | Seocho-Gu | Seoul | Korea, Republic of | 06591 |
153 | Inje Univ Busan Paik Hospital | Busan | Korea, Republic of | 47392 | |
154 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
155 | Wojewodzki Szpital Specjalistyczny | Iwaszkiewicza 5 | Legnica | Poland | 59-220 |
156 | Centrum Onkologii Ziemi Lubelskiej | Lublin | Lubelskie | Poland | 20-081 |
157 | Uniwersyteckie Centrum Kliniczne | Gdansk | Pomorskie | Poland | 80-214 |
158 | Szpitale Pomorskie Sp. z o. o. | Gdynia | Pomorskie | Poland | 81-519 |
159 | Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza, Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej | Brzozów | Poland | 36-200 | |
160 | Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii | Bydgoszcz | Poland | 85-168 | |
161 | Pratia Onkologia Katowice | Katowice | Poland | 40519 | |
162 | Pratia MCM Krakow | Krakow | Poland | 30-510 | |
163 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Warszawa | Poland | 02-781 | |
164 | Uniwersytecki Szpital Kliniczny Klinika | Wrocław | Poland | 50-367 | |
165 | Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii | Łódź | Poland | 93510 | |
166 | Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary" | Omsk | Omskaya Oblast' | Russian Federation | 644013 |
167 | Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency | Saint Petersburg | Russian Federation | 191024 | |
168 | Academician I.P. Pavlov First St-Petersburg State Medical University | Saint Petersburg | Russian Federation | 197022 | |
169 | Oncology Dispensary #2 of Krasnodar Region | Sochi | Russian Federation | 354057 | |
170 | Gleneagles Medical Centre | Singapore | Central Singapore | Singapore | 258499 |
171 | Hospital Duran I Reynals | Hospitalet De Llobregat | Barcelona | Spain | 08908 |
172 | Hospital Universitario de Toledo | Toledo | Castilla La Mancha | Spain | 45004 |
173 | Complejo Hospitalario Universitario de Santiago de Compostel | Santiago de Compostela | La Coruna | Spain | 15706 |
174 | Hospital Universitario Ramon y Cajal | Madrid | Madrid, Comunidad De | Spain | 28034 |
175 | Hospital Universitario Quironsalud Madrid | Pozuelo De Alarcón | Madrid | Spain | 28223 |
176 | Hospital General Universitario Gregorio Marañon | Madrid | Planta Baja | Spain | 28007 |
177 | Hospital General de Albacete | Albacete | Spain | 02006 | |
178 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
179 | Hospital Clinic de Barcelona | Barcelona | Spain | 08036 | |
180 | Hospital San Pedro de Alcántara | Caceres | Spain | 10003 | |
181 | Hospital Universitario Infanta Leonor-INTERNAL MED | Madrid | Spain | 28031 | |
182 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
183 | Hospital Universitario Marques De Valdecilla | Santander | Spain | 39008 | |
184 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | 41013 | |
185 | Hospital Universitario de Alava | Vitoria | Spain | 01005 | |
186 | Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale | Bellinzona | Svizzera | Switzerland | 6500 |
187 | China Medical University Hospital | Taichung City | Taichung | Taiwan | 40447 |
188 | Tri-Service General Hospital | Taipei City | Taipei | Taiwan | 114 |
189 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 | |
190 | Chang Gung Memorial Hospital - Linkou | Taoyuan, (r.o.c.) | Taiwan | 33342 | |
191 | Aberdeen Royal Infirmary | Aberdeen | Aberdeen City | United Kingdom | AB25 2ZN |
192 | The Royal Cornwall Hospital | Truro | Cornwall | United Kingdom | TR1 3LJ |
193 | Derriford Hospital | Plymouth | Devon | United Kingdom | PL6 8DH |
194 | Castle Hill Hospital | Cottingham | East Yorkshire | United Kingdom | HU16 5JQ |
195 | University College London Hospitals | London | Greater London | United Kingdom | WC1E 6HX |
196 | Norfolk and Norwich Hospital | Norwich | Norfolk | United Kingdom | NR4 7UY |
197 | Singleton Hospital | Swansea | Sa2 8qa | United Kingdom | |
198 | Western General Hospital | Edinburgh | Scotland | United Kingdom | EH4 2XU |
199 | Royal Marsden Hospital | Sutton | Surrey | United Kingdom | SM2 5PT |
200 | Milton Keynes University Hospital | Milton Keynes | United Kingdom | MK6 5LD | |
201 | GenesisCare Cambridge | Newmarket | United Kingdom | CB8 7XN |
Sponsors and Collaborators
- Loxo Oncology, Inc.
- Eli Lilly and Company
Investigators
- Study Director: Marisa Hill, MD, Loxo Oncology, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LOXO-BTK-20020
- J2N-OX-JZNN