ReferenceCitation: Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. doi: 10.1001/jamaoncol.2019.1146.

name: Department of Medicine and Yale Cancer Center, Yale University School of Medicine, New Haven, Connecticut

family: Burtness

full_name: Barbara Burtness

given: Barbara

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts

family: Haddad

full_name: Robert Haddad

name: Instituto Português de Oncologia, Porto, Portugal

family: Dinis

full_name: José Dinis

given: José

name: Department of Medical Oncology, Hospital Virgen de la Victoria, IBIMA, Malaga, Spain

family: Trigo

full_name: José Trigo

name: Division of Gastrointestinal Oncology, Shizuoka Cancer Centre, Shizuoka, Japan

family: Yokota

full_name: Tomoya Yokota

given: Tomoya

name: Department of Medical Oncology, Hospital Marcio Cunha, Ipatinga, Brazil

family: de Souza Viana

full_name: Luciano de Souza Viana

given: Luciano

name: Russian Oncological Research Centre, Moscow, Russia

family: Romanov

full_name: Ilya Romanov

given: Ilya

name: Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium

family: Vermorken

full_name: Jan Vermorken

given: Jan

name: Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

family: Bourhis

full_name: Jean Bourhis

given: Jean

name: Department of Head and Neck Medical Oncology, National Cancer Centre Hospital East, Kashiwa, Japan

family: Tahara

full_name: Makoto Tahara

given: Makoto

name: Department of Clinical Oncology, Hospital Amaral Carvalho, Jau, Brazil

family: Martins Segalla

full_name: José Getulio Martins Segalla

given: José Getulio

name: Department of Internal Medicine, National Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece

family: Psyrri

full_name: Amanda Psyrri

given: Amanda

name: Oncology Centre of Moskovskiy, St Petersburg, Russia

family: Vasilevskaya

full_name: Irina Vasilevskaya

given: Irina

name: Comprehensive Cancer Centre, University of California at Irvine, Orange

family: Nangia

full_name: Chaitali Singh Nangia

given: Chaitali Singh

name: Department of Oncology, Hospital Virgen del Rocio, Sevilla, Spain

family: Chaves-Conde

full_name: Manuel Chaves-Conde

given: Manuel

name: Department of Medical Oncology and Hematology, Kobe University Hospital Cancer Center, Kobe, Japan

family: Kiyota

full_name: Naomi Kiyota

given: Naomi

name: Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan

family: Homma

full_name: Akihiro Homma

given: Akihiro

name: Department of Oncology and Radiotherapy, Hospital Na Bulovce and 1st Medical Faculty of Charles University, Prague, Czech Republic

family: Holeckova

full_name: Petra Holeckova

given: Petra

name: Department of Oncology, Vall d’Hebron University Hospital, Barcelona, Spain

family: Del Campo

full_name: Josep Maria Del Campo

given: Josep Maria

name: Shree Krishna Hospital and Medical Research Centre, Gujarat, India

family: Asarawala

full_name: Nirav Asarawala

given: Nirav

name: Department of Clinical Oncology, AC Camargo Cancer Center, São Paulo, Brazil

family: Nicolau

full_name: Ulisses Ribaldo Nicolau

given: Ulisses Ribaldo

name: Inselspital, University Hospital Bern, Bern, Switzerland

family: Rauch

full_name: Daniel Rauch

given: Daniel

name: Department of Head and Neck Cancer, Gustave Roussy, Villejuif, France

family: Even

full_name: Caroline Even

given: Caroline

name: Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut

family: Wang

full_name: Bushi Wang

given: Bushi

name: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany

family: Gibson

full_name: Neil Gibson

given: Neil

name: Boehringer Ingelheim, Danmark A/S, Denmark

name: Division of Radiotherapy and Imaging, The Royal Marsden Hospital/The Institute of Cancer Research, National Institute for Health Research Biomedical Research Centre, London, United Kingdom

name: Department of Translational Science, Moores Cancer Centre, University of California at San Diego, La Jolla

ReferenceCitation: Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen EE. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014 Nov 29;15:469. doi: 10.1186/1745-6215-15-469.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
France
Japan
Argentina
Canada
Chile
Sweden
Switzerland
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Egypt
Spain

location_facility: 1200.131.00155 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03052 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.35155 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00181 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.06151 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04964 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04959 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03258 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05556 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00762 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03454 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00175 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09173 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00185 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00188 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03960 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04455 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09172 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03460 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09151 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05652 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03957 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04962 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03656 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00753 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09165 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04954 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03353 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.35152 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03362 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.35153 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00755 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03255 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08161 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08163 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00760 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03151 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04453 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08151 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04460 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04551 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09170 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03252 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05551 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03259 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04351 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09162 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03357 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03254 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05457 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00173 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00759 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08157 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00171 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03253 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03356 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04152 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03461 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03464 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03854 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03955 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03463 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04961 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03452 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09180 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09179 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04459 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09164 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03654 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00198 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03951 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09163 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08160 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08155 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03367 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03465 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.97251 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04963 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04353 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04251 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03455 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05555 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03354 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03369 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03652 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00182 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00177 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00172 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03655 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04951 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05458 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04957 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09178 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08164 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03355 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04652 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03366 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05553 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05557 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04357 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.35151 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.35851 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04254 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04953 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08154 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03152 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04457 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03651 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00184 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04253 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08159 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00179 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04355 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04454 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04456 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03457 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09152 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03365 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09159 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04458 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03456 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03256 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05452 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03459 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.97253 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05651 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.35154 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05554 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03054 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.10200 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.2052 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04452 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00183 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04956 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05252 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09176 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00761 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00154 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03458 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04359 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03851 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03451 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.09175 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05453 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03370 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00152 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03466 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08153 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00157 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00763 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03359 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04151 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04451 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00151 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.05451 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03462 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00153 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08152 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.08156 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.04651 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.00176 Boehringer Ingelheim Investigational Site

location_facility: 1200.131.03153 Boehringer Ingelheim Investigational Site

title: A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

summary: This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.


type: EudraCT Number

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

acronym: Tugela

summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.

ReferenceCitation: Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.

ReferenceCitation: Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.

ReferenceCitation: Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA

ReferenceCitation: Zelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illés Á, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.

ReferenceType: derived

ReferenceCitation: Montillo M, Illés Á, Robak T, Pristupa AS, Wach M, Egyed M, Delgado J, Jurczak W, Morschhauser F, Schuh A, Eradat H, Shreay S, Barrientos JC, Zelenetz AD. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019 Nov 15;17(1):173. doi: 10.1186/s12955-019-1232-8.

family: Montillo

full_name: Marco Montillo

given: Marco

sequence: first

family: Illés

full_name: Árpád Illés

given: Árpád

sequence: additional

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

family: Pristupa

full_name: Alexander S. Pristupa

given: Alexander S.

family: Wach

full_name: Malgorzata Wach

given: Malgorzata

family: Egyed

full_name: Miklós Egyed

given: Miklós

family: Delgado

full_name: Julio Delgado

given: Julio

family: Jurczak

full_name: Wojciech Jurczak

given: Wojciech

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Schuh

full_name: Anna Schuh

given: Anna

family: Eradat

full_name: Herbert Eradat

given: Herbert

family: Shreay

full_name: Sanatan Shreay

given: Sanatan

family: Barrientos

full_name: Jacqueline C. Barrientos

given: Jacqueline C.

family: Zelenetz

full_name: Andrew D. Zelenetz

given: Andrew D.

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Health and Quality of Life Outcomes

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

evidence: oa repository (via pmcid lookup)

license_normalized: no license

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Italy
United States
Spain
Croatia
Czechia
France
Greece
Poland
Romania
Hungary
Belgium
Australia
Ireland
Portugal
Russian Federation
Canada
United Kingdom
Turkey

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: "Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

location_facility: Research Institute of Hematology and Blood Transfusion

location_facility: Russian Oncology Research Center (N.N. Blokhin)

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Ondokuz Mayis University Faculty of Medicine

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Winship Cancer Institute at Emory University

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Emergency County Clinical Hospital Brasov

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Ospedale Oncologico Regionale A. Businco


title: The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine

acronym: BEACON

summary:
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

name: College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea

name: D&D Pharmatech, Seongnam, Republic of Korea

family: Park

full_name: Eun Ji Park

given: Eun Ji

family: Choi

full_name: Jiyoung Choi

given: Jiyoung

name: College of Pharmacy, SungKyunKwan University, Suwon, Republic of Korea

family: Lee

full_name: Kang Choon Lee

given: Kang Choon

full_name: Dong Hee Na

given: Dong Hee

journal_name: Expert Opinion on Emerging Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Emerging PEGylated non-biologic drugs

ReferenceCitation: Cortés J, Rugo HS, Awada A, Twelves C, Perez EA, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, O'Shaughnessy J. Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial. Breast Cancer Res Treat. 2017 Sep;165(2):329-341. doi: 10.1007/s10549-017-4304-7. Epub 2017 Jun 13. Erratum in: Breast Cancer Res Treat. 2017 Nov;166(1):327-328.

family: Cortés

full_name: Javier Cortés

given: Javier

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Twelves

full_name: Chris Twelves

given: Chris

family: Perez

full_name: Edith A. Perez

given: Edith A.

family: Im

full_name: Seock–Ah Im

given: Seock–Ah

family: Gómez-Pardo

full_name: Patricia Gómez-Pardo

given: Patricia

family: Schwartzberg

full_name: Lee S. Schwartzberg

given: Lee S.

family: Diéras

full_name: Veronique Diéras

given: Veronique

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

family: Potter

full_name: David A. Potter

given: David A.

family: Mailliez

full_name: Audrey Mailliez

given: Audrey

family: Moreno-Aspitia

full_name: Alvaro Moreno-Aspitia

given: Alvaro

family: Ahn

full_name: Jin-Seok Ahn

given: Jin-Seok

family: Zhao

full_name: Carol Zhao

given: Carol

family: Hoch

full_name: Ute Hoch

given: Ute

family: Tagliaferri

full_name: Mary Tagliaferri

given: Mary

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Twelves C, Cortés J, O'Shaughnessy J, Awada A, Perez EA, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Rugo HS. Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial. Eur J Cancer. 2017 May;76:205-215. doi: 10.1016/j.ejca.2017.02.011. Epub 2017 Mar 27.

ReferenceCitation: Perez EA, Awada A, O'Shaughnessy J, Rugo HS, Twelves C, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Cortes J. Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine (BEACON): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1556-1568. doi: 10.1016/S1470-2045(15)00332-0. Epub 2015 Oct 22.

location_country:
Italy
United States
Netherlands
Germany
France
Belgium
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Istituto Nazionale tumori Regina Elena IRCCS

location_facility: Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center

location_facility: PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists

location_facility: UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways"

location_facility: Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Cancer Clinical Trials Centre, Weston Park Hospital

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Clinical Trials Unit, Velindre Cancer Centre

location_facility: Centre Hospitalier Universitaire de Liège- Site du Sart Tilman

location_facility: Institut Paoli Calmettes, Service Pharmacie

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: The Christie Hospitals NHS Foundation Trust

location_facility: St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary"

location_facility: Istituto tumori Giovanni Paolo II-ospedale oncologico, Oncologia Medica e Sperimentale

location_facility: State Institution "Russian Oncology Research Centre named after N.N. Blokhin RAMS"

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY

location_facility: Desert Hematology Oncology Medical Group

location_facility: Odette Cancer Centre OCC Clinical Research

location_facility: Seoul National University Bundang Hospital

location_facility: Hematology-oncology Department, Ajou University Hospital

location_facility: Louisville Oncology Clinical Research Program

location_facility: Hematology-oncology Department, Ewha Womans University Mokdong Hospital

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Peachtree Hematology Oncology Consultants

location_facility: Frontier Cancer Center and Blood Institute

location_facility: Hopital Tenon Service oncologie médicale

location_facility: Scientific Research Oncology Institute named after N.N. Petrov

location_facility: Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

location_facility: Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care

location_facility: Centra Regional de Lutte contre le Cancer

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Institut Bergonie Service Oncologie Médicale

location_facility: Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Carolinas Hematology Oncology Associates

location_facility: Hematology Oncology Associates of the Treasure Coast


ReferenceCitation: Mourad G, Glyda M, Albano L, Viklický O, Merville P, Tydén G, Mourad M, Lõhmus A, Witzke O, Christiaans MHL, Brown MW, Undre N, Kazeem G, Kuypers DRJ; Advagraf-based immunosuppression regimen examining new onset diabetes mellitus in kidney transplant recipients (ADVANCE) study investigators. Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1924-1934. doi: 10.1097/TP.0000000000001453.

family: Mourad

full_name: Georges Mourad

given: Georges

family: Glyda

full_name: Maciej Glyda

given: Maciej

family: Albano

full_name: Laetitia Albano

given: Laetitia

family: Viklický

full_name: Ondrej Viklický

given: Ondrej

family: Merville

full_name: Pierre Merville

given: Pierre

family: Tydén

full_name: Gunnar Tydén

given: Gunnar

full_name: Michel Mourad

given: Michel

family: Lõhmus

full_name: Aleksander Lõhmus

given: Aleksander

family: Witzke

full_name: Oliver Witzke

given: Oliver

family: Christiaans

full_name: Maarten H. L. Christiaans

given: Maarten H. L.

family: Brown

full_name: Malcolm W. Brown

given: Malcolm W.

family: Undre

full_name: Nasrullah Undre

given: Nasrullah

family: Kazeem

full_name: Gbenga Kazeem

given: Gbenga

family: Kuypers

full_name: Dirk R. J. Kuypers

given: Dirk R. J.

journal_name: Transplantation

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

intervention_type: Drug

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

primary_purpose: Prevention

location_country:
Finland
Romania
Belgium
Australia
Russian Federation
France
Poland
Lithuania
Slovakia
Norway
Korea, Republic of
Colombia
Sweden
Switzerland
Netherlands
Hungary
Portugal
Germany
Italy
Mexico
Czechia
Spain
Estonia
Latvia

acronym: ADVANCE

ipd_sharing: Yes

source: euctr

title: Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study

summary: The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

lead_sponsor_type: industriel


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease

summary:
The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

lead_sponsor: Neovacs

location_country:
Netherlands
Croatia
Bulgaria
France
Romania
Hungary
Belgium
Germany
Czech Republic

location_facility: Free University Medical Centre in Amsterdam (VUMC)

location_facility: Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza

location_facility: Medical Institute- Ministry of Interior Clinic of Gastroenterology

location_facility: Hamburgisches Forschungsinstitut für CED

location_facility: Universitätsklinik und Poliklinik für Innere Medizin I

location_facility: Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte

location_facility: Clinic of Gastroenterology/ University Hospital Varna

location_facility: Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne

location_facility: University Multiprofile Hospital St. Georgi

location_facility: Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie

location_facility: Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten

location_facility: I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf

location_facility: Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH

location_facility: Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung

intervention_type: Biological

status_simplified: Completed


title: OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

acronym: OASIS

summary: Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

status: Suspended

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

family: Marshall

full_name: John C. Marshall

given: John C.

family: Dellinger

full_name: R. Phillip Dellinger

given: R. Phillip

family: Simonson

full_name: Steven G. Simonson

given: Steven G.

family: Guntupalli

full_name: Kalpalatha Guntupalli

given: Kalpalatha

family: Levy

full_name: Mitchell M. Levy

given: Mitchell M.

family: Singer

full_name: Mervyn Singer

given: Mervyn

family: Malik

full_name: Rajesh Malik

given: Rajesh

journal_name: Critical Care Medicine

title: Talactoferrin in Severe Sepsis

lead_sponsor: Agennix

location_country:
United States
Netherlands
Germany
France
Israel
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries

location_facility: University of Oklahoma Health Science Center

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

location_facility: Queen Elizabeth II Health Sciences Center

status_simplified: Unknown


ReferenceCitation: Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3. Erratum in: Lancet. 2014 Jan 4;383(9911):30.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

location_country:
Italy
Brazil
Chile
South Africa
Mexico
Netherlands
Spain
France
Poland
Greece
Romania
Hungary
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Canada
Taiwan

acronym: SAILING

title: A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults

summary: ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.


ReferenceCitation: Davies A, Merli F, Mihaljević B, Mercadal S, Siritanaratkul N, Solal-Céligny P, Boehnke A, Berge C, Genevray M, Zharkov A, Dixon M, Brewster M, Barrett M, MacDonald D. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017 Jun;4(6):e272-e282. doi: 10.1016/S2352-3026(17)30078-9. Epub 2017 May 2.

family: Davies

full_name: Andrew Davies

given: Andrew

family: Merli

full_name: Francesco Merli

given: Francesco

family: Mihaljević

full_name: Biljana Mihaljević

given: Biljana

family: Mercadal

full_name: Santiago Mercadal

given: Santiago

family: Siritanaratkul

full_name: Noppadol Siritanaratkul

given: Noppadol

family: Solal-Céligny

full_name: Philippe Solal-Céligny

given: Philippe

family: Boehnke

full_name: Axel Boehnke

given: Axel

family: Berge

full_name: Claude Berge

given: Claude

family: Genevray

full_name: Magali Genevray

given: Magali

family: Zharkov

full_name: Artem Zharkov

given: Artem

family: Dixon

full_name: Mark Dixon

given: Mark

family: Brewster

full_name: Michael Brewster

given: Michael

family: Barrett

full_name: Martin Barrett

given: Martin

family: MacDonald

full_name: David MacDonald

given: David

journal_name: The Lancet Haematology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Céligny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, Macdonald D. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 2014 Mar;15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1. Epub 2014 Feb 10.

family: Mihaljevic

full_name: Biljana Mihaljevic

full_name: Phillippe Solal-Céligny

given: Phillippe

family: Bittner

full_name: Beate Bittner

given: Beate

ReferenceCitation: Mao CP, Brovarney MR, Dabbagh K, Birnböck HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

title: Subcutaneous versus Intravenous Administration of Rituximab: Pharmacokinetics, CD20 Target Coverage and B-Cell Depletion in Cynomolgus Monkeys

ReferenceCitation: Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Ninewells Hospital & Medical School; Ward 34

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

location_facility: Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

location_facility: Pinderfields General Hospital; Dept of Haematology

location_facility: Clinical Center Vojvodine; Clinic for Hematology

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie

location_facility: Azienda Ospedaliera Ospedale S.Carlo; Ematologia

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: National Cancer Inst. ; Dept. of Chemotherapy

location_facility: Centre hospitalier regional de Trois-Rivieres

location_facility: Ampang Hospital; Department of Haematology

location_facility: Haematology Research Center; Haematology

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Aarhus Universitetshospital, Hæmatologisk Afdeling R

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Caritas Kilinik St. Theresia; Abt. Innere Medizin

location_facility: Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay

location_facility: Ospedale Di Vicenza; Nefrologia, Ematologia

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

location_facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology

location_facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Specialised Hospital For Treatment Of Hematological Diseases; Hematology

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.

location_facility: Odense Universitetshospital; Hæmatologisk Afdeling

location_facility: Research Inst. of Hematology & Blood Transfusion ; Hematology

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: National Cancer Centre; Medical Oncology

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Singapore General Hospital; Department of Haematology

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie

location_facility: Derriford Hospital; Department of Haematology

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Bilim University School of Medicine; Hematology

location_facility: University Malaya Medical Center; Hematology Unit of Department of Internal Medicine

location_facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie

location_facility: Hospital Ramon y Cajal; Servicio de Hematologia

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

location_facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Herlev Uni Hospital; Hæmatologisk Afdeling L 121

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: University Clinic of Hematology Skopje, Hospital Care Department

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

location_facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Ospedale S. Eugenio; Divisione Di Ematologia

location_facility: King Edward VIII; Department of Haematology

location_facility: University Clinical Center Sarajevo, Clinic for Hematology

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: University Clinic for Hematology; HSCT Department

location_facility: Hospital Universitario Puerta del Mar; Servicio de Hematologia

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

location_facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: New Cross Hospital; Dept. Of Haematology

location_facility: Gold Coast Hospital; Haematology Department

location_facility: Institute of Hematology and Transfusiology

location_facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: Vejle Hospital; Dept of Medicine, Division of Hematology

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

title: A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV

summary: This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.


title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

acronym: DESKTOP III

summary: It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.

primary_purpose: Other

ReferenceCitation: Bommert M, Harter P, Heitz F, du Bois A. When should Surgery be used for Recurrent Ovarian Carcinoma? Clin Oncol (R Coll Radiol). 2018 Aug;30(8):493-497. doi: 10.1016/j.clon.2018.04.006. Epub 2018 May 7. Review.

family: Bommert

full_name: M. Bommert

given: M.

family: Harter

full_name: P. Harter

given: P.

family: Heitz

full_name: F. Heitz

given: F.

family: du Bois

full_name: A. du Bois

given: A.

journal_name: Clinical Oncology

lead_sponsor: AGO Study Group

location_country:
Italy
Austria
Sweden
Spain
France
Norway
Belgium
China
Denmark
Germany
United Kingdom
Korea, Republic of

location_facility: Istituto Nazionale Tumori di Napoli, Gynecologic Oncology

location_facility: Fudan University Zhongshan Hospital, Obstetrics and Gynecology

location_facility: Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe

location_facility: Fundación Instituto Valenciano de Oncologia

location_facility: Fudan University Cancer Hospital, Gynecologic Oncology

location_facility: Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: Seoul National University Hospital, Department of Obstetrics and Gynecology

location_facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie

location_facility: Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung

location_facility: Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology

location_facility: Insitut Jean Godinot, Service Rubis - Oncologie Médicale

location_facility: Royal Surrey Country Hospital,St Lukes Cancer Centre

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology

location_facility: Centre Hospitalier Universitaire Charles-Nicolle

location_facility: HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie

location_facility: Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik

location_facility: Nottingham University Hospital, City Campus, Oncology

location_facility: Linköping University Hospital, Department of Obstetrics and Gynecology

location_facility: Gynecologic Clinic of the Ernst-Moritz-Arndt-University

location_facility: Klinikum Dritter Orden, Gynäkologie und Geburtshilfe

location_facility: Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik

location_facility: Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde

location_facility: Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre

location_facility: Klinikum Fürth, Frauenklinik Nathanstift

location_facility: Northampton General Hospital, Gynaecological Oncology

location_facility: East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology

location_facility: Hospital de la Santa Creu i Sant Pau, Oncology

location_facility: Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House

location_facility: Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe

location_facility: Suzhou Municipal Hospital, Gynecologic and Obstetrics

location_facility: Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology

location_facility: Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie

location_facility: Ringshospitalet Copenhagen University Hospital; Oncology

location_facility: Odense University Hospital, Gynaecology and Obstetrics

location_facility: Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology

location_facility: Norfolk & Norwich University Hospital,Obstetrics & Gynaecology

location_facility: Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe

location_facility: Karolinska University Hospital, Oncology

location_facility: Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre

location_facility: ICO Badalona - H. U. Germans Trias i Pujol

location_facility: Zhejiang Cancer Hospital, Gynecology Oncology

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde

location_facility: Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica

location_facility: Birmingham City Hospital, Cancer Research Team

location_facility: Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology

location_facility: Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre

location_facility: Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg

location_facility: Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: University College London Hospital, Cancer clinical trails unit

location_facility: Fondazione IRCCS Istituto Nazionale Tumori di Milano

location_facility: Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe

location_facility: Hospital Universitari i Politècnic la Fe, Oncology

location_facility: Istituto Europeo di Oncologia, Divisione di Ginecologia

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe

location_facility: St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre

location_facility: ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona

intervention_type: Procedure


ReferenceCitation: Harbeck N, Huang CS, Hurvitz S, Yeh DC, Shao Z, Im SA, Jung KH, Shen K, Ro J, Jassem J, Zhang Q, Im YH, Wojtukiewicz M, Sun Q, Chen SC, Goeldner RG, Uttenreuther-Fischer M, Xu B, Piccart-Gebhart M; LUX-Breast 1 study group. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):357-366. doi: 10.1016/S1470-2045(15)00540-9. Epub 2016 Jan 26.

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

family: Huang

full_name: Chiun-Sheng Huang

given: Chiun-Sheng

family: Hurvitz

full_name: Sara Hurvitz

given: Sara

family: Yeh

full_name: Dah-Cherng Yeh

given: Dah-Cherng

family: Shao

full_name: Zhimin Shao

given: Zhimin

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Jung

full_name: Kyung Hae Jung

given: Kyung Hae

family: Shen

full_name: Kunwei Shen

given: Kunwei

family: Ro

full_name: Jungsil Ro

given: Jungsil

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Zhang

full_name: Qingyuan Zhang

given: Qingyuan

full_name: Young-Hyuck Im

given: Young-Hyuck

family: Wojtukiewicz

full_name: Marek Wojtukiewicz

given: Marek

family: Sun

full_name: Qiang Sun

given: Qiang

family: Chen

full_name: Shin-Cheh Chen

given: Shin-Cheh

family: Goeldner

full_name: Rainer-Georg Goeldner

given: Rainer-Georg

family: Uttenreuther-Fischer

full_name: Martina Uttenreuther-Fischer

given: Martina

family: Xu

full_name: Binghe Xu

given: Binghe

family: Piccart-Gebhart

full_name: Martine Piccart-Gebhart

given: Martine

journal_name: The Lancet Oncology

lead_sponsor: Boehringer Ingelheim

location_country:
Peru
Australia
Belgium
Russian Federation
Taiwan
India
Spain
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Netherlands
Sri Lanka
Singapore
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Czechia
Israel
Egypt
Belarus
Turkey
Latvia

acronym: LUX-Breast 1

location_facility: Centro de Referência da Saude da Mulher-Hosp Perola Byington

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil

location_facility: Wojewodzki Specialist Hospital No. 4, Bytom

location_facility: Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc

location_facility: Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: GUZ "Regional Clinical Oncology Dispensary"

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: POKO Policlinic Dept. of Clinical Oncology

location_facility: Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: Provincial Specialist M. Kopernik Hospital

location_facility: Cancer Care Associates Medical Group, Inc

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: Instituto Clínico Oncológico del Sur - ICOS

location_facility: N. N. Alexandrov National Cancer Center of Belarus

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: The Third Affiliated Hospital of Harbin Medical University

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: CHUC, EPE - CHC-Maternidade Bissaya Barreto

location_facility: DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU

location_facility: N.A. Semashko Central Clinical Hospital, Moscow

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Centro de Pesquisas Clínicas em Oncología

location_facility: Máxima Medisch Centrum, locatie Eindhoven

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Universitätsfrauenklinik am Klinikum Südstadt

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim

location_facility: Public Health Inst. Minsk City Clinical Oncology Dispensary

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Cancer Hospital of Chinese Academy of Medical Science

location_facility: P. Stradins Clinical Univ. Hospital, Oncology Clinic

location_facility: National Institute of Oncology, Bratislava

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: Central Coast Medical Oncology Corporation

location_facility: Koo Foundation Sun Yet-Sen Cancer Center

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: Riga East Univ. Hospital, Oncology Centre

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Ziemia Lubelska Oncological Center, Lublin

location_facility: St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov

location_facility: Instituto Medico de Asistencia e Investigaciones S. A.

location_facility: Hammoud Hospital University Medical Centre (HHUMC)

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

title: LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment

summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment


ReferenceCitation: Perez EA, de Haas SL, Eiermann W, Barrios CH, Toi M, Im YH, Conte PF, Martin M, Pienkowski T, Pivot XB, Burris HA 3rd, Stanzel S, Patre M, Ellis PA. Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine ± pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer. BMC Cancer. 2019 May 30;19(1):517. doi: 10.1186/s12885-019-5687-0. Erratum in: BMC Cancer. 2019 Jun 24;19(1):620.

family: Perez

full_name: Edith A. Perez

given: Edith A.

family: de Haas

full_name: Sanne Lysbet de Haas

given: Sanne Lysbet

family: Eiermann

full_name: Wolfgang Eiermann

given: Wolfgang

family: Barrios

full_name: Carlos H. Barrios

given: Carlos H.

family: Toi

full_name: Masakazu Toi

given: Masakazu

family: Conte

full_name: Pier Franco Conte

given: Pier Franco

family: Martin

full_name: Miguel Martin

given: Miguel

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Pivot

full_name: Xavier B. Pivot

given: Xavier B.

family: Burris

full_name: Howard A. Burris

given: Howard A.

suffix: III

family: Stanzel

full_name: Sven Stanzel

given: Sven

family: Patre

full_name: Monika Patre

given: Monika

family: Ellis

full_name: Paul Anthony Ellis

given: Paul Anthony

journal_name: BMC Cancer

repository_institution: Kyoto University - Kyoto University Research Information Repository

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Bighin C, Pronzato P, Del Mastro L. Trastuzumab emtansine in the treatment of HER-2-positive metastatic breast cancer patients. Future Oncol. 2013 Jul;9(7):955-7. doi: 10.2217/fon.13.74.

family: Bighin

full_name: Claudia Bighin

given: Claudia

family: Pronzato

full_name: Paolo Pronzato

given: Paolo

ReferenceCitation: Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236. Review.

title: Antibody therapy of cancer

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: Prince of Songkla Uni ; Unit of Medical Oncology

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: St. John'S Mercy Medical Center; David C. Pratt Cancer Center

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Hiroshima University Hospital; Breast Surgery

location_facility: Peterborough City Hospital; Oncology Ward

location_facility: National Cancer Center Hospital; Breast and Medical Oncology

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

location_facility: Kawasaki Medical School Hospital; Breast and Thyroid Surgery

location_facility: Waikato Hospital; Regional Cancer Center

location_facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Tri-Service General Hospital; Hematology and Oncology

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Wesley Medical Centre; Clinic For Haematology and Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Hopital Saint Louis; Service Onco Thoracique

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Kyorin University Hospital; Breast Surgery

location_facility: Ospedale Papardo- Piemonte;Oncologia Medica

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Kitakyushu Municipal Medical Center; Surgery

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Columbia Comprehensive Cancer Center Clinic

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Uni of Texas Southwestern Medical Center

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: University Hospital of Larissa; Oncology

location_facility: Jichi Medical University; Breast Oncology

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Korea University Guro Hospital; Oncology

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Osaka University Hospital; Breast and Endocrine Surgery

location_facility: Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii

location_facility: Instituto Colombiano Para El Avance De La Medicina: Icamedic

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hyogo College Of Medicine; Breast And Endocrine Surgery

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: Cukurova Uni Faculty of Medicine; Medical Oncology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Mater Misericordiae Hospital; Chemotherapy Cottage

location_facility: Saitama Medical University International Medical Center; Medical Oncology

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Tokai University Hospital, Breast and Endocrine Surgery

location_facility: Sharp Healthcare; Oncology Research Program

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: Tohoku University Hospital; Breast And Endocrine Surgery

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: The Providence Regional Medical Center Everett

location_facility: Kanazawa University Hospital; Breast Oncology

location_facility: Seoul National University Bundang Hospital; Hematology Medical Oncology

location_facility: The Don & Sybil Harrington Cancer Center; Department of Clinical Research

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Gunma University Hospital; Department of Breast and Endocrine Surgery

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Cuse - Centre Universitaire De Sante; Site Fleurimont

location_facility: Little Rock Hematology Oncology Associates, PA

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Shizuoka Cancer Center; Female Internal Medicine

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Maharaj Nakorn Hospital; Internal Medicine

location_facility: National Hospital Organization Hokkaido Cancer Center; Breast Surgery

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Hackensack Uni Medical Center; Northern Nj Cancer Center

location_facility: Ospedale Degli Infermi; Divisione Di Oncologia

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Uni of Colorado Cancer Center; Anschutz Cancer Pavilion

location_facility: Showa University Hospital; Breast Surgery

location_facility: Oncology Associates at Mercy Medical Center

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Kumamoto University Hospital; Breast and Endocrine Surgery

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: South Carolina Oncology Associates - SCRI

location_facility: Centro de Investigacion; Clinica Del Pacifico

location_facility: GUZ Vladimir Regional Clinical Oncological Dispensary

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Nebraska Methodist Hospital; Cancer Center

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Gifu University Hospital; Second Department of Surgery

location_facility: Northeast Georgia Medical Center; Oncology Research Dept-5C

location_facility: Mercy Medical Center; Medical Oncology & Hematology

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

location_facility: Mikawa Breast Cancer Clinic; Breast Surgery

location_facility: University of California; Moores Cancer Center

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Cancer Research Center of Hawaii; Clinical Sciences

location_facility: Toranomon Hospital; Breast and Endocrine Surgery

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Okayama University Hospital; Breast, Thyroid Surgery

location_facility: Innovative Medical Research of South Florida

location_facility: Kantonsspital Baden; Medizinische Klinik, Onkologie

location_facility: James Graham Brown Cancer Center, University of Louisville

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center

title: A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

summary: This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.


type: Other Identifier

title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

summary: This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.

ReferenceCitation: Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.

family: Yoshida

full_name: Kenta Yoshida

given: Kenta

family: Moein

full_name: Anita Moein

given: Anita

family: Bittner

full_name: Tobias Bittner

given: Tobias

family: Ostrowitzki

full_name: Susanne Ostrowitzki

given: Susanne

family: Lin

full_name: Helen Lin

given: Helen

family: Honigberg

full_name: Lee Honigberg

given: Lee

family: Jin

full_name: Jin Y. Jin

given: Jin Y.

family: Quartino

full_name: Angelica Quartino

given: Angelica

journal_name: Alzheimer's Research & Therapy

title: Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer’s disease

lead_sponsor: Genentech, Inc.

location_country:
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: University of California Davis Medical System

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: Great Western Hosp.; Kingshill Research Ctr

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: West London Research Unit; Brentford Lodge

location_facility: Florida Atlantic University; College of Medicine

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: Hospital Universitario Virgen de la Macarena;

location_facility: Investigational Drug Service; Univ of Rochester Medical Ctr

location_facility: Studienambulanz emovis GmbH; St. Joseph Krankenhaus

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Royal Sussex County Hospital, CIRU Level 5

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: IU Healthy Partners Adult Neurology Clinic

location_facility: University of Rochester Medical Center; Monroe Community Hospital

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: Villa Sauer, Praxis für; Neurologie und Psychiatrie

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Univ Berlin; Klin fur Psychi & Psycho Charite

location_facility: Providence Care Centre; Mental Health Site

location_facility: The National Hospital for Neurology & Neurosurgery; Dementia Research Center

location_facility: Camden Mews Day Hospital; Camden and Islington

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr


title: A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer

summary: Dabrafenib is a potent and selective inhibitor of BRAF kinase activity. This is a Phase II, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Subjects will receive dabrafenib 150 mg twice daily (BID) in monotherapy treatment and dabrafenib 150 mg bid and trametinib 2 mg once daily in combination therapy and continue on treatment until disease progression, death, or unacceptable adverse event.

design_allocation: Non-Randomized

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Robert

full_name: Caroline Robert

given: Caroline

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

family: Tawbi

full_name: Hussein A. Tawbi

given: Hussein A.

family: Menzies

full_name: Alexander M. Menzies

given: Alexander M.

family: Banerjee

full_name: Hiya Banerjee

given: Hiya

family: Lau

full_name: Mike Lau

given: Mike

family: Long

full_name: Georgina V. Long

given: Georgina V.

journal_name: European Journal of Cancer

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Li J, Sasane M, Zhang J, Zhao J, Ricculli ML, Yao Z, Redhu S, Signorovitch J. Is time to progression associated with post-progression survival in previously treated metastatic non-small cell lung cancer with BRAF V600E mutation? A secondary analysis of phase II clinical trial data. BMJ Open. 2018 Aug 17;8(8):e021642. doi: 10.1136/bmjopen-2018-021642.

family: Li

full_name: Junlong Li

given: Junlong

family: Sasane

full_name: Medha Sasane

given: Medha

family: Zhang

full_name: Jie Zhang

given: Jie

family: Zhao

full_name: Jing Zhao

given: Jing

family: Ricculli

full_name: Marie Louise Ricculli

given: Marie Louise

family: Yao

full_name: Zhiwen Yao

given: Zhiwen

family: Redhu

full_name: Suman Redhu

given: Suman

family: Signorovitch

full_name: James Signorovitch

given: James

ReferenceCitation: Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. doi: 10.1016/S1470-2045(17)30679-4. Epub 2017 Sep 11.

title: Dabrafenib plus trametinib in patients with previously untreated BRAFV600E-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial

ReferenceCitation: Planchard D, Besse B, Groen HJM, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-993. doi: 10.1016/S1470-2045(16)30146-2. Epub 2016 Jun 6.

title: Dabrafenib plus trametinib in patients with previously treated BRAFV600E-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial

ReferenceCitation: Planchard D, Kim TM, Mazieres J, Quoix E, Riely G, Barlesi F, Souquet PJ, Smit EF, Groen HJ, Kelly RJ, Cho BC, Socinski MA, Pandite L, Nase C, Ma B, D'Amelio A Jr, Mookerjee B, Curtis CM Jr, Johnson BE. Dabrafenib in patients with BRAF(V600E)-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 May;17(5):642-50. doi: 10.1016/S1470-2045(16)00077-2. Epub 2016 Apr 11.

title: Dabrafenib in patients with BRAFV600E-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Italy
United States
Netherlands
France
Japan
Norway
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan


title: A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

summary: This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

ReferenceCitation: Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Chawla

full_name: Sant Chawla

given: Sant

family: Maki

full_name: Robert G Maki

given: Robert G

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

family: Choy

full_name: Edwin Choy

given: Edwin

family: Grignani

full_name: Giovanni Grignani

given: Giovanni

family: Camargo

full_name: Veridiana Camargo

given: Veridiana

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

family: Rha

full_name: Sun Young Rha

given: Sun Young

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

family: D'Adamo

full_name: David D'Adamo

given: David

family: Guo

full_name: Matthew Guo

given: Matthew

family: Chmielowski

full_name: Bartosz Chmielowski

given: Bartosz

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Demetri

full_name: George D Demetri

given: George D

family: Patel

full_name: Shreyaskumar R Patel

given: Shreyaskumar R

journal_name: The Lancet

lead_sponsor: Eisai Inc.

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Netherlands
Singapore
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain