location_country:
Peru
Finland
Belgium
Australia
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
New Zealand
Spain

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

location_facility: Peking University First Hospital / Urology Department

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Przychodnia Lekarska "Komed" Roman Karaszewski

location_facility: Providence Cancer Institute Newberg Clinic

location_facility: NZOZ Szpital Mazovia; Oddzial urologiczny

location_facility: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital (CMJAH), Clinical Trial Site

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Universitatsklinikum Erlangen AURONTE/Medizinische Klinik 5

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli

location_facility: South Jordan Health Center -University of Utah

location_facility: Clinical Trial Pharmacy, National Cancer Center

location_facility: Providence Cancer Institute Clackamas Clinic

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Lakeland Regional Health Hollis Cancer Center

location_facility: UPMC Hillman Cancer Center - Passavant (HOA)

location_facility: Fudan University Cancer Hospital, Deptartment of Urology

location_facility: AdventHealth Medical Group Hematology & Oncology at Celebration

location_facility: Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Tom Baker Cancer Centre - Alberta Health Services

location_facility: TriState urologic Services PSC Inc., dba The Urology Group

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born

location_facility: Imperial College Healthcare NHS Trust, Charing Cross Hospital

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

location_facility: University of Colorado Hospital- Anschutz Outpatient Pavilion

location_facility: UPMC Hillman Cancer Center - Arnold Palmer - Mt View

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: AMITA Health Adventist Medical Center Hinsdale

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)

location_facility: Inova Schar Cancer Institute Infusion Pharmacy

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Investigational Drug Services, Advent Health Orlando

location_facility: Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School

location_facility: Cancer Center Clinical Trial, Asan Medical Center

location_facility: Clinique Victor Hugo-Centre Jean Bernard

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

location_facility: The First People's Hospital of Lianyungang

location_facility: Corporacio Sanitaria i Universitaria Parc Tauli

location_facility: GU Research Network/Urology Cancer Center

location_facility: Centro de Investigacion Pergamino SA - Clinica Pergamino SA

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: NHS Greater Glasgow and Clyde, The Beatson West of Scotland Cancer Centre

location_facility: Associated Medical Professionals of New York, PLLC

location_facility: Auckland Regional Blood & Cancer Service

location_facility: Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA)

location_facility: The Second Hospital of Tianjin Medical University

location_facility: University of Wisconsin Clinical Science Center

location_facility: UPMC Hillman Cancer Center - Passavant (OHA)

location_facility: University of Wisconsin Hospital & Clinics

location_facility: The University of Kansas Clinical Research Center

location_facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)

location_facility: Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao

location_facility: The First affiliated Hospital of Anhui Medical University

location_facility: John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy

location_facility: Montefiore Medical Center - Montefiore Medical Park

location_facility: Vanderbuilt University Medical Center, Department of Urology

location_facility: UPMC Hillman Cancer Center - Monroeville

location_facility: New Jersey Cancer Care and Blood Disorders

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza

location_facility: Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Redwood Health Center-University of Utah

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Centre integre universitaire de sante et de services sociaux de l'Estrie

location_facility: Farmington Health Center -University of Utah

location_facility: Hospital Militar Central "Coronel Luis Arias Schreiber"

location_facility: Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Centro de Pesquisa Clinica de Oncologia e Hematologia/Hospital Mae de Deus

location_facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Second Affiliated Hospital of Suzhou University

location_facility: Cancercare Langenhoven Drive Oncology Centre

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet

location_facility: Providence Cancer Institute Franz Clinic

location_facility: University of Colorado Hospital- Anschutz Inpatient Pavilion

location_facility: AdventHealth Medical Group Hematology & Oncology at Kissimmee

location_facility: UPMC Hillman Cancer Center - Upper St. Clair

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA

location_facility: Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Integrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Clinical Trial Pharmacy, The Catholic University of Korea

location_facility: The Clatterbridge Cancer Centre - Liverpool

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: St. Olavs Hospital, Trondheim University Hospital

location_facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: The First Affiliated Hospital College of Medicine, Zhejiang University

location_facility: Desert Hematology Oncology Medical Group, Incorporation

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: The Fifth People's Hospital of Shanghai, Fudan University

location_facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Hopitaux Universitaires de Strasbourg - ICANS

location_facility: Loma Linda University Cancer Center - Hematology/Oncology Clinic

location_facility: Centro Clínico Académico - Braga, Associação (2CABraga)

location_facility: West China Hospital of Sichuan University

location_facility: University of California, Irvine Medical Center

location_facility: Universitaetsklinikum Erlangen, Urologische und Kinderurologische Klinik

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

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio Libanês

location_facility: Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi

location_facility: Oslo University Hospital -Ullevål & Radiumhospitalet

location_facility: Providence Oncology and Hematology Care Clinic - Westside

title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

summary: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.


title: A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

acronym: CheckMate 9DX

summary: This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Netherlands
Singapore
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
New Zealand
Spain

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi

location_facility: Hospital Clinico de la Universidad De Chile

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: S.C. Oncocenter Oncologie Clinica S.R.L.

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Washington University School of Medicine

location_facility: Kings College Hospital-King's College Hospital NHS Foundation Trust

location_facility: Wellcome Trust Imperial Clinical Research Facility (CRF) (Sir John McMichael Centre (SJMC))

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: University of Miami Sylvester Cancer Center

location_facility: H. Lee Moffit Cancer center and research institute

location_facility: Tulane University Health Sciences Center

location_facility: Azienda Ospedaliera Specialistica dei Colli Monaldi-Cotugno-CTO

location_facility: Consultorio medico de la Dra. Alma Laura Ladran de Guevara Cetina

location_facility: California Pacific Medical Center Research Institute

location_facility: Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Drug

status: Completed

lead_sponsor: Novartis Pharmaceuticals

location_country: Italy Sweden Serbia Finland Croatia Czechia Bulgaria France Lithuania Norway Hungary Romania Slovakia Spain Estonia

ipd_sharing: No

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: An Open-label, Multi-Center, Phase IIIb Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia Who Are Eligible for "7+3" or "5+2" Chemotherapy

summary: The purpose of this study is to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation

status_simplified: Completed


type: Registry Identifier

title: Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

acronym: FACE

summary: Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Spain
Germany
France
Japan
Israel
Norway
Ireland
Australia
Belgium
China
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: Sarah Cannon Oncology Hematology Care, Inc

location_facility: Texas Cancer Center ( Medical City Dallas Hospital)

location_facility: Center for Oncology Research and Treatment, PA

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: Northern Arizona Hematology/Oncology Associates, P.C.

location_facility: New York Oncology Hematology, P.C. NYOH Latham

location_facility: Chattanooga Oncology and Hematology Assoicates, PC

location_facility: Wichita Community Clinical Oncology Program

location_facility: Medical Oncology Associates of Wyorning Valley, PC

location_facility: Birmingham Hematology and Oncology Associates


title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

summary: Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.

ReferenceType: derived

ReferenceCitation: Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5.

name: Loyola University Medical Center and Hines Veterans Administration Hospital, Chicago, Illinois

family: Johnson

full_name: Stuart Johnson

given: Stuart

sequence: first

family: Louie

full_name: Thomas J. Louie

given: Thomas J.

sequence: additional

family: Gerding

full_name: Dale N. Gerding

given: Dale N.

name: Department of Internal Medicine, Clinical Trials Centre Cologne, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, University of Cologne, Germany

family: Cornely

full_name: Oliver A. Cornely

given: Oliver A.

family: Chasan-Taber

full_name: Scott Chasan-Taber

given: Scott

name: ViroPharma Incorporated, Exton, Pennsylvania

family: Fitts

full_name: David Fitts

given: David

family: Gelone

full_name: Steven P. Gelone

given: Steven P.

family: Broom

full_name: Colin Broom

given: Colin

family: Davidson

full_name: David M. Davidson

given: David M.

name: for the Polymer Alternative for CDI Treatment (PACT) investigators

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Infectious Diseases

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Vancomycin, Metronidazole, or Tolevamer for Clostridium difficile Infection: Results From Two Multinational, Randomized, Controlled Trials

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Austria
Sweden
Switzerland
Spain
United Kingdom
France
Norway
Ireland
Australia
Belgium
Portugal
Denmark
Germany
Czech Republic


title: Efficacy and Safety of Subsequent Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Further Treatment in Patients With Stage III or IV Follicular Non-Hodgkin's Lymphoma Having Achieved Partial or Complete Remission After First Line Chemotherapy. A Prospective, Multicenter, Randomized Phase III Clinical Trial

summary: The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in patients with stage III or IV follicular lymphoma whose disease is in partial or complete remission after first line chemotherapy. The radioactive antibody will be compared with no further treatment to see which is better in the long term after standard lymphoma treatment.

lead_sponsor: Bayer

location_country:
Italy
Sweden
Switzerland
Netherlands
Spain
Germany
France
Norway
Belgium
Portugal
Denmark
Canada
United Kingdom


title: Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS): Prospective Observational Cohort of Patients With Moderate-to-severe SLE to Characterize Cross-sectional and Longitudinal Disease Activity, Treatment Patterns and Effectiveness, Outcomes and Comorbidities, Healthcare Resource Utilization, and the Impact of SLE on Quality of Life by Type I Interferon Expression

acronym: SPOCS

summary: SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical features, disease progression and treatment patterns, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Hammond ER, Tummala R, Berglind A, Syed F, Wang X, Desta B, Nab H. Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature. BMJ Open. 2020 Sep 1;10(9):e036563. doi: 10.1136/bmjopen-2019-036563.

family: Hammond

full_name: Edward R Hammond

given: Edward R

family: Tummala

full_name: Raj Tummala

given: Raj

family: Berglind

full_name: Anna Berglind

given: Anna

family: Syed

full_name: Farhat Syed

given: Farhat

family: Wang

full_name: Xia Wang

given: Xia

family: Desta

full_name: Barnabas Desta

given: Barnabas

family: Nab

full_name: Henk Nab

given: Henk

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Germany
France
Australia
Spain
Canada
United Kingdom


title: Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

acronym: CRYSTAL

summary:
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor.

Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data.

After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.

The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.

ReferenceType: result

ReferenceCitation: Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Köhne

full_name: Claus-Henning Köhne

given: Claus-Henning

family: Hitre

full_name: Erika Hitre

given: Erika

family: Zaluski

full_name: Jerzy Zaluski

given: Jerzy

family: Chang Chien

full_name: Chung-Rong Chang Chien

given: Chung-Rong

family: Makhson

full_name: Anatoly Makhson

given: Anatoly

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Pintér

full_name: Tamás Pintér

given: Tamás

family: Lim

full_name: Robert Lim

given: Robert

family: Bodoky

full_name: György Bodoky

given: György

family: Roh

full_name: Jae Kyung Roh

given: Jae Kyung

family: Folprecht

full_name: Gunnar Folprecht

given: Gunnar

family: Ruff

full_name: Paul Ruff

given: Paul

family: Stroh

full_name: Christopher Stroh

given: Christopher

family: Tejpar

full_name: Sabine Tejpar

given: Sabine

family: Schlichting

full_name: Michael Schlichting

given: Michael

family: Nippgen

full_name: Johannes Nippgen

given: Johannes

family: Rougier

full_name: Philippe Rougier

given: Philippe

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer

ReferenceCitation: Van Cutsem E, Lang I, Folprecht G, Nowacki M, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Celik I, Kohne C Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer (mCRC): The influence of KRAS and BRAF biomarkers on outcome: Updated data from the CRYSTAL trial. ASCO 2010 Gastrointestinal Cancers Symposium, Orlando, USA January 2010 Abstract No: 281

ReferenceCitation: Lang I, Kohne CH, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Zubel A, Van Cutsem E Cetuximab plus FOLFIRI in 1st-line treatment of metastatic colorectal cancer: Quality of life (QoL) analysis of patients (pts) with KRAS wild-type (wt) tumours in the CRYSTAL trial. European Journal of Cancer Supplements. 2009 7(2):345

ReferenceCitation: Dercle L, Lu L, Lichtenstein P, Yang H, Wang D, Zhu J, Wu F, Piessevaux H, Schwartz LH, Zhao B. Impact of Variability in Portal Venous Phase Acquisition Timing in Tumor Density Measurement and Treatment Response Assessment: Metastatic Colorectal Cancer as a Paradigm. JCO Clin Cancer Inform. 2017 Nov;1:1-8. doi: 10.1200/CCI.17.00108.

name: Laurent Dercle, Lin Lu, Philip Lichtenstein, Hao Yang, Jianguo Zhu, Feiyun Wu, Lawrence H. Schwartz, and Binsheng Zhao, Columbia University Medical Center, and Presbyterian Hospital, New York, NY; Laurent Dercle, Gustave Roussy, Université Paris-Saclay, UMR1015, Villejuif, France; Deling Wang, Sun Yat-sen University Cancer Center; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Hong Kong, Special Administrative Region, People’s...

family: Dercle

full_name: Laurent Dercle

given: Laurent

family: Lu

full_name: Lin Lu

given: Lin

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Tejpar S, Stintzing S, Ciardiello F, Tabernero J, Van Cutsem E, Beier F, Esser R, Lenz HJ, Heinemann V. Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials. JAMA Oncol. 2017 Feb 1;3(2):194-201. doi: 10.1001/jamaoncol.2016.3797. Erratum in: JAMA Oncol. 2017 Dec 1;3(12):1742.

name: Molecular Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium

name: Department of Hematology and Oncology, University of Munich (Ludwig-Maximilians-Universität), Munich, Germany

name: Dipartimento Medico-Chirurgico di Internistica Clinica e Sperimentale, Seconda Università di Napoli, Naples, Italy

name: Medical Oncology Department, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain

name: Digestive Oncology, University Hospitals Leuven and KULeuven, Leuven, Belgium

name: Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA

ReferenceCitation: Licitra L, Störkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.

title: Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: Analysis of data from the EXTREME and CRYSTAL studies

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
France
Poland
Slovakia
Argentina
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Spain
Turkey


title: A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

summary: Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

status: No longer available

study_type: Expanded Access

location_country:
Italy
United States
Brazil
South Africa
Switzerland
Spain
Germany
France
Czechia
Poland
Norway
Belgium
Australia
New Zealand
Puerto Rico
Russian Federation
Canada
United Kingdom
Taiwan

status_simplified: Unknown


title: A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

summary: The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

status: Approved for marketing

ReferenceCitation: Barrios CH, Herchenhorn D, Chacón M, Cabrera-Galeana P, Sajben P, Zhang K. Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma. Onco Targets Ther. 2016 Sep 23;9:5839-5845. eCollection 2016.

ReferenceCitation: Lee SH, Bang YJ, Mainwaring P, Ng C, Chang JW, Kwong P, Li RK, Sriuranpong V, Toh CK, Yuan J, Pitman Lowenthal S, Chung HC. Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy. Asia Pac J Clin Oncol. 2014 Sep;10(3):237-45. doi: 10.1111/ajco.12163. Epub 2014 Feb 27.

name: Department of Internal Medicine; Seoul National University Hospital and Cancer Research Institute; Seoul National University College of Medicine; Seoul South Korea

family: Lee

full_name: Se-Hoon Lee

given: Se-Hoon

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

name: Medical Oncology; Mater Adult Hospital; South Brisbane Queensland Australia

family: Mainwaring

full_name: Paul Mainwaring

name: Medical Oncology, Department of Medicine; University Malaya Medical Centre; Kuala Lumpur Malaysia

family: Ng

full_name: Christina Ng

given: Christina

name: Division of Hematology-Oncology, Department of Internal Medicine; Chang Gung Memorial Hospital; Chang Gung University College of Medicine; Taoyuan Taiwan

family: Chang

full_name: John W-C Chang

given: John W-C

name: Department of Clinical Oncology; Queen Mary Hospital; Hong Kong China

family: Kwong

full_name: Philip Kwong

given: Philip

name: Cancer Institute; St Luke's Medical Center; Quezon City Philippines

family: Li

full_name: Rubi K Li

given: Rubi K

name: Medical Oncology Unit, Department of Medicine, Faculty of Medicine; Chulalongkorn University; Bangkok Thailand

family: Sriuranpong

full_name: Virote Sriuranpong

given: Virote

name: Department of Medical Oncology; National Cancer Centre; Singapore

family: Toh

full_name: Chee-Keong Toh

given: Chee-Keong

family: Yuan

full_name: Jinyu Yuan

given: Jinyu

family: Pitman Lowenthal

full_name: Susan Pitman Lowenthal

given: Susan

name: Yonsei Cancer Center; Yonsei University College of Medicine; Yonsei University Health System; Seoul South Korea

family: Chung

full_name: Hyun C Chung

given: Hyun C

journal_name: Asia-Pacific Journal of Clinical Oncology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Sunitinib in metastatic renal cell carcinoma: An ethnic Asian subpopulation analysis for safety and efficacy

ReferenceCitation: Gore ME, Hariharan S, Porta C, Bracarda S, Hawkins R, Bjarnason GA, Oudard S, Lee SH, Carteni G, Nieto A, Yuan J, Szczylik C. Sunitinib in metastatic renal cell carcinoma patients with brain metastases. Cancer. 2011 Feb 1;117(3):501-9. doi: 10.1002/cncr.25452. Epub 2010 Sep 22.

family: Gore

full_name: Martin E. Gore

given: Martin E.

family: Hariharan

full_name: Subramanian Hariharan

given: Subramanian

family: Porta

full_name: Camillo Porta

given: Camillo

family: Bracarda

full_name: Sergio Bracarda

given: Sergio

family: Hawkins

full_name: Robert Hawkins

family: Bjarnason

full_name: Georg A. Bjarnason

given: Georg A.

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

family: Carteni

full_name: Giacomo Carteni

given: Giacomo

family: Nieto

full_name: Alejandra Nieto

ReferenceCitation: Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, Hariharan S, Lee SH, Haanen J, Castellano D, Vrdoljak E, Schöffski P, Mainwaring P, Nieto A, Yuan J, Bukowski R. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 2009 Aug;10(8):757-63. doi: 10.1016/S1470-2045(09)70162-7. Epub 2009 Jul 15.

location_country:
Peru
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ecuador
India
Croatia
France
Panama
Poland
Slovakia
Norway
Thailand
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Bulgaria
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Brazil
Serbia
Lebanon
Mexico
Venezuela
Israel
Egypt
Spain
Turkey


title: An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.

summary:
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).

design_allocation: Non-Randomized

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Greece
Belgium
Australia
Portugal
Denmark
Canada
United Kingdom

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: 1st Social Insurance Foundation (IKA) Pentelis

location_facility: Korgialenio-Benakio-Hellenic Red Cross General Hospital

location_facility: McGill University Health Centre, Suite A5-140

location_facility: ifi Institut für interdisziplinäre Infektiologie

location_facility: Canadian Immunodeficiency Research Collaborative Inc.

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Montreal Chest Institute - McGill University Health Centre

location_facility: Centre Hospitalier Universitaire St. Pierre


title: Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation

summary:
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.

PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.

status: Unknown status

ReferenceCitation: Eggermont AM, Suciu S, Ruka W, et al.: EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results. [Abstract] J Clin Oncol 26 (Suppl 15): A-9004, 2008.

ReferenceCitation: Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.

family: Patel

full_name: Poulam M. Patel

given: Poulam M.

family: Suciu

full_name: Stefan Suciu

given: Stefan

family: Mortier

full_name: Laurent Mortier

given: Laurent

family: Kruit

full_name: Wim H. Kruit

given: Wim H.

family: Robert

full_name: Caroline Robert

given: Caroline

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Trefzer

full_name: Uwe Trefzer

given: Uwe

family: Punt

full_name: Cornelis J.A. Punt

given: Cornelis J.A.

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Davidson

full_name: Neville Davidson

given: Neville

family: Becker

full_name: Juergen Becker

given: Juergen

family: Conry

full_name: Robert Conry

given: Robert

family: Thompson

full_name: John A. Thompson

given: John A.

family: Hwu

full_name: Wen-Jen Hwu

given: Wen-Jen

family: Engelen

full_name: Kristel Engelen

given: Kristel

family: Agarwala

full_name: Sanjiv S. Agarwala

given: Sanjiv S.

family: Keilholz

full_name: Ulrich Keilholz

given: Ulrich

family: Eggermont

full_name: Alexander M.M. Eggermont

given: Alexander M.M.

family: Spatz

full_name: Alain Spatz

given: Alain

bso_classification: Chemistry

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: Final results of a randomised phase III study (EORTC 18032)

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Serbia
Switzerland
Netherlands
Spain
Finland
France
Poland
Israel
Norway
Belgium
Australia
Russian Federation
Portugal
Estonia
Denmark
Germany
United Kingdom

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: St. Luke's Cancer Centre at Royal Surrey County Hospital

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Instituto Portugues de Oncologia Centro do Porto, S. A.

location_facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Selly Oak Hospital at University Hospital NHS Trust

location_facility: Royal Free and University College Medical School

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: Royal Marsden NHS Foundation Trust - London

location_facility: North-Estonian Regional Hospital Surgical Oncology Centre

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Ospendale S.M. Annunziata-A.S.DI Florence

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centro di Riferimento Oncologico - Aviano

intervention_type: Procedure


title: First Line Infusional 5-Fluorouracil, Folinic Acid and Oxaliplatin for Metastatic Colorectal Cancer or Loco-Regional Recurrency - Role of Chronomodulated Delivery Upon Survival - A Multicenter Randomized Phase III Trial

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil, leucovorin, and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Efficace F, Innominato PF, Bjarnason G, Coens C, Humblet Y, Tumolo S, Genet D, Tampellini M, Bottomley A, Garufi C, Focan C, Giacchetti S, Lévi F; Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. Validation of patient's self-reported social functioning as an independent prognostic factor for survival in metastatic colorectal cancer patients: results of an international study by the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2008 Apr 20;26(12):2020-6. doi: 10.1200/JCO.2007.12.3117.

ReferenceCitation: Giacchetti S, Zidani R, Perpoint B, et al.: Phase III trial of 5-fluorouracil (5-FU), folinic acid (FA), with or without oxaliplatin (OXA) in previously untreated patients (pts) with metastatic colorectal cancer (MCC). [Abstract] Proceedings of the American Society of Clinical Oncology 16: A805, 229a, 1997.

ReferenceCitation: Lévi F, Zidani R, Misset JL. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chronotherapy. Lancet. 1997 Sep 6;350(9079):681-6.

ReferenceCitation: Mormont MC, Bleuzen P, Lellouch J, et al.: Prognostic value of circadian rhythm assessment for survival of patients with metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-956, 269a, 1997.

ReferenceCitation: Innominato PF, Giacchetti S, Moreau T, Smaaland R, Focan C, Bjarnason GA, Garufi C, Iacobelli S, Tampellini M, Tumolo S, Carvalho C, Karaboué A, Lévi F; ARTBC International Chronotherapy Group. Prediction of survival by neutropenia according to delivery schedule of oxaliplatin-5-Fluorouracil-leucovorin for metastatic colorectal cancer in a randomized international trial (EORTC 05963). Chronobiol Int. 2011 Aug;28(7):586-600. doi: 10.3109/07420528.2011.597532.

family: Innominato

full_name: Pasquale F. Innominato

given: Pasquale F.

family: Giacchetti

full_name: Sylvie Giacchetti

given: Sylvie

family: Moreau

full_name: Thierry Moreau

given: Thierry

family: Smaaland

full_name: Rune Smaaland

given: Rune

family: Focan

full_name: Christian Focan

given: Christian

family: Bjarnason

full_name: Georg A. Bjarnason

given: Georg A.

family: Garufi

full_name: Carlo Garufi

given: Carlo

family: Iacobelli

full_name: Stefano Iacobelli

given: Stefano

family: Tampellini

full_name: Marco Tampellini

given: Marco

family: Tumolo

full_name: Salvatore Tumolo

given: Salvatore

family: Carvalho

full_name: Carlos Carvalho

given: Carlos

family: Karaboué

full_name: Abdoulaye Karaboué

given: Abdoulaye

family: Lévi

full_name: Francis Lévi

given: Francis

journal_name: Chronobiology International

oa_host_type: repository

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

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Prediction of Survival by Neutropenia According To Delivery Schedule of Oxaliplatin–5-Fluorouracil–Leucovorin for Metastatic Colorectal Cancer in a Randomized International Trial (EORTC 05963)

ReferenceCitation: Giacchetti S, Bjarnason G, Garufi C, Genet D, Iacobelli S, Tampellini M, Smaaland R, Focan C, Coudert B, Humblet Y, Canon JL, Adenis A, Lo Re G, Carvalho C, Schueller J, Anciaux N, Lentz MA, Baron B, Gorlia T, Lévi F; European Organisation for Research and Treatment of Cancer Chronotherapy Group. Phase III trial comparing 4-day chronomodulated therapy versus 2-day conventional delivery of fluorouracil, leucovorin, and oxaliplatin as first-line chemotherapy of metastatic colorectal cancer: the European Organisation for Research and Treatment of Cancer Chronotherapy Group. J Clin Oncol. 2006 Aug 1;24(22):3562-9.

ReferenceCitation: Garufi C, Bjarnason GA, Giacchetti S, et al.: Independent prognostic value of the rest/activity circadian rhythm on overall survival (OS) in patients (pts) with metastatic colorectal cancer (MCC) receiving first line chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin: a companion study to EORTC 05963. [Abstract] J Clin Oncol 23 (Suppl 16): A-3553, 259s, 2005.

ReferenceCitation: Innominato PF, Focan C, Bjarnason GA, et al.: Quality of life (QoL) correlates with the rest/activity circadian rhythm (RAR) in patients (pts) with metastatic colorectal cancer (MCC) on first line chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin : an international multicenter study (EORTC 05963). [Abstract] J Clin Oncol 23 (Suppl 16): A-8029, 736s, 2005.

ReferenceCitation: Lévi F, Gorlia T, Tubiana N, et al.: Gender as a predictor for optimal dynamic scheduling of oxaliplatin, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer. Results from EORTC randomized phase III trial 05963. [Abstract] J Clin Oncol 23 (Suppl 16): A-3587, 267s, 2005.

ReferenceCitation: Giacchetti S, Bjarnason GA, Garufi C, et al.: First line infusion of 5-fluorouracil, leucovorin, oxaliplatin for metastatic colorectal cancer chronomodulated versus conventional delivery. A multicenter randomized trial of the EORTC chronotherapy group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2231, 2002.

location_country: Italy Austria Germany France Greece Norway Belgium Portugal Canada

location_facility: Sunnybrook and Women's College Health Sciences Centre

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Azienda Ospedale S. Luigi - Universita Di Torino

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Haukeland Hospital - University of Bergen

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Azienda Ospedaliera "Santa Maria Degli Angeli"


title: Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every 3 Weeks

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors.

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
France
Greece
Israel
Norway
Belgium
Portugal
Denmark
Germany
United Kingdom

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Schneider Children's Medical Center of Israel

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Ludwig Boltzmann - Institute for Applied Cancer Research


title: PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors.


title: PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer.


ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.

name: Institute of Cellular Medicine, Faculty of Medical Sciences Newcastle University Newcastle upon Tyne United Kingdom

name: The Liver Unit Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust Newcastle upon Tyne United Kingdom

family: Anstee

full_name: Quentin M. Anstee

given: Quentin M.

name: Texas Liver Institute University of Texas Health San Antonio San Antonio TX

family: Lawitz

full_name: Eric J. Lawitz

given: Eric J.

family: Alkhouri

full_name: Naim Alkhouri

given: Naim

name: Department of Medicine and Therapeutics The Chinese Hospital of Hong Kong Hong Kong

family: Wong

full_name: Vincent Wai‐Sun Wong

given: Vincent Wai‐Sun

name: Hospital Universitario Virgen del Rocio Seville Spain

family: Romero‐Gomez

full_name: Manuel Romero‐Gomez

given: Manuel

name: Saiseikai Suita Hospital Suita City, Osaka Japan

family: Okanoue

full_name: Takeshi Okanoue

given: Takeshi

name: Division of Gastroenterology and Hepatology Medical University of Vienna Vienna Austria

family: Trauner

full_name: Michael Trauner

given: Michael

family: Kersey

full_name: Kathryn Kersey

given: Kathryn

family: Li

full_name: Georgia Li

given: Georgia

family: Han

full_name: Ling Han

given: Ling

family: Jia

full_name: Catherine Jia

given: Catherine

family: Wang

full_name: Lulu Wang

given: Lulu

family: Chen

full_name: Guang Chen

given: Guang

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: Myers

full_name: Robert P. Myers

given: Robert P.

family: Djedjos

full_name: C. Stephen Djedjos

given: C. Stephen

name: The Institute for Liver Health Chandler AZ

family: Kohli

full_name: Anita Kohli

given: Anita

family: Bzowej

full_name: Natalie Bzowej

given: Natalie

family: Younes

full_name: Ziad Younes

given: Ziad

name: Institute of Liver and Biliary Sciences New Delhi Delhi India

family: Sarin

full_name: Shiv Sarin

given: Shiv

name: Bon Secours Liver Institute of Virginia Richmond VA

family: Shiffman

full_name: Mitchell L. Shiffman

given: Mitchell L.

name: Pinnacle Clinical Research San Antonio TX

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

name: Beth Israel Deaconess Medical Center and Harvard Medical School Boston MA

family: Afdhal

full_name: Nezam H. Afdhal

given: Nezam H.

family: Goodman

full_name: Zachary Goodman

given: Zachary

family: Younossi

full_name: Zobair M. Younossi

given: Zobair M.

ReferenceCitation: Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.

ReferenceCitation: Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3 and STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.

ReferenceCitation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.

ReferenceCitation: Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.

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:
Australia
Belgium
Taiwan
India
France
Japan
Poland
Canada
Korea, Republic of
Hong Kong
Switzerland
Singapore
Puerto Rico
United States
Germany
United Kingdom
Italy
Austria
Mexico
Israel
New Zealand
Spain

location_facility: University of Colorado Denver and Hospital

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: Huntington Medical Research Institutes (HMRI) Liver Center

location_facility: Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

location_facility: The University of Chicago Medical Center

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik III

location_facility: University of Louisville Clinical Trials Unit

location_facility: Institute of Post Graduate Medical Education and Research (IPGMER)

location_facility: Indiana University Health - University Hospital

location_facility: Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease

location_facility: Toronto Center for Liver Diseases (TCLD), Toronto General Hospital

location_facility: Kawasaki Medical School General Medical Center

location_facility: Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie

location_facility: Walter Reed National Military Medical Center

location_facility: Department of Hepatology PGIMER Chandigarh

location_facility: University of California, San Francisco-Liver Clinic

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Intermountain Liver Disease and Transplant Clinic

location_facility: London Health Sciences Centre - University Hospital

location_facility: NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: CHOP_Complejo Hospitalario Universitario de Pntevedra

location_facility: Medical University of South Carolina, University Hospital

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Duke University Medical Center - Duke South Clinics

location_facility: Greenville Health System Gastroenterology and Liver Center

location_facility: Hospital Universitario Puerto de Hierro Majadahonda

location_facility: Southern Therapy and Advanced Research LLC (STAR)

location_facility: University of Manitoba, Health Sciences Centre, John Buhler Research Centre

location_facility: CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

location_facility: The University of Vermont Medical Center

location_facility: Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: American Research Corporation, The Texas Liver Institute

location_facility: Island View Gastroenterology Associates- Ventura

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: Carolinas HealthCare System Center for Liver Disease

location_facility: Groupe Hospitalier Universitaire La Pitie Salpetriere

location_facility: Global Clinical Reseaech Services PVT LTD

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Universitatsklinikum Frankfurt der Goethe-Universitat

location_facility: Seoul National University Bundang Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: University of California, San Diego (Altman Clinical and Translational Research Center)

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: University of Florida Hepatology Research at CTRB

location_facility: Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii

location_facility: Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Penn State University, The Milton S. Hershey Medical Center

location_facility: University of Buffalo, Clinical and Translational Research Center

location_facility: University of California, Davis Medical Center

location_facility: University of Massachusetts Medical School

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Health Insurance Service- Ilsan Hospital

location_facility: Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

location_facility: UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute

location_facility: Tokyo Womens Medical University Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

location_facility: St. Joseph's Hospital and Medical Center

location_facility: NorthShore University HealthSystem - Glenbrook ACC

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Tulane University Health Sciences Center

location_facility: Rutgers New Jersey Medical School- Doctors Office Center

location_facility: Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)

location_facility: Northwell Health - Sandra Atlas Bass Center for Liver Diseases

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

summary: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.


title: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER

summary: A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population

ReferenceCitation: Solomon BJ, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Shaw AT. Plain language summary of the CROWN study comparing lorlatinib with crizotinib for people with untreated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(34):4649-4656. doi: 10.2217/fon-2021-0904. Epub 2021 Sep 29.

name: Peter MacCallum Cancer Centre, Melbourne, VIC, Australia

family: Solomon

full_name: Benjamin J Solomon

given: Benjamin J

name: Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA

family: Bauer

full_name: Todd M Bauer

given: Todd M

name: European Institute of Oncology, IRCCS, Milan, Italy

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

name: Vall d’Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

name: National Cancer Center Hospital, Tokyo, Japan

family: Goto

full_name: Yasushi Goto

given: Yasushi

name: Princess Margaret Cancer Centre, Toronto, Canada

family: Liu

full_name: Geoffrey Liu

given: Geoffrey

name: Toulouse University Hospital, Toulouse, France

family: Mazieres

full_name: Julien Mazieres

given: Julien

name: Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea

family: Kim

full_name: Dong-Wan Kim

given: Dong-Wan

name: State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong

family: Mok

full_name: Tony Mok

given: Tony

family: Polli

full_name: Anna Polli

given: Anna

family: Thurm

full_name: Holger Thurm

given: Holger

family: Calella

full_name: Anna Maria Calella

given: Anna Maria

family: Peltz

full_name: Gerson Peltz

given: Gerson

name: Massachusetts General Hospital Cancer Center, Boston, MA, USA

family: Shaw

full_name: Alice T Shaw

given: Alice T

journal_name: Future Oncology

evidence: open (via page says license)

license: cc-by-nd

license_normalized: cc-by-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Shaw AT, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Solomon BJ; CROWN Trial Investigators. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020 Nov 19;383(21):2018-2029. doi: 10.1056/NEJMoa2027187.

name: From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) — both in Boston; Sarah Cannon Research Institute–Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) — both in Milan; Vall d’Hebron University Hospital and Institute of Oncology, International Oncology Bureau–Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital,...

full_name: Alice T. Shaw

given: Alice T.

full_name: Todd M. Bauer

given: Todd M.

ReferenceCitation: Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. doi: 10.1016/S1470-2045(17)30680-0. Epub 2017 Oct 23.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10.

title: J-ALEX: alectinib versus crizotinib in ALK -positive lung cancer

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Belgium
Australia
Russian Federation
Taiwan
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Singapore
China
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Spain
Turkey

location_facility: Department of Respiratory,the First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: The William P. Beetham Eye Institute, Joslin Diabetes Center

location_facility: Groupe Hospitalier Bichat Claude Bernard, AP-HP

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Hopital Haut-Léveque-Centre François Magendie

location_facility: Technische Universitat Dresden , Medizinische Fakultat Carl Gustav Carus

location_facility: Wakayama Medical University Department of Pulmonary Medicine and Oncology

location_facility: Division of Medical Oncology, Severance Hospital, Yonsei University Health System

location_facility: AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico

location_facility: Promotora Medica Aguascalientes SA de CV

location_facility: Azienda Ospedaliera di Perugia - Ospedale S. M. Misericordia

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas

location_facility: Budgetary Healthcare Institution Omsk Region "Clinical Oncological Dispensary"

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Sahyadri Clinical Research and Development Centre

location_facility: Marmara Univ Pendik Training and Research Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: RBHI Kursk Regional Clinical Oncology Dispensary

location_facility: Uberortliche Radiologische Gemeinschaftspraxis Dr. med. Marc Amler

location_facility: The University of Hong Kong, Department of Clinical Oncology

location_facility: LEC at SBIH "Saint-Petersburg Clinical Research Practical Center of specialized types of

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

location_facility: Srinivasam Cancer Care Multispeciality Hospitals India Pvt Ltd

location_facility: Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: Azienda Ospedaliera Dei Colli Ospedale Monaldi

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: University of Rochester Cancer Center Pharmacy

location_facility: The University of Hong Kong, Department of Medicine

location_facility: Grand Hopital de Charleroi - Site Notre Dame

location_facility: Bendigo Day Surgery Collection Centre and Laboratory

location_facility: Universitätsklinikum des Saarlandes, Innere Medizin V

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: FSBI "N.N.Blokhin Medical Research Center of Oncology"

location_facility: Universitatsklinikum Regensburg, Institut fur Rontgendiagnostik

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: The Catholic University of Korea, St. Vincents Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Bendigo Medical Imaging, Bendigo Hospital

location_facility: Institut Catala d'Oncologia L'Hospitalet

location_facility: Fakultni nemocnice Olomouc, Klinika plicnich nemoci a tuberkulozy

location_facility: The Affiliated Hospital of Military Medical Sciences

location_facility: Private Medical Institution "Euromedservice"

location_facility: Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch


type: Other Identifier

title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

acronym: HERCULES

summary:
Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS

Secondary Objective:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

status: Recruiting

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Spain
France
Japan
Lithuania
Poland
Norway
Argentina
Canada
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Belarus
Turkey

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ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Sweden
Switzerland
Netherlands
Spain
Germany
Finland
France
Poland
Norway
Ireland
Belgium
Australia
Portugal
Turkey
Denmark
United States
United Kingdom
Korea, Republic of

acronym: AcceleRET-Lung

location_facility: University of Texas Health Science Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Universitaetsklinikum Essen; Westdeutsches Tumorzentrum; Innere Klinik (Tumorforschung)

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Università degli Studi della Campania Luigi Vanvitelli

location_facility: Hospital Regional Universitario de Malaga

location_facility: Universitätsklinikum Frankfurt; Medizinische Klinik II; Onkologie

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Rigshospitalet, Onkologisk Klinik; Klinisk Forskningsenhed

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Hôpital Louis Pradel, Hospices Civils de Lyon

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E

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

location_facility: University of Maryland Marlene and Stewart Greenebaum Cancer Center

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Leopoldina-Krankenhaus Medizinische Klinik II

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: University College Hospital; Department of Oncology

location_facility: Universitätsklinikum Hamburg-Eppendorf; Med. II. Klinik

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: AZ. Ospedaliera San Giovanni - Addolorata

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital de Braga; Serviço de Pneumologia

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

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: CHRU Lille Service de Pneumologie et Oncologie Thoracique

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Klinik Schillerhöhe; Pneumologische Onkologie

location_facility: Hospital Garcia de Orta; Servico de Pneumologia

location_facility: Institut Jules Bordet; Pulmonary Oncology

title: A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.