title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

summary:
Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

ReferenceType: background

ReferenceCitation: Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.

ReferenceCitation: Skoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, Italiano A, Schuler M, Borghaei H, Barlesi F, Kato T, Curioni-Fontecedro A, Sacher A, Spira A, Ramalingam SS, Takahashi T, Besse B, Anderson A, Ang A, Tran Q, Mather O, Henary H, Ngarmchamnanrith G, Friberg G, Velcheti V, Govindan R. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021 Jun 24;384(25):2371-2381. doi: 10.1056/NEJMoa2103695. Epub 2021 Jun 4.

ReferenceCitation: Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRAS(G12C) Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. doi: 10.1056/NEJMoa1917239. Epub 2020 Sep 20.

name: From the Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, University of Texas M.D. Anderson Cancer Center, Houston (D.S.H., F.M.-B.); the Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte (M.G.F.), the University of California, San Francisco, San Francisco (P.N.M.), and Amgen, Thousand Oaks (H.H., J.N., G.N., J.K., B.E.H., J.C., J.R.L., G.F.) — all in California; Duke University Medical Center, Durham, NC (J.H...

family: Hong

full_name: David S. Hong

given: David S.

family: Fakih

full_name: Marwan G. Fakih

given: Marwan G.

family: Strickler

full_name: John H. Strickler

given: John H.

family: Desai

full_name: Jayesh Desai

given: Jayesh

family: Durm

full_name: Gregory A. Durm

given: Gregory A.

family: Shapiro

full_name: Geoffrey I. Shapiro

given: Geoffrey I.

family: Falchook

full_name: Gerald S. Falchook

given: Gerald S.

family: Price

full_name: Timothy J. Price

given: Timothy J.

family: Sacher

full_name: Adrian Sacher

given: Adrian

family: Denlinger

full_name: Crystal S. Denlinger

given: Crystal S.

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

family: Dy

full_name: Grace K. Dy

given: Grace K.

family: Krauss

full_name: John C. Krauss

given: John C.

family: Kuboki

full_name: Yasutoshi Kuboki

given: Yasutoshi

family: Kuo

full_name: James C. Kuo

given: James C.

family: Coveler

full_name: Andrew L. Coveler

given: Andrew L.

family: Park

full_name: Keunchil Park

given: Keunchil

family: Kim

full_name: Tae Won Kim

given: Tae Won

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Munster

full_name: Pamela N. Munster

given: Pamela N.

family: Ramalingam

full_name: Suresh S. Ramalingam

given: Suresh S.

family: Burns

full_name: Timothy F. Burns

given: Timothy F.

family: Meric-Bernstam

full_name: Funda Meric-Bernstam

title: KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors

ReferenceCitation: Lanman BA, Allen JR, Allen JG, Amegadzie AK, Ashton KS, Booker SK, Chen JJ, Chen N, Frohn MJ, Goodman G, Kopecky DJ, Liu L, Lopez P, Low JD, Ma V, Minatti AE, Nguyen TT, Nishimura N, Pickrell AJ, Reed AB, Shin Y, Siegmund AC, Tamayo NA, Tegley CM, Walton MC, Wang HL, Wurz RP, Xue M, Yang KC, Achanta P, Bartberger MD, Canon J, Hollis LS, McCarter JD, Mohr C, Rex K, Saiki AY, San Miguel T, Volak LP, Wang KH, Whittington DA, Zech SG, Lipford JR, Cee VJ. Discovery of a Covalent Inhibitor of KRAS(G12C) (AMG 510) for the Treatment of Solid Tumors. J Med Chem. 2020 Jan 9;63(1):52-65. doi: 10.1021/acs.jmedchem.9b01180. Epub 2019 Dec 24.

title: Discovery of a Covalent Inhibitor of KRASG12C (AMG 510) for the Treatment of Solid Tumors

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Austria
Brazil
Switzerland
Spain
Germany
France
Japan
Greece
Korea, Republic of
Romania
Hungary
Australia
Belgium
Portugal
United States
Canada

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Duke University Medical Center, Morris Cancer Clinic

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Gibbs Cancer Center and Research Institute - Spartanburg

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer

location_facility: Institutul Oncologic, Prof Dr Alexandru Trestioreanu

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Klinikum der Universität München Campus Grosshadern

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Vanderbilt University Ingram Cancer Center

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: American Oncology Partners of Maryland, PA

location_facility: Hospital General Universitario de Valencia

location_facility: Laura and Isaac Perlmutter Cancer Center at New York University Langone

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: St Marianna University School of Medicine Hospital

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: US Oncology Research Investigational Products Center

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Pittsburgh Medical Center Cancer Pavillion


ReferenceType: derived

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Ernst

full_name: Moritz Ernst

given: Moritz

sequence: additional

family: Oeser

full_name: Annika Oeser

given: Annika

family: Besiroglu

full_name: Burcu Besiroglu

given: Burcu

family: Caro-Valenzuela

full_name: Julia Caro-Valenzuela

given: Julia

name: Department of Surgery; Mayo Clinic; Rochester Minnesota USA

family: Abd El Aziz

full_name: Mohamed Abd El Aziz

given: Mohamed

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department I of Internal Medicine; University Hospital of Cologne; Cologne Germany

family: Borchmann

full_name: Peter Borchmann

given: Peter

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

family: Goldkuhle

full_name: Marius Goldkuhle

given: Marius

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

family: Kambhampati

full_name: Swetha Kambhampati

given: Swetha

sequence: first

family: Hunter

full_name: Bradley Hunter

given: Bradley

family: Varnavski

full_name: Andrei Varnavski

given: Andrei

family: Fakhri

full_name: Bita Fakhri

given: Bita

family: Kaplan

full_name: Lawrence Kaplan

given: Lawrence

family: Ai

full_name: Weiyun Z. Ai

given: Weiyun Z.

family: Pampaloni

full_name: Miguel Pampaloni

given: Miguel

family: Huang

full_name: Chiung-Yu Huang

given: Chiung-Yu

family: Martin

full_name: Thomas Martin

given: Thomas

suffix: III

family: Damon

full_name: Lloyd Damon

given: Lloyd

family: Andreadis

full_name: Charalambos B. Andreadis

given: Charalambos B.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Italy
Austria
Brazil
Hong Kong
Netherlands
Spain
Germany
Switzerland
France
Japan
Norway
Singapore
Australia
Belgium
China
United States
United Kingdom
Taiwan

location_facility: University of California Los Angeles University of California LA

location_facility: Baylor Scott and White Research Institute

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: Emory University School of Medicine/Winship Cancer Institute SC

location_facility: University of Texas MD Anderson Cancer Center MD Anderson Cancer Center

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: Wayne State University - Karmanos Cancer Institute SC

title: Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)

summary: This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.


design_allocation: Randomized

intervention_type: Biological

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Actual

primary_purpose: Prevention

location_country:
United States
Brazil
Sweden
Mexico
Germany
France
Belgium
Australia
Canada
Colombia

acronym: Safety and Immunogenicity of V114 in Recipients of Allo-HSCT

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0145)

location_facility: Universitaetsklinikum Koeln ( Site 0105)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0075)

location_facility: Children's Hospital Colorado ( Site 0166)

location_facility: Baylor College of Medicine - Texas Children's Hospital ( Site 0165)

location_facility: CHU de Grenoble Hopital Nord ( Site 0083)

location_facility: The Children s Hospital at Westmead ( Site 0191)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0122)

location_facility: Hospital Infantil de Mexico Federico Gomez ( Site 0061)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0031)

location_facility: AZ Sint Jan Brugge-Oostende ( Site 0118)

location_facility: Austin Health-Austin Hospital ( Site 0038)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0090)

location_facility: Cleveland Clinic Foundation ( Site 0168)

location_facility: Karolinska Universitetssjukhuset ( Site 0143)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0050)

location_facility: Instituto Nacional de Cancerologia. ( Site 0060)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0187)

location_facility: Instituto Nacional de Pediatria ( Site 0062)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0058)

location_facility: Indiana Blood and Marrow Transplantation ( Site 0001)

location_facility: Hopital Jean Minjoz Besancon ( Site 0085)

location_facility: Cincinnati Children's Hospital Medical Center ( Site 0010)

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0121)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 0051)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0107)

location_facility: University of Kansas Medical Center ( Site 0007)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0033)

location_facility: Servicio de hematologia Universidad Autonoma de Nuevo Leon ( Site 0057)

location_facility: Oregon Health & Science University ( Site 0018)

ipd_sharing: Yes

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

summary: This study is designed 1) to describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adult and pediatric recipients of allogeneic hematopoietic stem cell transplant (HSCT), and 2) to describe the safety and tolerability of PNEUMOVAX™23 when administered 12 months after HSCT.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)

acronym: FLEX V

summary:
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.

This study is comprised of 2 periods:

Period 1: 24-week blinded treatment

Period 2: 48-week post-treatment follow-up

status: Terminated

primary_purpose: Treatment

ReferenceCitation: Schiff M, Combe B, Dörner T, Kremer JM, Huizinga TW, Veenhuizen M, Gill A, Komocsar W, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study. RMD Open. 2015 Aug 12;1(1):e000037. doi: 10.1136/rmdopen-2014-000037. eCollection 2015.

family: Schiff

full_name: Michael Schiff

given: Michael

family: Combe

full_name: Bernard Combe

given: Bernard

family: Dörner

full_name: Thomas Dörner

family: Kremer

full_name: Joel M Kremer

given: Joel M

family: Huizinga

full_name: Thomas W Huizinga

given: Thomas W

family: Veenhuizen

full_name: Melissa Veenhuizen

given: Melissa

family: Gill

full_name: Anne Gill

given: Anne

family: Komocsar

full_name: Wendy Komocsar

given: Wendy

family: Berclaz

full_name: Pierre-Yves Berclaz

given: Pierre-Yves

family: Ortmann

full_name: Robert Ortmann

given: Robert

family: Lee

full_name: Chin Lee

given: Chin

currency_apc_doaj: GBP

journal_name: RMD Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Brazil
South Africa
Mexico
Spain
Germany
France
Japan
Greece
Malaysia
Poland
Argentina
Australia
New Zealand
Russian Federation
United States
Korea, Republic of
Taiwan
Colombia

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

intervention_type: Drug

status_simplified: Unknown


ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

name: Glenn Heller, Martin Fleisher, and Howard I. Scher, Memorial Sloan Kettering Cancer Center; Howard I. Scher, Weill Cornell Medical College, New York, NY; Robert McCormack, Janssen Research & Development, Raritan, NJ; Thian Kheoh and Arturo Molina, Janssen Research & Development, Los Angeles; Dana T. Aftab, Exelixis, South San Francisco; Mohammad Hirmand, Medivation, San Francisco, CA; Matthew R. Smith, Massachusetts General Hospital, Boston; Ana Limon, Takeda Oncology, Cambridge, MA; Robert Dreicer,...

family: Heller

full_name: Glenn Heller

given: Glenn

family: McCormack

full_name: Robert McCormack

family: Kheoh

full_name: Thian Kheoh

given: Thian

family: Molina

full_name: Arturo Molina

given: Arturo

family: Smith

full_name: Matthew R. Smith

given: Matthew R.

family: Dreicer

full_name: Robert Dreicer

family: Saad

full_name: Fred Saad

given: Fred

family: de Wit

full_name: Ronald de Wit

given: Ronald

family: Aftab

full_name: Dana T. Aftab

given: Dana T.

family: Hirmand

full_name: Mohammad Hirmand

given: Mohammad

family: Limon

full_name: Ana Limon

given: Ana

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Fleisher

full_name: Martin Fleisher

given: Martin

family: de Bono

full_name: Johann S. de Bono

given: Johann S.

family: Scher

full_name: Howard I. Scher

given: Howard I.

journal_name: Journal of Clinical Oncology

oa_host_type: repository

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.

name: Clinical PharmacologyMillennium Pharmaceuticals, Inc.Cambridge Massachusetts USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

family: Suri

full_name: A Suri

given: A

name: Ann Arbor Pharmacometrics GroupAnn Arbor Michigan USA

family: Chapel

full_name: S Chapel

given: S

name: Drug Metabolism and PharmacokineticsMillennium Pharmaceuticals, Inc.Cambridge Massachusetts USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

family: Lu

full_name: C Lu

given: C

family: Venkatakrishnan

full_name: K Venkatakrishnan

given: K

journal_name: Clinical Pharmacology & Therapeutics

title: Physiologically based and population PK modeling in optimizing drug development: A predict–learn–confirm analysis

ReferenceCitation: Fizazi K, Jones R, Oudard S, Efstathiou E, Saad F, de Wit R, De Bono J, Cruz FM, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak DP, Lee SY, Webb IJ, Tejura B, Borgstein N, Dreicer R. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol. 2015 Mar 1;33(7):723-31. doi: 10.1200/JCO.2014.56.5119. Epub 2015 Jan 26.

name: Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal,...

title: Phase III, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or After Docetaxel-Based Therapy: ELM-PC 5

location_country:
Italy
United States
Netherlands
Finland
France
Czechia
Greece
Poland
Hungary
Belgium
Australia
Spain
Estonia
Canada

title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.

summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy


title: A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period

summary: This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.

ReferenceCitation: Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

family: Georgiades

full_name: Anastasia Georgiades

given: Anastasia

family: Davis

full_name: Vicki G. Davis

given: Vicki G.

family: Atkins

full_name: Alexandra S. Atkins

given: Alexandra S.

family: Khan

full_name: Anzalee Khan

given: Anzalee

family: Walker

full_name: Trina W. Walker

given: Trina W.

family: Loebel

full_name: Antony Loebel

given: Antony

family: Haig

full_name: George Haig

given: George

family: Hilt

full_name: Dana C. Hilt

given: Dana C.

family: Dunayevich

full_name: Eduardo Dunayevich

given: Eduardo

family: Umbricht

full_name: Daniel Umbricht

given: Daniel

family: Sand

full_name: Michael Sand

given: Michael

family: Keefe

full_name: Richard S.E. Keefe

given: Richard S.E.

bso_classification: Social sciences

journal_name: Schizophrenia Research

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Bugarski-Kirola D, Blaettler T, Arango C, Fleischhacker WW, Garibaldi G, Wang A, Dixon M, Bressan RA, Nasrallah H, Lawrie S, Napieralski J, Ochi-Lohmann T, Reid C, Marder SR. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies. Biol Psychiatry. 2017 Jul 1;82(1):8-16. doi: 10.1016/j.biopsych.2016.11.014. Epub 2016 Dec 15.

family: Bugarski-Kirola

full_name: Dragana Bugarski-Kirola

given: Dragana

family: Blaettler

full_name: Thomas Blaettler

given: Thomas

family: Arango

full_name: Celso Arango

given: Celso

family: Fleischhacker

full_name: Wolfgang W. Fleischhacker

given: Wolfgang W.

family: Garibaldi

full_name: George Garibaldi

family: Wang

full_name: Alice Wang

given: Alice

family: Dixon

full_name: Mark Dixon

given: Mark

family: Bressan

full_name: Rodrigo A. Bressan

given: Rodrigo A.

family: Nasrallah

title: Bitopertin in Negative Symptoms of Schizophrenia—Results From the Phase III FlashLyte and DayLyte Studies

location_country:
Sweden
India
Mexico
Finland
France
Romania
Hungary
Argentina
Australia
Russian Federation
United States
United Kingdom
Korea, Republic of
Colombia

location_facility: Hôpital de la Conception; Pôle Psychiatrique Centre

location_facility: Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri

location_facility: Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.

location_facility: Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie

location_facility: Belmont Center for Comprehensive Treatment; Research

location_facility: Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie

location_facility: Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård

location_facility: Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.

location_facility: Centro de Investigacion Clinica Farmacologica en Psiquiatria

location_facility: CIAP - Centro de Investigacion y Asistencia en Psiquiatria

location_facility: Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital

location_facility: Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry

location_facility: GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department

location_facility: R. K.Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: Kemerovo Regional Clinical Psychiatric Hospital

location_facility: Spitalul Universitar de Psihiatrie Socola

location_facility: Frankston Hospital; Mental Health Service

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Hospital Lomas de San Luis Internacional

location_facility: Fundacion para el Estudio y Tratamiento des las Enfi Mentales

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala

location_facility: Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation

location_facility: Centro de Asistencia e Investigación en Neurociencias

location_facility: University of Iowa College of Medicine; Psychiatry Research

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia

location_facility: St. Petersburg GUZ City Psychiatric Hospital #6

location_facility: St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation

location_facility: Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: Arkhangelsk Regional Clinical Psychiatric Hospital

location_facility: Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie

location_facility: Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria

location_facility: Westmead Hospital; Department of Psychiatry

location_facility: CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I

location_facility: The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)

location_facility: Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I

location_facility: Instituto de informacion e investigacion en salud mental AC

location_facility: Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie

location_facility: Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II

location_facility: Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu

location_facility: Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst

location_facility: Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III

location_facility: Central Moscow Regional Clinical Psychiatric Hospital

location_facility: Comprehensive Clinical Development- Cerritos CA

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

location_facility: Gujarat Institute of Psychological Research (GIPS)

location_facility: Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento

location_facility: Manav Neuropsychiatric Hospital Pvt. Ltd.

location_facility: Dr. Kenessey Albert Hospital; Psychiatry I.

location_facility: Resolution Psicopharmacology Research Institute

location_facility: Instituto de Neurociencias San Agustín S.A.

location_facility: CHU Gabriel Montpied; Service de Psychiatrie

location_facility: Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie

location_facility: Mhi City Clinical Hospital #2 Named After v.i. Razumousky

location_facility: North Carolina Psychiatric Research Center

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Gr


title: A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

summary: This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

lead_sponsor: Hoffmann-La Roche

location_country: Switzerland Netherlands Spain France Egypt China Turkey Denmark Germany


ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Taniguchi H, Yoshino T, Yamaguchi K, Yamazaki K, Nixon AB, Tabernero J, Van Cutsem E, Robling KR, Abada PB, Hozak RR, Siegel R, Fill JA, Wijayawardana S, Walgren RA, Giles B, Jones A, Pitts KR, Drove N, Muro K. Clinical development and evaluation of a VEGF-D assay in plasma from patients with metastatic colorectal cancer in the RAISE study. Curr Med Res Opin. 2021 Oct;37(10):1769-1778. doi: 10.1080/03007995.2021.1940908. Epub 2021 Jul 28.

name: Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan

name: Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan

family: Taniguchi

full_name: Hiroya Taniguchi

given: Hiroya

family: Yoshino

full_name: Takayuki Yoshino

given: Takayuki

name: Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

family: Yamaguchi

full_name: Kensei Yamaguchi

given: Kensei

name: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shunt-gun, Japan

family: Yamazaki

full_name: Kentaro Yamazaki

given: Kentaro

name: Department of Medicine, Duke University School of Medicine, Durham, NC, USA

family: Nixon

full_name: Andrew B. Nixon

given: Andrew B.

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

family: Tabernero

full_name: Josep Tabernero

given: Josep

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

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

name: Clinical Diagnostics Laboratory, Eli Lilly and Company, Indianapolis, IN, USA

family: Robling

full_name: Kim R. Robling

given: Kim R.

name: Oncology Division, Eli Lilly and Company, Indianapolis, IN, USA

family: Abada

full_name: Paolo B. Abada

given: Paolo B.

name: Oncology Business Unit – Patient Tailoring & Global Strategic Planning, Eli Lilly and Company, Indianapolis, IN, USA

family: Hozak

full_name: Rebecca R. Hozak

given: Rebecca R.

name: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

family: Siegel

full_name: Robert Siegel

given: Robert

family: Fill

full_name: Jeffrey A. Fill

given: Jeffrey A.

name: Statistics – Oncology, Eli Lilly and Company, Indianapolis, IN, USA

family: Wijayawardana

full_name: Sameera Wijayawardana

given: Sameera

family: Walgren

full_name: Richard A. Walgren

given: Richard A.

family: Giles

full_name: Brendan Giles

given: Brendan

family: Jones

full_name: Abby Jones

given: Abby

family: Pitts

full_name: Kelly R. Pitts

given: Kelly R.

family: Drove

full_name: Nora Drove

given: Nora

family: Muro

full_name: Kei Muro

given: Kei

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Lim HH, Hopkins AM, Rowland A, Yuen HY, Karapetis CS, Sorich MJ. Effect of Early Adverse Events on Survival Outcomes of Patients with Metastatic Colorectal Cancer Treated with Ramucirumab. Target Oncol. 2019 Dec;14(6):743-748. doi: 10.1007/s11523-019-00683-z.

family: Lim

full_name: Huezin H. Lim

given: Huezin H.

family: Hopkins

full_name: Ashley M. Hopkins

given: Ashley M.

family: Rowland

full_name: Andrew Rowland

given: Andrew

ReferenceCitation: Yoshino T, Portnoy DC, Obermannová R, Bodoky G, Prausová J, Garcia-Carbonero R, Ciuleanu T, García-Alfonso P, Cohn AL, Van Cutsem E, Yamazaki K, Lonardi S, Muro K, Kim TW, Yamaguchi K, Grothey A, O'Connor J, Taieb J, Wijayawardana SR, Hozak RR, Nasroulah F, Tabernero J. Biomarker analysis beyond angiogenesis: RAS/RAF mutation status, tumour sidedness, and second-line ramucirumab efficacy in patients with metastatic colorectal carcinoma from RAISE-a global phase III study. Ann Oncol. 2019 Jan 1;30(1):124-131. doi: 10.1093/annonc/mdy461.

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

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

repositories:
LIRIAS (KU Leuven)
PubMed Central
recercat.cat

title: Biomarker analysis beyond angiogenesis: RAS/RAF mutation status, tumour sidedness, and second-line ramucirumab efficacy in patients with metastatic colorectal carcinoma from RAISE—a global phase III study

ReferenceCitation: Grothey A, Yoshino T, Bodoky G, Ciuleanu T, Garcia-Carbonero R, García-Alfonso P, Van Cutsem E, Muro K, Mytelka DS, Li L, Lipkovich O, Hsu Y, Sashegyi A, Ferry D, Nasroulah F, Tabernero J. Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set. ESMO Open. 2018 Apr 24;3(3):e000347. doi: 10.1136/esmoopen-2018-000347. eCollection 2018.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Tabernero J, Hozak RR, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Prausová J, Muro K, Siegel RW, Konrad RJ, Ouyang H, Melemed SA, Ferry D, Nasroulah F, Van Cutsem E. Analysis of angiogenesis biomarkers for ramucirumab efficacy in patients with metastatic colorectal cancer from RAISE, a global, randomized, double-blind, phase III study. Ann Oncol. 2018 Mar 1;29(3):602-609. doi: 10.1093/annonc/mdx767.

ReferenceCitation: Obermannová R, Van Cutsem E, Yoshino T, Bodoky G, Prausová J, Garcia-Carbonero R, Ciuleanu T, Garcia Alfonso P, Portnoy D, Cohn A, Yamazaki K, Clingan P, Lonardi S, Kim TW, Yang L, Nasroulah F, Tabernero J. Subgroup analysis in RAISE: a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression. Ann Oncol. 2016 Nov;27(11):2082-2090. Epub 2016 Aug 29.

ReferenceCitation: Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Van Cutsem E, Grothey A, Prausová J, Garcia-Alfonso P, Yamazaki K, Clingan PR, Lonardi S, Kim TW, Simms L, Chang SC, Nasroulah F; RAISE Study Investigators. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015 May;16(5):499-508. doi: 10.1016/S1470-2045(15)70127-0. Epub 2015 Apr 12. Erratum in: Lancet Oncol. 2015 Jun;16(6):e262.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Finland
Greece
Romania
Australia
Belgium
Denmark
Taiwan
India
France
Japan
Argentina
Slovenia
Korea, Republic of
Sweden
Netherlands
Hungary
Puerto Rico
Portugal
Germany
United States
Italy
Austria
Brazil
Czechia
Israel
Spain

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

summary: The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.


title: A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

acronym: HEPCAT

summary: The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Sweden
Mexico
Germany
France
Argentina
Australia
Puerto Rico
Denmark
Canada

location_facility: Instituto De Investigacion Cientifica Del Sur

location_facility: University Of California At San Francisco

location_facility: Transplant Center And Hepatology Clinic, B-154

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of North Carolina, Chapel Hill

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: Upper Delaware Valley Infectious Diseases, Pc


ReferenceCitation: Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

family: Richeldi

full_name: Luca Richeldi

given: Luca

family: Kreuter

full_name: Michael Kreuter

given: Michael

family: Selman

full_name: Moisés Selman

given: Moisés

family: Crestani

full_name: Bruno Crestani

given: Bruno

family: Kirsten

full_name: Anne-Marie Kirsten

given: Anne-Marie

family: Wuyts

full_name: Wim A Wuyts

given: Wim A

family: Xu

full_name: Zuojun Xu

given: Zuojun

family: Bernois

full_name: Katell Bernois

given: Katell

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

family: Quaresma

full_name: Manuel Quaresma

given: Manuel

family: Costabel

full_name: Ulrich Costabel

given: Ulrich

journal_name: Thorax

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

design_allocation: Non-Randomized

lead_sponsor: Boehringer Ingelheim

location_country:
Greece
Belgium
Australia
Russian Federation
France
Argentina
Canada
Chile
Netherlands
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: University Hospital of Heraklion, University Pulmonology Cl

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Scientific Research Institute of Pulmonology

location_facility: Royal Perth Hospital-Lung Transplant Unit

location_facility: University of Pecs, 1st internal Med. Dept., Pulmonology

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Klinikum der Universität München - Campus Großhadern

title: A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

summary:
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.


type: Registry Identifier

title: A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

summary: The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

ReferenceCitation: Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Pérol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1). pii: e000567. doi: 10.1136/esmoopen-2019-000567.

family: Garon

full_name: Edward B. Garon

given: Edward B.

family: Scagliotti

full_name: Giorgio Vittorio Scagliotti

given: Giorgio Vittorio

family: Gautschi

full_name: Oliver Gautschi

given: Oliver

family: Reck

full_name: Martin Reck

given: Martin

family: Thomas

full_name: Michael Thomas

family: Iglesias Docampo

full_name: Lara Iglesias Docampo

given: Lara

family: Kalofonos

full_name: Haralabos Kalofonos

given: Haralabos

family: Kim

full_name: Joo-Hang Kim

given: Joo-Hang

family: Gans

full_name: Steven Gans

given: Steven

family: Te Brustugun

full_name: Oddrje Te Brustugun

given: Oddrje

family: Orlov

full_name: Sergey V. Orlov

given: Sergey V.

family: Cuyun Carter

full_name: Gebra Cuyun Carter

given: Gebra

family: Zimmermann

full_name: Annamaria H. Zimmermann

given: Annamaria H.

family: Oton

full_name: Ana B. Oton

given: Ana B.

family: Alexandris

full_name: Ekaterine Alexandris

given: Ekaterine

family: Lee

full_name: Pablo Lee

given: Pablo

family: Wolff

full_name: Katharina Wolff

given: Katharina

family: Stefaniak

full_name: Victoria Jennifer Stefaniak

given: Victoria Jennifer

family: Socinski

full_name: Mark A. Socinski

given: Mark A.

family: Pérol

full_name: Maurice Pérol

given: Maurice

currency_apc_doaj: EUR

journal_name: ESMO Open

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Pérol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.

ReferenceCitation: Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31.

title: A Randomized, Double-Blind, Phase III Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non–Small-Cell Lung Cancer After Disease Progression After 1 Previous Platinum-Based Therapy (REVEL): Treatment Rationale and Study Design

location_country:
Greece
Romania
Russian Federation
Taiwan
India
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Puerto Rico
United States
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa

acronym: SHINE

summary: The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

ReferenceCitation: Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horváth B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9.

family: Prens

full_name: Lisette M. Prens

given: Lisette M.

family: Ardon

full_name: Christine B. Ardon

given: Christine B.

family: van Straalen

full_name: Kelsey R. van Straalen

given: Kelsey R.

family: van der Zee

full_name: Hessel H. van der Zee

given: Hessel H.

family: Seelen

full_name: Marc A.J. Seelen

given: Marc A.J.

family: Laman

full_name: Jon D. Laman

given: Jon D.

full_name: Errol P. Prens

given: Errol P.

family: Horváth

full_name: Barbara Horváth

given: Barbara

family: Damman

full_name: Jeffrey Damman

given: Jeffrey

journal_name: Journal of Investigative Dermatology

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ipd_sharing: No

lead_sponsor: InflaRx GmbH

location_country:
Netherlands
Germany
France
Bulgaria
Greece
Poland
Denmark
United States
Canada

location_facility:
InflaRx Investigational Site
InflaRX Investigational Site


title: A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies

summary: This study will be conducted to compare E2027 to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

lead_sponsor: Eisai Inc.

location_country:
Italy
United States
France
Japan
Spain
Germany
United Kingdom

location_facility: New Orleans Center for Clinical Research

location_facility: CHRU Nancy- CMRR de lorraine Hôpital de Brabois-Service de Gériatrie

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Clinica Neurologica Azienda Ospedaliera di Padova

location_facility: Centre de Recherche Clinique - Viellissement-Cerveau-Fragilite (CRC-VCF), Hopital des Charpennes

location_facility: Memory Assessment and Research Centre, Moorgreen Hospital

location_facility: Elias Research Associates (Allied Biomedical Research Institute)

location_facility: New England Institute for Clinical Research

location_facility: Pharmax Research of South Florida; Elias Research Associates

location_facility: Institut Internacional de Neurociències Aplicades

location_facility: Parkinsons and Movement Disorders Institute

location_facility: Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital

location_facility: University of Kentucky, Dept of Neurology Sanders Brown Center on Aging

location_facility: Manchester Mental Health and Social Care Trust

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre d'Investigation Clinique (CIC) Hopitaux universitaires Strasbourg HOPITAL DE HAUTEPIERRE - BATIMENT AX5


lead_sponsor: Janssen Scientific Affairs, LLC

location_country:
Italy
Brazil
Serbia
Netherlands
Germany
France
Bulgaria
Czechia
Korea, Republic of
Poland
Hungary
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom
Canada

acronym: SEAVUE

location_facility: Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

location_facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Gastroenterology Associates of Central Virginia

location_facility: Pennine Acute Hospitals-Fairfield General Hospital

location_facility: Gastroenterology Associates of Tidewater

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Oddział Gastroenterologii

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: University of Texas at Houston Medical School

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Gastroenterology Research of America, LLC

location_facility: Premier Medical Group Of The Hudson Valley, Pc

location_facility: Mater Hospital Brisbane (Inflammatory Bowel Diseases)

location_facility: GU 'Moscow Regional Research Clinical Institute n.a. M.F.Vla

location_facility: University of North Carolina at Chapel Hill

location_facility: Western Connecticut Health Network/Danbury Hospital

location_facility: University Hospitals Case Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Saratoga Schenectady Gastroenterology Associates

location_facility: Gastro Associates of Fairfield County PC

location_facility: Center for Advanced Gastroenterology - Main Office

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Endoskopia Sp. z o.o. z siedzibą w Sopocie

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

location_facility: Huron Gastroenterology Associates Center for Digestive Care

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida

location_facility: Southampton University Hospitals NHS Trust

location_facility: UFRJ-Hospital Universitário Clementino Fraga Filho

location_facility: Clinical Research Institute of Michigan, LLC

title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

summary: The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.


title: A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Romero Román A, Campo-Cañaveral de la Cruz JL, Macía I, Escobar Campuzano I, Figueroa Almánzar S, Delgado Roel M, Gálvez Muñoz C, García Fontán EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martínez Téllez E, Partida González C, Jiménez López MF, Jiménez Maestre U, Mongil Poce R, Sánchez Lorente D, Álvarez Kindelán A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.

name: Department of Thoracic Surgery, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain

family: Romero Román

full_name: Alejandra Romero Román

given: Alejandra

family: Campo-Cañaveral de la Cruz

full_name: Jose Luis Campo-Cañaveral de la Cruz

given: Jose Luis

family: Macía

full_name: Iván Macía

given: Iván

name: Department of Thoracic Surgery, Hospital Universitari de Bellvitge, Institut d’Investigació Biomèdica de Bellvitge (IDIBELL) and Unit of Human Anatomy and Embryology, Department of Pathology and Experimental Therapeutics, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona, Barcelona, Spain

name: Department of Thoracic Surgery, Hospital Universitari de Bellvitge;, Institut d’Investigació Biomèdica de Bellvitge (IDIBELL) and Department of Clinical Sciences, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona, Barcelona, Spain

family: Escobar Campuzano

full_name: Ignacio Escobar Campuzano

given: Ignacio

name: Department of Thoracic Surgery, Hospital Clinic Universitari de València, Valencia, Spain

family: Figueroa Almánzar

full_name: Santiago Figueroa Almánzar

given: Santiago

name: Department of Thoracic Surgery, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

family: Delgado Roel

full_name: María Delgado Roel

given: María

name: Department of Thoracic Surgery, Hospital General Universitario de Alicante, Alicante, Spain

family: Gálvez Muñoz

full_name: Carlos Gálvez Muñoz

given: Carlos

name: Department of Thoracic Surgery, Complejo Universitario de Vigo, Vigo, Spain

family: García Fontán

full_name: Eva M García Fontán

given: Eva M

name: Department of Thoracic Surgery, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain

family: Muguruza Trueba

full_name: Ignacio Muguruza Trueba

name: Department of Thoracic Surgery, Hospital Vall d'Hebrón, Barcelona, Spain

family: Romero Vielva

full_name: Laura Romero Vielva

given: Laura

name: Department of Thoracic Surgery, Complejo Hospitalario Universitario Insular de Gran Canaria, Las Palmas, Spain

family: Cano Garcia

full_name: José Ramón Cano Garcia

given: José Ramón

name: Department of Thoracic Surgery, Hospital Universitari de la Santa Creu i Sant Pau, Barcelona, Spain

family: Martínez Téllez

full_name: Elisabeth Martínez Téllez

given: Elisabeth

name: Department of Thoracic Surgery, Hospital Universitario La Paz, Madrid, Spain

family: Partida González

full_name: Concepción Partida González

given: Concepción

name: Department of Thoracic Surgery, Hospital Universitario de Salamanca, Salamanca, Spain

family: Jiménez López

full_name: Marcelo Fernando Jiménez López

given: Marcelo Fernando

name: Department of Thoracic Surgery, Hospital Universitario de Cruces, Bizkaia, Spain

family: Jiménez Maestre

full_name: Unai Jiménez Maestre

given: Unai

name: Department of Thoracic Surgery, Hospital Regional Universitario de Málaga, Málaga, Spain

family: Mongil Poce

full_name: Roberto Mongil Poce

given: Roberto

name: Department of Thoracic Surgery, Hospital Clinic i Provincial de Barcelona, Barcelona, Spain

family: Sánchez Lorente

full_name: David Sánchez Lorente

given: David

name: Department of Thoracic Surgery, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain

family: Álvarez Kindelán

full_name: Antonio Álvarez Kindelán

given: Antonio

name: Department of Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain

family: Provencio Pulla

full_name: Mariano Provencio Pulla

given: Mariano

journal_name: European Journal of Cardio-Thoracic Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_country:
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Thailand
Slovenia
Korea, Republic of
South Africa
Sweden
Switzerland
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Israel
Spain

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Nebraska Methodist Estabrook Cancer Center

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

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

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach

location_facility: Klinikum der Univer Regenburg; Klinik und Poliklinik fuer Inn

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

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

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

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

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

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

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

location_facility: Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

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

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

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

location_facility: Uppsala University Hospital; Department of Oncology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Uni Hospital in Lund; Respiratory Medicine & Allergology

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Hopital d'Instruction des Armees de Begin

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

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

status_simplified: Ongoing


title: A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial

acronym: ADVENT-HF

summary: Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.

ReferenceCitation: Perger E, Inami T, Lyons OD, Alshaer H, Smith S, Floras JS, Logan AG, Arzt M, Duran Cantolla J, Delgado D, Fitzpatrick M, Fleetham J, Kasai T, Kimoff RJ, Leung RST, Lorenzi Filho G, Mayer P, Mielniczuk L, Morrison DL, Parati G, Parthasarathy S, Redolfi S, Ryan CM, Series F, Tomlinson GA, Woo A, Bradley TD; ADVENT-HF Investigators. Distinct Patterns of Hyperpnea During Cheyne-Stokes Respiration: Implication for Cardiac Function in Patients With Heart Failure. J Clin Sleep Med. 2017 Nov 15;13(11):1235-1241. doi: 10.5664/jcsm.6788. Erratum in: J Clin Sleep Med. 2018 Apr 15;14(4):703.

name: University Health Network/Mount Sinai Hospital, Toronto, Ontario, Canada

name: Centre for Sleep Medicine and Circadian Biology of the University of Toronto, Toronto, Ontario, Canada

family: Perger

full_name: Elisa Perger

given: Elisa

family: Inami

full_name: Toru Inami

given: Toru

family: Lyons

full_name: Owen D. Lyons

given: Owen D.

family: Alshaer

full_name: Hisham Alshaer

given: Hisham

family: Smith

full_name: Stephanie Smith

given: Stephanie

family: Floras

full_name: John S. Floras

given: John S.

family: Logan

full_name: Alexander G. Logan

given: Alexander G.

name: Universitätsklinikum Regensburg, Regensburg, Germany

family: Arzt

full_name: Michael Arzt

given: Michael

name: Hospital Universitario Txagorritxu, Vitoria, Spain

family: Duran Cantolla

full_name: Joaquin Duran Cantolla

given: Joaquin

family: Delgado

full_name: Diego Delgado

given: Diego

name: Queen's University, Kingston, Ontario, Canada

family: Fitzpatrick

full_name: Michael Fitzpatrick

name: Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada

family: Fleetham

full_name: John Fleetham

given: John

name: Juntendo University Hospital, Tokyo, Japan

family: Kasai

full_name: Takatoshi Kasai

given: Takatoshi

name: McGill University Health Centre, Montreal, Quebec, Canada

family: Kimoff

full_name: R. John Kimoff

given: R. John

name: St Michael's Hospital, Toronto, Ontario, Canada

family: Leung

full_name: Richard S.T. Leung

given: Richard S.T.

name: Instituto do Coração do Hospital das Clínicas da FMUSP, Sao Paulo, Brazil

family: Lorenzi Filho

full_name: Geraldo Lorenzi Filho

given: Geraldo

name: Hôpital Hôtel-Dieu du CHUM, Université de Montréal, Montreal, Quebec, Canada

family: Mayer

full_name: Pierre Mayer

given: Pierre

name: University of Ottawa Heart Institute, Ottawa, Ontario, Canada

family: Mielniczuk

full_name: Lisa Mielniczuk

given: Lisa

name: Capital District Health Authority, Halifax, Nova Scotia, Canada

family: Morrison

full_name: Debra L. Morrison

given: Debra L.

family: Parati

full_name: Gianfranco Parati

given: Gianfranco

name: University of Arizona College of Medicine, Tucson, Arizona

family: Parthasarathy

full_name: Sairam Parthasarathy

given: Sairam

name: Groupe Hospitalier Pitie-Salpetriere Charles Fox, Paris, France

family: Redolfi

full_name: Stefania Redolfi

given: Stefania

family: Ryan

full_name: Clodagh M. Ryan

given: Clodagh M.

name: Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Quebec, Canada

repository_institution: Università degli Studi di Milano - Institutional Research Information System

publisher: American Academy of Sleep Medicine (AASM)

location_country:
Italy
Brazil
Germany
France
Japan
Spain
United States
United Kingdom
Canada

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval

location_facility: Glacier View Research Institute, Kalispell Regional Medical Center

location_facility: Pole d'exploration de L' apnée du sommeil, Nouvelle Clinique Bel Air

location_facility: Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri

location_facility: McGill University Health Centre, Glen Site

location_facility: Istituto Auxologico Italiano - Ospedale San Luca

location_facility: McMaster University Medical Centre, Hamilton Health Sciences

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Kingston General Hospital Sleep Disorders Laboratory/Queen's University

location_facility: Pronto Socorro Cardiologico de Pernambuco

location_facility: University of Arizona/Southern Arizona VA Health Care System

location_facility: CDEC Brasil - Centro de Desenvolvimento em Estudos Clínicos Brasil

location_facility: Wissenschaftliches Institut Bethanien e.V.

location_facility: Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP

location_facility: The Sleep Disorders Centre -Nuffield House, Guy's Hospital

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: University of Ottawa-Ottawa Heart Institute

location_facility: Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires, Centre Hospitalier Universitaire de Grenoble

location_facility: University Health Network/TRI/Mount Sinai

location_facility: Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri)

location_facility: London Health Sciences Centre - Victoria Hospital


ReferenceCitation: Cortes JE, Dombret H, Merchant A, Tauchi T, DiRienzo CG, Sleight B, Zhang X, Leip EP, Shaik N, Bell T, Chan G, Sekeres MA. Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials. Future Oncol. 2019 Nov;15(31):3531-3545. doi: 10.2217/fon-2019-0373. Epub 2019 Sep 13.

name: Georgia Cancer Center, Augusta University, Augusta, GA 30912, USA.

family: Cortes

full_name: Jorge E Cortes

given: Jorge E

name: Institut de Recherche Saint-Louis, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris Institut Universitaire d`Hematologie Hopital Saint Louis, Paris, France

family: Dombret

full_name: Hervé Dombret

given: Hervé

name: Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA

family: Merchant

full_name: Akil Merchant

given: Akil

name: Department of Hematology, Shin-Yurigaoka General Hospital, Kawasaki, Japan

family: Tauchi

full_name: Tetsuzo Tauchi

given: Tetsuzo

name: Pfizer Oncology, Pfizer Inc., New York, NY 10017, USA

family: DiRienzo

full_name: Christine G DiRienzo

given: Christine G

family: Sleight

full_name: Barbara Sleight

given: Barbara

family: Zhang

full_name: Xiaoxi Zhang

given: Xiaoxi

family: Leip

full_name: Eric P Leip

given: Eric P

family: Shaik

full_name: Naveed Shaik

given: Naveed

family: Bell

full_name: Timothy Bell

given: Timothy

family: Chan

full_name: Geoffrey Chan

given: Geoffrey

name: Leukemia Program, Cleveland Clinic, Cleveland, OH 44195, USA

family: Sekeres

full_name: Mikkael A Sekeres

given: Mikkael A

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

intervention_type: Procedure

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.

lead_sponsor: Pfizer

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Hungary
China
United States
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Spain

acronym: BRIGHT AML1019

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady

location_facility: Clinical Trial Center, Severance Hospital, Yonsei University Health System

location_facility: Blood Cancer and Stem Cell Transplant Clinic

location_facility: CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont

location_facility: Institutul Oncologic 'Prof. Dr. Ion Chiricuta'

location_facility: Uniklinikum Salzburg, Landeskrankenhaus Salzburg

location_facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály

location_facility: Georgia Cancer Center at Augusta University

location_facility: Spitalul Clinic Coltea, Clinica de Hematologie

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -

location_facility: A.O.U. di Ferrara- Arcispedale Sant'Anna,

location_facility: State Budgetary Healthcare Institution of Moscow

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

location_facility: State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH)

location_facility: Methodist Healthcare System of San Antonio

location_facility: Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: UCLA Hematology/Oncology - Westlake Village

location_facility: Henan Provincial People's Hospital/Hematology Department

location_facility: Sp. Clinic de Urgenta Militar Central Dr. Carol Davila

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno

location_facility: UC Irvine Health - Chao Family Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Universitaire Ziekenhuizen Brussel (UZ Brussel)

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

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: University Hospitals Birmingham NHS Foundation Trust

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

location_facility: UCLA Drug Information/Investigational Drugs

location_facility: SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek

location_facility: The First Affiliated Hospital of USTC, Anhui Provincial Hospital

location_facility: Guangdong Second Provincial General Hospital

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie

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

location_facility: Tufts Medical Center Investigational Drug Pharmacy

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

location_facility: MidAmerica Division, Inc., c/o Research Medical Center

location_facility: Azienda Ospedaliera Universitaria Senese.

location_facility: AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fujian Medical University Union Hospital

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia

location_facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

title: A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA

summary:
Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).

Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).


lead_sponsor: Affiris AG

location_country:
Austria
Croatia
France
Slovakia
Germany
Czech Republic

location_facility: "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

location_facility: Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

location_facility: Arzneimittelforschung Leipzig GmbH, Studienzentrum

location_facility: Opća bolnica Varaždin, Klinika za Neurologiju

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon

location_facility: MUW Klin. Pharmakologie und Klinik für Neurologie

location_facility: Centre Mémoire de Ressources et de Recherche, Service de Neurologie

location_facility: Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

location_facility: Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie

location_facility: Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie

location_facility: University Hospital Motol, Clinic of Neurology

location_facility: Christian Doppler Klinik, Univ. Klinik f. Neurologie

location_facility: Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

location_facility: CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

location_facility: Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

location_facility: Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju

title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease

summary: This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.


title: A Randomized, Placebo-controlled, Double-blinded Phase 2 Study of Second-line Treatment With OSI-906 in Patients With Advanced Hepatocellular Carcinoma (HCC) After Failure of First-line Treatment With Sorafenib

summary: This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at a continuous 150 mg twice daily (BID) dose.

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
United States
Hong Kong
France
Singapore
Belgium
Spain
Germany
Korea, Republic of
Taiwan

location_facility: Hopital Jean Verdier - Dervice d'Hepato-Gastroenterologie

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Seattle Cancer Care Alliance University of Washington

location_facility: Chang Gung Medical Foundation LinKou Branch

location_facility: Ospedale Fatebenefratelli, Dipartimento Medicina Interna

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare

location_facility: Tulane University Health Services Center

location_facility: Fondazione Ca' Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia

location_facility: Johns Hopkins Singapore International Medical Centre


ReferenceType: result

ReferenceCitation: Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017 Feb;33(2):231-238. doi: 10.1080/03007995.2016.1251893. Epub 2016 Nov 18.

family: Weatherall

full_name: James Weatherall

given: James

family: Bloudek

full_name: Lisa Bloudek

given: Lisa

family: Buchs

full_name: Sarah Buchs

given: Sarah

ReferenceCitation: Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

name: Division of Endocrinology, Department of Medicine, Georgetown University School of Medicine Washington DC USA

family: Ratner

full_name: R. E. Ratner

given: R. E.

name: Oxford Centre for Diabetes Endocrinology and Metabolism and NIHR Oxford Biomedical Research Centre  Oxford UK

family: Gough

full_name: S. C. L. Gough

given: S. C. L.

name: University Hospitals (UZ) Leuven KU Leuven  Leuven Belgium

family: Mathieu

full_name: C. Mathieu

given: C.

family: Del Prato

full_name: S. Del Prato

given: S.

name: Atlanta Diabetes Associates  Atlanta GA USA

family: Bode

full_name: B. Bode

given: B.

family: Mersebach

full_name: H. Mersebach

given: H.

family: Endahl

full_name: L. Endahl

given: L.

name: University of Toronto Mount Sinai Hospital  Toronto ON Canada

family: Zinman

full_name: B. Zinman

journal_name: Diabetes, Obesity and Metabolism

evidence: open (via free pdf)

license: cc-by

license_normalized: cc-by

title: Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre‐planned meta‐analysis of phase 3 trials

ReferenceCitation: Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013 Sep;36(9):2536-42. doi: 10.2337/dc12-2329. Epub 2013 May 28.

full_name: Stephen C.L. Gough

given: Stephen C.L.

family: Bhargava

full_name: Anuj Bhargava

given: Anuj

family: Jain

full_name: Rajeev Jain

given: Rajeev

full_name: Henriette Mersebach

given: Henriette

family: Rasmussen

title: Low-Volume Insulin Degludec 200 Units/mL Once Daily Improves Glycemic Control Similarly to Insulin Glargine With a Low Risk of Hypoglycemia in Insulin-Naïve Patients With Type 2 Diabetes

ReferenceCitation: Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

name: The Lunenfeld-Tanenbaum Research Institute; Mount Sinai Hospital; University of Toronto; Toronto Canada

ReferenceCitation: Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.

title: Insulin Degludec Versus Insulin Glargine in Type 1 and Type 2 Diabetes Mellitus: A Meta-Analysis of Endpoints in Phase 3a Trials

ReferenceCitation: Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014. Review.

title: Patient safety and minimizing risk with insulin administration – role of insulin degludec

ReferenceCitation: Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

title: Elderly Patients with Diabetes Experience a Lower Rate of Nocturnal Hypoglycaemia with Insulin Degludec than with Insulin Glargine: A Meta-Analysis of Phase IIIa Trials

ReferenceCitation: Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

title: Patients Achieving Good Glycemic Control (HBA1c <7%) Experience A Lower Rate of Hypoglycemia With Insulin Degludec Than with Insulin Glargine: A Meta-Analysis of Phase 3A Trials

ReferenceCitation: Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18. Review.

journal_name: Nutrition, Metabolism and Cardiovascular Diseases

ReferenceCitation: Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.

name: Department of Diabetes and Endocrinology Royal Liverpool University Hospitals  Liverpool UK

name: Division of Endocrinology and Diabetology, Department of Internal Medicine II University Hospital of Freiburg  Freiburg Germany

location_country:
South Africa
France
Ireland
Russian Federation
United States
United Kingdom
Canada
Ukraine

title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

summary: This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

family: Watts

full_name: Nelson B. Watts

given: Nelson B.

family: Bilezikian

full_name: John P. Bilezikian

given: John P.

family: Usiskin

full_name: Keith Usiskin

given: Keith

family: Edwards

full_name: Robert Edwards

given: Robert

family: Desai

full_name: Mehul Desai

given: Mehul

family: Law

full_name: Gordon Law

given: Gordon

family: Meininger

full_name: Gary Meininger

given: Gary

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

name:
Division of Nephrology, University of Maryland School of Medicine
Baltimore, MDUSA

family: Weir

full_name: Matthew R. Weir

given: Matthew R.

name: Janssen Research & Development, LLC Raritan, NJUSA

family: Kline

full_name: Irina Kline

given: Irina

family: Xie

full_name: John Xie

given: John

publisher: Informa Healthcare

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

name:
Drexel University College of Medicine
Philadelphia, PAUSA

family: Nyirjesy

full_name: Paul Nyirjesy

given: Paul

name:
Wayne State University School of Medicine
Detroit, MIUSA

family: Sobel

full_name: Jack D. Sobel

given: Jack D.

name: Janssen Research & Development LLC Raritan, NJUSA

name: Janssen Research & Development LLC Titusville, NJUSA

location_country:
United States
Brazil
South Africa
India
Mexico
Spain
Germany
France
Malaysia
Poland
Romania
Belgium
Australia
New Zealand
Russian Federation
Canada
Latvia
Korea, Republic of