acronym: ELIXA

lead_sponsor: Sanofi

summary:
Primary Objective:

- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure.
composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure.
urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.

ReferenceCitation: Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.

ReferenceCitation: Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Gerstein HC, Hess S, Claggett B, Dickstein K, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Diabetes Care. 2022 Sep 1;45(9):2152-2155. doi: 10.2337/dc22-0453.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Wijkman MO, Claggett B, Diaz R, Gerstein HC, Kober L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0.

repository_institution: Linkoping University - DiVA

repositories_concat: DiVA.org;PubMed Central

ReferenceCitation: Shin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25.

ReferenceCitation: Seferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.

repository_institution: Hindawi - Hindawi

repository_institution: Australian Catholic University - Research Bank

repository_normalized: Pure (Denmark)

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.

ReferenceCitation: Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Wohlfart P, Linz W, Hubschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.

repository_institution: University of Dundee - Discovery Research Portal

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title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Tunisia
Belgium
China
Peru
Estonia
Egypt
Philippines
Italy
Guatemala
Ecuador
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
United Arab Emirates
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


type: Other Identifier

title: Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"

acronym: COMBO-DN

summary: This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Sweden
Netherlands
Mexico
Switzerland
Korea, Republic of
Spain
Greece
Croatia
Turkey
Canada
France

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

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

acronym: RELAX-AHF-EU

lead_sponsor: Novartis Pharmaceuticals

summary: This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

ReferenceType: derived

ReferenceCitation: Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

status: Terminated

title: A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

type: EudraCT Number

source: euctr

location_country:
Finland
Germany
Poland
Croatia
Czechia
Serbia
France
Slovenia
Lithuania
Portugal
Slovakia
Hungary
Switzerland
Latvia
Iceland
Romania
Belgium
Estonia
Italy
United Kingdom
Austria
Spain
Greece
Bulgaria
Russian Federation

status_simplified: Unknown


title: Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications

summary: No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

oa_host_type: closed

publisher_dissemination: Informa

ReferenceCitation: Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7.

publisher_dissemination: Elsevier

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Australia
Canada
France
Czech Republic
Slovakia
Hungary
India
Romania
Belgium
Italy
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel

location_facility:
Research site
Research Site


title: A Long-term Follow-up of Adult Kidney and Liver Allograft Recipients Previously Enrolled Into a Tacrolimus (Advagraf) Trial. A Multicentre Non-interventional Post Authorization Study (PAS)

acronym: ADDRESS

summary: The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

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 Europe Ltd.

location_country:
Finland
Germany
Ireland
Poland
Czechia
Canada
France
Belarus
Portugal
Slovakia
Hungary
Switzerland
Latvia
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Russian Federation
Sweden

location_facility:
Site FR33027
Site HU36003
Site DE49014
Site DE49030
Site SE46001
Site FR33023
Site DE49022
Site FR33010
Site ES34012
Site BE32003
Site IT39012
Site KR82006
Site DE49011
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Site DE49017
Site AT43003
Site RO40003
Site IT39015
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Site DE49025
Site PL48001
Site IT39016
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Site GB44003
Site RU70004
Site IT39017
Site RU70013
Site ES34020
Site FR33031
Site ES34014
Site FR33002
Site IT39019
Site CZ42001
Site ES34009
Site FR33026
Site RU70002
Site AT43001
Site IT39014
Site PL48004
Site FR33012
Site FR33025
Site KR82007
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Site FR33034
Site ES34003
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Site RU70012
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Site FR33029
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Site PL48003
Site FR33004
Site LV37101
Site BE32009
Site HU36001
Site CA15001
Site FR33017
Site IT39005
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Site DE49006
Site IT39009
Site DE49010
Site ES34021
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Site RU70005
Site ES34001
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Site SE46004
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Site FR33008
Site BE32002
Site IT39002
Site KR82002
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Site DE49019
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Site FR33028
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Site RO40001
Site ES34015
Site HU36002
Site PL48005
Site ES34004
Site DE49004
Site CH41002
Site ES34018
Site KR82005
Site FR33011
Site IT39013
Site IT39011
Site DE49016
Site DE49005
Site FR33024
Site FR33014
Site FR33003
Site BE32005
Site IT39003
Site IT39001
Site ES34019
Site CZ42006
Site DE49027
Site PT35102
Site FI35802
Site FR33001
Site DE49013
Site BE32001
Site SK42102
Site IT39008
Site FR33020
Site PL48007
Site RU70011
Site FR33015
Site FR33022
Site SK42101
Site FR33032
Site DE49002
Site FR33009
Site DE49008
Site GB44001
Site ES34010
Site ES34017
Site IT39004
Site CZ42002
Site KR82001
Site NL31001
Site EE37201
Site BE32008
Site RU70007
Site FR33030
Site ES34005
Site SE46002
Site FR33019
Site IT39020
Site DE49015
Site DE49018
Site GB44002
Site RU70014
Site AT43002
Site CZ42003


lead_sponsor: Hoffmann-La Roche

summary: This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

ReferenceCitation: Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
Hoffmann-La Roche
German CLL Study Group
Genentech, Inc.

title: An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Thailand
Croatia
Czechia
Canada
France
Slovakia
Hong Kong
Denmark
Switzerland
United States
Romania
Estonia
Egypt
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation

collaborators:
German CLL Study Group
Genentech, Inc.


acronym: STIMULI

lead_sponsor: ETOP IBCSG Partners Foundation

summary:
Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months.

Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC.

The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC.

ReferenceType: background

ReferenceCitation: Lynch TJ, Bondarenko I, Luft A, Serwatowski P, Barlesi F, Chacko R, Sebastian M, Neal J, Lu H, Cuillerot JM, Reck M. Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIB/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter phase II study. J Clin Oncol. 2012 Jun 10;30(17):2046-54. doi: 10.1200/JCO.2011.38.4032. Epub 2012 Apr 30. Erratum In: J Clin Oncol. 2012 Oct 10;30(29):3654.

ReferenceCitation: Reck M, Bondarenko I, Luft A, Serwatowski P, Barlesi F, Chacko R, Sebastian M, Lu H, Cuillerot JM, Lynch TJ. Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: results from a randomized, double-blind, multicenter phase 2 trial. Ann Oncol. 2013 Jan;24(1):75-83. doi: 10.1093/annonc/mds213. Epub 2012 Aug 2.

ReferenceCitation: Margolin K, Ernstoff MS, Hamid O, Lawrence D, McDermott D, Puzanov I, Wolchok JD, Clark JI, Sznol M, Logan TF, Richards J, Michener T, Balogh A, Heller KN, Hodi FS. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol. 2012 May;13(5):459-65. doi: 10.1016/S1470-2045(12)70090-6. Epub 2012 Mar 27.

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

sponsor_collaborators: Ludwig Center for Cancer Research of Lausanne

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Clínico Universitario De Valencia

location_facility: Hospital Universitario Fundacion Jimenez Díaz

location_facility: Hospital Universitario Central De Asturias

location_facility: Royal Brisbane and Women's Hospital (QLD)

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: University Hospital Gasthuisberg, KU Leuven

status: Unknown status

title: A Randomised Open-label Phase II Trial of Consolidation With Nivolumab and Ipilimumab in Limited-stage SCLC After Chemo-radiotherapy

type: Registry Identifier

study_completion_date_type: Anticipated

location_country:
Germany
United Kingdom
Australia
Netherlands
Switzerland
Belgium
Spain
France


title: A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

acronym: OlympiA

summary: Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

status: Active, not recruiting

ReferenceCitation: Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.

ReferenceCitation: Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.

repository_institution: Leiden University - Leiden Repository

version: acceptedVersion

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

repository_institution: California Digital Library - eScholarship

version: submittedVersion

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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

collaborators: Frontier Science & Technology Research Foundation, Inc.

collaborators: Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet

location_country:
Germany
Poland
Argentina
Australia
Japan
Canada
France
Portugal
Hungary
Switzerland
United States
Iceland
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel

status_simplified: Ongoing


acronym: OAK

summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

ReferenceCitation: Cortellini A, Ricciuti B, Borghaei H, Naqash AR, D'Alessio A, Fulgenzi CAM, Addeo A, Banna GL, Pinato DJ. Differential prognostic effect of systemic inflammation in patients with non-small cell lung cancer treated with immunotherapy or chemotherapy: A post hoc analysis of the phase 3 OAK trial. Cancer. 2022 Aug 15;128(16):3067-3079. doi: 10.1002/cncr.34348. Epub 2022 Jun 21.

oa_host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Geneva - Archive ouverte UNIGE

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Gadgeel S, Hirsch FR, Kerr K, Barlesi F, Park K, Rittmeyer A, Zou W, Bhatia N, Koeppen H, Paul SM, Shames D, Yi J, Matheny C, Ballinger M, McCleland M, Gandara DR. Comparison of SP142 and 22C3 Immunohistochemistry PD-L1 Assays for Clinical Efficacy of Atezolizumab in Non-Small Cell Lung Cancer: Results From the Randomized OAK Trial. Clin Lung Cancer. 2022 Jan;23(1):21-33. doi: 10.1016/j.cllc.2021.05.007. Epub 2021 May 30.

ReferenceCitation: Gandara D, Reck M, Moro-Sibilot D, Mazieres J, Gadgeel S, Morris S, Cardona A, Mendus D, Ballinger M, Rittmeyer A, Peters S. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel. J Immunother Cancer. 2021 Mar;9(3):e001882. doi: 10.1136/jitc-2020-001882.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of California - eScholarship University of California

publisher_dissemination: British Medical Journal

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

ReferenceCitation: Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

evidence: open (via crossref license)

unpaywall_oa_status: hybrid

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

oa_colors: green hybrid

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature

ReferenceCitation: Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, Park K, Cortinovis D, de Marinis F, Rittmeyer A, Patel JD, von Pawel J, O'Hear C, Lai C, Hu S, Ballinger M, Sandler A, Gandhi M, Fehrenbacher L. Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases: Exploratory analyses of the phase III OAK study. Lung Cancer. 2019 Feb;128:105-112. doi: 10.1016/j.lungcan.2018.12.017. Epub 2018 Dec 19.

ReferenceCitation: Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, Sandler A, Yu W, He P, Matheny C, Felizzi F, Rittmeyer A. Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. Clin Lung Cancer. 2018 Sep;19(5):441-449.e4. doi: 10.1016/j.cllc.2018.05.011. Epub 2018 May 31.

ReferenceCitation: Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, Seto T, Kawakami T, Nakagawa S, Kubo T. Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study. Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1.

ReferenceCitation: Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. Erratum In: Lancet. 2017 Apr 8;389(10077):e5.

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Kobe City Medical Center General Hospital; Respiratory Medicine

location_facility: Samsung Medical Center; Gastroenterology

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

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

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

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Clinic for Pulmonology, Clinical Center of Serbia

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: National Cancer Center Hospital East; Thoracic Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: University of Pecs, I st Dept of Internal Medicine

location_facility: Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine

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

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Seconda Universita' Degli Studi; Divsione Di Oncologia Medica

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Chulalongkorn Hospital; Medical Oncology

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

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

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

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Aurora Health Care; Patient Centered Research

location_facility: Luckow Pavillion, Valley Hosp; Office of Clinical Trials

location_facility: St. Mary's Hospital Regional Cancer Center

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Antonius Ziekenhuis; Dept of Lung Diseases

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: POLICLINICO RODOLICO, U.O. di Oncologia Medica

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: Seoul St.Mary's Hospital; Medical Oncology

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Cancer Treatment Centers of America-Tulsa

location_facility: Tokyo Medical University Hospital; Dept of Surgery

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University Hospital of Patras Medical Oncology

location_facility: National Hospital Organization Kyushu Cancer Center, Thoracic Oncology

location_facility: North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

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

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: Helsinki University Central Hospital; Dep. of Pulmonary Medicine

location_facility: US Oncology Research at Minnesota Oncology

location_facility: Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato

location_facility: Luzerner Kantonsspital; Medizinische Onkologie

location_facility: National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine

location_facility: Uzhgorod Nat. University Central Municip Hosp; Onc Center

location_facility: Izmir Suat Seren Chest Diseases and Surgery Research Hospital

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Seoul National University Bundang Hospital; Hematology Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Institute for pulmonary diseases of Vojvodina

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

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

location_facility: Univ of Calif, Los Angeles; Hematology/Oncology

location_facility: Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

location_facility: National Cancer Center; Medical Oncology

location_facility: Kantonsspital Baden; Medizinische Klinik, Onkologie

location_facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

location_facility: Seoul National Uni Hospital; Internal Medicine

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: National Hospital Organization Shikoku Cancer Center; Internal Medicine

location_facility: Roy & Patricia Disney Family Cancer Center

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building

location_facility: Catharina Ziekenhuis; Dept of Lung Diseases

location_facility: Centre Jean Bernard; Radiotherapie Chimiotherapie

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Miyagi Cancer Center; Respiratory Medicine

location_facility: Waikato Hospital; Dept of Medical Oncology

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Centre Hospitalier Lyon Sud; Pneumologie

location_facility: Azienda Ospedaliera Univ Parma; Dept Oncologia Medica

location_facility: Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02

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

location_facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

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

location_facility: Lkh Vöcklabruck; I. Abt. Für Innere Medizin

location_facility: New York Oncology Hematology PC - Latham

title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Japan
Brazil
Thailand
Turkey
Chile
Canada
Serbia
France
Portugal
Hungary
Switzerland
United States
Ukraine
Italy
Guatemala
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Panama
Taiwan
Russian Federation
Sweden


title: MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)

acronym: MORE CRT MPP

summary: The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

ReferenceCitation: Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.

publisher_dissemination: Oxford University Press

ReferenceCitation: Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Cohorn C, Thibault B; MORE-CRT MPP Investigators. Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II). Am Heart J. 2019 Mar;209:1-8. doi: 10.1016/j.ahj.2018.12.004. Epub 2018 Dec 8.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repositories_concat: HAL

lead_sponsor: Abbott Medical Devices

location_country:
Finland
Germany
Poland
Australia
Malta
Canada
France
Colombia
Portugal
Denmark
Switzerland
United States
India
Lebanon
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Saudi Arabia
Spain
Greece
Taiwan
Israel

location_facility: St. Elizabeth Medical Center - South Unit

location_facility: Ospedale S. Giovanni Calibita Fatebenefratelli di Roma

location_facility: CHI Health Creighton University Medical Center-Bergan Mercy

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Escorts Heart Institute and Research Centre

location_facility: Centre Hospitalier de Belfort-Montbeliard

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Samaritan Heart & Vascular Institute - Cardiology Dept.

location_facility: Szpital Kliniczny Premienienia Panskiego

location_facility: Manchester Heart Center, Manchester Royal Infirmary

location_facility: Wojewodzki Specjalistyczny Szpital im. Bieganskiego

location_facility: Az. Osp. Universitaria Pisana-Presidio Santa Chiara

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen

location_facility: Hospital Universitario Virgen de la Nieves

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Az Osp.Universitaria Maggiore della Carità

location_facility: Centro Hospitalar do Alto Ave, Unidade de Guimarães

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem

location_facility: American University of Beirut Medical Center

location_facility: McGill University Health Centre General Hospital

location_facility: Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)

location_facility: Seoul National University Bundang Hospital

location_facility: Baylor All Saints Medical Center at Fort Worth

location_facility: Ospedale Civile Maggiore di Verona Borgo Trento

location_facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: Medizinische Einrichtungen der Universität zu Köln

location_facility: Azienda Ospedaliera S. Anna e S Sebastiano

location_facility: Azienda Ospedaliera "Civile - Maria Paternò Arezzo"

intervention_type: Device


title: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

acronym: ADVANCE-ON

summary: The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

ReferenceCitation: Patel A; ADVANCE Collaborative Group; MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S, Poulter N, Marre M, Cooper M, Glasziou P, Grobbee DE, Hamet P, Heller S, Liu LS, Mancia G, Mogensen CE, Pan CY, Rodgers A, Williams B. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007 Sep 8;370(9590):829-40. doi: 10.1016/S0140-6736(07)61303-8.

ReferenceCitation: ADVANCE Collaborative Group; Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.

ReferenceCitation: Wang N, Harris K, Hamet P, Harrap S, Mancia G, Poulter N, Williams B, Zoungas S, Woodward M, Chalmers J, Rodgers A. Cumulative Systolic Blood Pressure Load and Cardiovascular Risk in Patients With Diabetes. J Am Coll Cardiol. 2022 Sep 20;80(12):1147-1155. doi: 10.1016/j.jacc.2022.06.039.

ReferenceCitation: Oshima M, Jun M, Ohkuma T, Toyama T, Wada T, Cooper ME, Hadjadj S, Hamet P, Harrap S, Mancia G, Marre M, Williams B, Chalmers J, Woodward M, Perkovic V; ADVANCE Collaborative Group. The relationship between eGFR slope and subsequent risk of vascular outcomes and all-cause mortality in type 2 diabetes: the ADVANCE-ON study. Diabetologia. 2019 Nov;62(11):1988-1997. doi: 10.1007/s00125-019-4948-4. Epub 2019 Jul 13.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;UCL Discovery;University of Melbourne - Minerva Access

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Mohammedi K, Woodward M, Hirakawa Y, Zoungas S, Colagiuri S, Hamet P, Harrap S, Poulter N, Matthews DR, Marre M, Chalmers J; ADVANCE Collaborative Group. Presentations of major peripheral arterial disease and risk of major outcomes in patients with type 2 diabetes: results from the ADVANCE-ON study. Cardiovasc Diabetol. 2016 Sep 2;15(1):129. doi: 10.1186/s12933-016-0446-x.

repository_institution: Monash University - Monash University Research Portal

repository_institution: Imperial College London - Spiral

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;monash.edu;ora.ox.ac.uk;spiral.imperial.ac.uk

ReferenceCitation: Wong MG, Perkovic V, Chalmers J, Woodward M, Li Q, Cooper ME, Hamet P, Harrap S, Heller S, MacMahon S, Mancia G, Marre M, Matthews D, Neal B, Poulter N, Rodgers A, Williams B, Zoungas S; ADVANCE-ON Collaborative Group. Long-term Benefits of Intensive Glucose Control for Preventing End-Stage Kidney Disease: ADVANCE-ON. Diabetes Care. 2016 May;39(5):694-700. doi: 10.2337/dc15-2322. Epub 2016 Mar 22.

ReferenceCitation: Zoungas S, Chalmers J, Neal B, Billot L, Li Q, Hirakawa Y, Arima H, Monaghan H, Joshi R, Colagiuri S, Cooper ME, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Lisheng L, Mancia G, Marre M, Matthews DR, Mogensen CE, Perkovic V, Poulter N, Rodgers A, Williams B, MacMahon S, Patel A, Woodward M; ADVANCE-ON Collaborative Group. Follow-up of blood-pressure lowering and glucose control in type 2 diabetes. N Engl J Med. 2014 Oct 9;371(15):1392-406. doi: 10.1056/NEJMoa1407963. Epub 2014 Sep 19.

repository_institution: Australian National University - ANU Open Research

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University of Illinois at Chicago - INDIGO

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Canada
France
Czech Republic
Lithuania
Slovakia
Hungary
India
China
Malaysia
Estonia
Philippines
Italy
United Kingdom
Netherlands
Russian Federation

location_facility: Universiti Kebangsaan Malaysia & Universiti Teknologi MARA

location_facility: LCC 607 - People's Hospital of Binzhou City

location_facility: LCC 109 - Rural Clinical Trials Research Unit

location_facility: LCC 616 - Center Hospital of Zhumadian City

location_facility: LCC 655 - The 1st Aff Hospital of Jiangxi Medical College

location_facility: LCC 637 - Chinese Air Force General Hospital

location_facility: LCC 633 - Cardiovascular Institute & Fu Wai Hospital

location_facility: LCC 643 - 2nd Aff Hospital of Baotou Medical College

location_facility: LCC 626 - First Hospital of Peking University

location_facility: LCC 466 - Centre de recherche d'endocrinologie

location_facility: LCC 420 - Russian Peoples Friendship University

location_facility: LCC 624 - The First Affiliated Hospital of Fujian Medical University

location_facility: LCC 376 - CH Avignon - Hôpital Henri Duffaut

location_facility: LCC 651 - Jiangsu Institute of Geriatrics,

location_facility: LCC 453 - Centre hospitalier de l'Universite de Montreal

location_facility: LCC 336 - Heart Center Foundation-DRC Ltd

location_facility: LCC 816 - Peninsula Medical School Headquarters

location_facility: LCC 639 - Metabolic Disease Hospital of Tianjin Medical University

location_facility: LCC 354 - Stichting Huisartsen Laboratorium

location_facility: LCC 654 - The 3rd Aff Hospital of Jiangxi Medical University

location_facility: LCC 424 - Research Institute of Cardiology

location_facility: LCC 644 - Baotou Iron & Steel Corporation's Hospital,

location_facility: LCC 642 - The Institute of Aged Gerontology of Inner Mongolia

location_facility: LCC 606 - Shandong Academy of Medical Sciences,

location_facility: LCC 653 - Aff Hospital of Anhui Medical University

location_facility: LCC 638 - Shanghai 6th People's Hospital

location_facility: LCC 632 - Dept Endocrinology Beijing 306 Hospital

location_facility: LCC 622 - The First People's Hospital of Lianyungang City

location_facility: LCC 614 -The First Affiliated Hospital of Henan Medical University

location_facility: LCC 618 - Hebei Academy of Medical Sciences

location_facility: LCC 809 - Royal Liverpool University Hospital

location_facility: LCC 661 - Institute of Gerontology of Benxi City

location_facility: LCC 635 -Aff Ruijin Hospital of Shanghai Second Medical University

location_facility: LCC 630 - Beijing Hypertension League Institute

location_facility: LCC 610 - Second Affiliated Hospital of Dalian Medical University

location_facility: LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke

location_facility: LCC 356 - Huisartsenpraktijk Tollenslaan

location_facility: LCC 619 - The First Hospital of Ning Bo City Municipal

location_facility: LCC 636 - Chang Zheng Hospital of Shanghai

location_facility: LCC 330 - Klinikyum der Universitat Munchen

location_facility: LCC 315 - Hôpital Jean Bernard la Miletrie

location_facility: LCC 660 - Shandong Academy of Medical Sciences

location_facility: LCC 273 - Institute Psychophysiology and Rehabilitation

location_facility: LCC 394 - II Oddzial Chorob Wewnetrznvch

location_facility: LCC 902 - University of Malaya Medical Centre

location_facility: LCC 741 - Madras Diabetic Research Foundation

location_facility: LCC 627 - Peking Union Medical College Hospital

location_facility: LCC 647 - First Hospital of Yang Quan City

location_facility: LCC 658 - The 1st Aff Hospital of Guiyang Medical College

location_facility: LCC 646 - The 2nd Aff Hospital of Hebei Medical University

location_facility: LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii

location_facility: LCC 421 - St Petersburg State Medical University

location_facility: LCC 452 - Centre de recherche clinique de Laval

location_facility: LCC 467 - Queen Elizabeth II Health Science Centre

location_facility: LCC 613 - Cardiovascular Institute of Shanxi Province

location_facility: LCC 641 - The 2nd Aff Hospital of Harbin Medical University

location_facility: LCC 468 - Calgary Metabolic Education and Research Centre

location_facility: LCC 620 - Municipal Hospital of Chengdou


lead_sponsor: Pfizer

summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

ReferenceCitation: Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

ReferenceCitation: Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.

ReferenceCitation: Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crino L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326.

ReferenceCitation: Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Janne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum In: N Engl J Med. 2015 Oct 15;373(16):1582.

ReferenceCitation: Tamiya A, Okamoto I, Miyazaki M, Shimizu S, Kitaichi M, Nakagawa K. Severe acute interstitial lung disease after crizotinib therapy in a patient with EML4-ALK-positive non-small-cell lung cancer. J Clin Oncol. 2013 Jan 1;31(1):e15-7. doi: 10.1200/JCO.2012.43.3730. Epub 2012 Nov 19. No abstract available.

location_facility: Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk

location_facility: Tuen Mun Hospital, Department of Clinical Oncology

location_facility: University of Pittsburgh Medical Center-Shadyside

location_facility: Taipei Veterans General Hospital, Chest Department

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung

location_facility: H Lee Moffitt Cancer Center & Research Institute

location_facility: UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)

location_facility: Lawrence and Idell Weisberg Cancer Treatment Center

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Investigational Drug Service, Pharmacy Department, UNC Hospitals

location_facility: Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion

location_facility: Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie

location_facility: Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

location_facility: Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette

location_facility: University General Hospital of Heraklion/ Department of Clinical Oncology

location_facility: University of California, Irvine-Medical Center

location_facility: Ingalls Memorial Hospital (Drug Shipment Only)

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: HSK Dr.- Horst-Schmidt-Kliniken, Innere Medizin III Haematologie, Onkologie, Palliativmedizin

location_facility: University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute

location_facility: MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Washington University, School of Medicine

location_facility: Zhongshan Hospital Fudan University / Respiratory Department

location_facility: UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy

location_facility: Hospital General Universitari Vall D´Hebron

location_facility: State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"

location_facility: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia

location_facility: Southampton University Hospitals NHS Trust

location_facility: MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi

location_facility: National Cancer Center, Center for Lung Cancer

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic

location_facility: Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: University of California Davis Medical Center

location_facility: Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie

location_facility: Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative

location_facility: Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly

location_facility: State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region

location_facility: Ship Drug to: Investigational Drug Services

location_facility: Pracownia Tomografii Komputerowej "ALL MEDI" Sp. z o.o.

location_facility: Cancer Center of South Florida Foundation, Inc.

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

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: Alberta Health Services, Holy Cross Site

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine

location_facility: Santa Monica-UCLA Medical Center and Orthopaedic Hospital

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Georgia Cancer Specialists-Administrative Annex

location_facility: A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati

location_facility: MBAL Voennomeditsinska Academia, MMA HAT Sofia

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital

location_facility: Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute

location_facility: Hospital Universitario Central de Asturias

location_facility: Orszagos Koranyi TBC és Pulmonologiai Intezet, VI. Bronchologia

location_facility: Karolinska Universitetssjukhuset, Onkologiska kliniken

location_facility: Institut Catala Doncologia - Hospital Duran I Reynals

location_facility: Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA

location_facility: Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP

location_facility: Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion

location_facility: Centre Rene Gauducheau / Service d'Oncologie Medicale

location_facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: Unviersity of Colorado Hospital, Anschutz Cancer Pavilion

location_facility: Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika

location_facility: Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion

location_facility: Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

location_facility: Pest Megyei Tudogyogyintezet, III. Osztaly

location_facility: Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP

location_facility: NSLIJ Health System/Monter Cancer Center

location_facility: Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Shanghai Pulmonary Hospital/Dept. of Oncology

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren

location_facility: Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians

title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

location_country:
Germany
Ireland
Poland
Australia
Brazil
Japan
Canada
France
Hungary
Hong Kong
United States
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
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Bulgaria
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