title: A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC)

acronym: Mainsail

summary:
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

ReferenceCitation: Vogelzang NJ, Fizazi K, Burke JM, De Wit R, Bellmunt J, Hutson TE, Crane E, Berry WR, Doner K, Hainsworth JD, Wiechno PJ, Liu K, Waldman MF, Gandhi A, Barton D, Jungnelius U, Fandi A, Sternberg CN, Petrylak DP. Circulating Tumor Cells in a Phase 3 Study of Docetaxel and Prednisone with or without Lenalidomide in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Feb;71(2):168-171. doi: 10.1016/j.eururo.2016.07.051. Epub 2016 Aug 10.

ReferenceType: result

ReferenceCitation: Petrylak DP, Vogelzang NJ, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, de Olza MO, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, Van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, de Wit R, Fizazi K. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015 Apr;16(4):417-25. doi: 10.1016/S1470-2045(15)70025-2. Epub 2015 Mar 3.

ReferenceCitation: de Morree ES, Vogelzang NJ, Petrylak DP, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, Ochoa de Olza M, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, Li JS, de Wit R. Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study. JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000.

publisher_dissemination: American Medical Association

lead_sponsor: Celgene

location_country:
Germany
Poland
Australia
Czechia
Canada
France
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Russian Federation
Israel

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La

location_facility: Northern Lincolnshire and Goole Hospitals NHS Foundation Trust

location_facility: Summit Medical Group Overlook Oncology Center

location_facility: NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways

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

location_facility: The Angeles Clinc and Research Institute

location_facility: Albert Schweitzer Ziekenhuis Amstelwijck

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.

location_facility: Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg

location_facility: Hematology-Oncology Associates of NNJ, P

location_facility: Fairfax Northern Virginia Hematology Oncology

location_facility: Northern AZ Hematology and Oncology Assoc

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Cancer Centers of Florida, P.A.- West Gore Street

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Miserico

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Rocky Mountain Cancer Centers-Colorado Springs Circle

location_facility: Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Hematology Oncology Associates of South Jersey

location_facility: ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii

location_facility: Consultorio Privado- Dr Jose Arturo Rodriguez Rivera

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Praxis fuer Haematologie und Onkologie Koblenz

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: State Institution of Heath Omsk Regional Oncology Dispensary

location_facility: The Health Institute for Men CMX Research Inc

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

location_facility: Regionalny Osrodek Onkologiczny WSS im. M. Kopernika

location_facility: Scripps Cancer Center - Clinical Research

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: Netcare Oncology and Interventional Centre

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Weill Cornell Medical College Dr. Feldman's Office

location_facility: Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

location_facility: NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Texas Oncology Deke Slayton Cancer Center

location_facility: IORC- Innovation Onkologie Research and Consulting GmbH

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Veterans Education and Research Association of Northern New England, Inc.

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Oncology Dispensary 2 of Krasnodar Region


type: Registry Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

acronym: EXAMINE

summary: The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ferreira JP, Rossignol P, Bakris G, Mehta C, White WB, Zannad F. Blood and Urine Biomarkers Predicting Worsening Kidney Function in Patients with Type 2 Diabetes Post-Acute Coronary Syndrome: An Analysis from the EXAMINE Trial. Am J Nephrol. 2021;52(12):969-976. doi: 10.1159/000519436. Epub 2021 Dec 6.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_concat: HAL

unpaywall_oa_status: bronze

publisher_dissemination: S. Karger AG

ReferenceCitation: Ferreira JP, Mehta C, Sharma A, Nissen SE, Rossignol P, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial. BMC Med. 2020 Jun 4;18(1):165. doi: 10.1186/s12916-020-01616-8.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Sharma A, Vaduganathan M, Ferreira JP, Liu Y, Bakris GL, Cannon CP, White WB, Zannad F. Clinical and Biomarker Predictors of Expanded Heart Failure Outcomes in Patients With Type 2 Diabetes Mellitus After a Recent Acute Coronary Syndrome: Insights From the EXAMINE Trial. J Am Heart Assoc. 2020 Jan 7;9(1):e012797. doi: 10.1161/JAHA.119.012797. Epub 2020 Jan 4.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

ReferenceCitation: White WB, Jalil F, Cushman WC, Bakris GL, Bergenstal R, Heller SR, Liu Y, Mehta C, Zannad F, Cannon CP. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Ischemic Heart Disease in the EXAMINE Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009114. doi: 10.1161/JAHA.118.009114.

ReferenceCitation: Jarolim P, White WB, Cannon CP, Gao Q, Morrow DA. Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. Diabetes Care. 2018 Jul;41(7):1510-1515. doi: 10.2337/dc18-0109. Epub 2018 May 30.

ReferenceCitation: Sharma A, Cannon CP, White WB, Liu Y, Bakris GL, Cushman WC, Zannad F. Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial. J Am Heart Assoc. 2018 May 16;7(11):e007649. doi: 10.1161/JAHA.117.007649.

ReferenceCitation: White WB, Heller SR, Cannon CP, Howitt H, Khunti K, Bergenstal RM; EXAMINE Investigators. Alogliptin in Patients with Type 2 Diabetes Receiving Metformin and Sulfonylurea Therapies in the EXAMINE Trial. Am J Med. 2018 Jul;131(7):813-819.e5. doi: 10.1016/j.amjmed.2018.02.023. Epub 2018 Mar 23.

ReferenceCitation: Hwang YC, Morrow DA, Cannon CP, Liu Y, Bergenstal R, Heller S, Mehta C, Cushman W, Bakris GL, Zannad F, White WB. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial. Diabetes Obes Metab. 2018 Mar;20(3):654-659. doi: 10.1111/dom.13136. Epub 2017 Nov 21.

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

ReferenceCitation: Kay S, Strickson A, Puelles J, Selby R, Benson E, Tolley K. Comparative Effectiveness of Adding Alogliptin to Metformin Plus Sulfonylurea with Other DPP-4 Inhibitors in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Ther. 2017 Apr;8(2):251-273. doi: 10.1007/s13300-017-0245-8. Epub 2017 Mar 8.

ReferenceCitation: Cavender MA, White WB, Jarolim P, Bakris GL, Cushman WC, Kupfer S, Gao Q, Mehta CR, Zannad F, Cannon CP, Morrow DA. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care). Circulation. 2017 May 16;135(20):1911-1921. doi: 10.1161/CIRCULATIONAHA.116.024632. Epub 2017 Feb 28.

ReferenceCitation: White WB, Kupfer S, Zannad F, Mehta CR, Wilson CA, Lei L, Bakris GL, Nissen SE, Cushman WC, Heller SR, Bergenstal RM, Fleck PR, Cannon CP; EXAMINE Investigators. Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial. Diabetes Care. 2016 Jul;39(7):1267-73. doi: 10.2337/dc16-0303. Epub 2016 Jun 11.

ReferenceCitation: Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Lam H, White WB; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015 May 23;385(9982):2067-76. doi: 10.1016/S0140-6736(14)62225-X. Epub 2015 Mar 10.

ReferenceCitation: White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35. doi: 10.1056/NEJMoa1305889. Epub 2013 Sep 2.

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

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

repository_institution: Aston University - Aston Publications Explorer

ReferenceCitation: White WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P, Heller S, Mehta C, Nissen SE, Perez A, Wilson C, Zannad F. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J. 2011 Oct;162(4):620-626.e1. doi: 10.1016/j.ahj.2011.08.004. Epub 2011 Sep 14.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Kuwait
Thailand
Turkey
Croatia
Chile
Canada
Serbia
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Ukraine
India
Romania
Belgium
Malaysia
Peru
Puerto Rico
Egypt
Philippines
Italy
Guatemala
United Kingdom
Sweden
Austria
Mexico
United Arab Emirates
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

summary: The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

ReferenceType: background

ReferenceCitation: Wendtner CM, Hallek M, Fraser GA, Michallet AS, Hillmen P, Durig J, Kalaycio M, Gribben JG, Stilgenbauer S, Buhler A, Kipps TJ, Purse B, Zhang J, De Bedout S, Mei J, Chanan-Khan A. Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial. Leuk Lymphoma. 2016;57(6):1291-9. doi: 10.3109/10428194.2015.1128540. Epub 2016 Jan 14.

ReferenceCitation: Buhler A, Wendtner CM, Kipps TJ, Rassenti L, Fraser GA, Michallet AS, Hillmen P, Durig J, Gregory SA, Kalaycio M, Aurran-Schleinitz T, Trentin L, Gribben JG, Chanan-Khan A, Purse B, Zhang J, De Bedout S, Mei J, Hallek M, Stilgenbauer S. Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial. Blood Cancer J. 2016 Mar 11;6(3):e404. doi: 10.1038/bcj.2016.9.

location_facility: Long Island Jewish Medical Center CLL Research and Treatment Program

location_facility: Drexel University, College of Medicine, Clinical Research Group

location_facility: University of Ulm Abteilung Innere Medizin III

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Northwestern University Medical Center Division of Hematology Oncology

location_facility: Wake Forest University School of Medicine

location_facility: Desert Hematology Oncology Medical Group, Inc.

title: A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide (REVLIMID®) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

type: EudraCT Number

source: euctr

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

lead_sponsor_type: industriel

status_simplified: Completed


acronym: IMELDA

lead_sponsor: Hoffmann-La Roche

summary: This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

ReferenceCitation: Gligorov J, Doval D, Bines J, Alba E, Cortes P, Pierga JY, Gupta V, Costa R, Srock S, de Ducla S, Freudensprung U, Mustacchi G. Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1351-60. doi: 10.1016/S1470-2045(14)70444-9. Epub 2014 Sep 28.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

title: A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy

location_country:
Italy
Poland
India
Hong Kong
Brazil
China
Saudi Arabia
Spain
Turkey
Egypt
France


lead_sponsor: Ipsen

summary: This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer.

location_facility: DU "Instytut medychnoi radiologii im. S.P. Grygorieva AMN Ukrainy"

location_facility: Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno-diagnostychnyi tsentr

location_facility: University Hospitals of Leicester, Leicester Royal Infirmary

location_facility: GUZ of Stavropol Territorial Clinical Oncological Dispensary, Pyatigorsk Branch

location_facility: Riga Eastern CUH - Latvian Oncology Centre, Department No 9

location_facility: DU "Natsionalnyi instytut raku", m. Kyiv

location_facility: BAZ Megyei Kórház és Egyetemi Oktató Kórház, Sugártherápiás és Onkológiai Intézet

location_facility: Medical Radiology Research Center of RAMS

location_facility: Vilniaus universiteto Onkologijos institutas

location_facility: FGU "Research Institute of Oncology named after N.N.Petrov"

location_facility: Oblasnyi onkologichnyi klinichnyi dyspanser, misto Uzhgorod. Uzhgorods'kyi natsionalnyi universytet

location_facility: University of Liverpool Clatterbridge Centre for Oncology

location_facility: Krajska zdravotni s.r.o. - Masarykova nemocnice Usti nad Labem

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Centrum Onkologii Instytut Marii Sklodowskiej Curie

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Orvos-és Gyógyszerésztudományi Centrum

location_facility: Beatson Oncology Centre, Gartnavel General Hospital

location_facility: GUZ "Orenburg Regional Clinical Oncology Dispensary"

location_facility: Oddział Ginekologii Onkologicznej Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

location_facility: Kauno universiteto medicinos kliniku onkologijos ligonine

location_facility: Saint-Petersburg GUZ City Clinical Oncology Dispensary

title: A Phase II International Multicentre Randomised Open Label Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer

location_country:
Lithuania
Poland
Hungary
United Kingdom
Belgium
Latvia
Spain
Czechia
Moldova, Republic of
Ukraine
Russian Federation
France


title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD

acronym: INTENSITY

summary: This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

ReferenceCitation: Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Poland
Turkey
Canada
France
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Austria
Mexico
Spain
Greece
Russian Federation
Israel

location_facility:
Novartis Investigative Center
Novartis Investigative SIte
Novartis Investigative Site
Novartis Investigator Site


title: A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD

acronym: INVIGORATE

summary: This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

ReferenceCitation: Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, Cameron R, Shoaib M, Lawrence D, Young D, McBryan D; INVIGORATE investigators. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013 Sep;1(7):524-33. doi: 10.1016/S2213-2600(13)70158-9. Epub 2013 Aug 21.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Costa Rica
Thailand
Turkey
Canada
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
Iceland
India
Romania
Belgium
China
Peru
Estonia
Philippines
Italy
United Kingdom
Venezuela
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)

acronym: BRISK PS

summary: The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib

ReferenceCitation: Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Rios J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM. Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC. J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26.

oa_host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. doi: 10.1200/JCO.2012.47.3009. Epub 2013 Aug 26.

oa_host_type: publisher

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Argentina
Japan
Brazil
Canada
France
Hong Kong
United States
India
Belgium
China
Puerto Rico
Italy
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation

location_facility: The University Of Texas Health Science Center


title: Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses

summary:
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse.

The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

ReferenceCitation: Sprenger T, Kappos L, Sormani MP, Miller AE, Poole EM, Cavalier S, Wuerfel J. Effects of teriflunomide treatment on cognitive performance and brain volume in patients with relapsing multiple sclerosis: Post hoc analysis of the TEMSO core and extension studies. Mult Scler. 2022 Oct;28(11):1719-1728. doi: 10.1177/13524585221089534. Epub 2022 Apr 29.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: SAGE Publications

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

repository_institution: University of Ottawa - uO Research

repositories_concat: PubMed Central;ruor.uottawa.ca

ReferenceCitation: Sprenger T, Kappos L, Radue EW, Gaetano L, Mueller-Lenke N, Wuerfel J, Poole EM, Cavalier S. Association of brain volume loss and long-term disability outcomes in patients with multiple sclerosis treated with teriflunomide. Mult Scler. 2020 Sep;26(10):1207-1216. doi: 10.1177/1352458519855722. Epub 2019 Jun 14.

ReferenceCitation: Sormani MP, Truffinet P, Thangavelu K, Rufi P, Simonson C, De Stefano N. Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e379. doi: 10.1212/NXI.0000000000000379. eCollection 2017 Sep.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Sanofi

location_country:
Finland
Germany
Poland
Turkey
Chile
Canada
France
Czech Republic
Portugal
Denmark
Switzerland
United States
Ukraine
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Russian Federation
Sweden

location_facility:
Investigational Site Number 2408
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acronym: STORM

lead_sponsor: Bayer

summary: To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

ReferenceCitation: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

ReferenceCitation: Pinyol R, Montal R, Bassaganyas L, Sia D, Takayama T, Chau GY, Mazzaferro V, Roayaie S, Lee HC, Kokudo N, Zhang Z, Torrecilla S, Moeini A, Rodriguez-Carunchio L, Gane E, Verslype C, Croitoru AE, Cillo U, de la Mata M, Lupo L, Strasser S, Park JW, Camps J, Sole M, Thung SN, Villanueva A, Pena C, Meinhardt G, Bruix J, Llovet JM. Molecular predictors of prevention of recurrence in HCC with sorafenib as adjuvant treatment and prognostic factors in the phase 3 STORM trial. Gut. 2019 Jun;68(6):1065-1075. doi: 10.1136/gutjnl-2018-316408. Epub 2018 Aug 14.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Padova - Padua Research Archive

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher_dissemination: British Medical Journal

ReferenceCitation: Bouattour M, Soubrane O, de Gramont A, Faivre S. Adjuvant therapies in advanced hepatocellular carcinoma: moving forward from the STORM. Trials. 2016 Nov 25;17(1):563. doi: 10.1186/s13063-016-1675-8.

ReferenceCitation: Kudo M. Adjuvant therapy after curative treatment for hepatocellular carcinoma. Oncology. 2011;81 Suppl 1:50-5. doi: 10.1159/000333259. Epub 2011 Dec 22.

ReferenceCitation: Printz C. Clinical trials of note. Sorafenib as adjuvant treatment in the prevention of disease recurrence in patients with hepatocellular carcinoma (HCC) (STORM). Cancer. 2009 Oct 15;115(20):4646. doi: 10.1002/cncr.24673. No abstract available.

title: A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Portugal
Hong Kong
Switzerland
United States
Romania
Belgium
China
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden


acronym: SCORPIO

lead_sponsor: Astellas Pharma Inc

summary: The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

ReferenceCitation: Khullar V, Amarenco G, Angulo JC, Cambronero J, Hoye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.

ReferenceCitation: Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.

publisher_dissemination: Springer

title: A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder

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

location_country:
Finland
Germany
Ireland
Poland
Australia
Czechia
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
Iceland
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
South Africa
Bulgaria
Russian Federation
Sweden

ipd_sharing: Yes


title: A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm^2 Patch in Patients With Mild to Moderate Alzheimer's Disease (AD) Showing Functional and Cognitive Decline

summary: The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm^2.

ReferenceCitation: Molinuevo JL, Frolich L, Grossberg GT, Galvin JE, Cummings JL, Krahnke T, Strohmaier C. Responder analysis of a randomized comparison of the 13.3 mg/24 h and 9.5 mg/24 h rivastigmine patch. Alzheimers Res Ther. 2015 Mar 8;7(1):9. doi: 10.1186/s13195-014-0088-8. eCollection 2015.

ReferenceCitation: Grossberg G, Cummings J, Frolich L, Bellelli G, Molinuevo JL, Krahnke T, Strohmaier C. Efficacy of higher dose 13.3 mg/24 h rivastigmine patch on instrumental activities of daily living in patients with mild-to-moderate Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2013 Sep;28(6):583-91. doi: 10.1177/1533317513495104.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

location_country:
Germany
Italy
Switzerland
United States
Spain
Canada
France

location_facility:
Novartis Investigative Site
Novartis investigative site


title: A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily

summary: The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

ReferenceCitation: Nielsen R, Kankaanranta H, Bjermer L, Lange P, Arnetorp S, Hedegaard M, Stenling A, Mittmann N. Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries. Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.

evidence: open (via crossref license)

ReferenceCitation: Mittmann N, Hernandez P, Mellstrom C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics. 2011 May;29(5):403-14. doi: 10.2165/11590380-000000000-00000.

ReferenceCitation: Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.

ReferenceCitation: Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.

lead_sponsor: AstraZeneca

location_country: Germany Poland Slovakia Hungary Australia Sweden Spain Canada France


lead_sponsor: Pfizer

summary: This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: QEII Health Sciences Centre - Victoria General Site

location_facility: Tuen Mun Hospital, Department of Clinical Oncology

location_facility: Centro de Oncologia do Instituto de Radiologia

location_facility: Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology

location_facility: US Oncology Research and Clinical Pharmacy (Drug Shipment Only)

location_facility: Management Offices, 4th Floor, Thomas Guy House

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

location_facility: Chang Gung Medical Foundation, Linkou Branch

location_facility: Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital,

location_facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine

location_facility: The Strelitz Diabetes Institute of Eastern Virginia Medical School

location_facility: Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe

location_facility: UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology

location_facility: QEII Health Sciences Centre - Halifax Infirmary Site

location_facility: Universitaetsklinikum Giessen und Marburg, Standort Marburg

location_facility: Universitaetsklinikum Charité, Campus Virchow Klinikum

location_facility: Cliniques Universitaires Saint-Luc, Oncologie

location_facility: National University Hospital/Department of Heamatology-Oncology

location_facility: National Cancer Center/Department of Medical Oncology

location_facility: Yeungnam University Medical Center/Department of Internal medicine

location_facility: Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine

location_facility: Centro Oncologico Md Anderson International España

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer

location_facility: Taichung Veterans General Hospital, Department of Surgery

location_facility: Department of Clinical Oncology, Tuen Mun Hospital

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie

location_facility: Seoul National University Bundang Hospital

location_facility: Queen Elizabeth Hospital, Department of Clinical Oncology

location_facility: Hospital Universitario San Vicente de Paul

location_facility: Emory University, Winship Cancer Institute

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Washington University School of Medicine, Siteman Cancer Center

location_facility: QEII Health Sciences Centre - Nova Scotia Cancer Centre

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: University of Iowa Hospitals and Clinics

location_facility: Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen

location_facility: Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein

location_facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery

location_facility: National Taiwan University Hospital/Department of Oncology

location_facility: Seoul National University Hospital / Department of Internal Medecine

location_facility: Cardiology Department, Wythenshawe Hospital

location_facility: Cliniques Universitaires Saint Luc / Gastroentérologie

location_facility: Fundacion Centro de Investigacion Clinica CIC

location_facility: Groupe Hospitalier Cochin, Cancer Quest AP-HP

title: An Open-label Sunitinib Malate (su011248) Continuation Protocol For Patients Who Have Completed A Prior Sunitinib Study And Are Judged By The Investigator To Have The Potential To Benefit From Sunitinib Treatment

location_country:
Germany
Colombia
United Kingdom
Argentina
Hong Kong
Australia
Brazil
Singapore
Mexico
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Philippines
France


acronym: START

lead_sponsor: EMD Serono

summary:
The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.

ReferenceCitation: Butts C, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Helwig C, Falk MH, Shepherd FA. START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer. American Society of Clinical Oncology - 49th Annual Meeting. 2013; Abstr No. 7500.

ReferenceCitation: Shepherd FA, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Helwig C, Schroeder A, Butts C. Updated analysis and secondary endpoints with L-BLP25 in unresectable stage III non-small cell lung cancer in the phase III START study. European Society for Medical Oncology 38th Congress - ECCO 17, ESMO 38, ESTRO 32. 2013. Abstr No. 3419.

ReferenceCitation: Mitchell P, Butts C, Socinski M, Thatcher N, Wichardt-Johansson G, Ellis P, Gladkov O, Pereira J, Eberhardt W, Horwood K, Szczesna A, Helwig C, Schröder A, Shepherd F. Tecemotide (L-BLP25) in unresectable stage III non-small cell lung cancer in the phase III START study: Further endpoint and exploratory biomarker results. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2779.

ReferenceCitation: Thatcher N, Shepherd FA, Mitchell P, Socinski MA, Paredes A, Lambrechts M, Thomas M, Kollmeier J, Zemanová M, Sadjadian P, Peylan-Ramu N, Helwig C, Schröder A, Butts C. Geographic differences in the combined-modality treatment of stage III unresectable non-small cell lung cancer: Results from a global phase III trial of tecemotide (L-BLP25). World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2712.

ReferenceCitation: Socinski M, Butts C, Mitchell P, Thatcher N, Scagliotti G, Robinet G, Martin C, Zukin M, Ragulin Y, Bonomi P, Yang CH, Regnault A, Helwig C, de Nigris E, Shepherd F. Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide in non-small cell lung cancer. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2744.

ReferenceCitation: Butts C, Socinski MA, Mitchell PL, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquee L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Wickart-Johansson G, Ellis P, Gladkov O, Pereira JR, Eberhardt WE, Helwig C, Schroder A, Shepherd FA; START trial team. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jan;15(1):59-68. doi: 10.1016/S1470-2045(13)70510-2. Epub 2013 Dec 9.

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

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

ReferenceCitation: DeGregorio M, Soe L, Wolf M. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small cell lung cancer (START): a randomized, double-blind, phase III trial. J Thorac Dis. 2014 Jun;6(6):571-3. doi: 10.3978/j.issn.2072-1439.2014.05.15. No abstract available.

ReferenceCitation: Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.

publisher_dissemination: Wiley

ReferenceCitation: Mitchell P, Thatcher N, Socinski MA, Wasilewska-Tesluk E, Horwood K, Szczesna A, Martin C, Ragulin Y, Zukin M, Helwig C, Falk M, Butts C, Shepherd FA. Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses. Ann Oncol. 2015 Jun;26(6):1134-1142. doi: 10.1093/annonc/mdv104. Epub 2015 Feb 26.

license: publisher-specific-oa

license_normalized: publisher-specific

sponsor_collaborators:
EMD Serono
Merck KGaA, Darmstadt, Germany

location_facility: University of Maryland, Marlene and Steward Greenbaum Cancer Center

location_facility: Cape Breton Districk Health Authority Cancer Care

location_facility: Hematology and Oncology Specialists, LLC

location_facility: Univ. of Pennsylvania Abramson Cancer Center

location_facility: Stockton Hematology Oncology Medical Group, Inc.

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Big Sky Oncology, Sletten Cancer Institute

location_facility: The Center for Cancer and Blood Disorders

location_facility: Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center

location_facility: Cancer Therapy & Research Center, Institute for Drug Development

location_facility: Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia

location_facility: Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia

location_facility: Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano

location_facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

location_facility: Hospital das Clinicas da Faculdade de Medinina de Univeridade

location_facility: Instituto Nacional de Cancerologia (INCAN)

location_facility: Hematology Oncology Associates of Rockland

location_facility: Clinical Trials and Research Associates, Inc.

location_facility: Desert Hematology Oncology Medical Group, Inc

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: St. Vincents Comprehensive Cancer Center

location_facility: Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center

location_facility: Fairfax-Northern Virginia Hematology Oncology, PC

location_facility: University of Miami, Sylvester Comprehensive Cancer Center

location_facility: Instituto Especializado Alexander Fleming

location_facility: University of Minnesota Physicians, Masonic Cancer Center

location_facility: Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos

location_facility: Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute

title: A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Romania
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Double Blind, Randomised, 3-Arm Parallel Group, Multicentre, 8-Week, Phase III Study to Assess Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) /HCT 32/12.5mg and 32/25mg vs. CC 32mg Alone in Patients With Inadequate BP Control on Monotherapy With CC 32mg

summary: In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.

location_country:
Germany
Lithuania
Poland
United Kingdom
Denmark
Sweden
Netherlands
Ukraine
Former Serbia and Montenegro
Estonia
France

location_facility:
Research SIte
Research Site


title: A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes

summary:
This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.

ReferenceCitation: Mathiesen ER, Kinsley B, Amiel SA, Heller S, McCance D, Duran S, Bellaire S, Raben A; Insulin Aspart Pregnancy Study Group. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabetes Care. 2007 Apr;30(4):771-6. doi: 10.2337/dc06-1887.

ReferenceCitation: Hod M, Jovanovic L. Improving outcomes in pregnant women with type 1 diabetes. Diabetes Care. 2007 Jul;30(7):e62. doi: 10.2337/dc07-0488. No abstract available.

ReferenceCitation: Hod M, Damm P, Kaaja R, Visser GH, Dunne F, Demidova I, Hansen AS, Mersebach H; Insulin Aspart Pregnancy Study Group. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol. 2008 Feb;198(2):186.e1-7. doi: 10.1016/j.ajog.2007.08.005. Epub 2007 Oct 1.

ReferenceCitation: McCance DR, Damm P, Mathiesen ER, Hod M, Kaaja R, Dunne F, Jensen LE, Mersebach H. Evaluation of insulin antibodies and placental transfer of insulin aspart in pregnant women with type 1 diabetes mellitus. Diabetologia. 2008 Nov;51(11):2141-3. doi: 10.1007/s00125-008-1120-y. Epub 2008 Aug 23. No abstract available.

ReferenceCitation: Heller S, Damm P, Mersebach H, Skjoth TV, Kaaja R, Hod M, Duran-Garcia S, McCance D, Mathiesen ER. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study. Diabetes Care. 2010 Mar;33(3):473-7. doi: 10.2337/dc09-1605. Epub 2009 Dec 10.

ReferenceCitation: Damm P, Mersebach H, Rastam J, Kaaja R, Hod M, McCance DR, Mathiesen ER. Poor pregnancy outcome in women with type 1 diabetes is predicted by elevated HbA1c and spikes of high glucose values in the third trimester. J Matern Fetal Neonatal Med. 2014 Jan;27(2):149-54. doi: 10.3109/14767058.2013.806896. Epub 2013 Jun 20.

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

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

publisher_dissemination: Informa

ReferenceCitation: Altschuler JA, Casella SJ, MacKenzie TA, Curtis KM. The effect of cinnamon on A1C among adolescents with type 1 diabetes. Diabetes Care. 2007 Apr;30(4):813-6. doi: 10.2337/dc06-1871.

ReferenceCitation: Williams MM, Clouse RE, Nix BD, Rubin EH, Sayuk GS, McGill JB, Gelenberg AJ, Ciechanowski PS, Hirsch IB, Lustman PJ. Efficacy of sertraline in prevention of depression recurrence in older versus younger adults with diabetes. Diabetes Care. 2007 Apr;30(4):801-6. doi: 10.2337/dc06-1825.

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Ireland
Poland
Israel
Argentina
Denmark
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Croatia
Bulgaria
Canada
Russian Federation
France


title: RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

acronym: RECORD 3

summary: The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

primary_purpose: Prevention

ReferenceCitation: Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.

location_country:
Germany
Poland
Canada
France
Czech Republic
Colombia
Denmark
Belgium
China
Peru
Italy
Norway
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Israel


type: Other Identifier

title: An Open-label Trial With TMC125 as Part of an ART Including TMC114/Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial (TMC125-C206 or TMC125-C216).

summary: The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.

design_allocation: Non-Randomized

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Germany
Argentina
Australia
Brazil
Mexico
Belgium
United States
Spain
Thailand
Panama
Chile
Canada
Puerto Rico
France


title: ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

summary: The purpose of this study is to compare eritoran tetrasodium and placebo in patients with severe sepsis and to demonstrate a reduction of mortality from all causes.

ReferenceCitation: Opal SM, Laterre PF, Francois B, LaRosa SP, Angus DC, Mira JP, Wittebole X, Dugernier T, Perrotin D, Tidswell M, Jauregui L, Krell K, Pachl J, Takahashi T, Peckelsen C, Cordasco E, Chang CS, Oeyen S, Aikawa N, Maruyama T, Schein R, Kalil AC, Van Nuffelen M, Lynn M, Rossignol DP, Gogate J, Roberts MB, Wheeler JL, Vincent JL; ACCESS Study Group. Effect of eritoran, an antagonist of MD2-TLR4, on mortality in patients with severe sepsis: the ACCESS randomized trial. JAMA. 2013 Mar 20;309(11):1154-62. doi: 10.1001/jama.2013.2194.

repository_institution: Ghent University - Ghent University Academic Bibliography

lead_sponsor: Eisai Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Portugal
Hong Kong
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Israel


title: A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

acronym: RE-MEDY

summary: The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

ReferenceCitation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.

ReferenceCitation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

ReferenceCitation: Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.

evidence: open (via free article)

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

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Denmark
United States
Ukraine
India
Belgium
China
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

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location_facility: 1160.47.86011 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.02017 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.35104 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.91009 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.07009 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.43002 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.55007 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.91001 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.02008 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.01052 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.91002 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.91004 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.52034 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.34006 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.35105 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.54006 Boehringer Ingelheim Investigational Site

location_facility: 1160.47.55012 Boehringer Ingelheim Investigational Site


title: Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension

acronym: OLMETREAT

summary: This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

lead_sponsor: Sankyo Pharma Gmbh

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Azienda Ospedaliera "Madonna delle Grazie"

location_facility: Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan

location_facility: Division of Cardiovascular and Endocrine Sciences

location_facility: Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care

location_facility: Azienda Policlinico Universitario a Gestione Diret

location_facility: Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I


title: Assess Lot-to-lot Consistency of 3 Lots (Double Blind Design) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Vaccine and Evaluate Non-inferiority to Prevenar™ (Single Blind Design) When Administered as 3-dose Primary Immunization Course Before 6 Months of Age

summary: Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.

ReferenceCitation: Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.

ReferenceCitation: Hausdorff WP, Dagan R, Beckers F, Schuerman L. Estimating the direct impact of new conjugate vaccines against invasive pneumococcal disease. Vaccine. 2009 Dec 9;27(52):7257-69. doi: 10.1016/j.vaccine.2009.09.111. Epub 2009 Oct 13.

ReferenceCitation: Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.

ReferenceCitation: Poolman J, Frasch C, Nurkka A, Kayhty H, Biemans R, Schuerman L. Impact of the conjugation method on the immunogenicity of Streptococcus pneumoniae serotype 19F polysaccharide in conjugate vaccines. Clin Vaccine Immunol. 2011 Feb;18(2):327-36. doi: 10.1128/CVI.00402-10. Epub 2010 Dec 1.

ReferenceCitation: Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.

ReferenceCitation: Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12.

ReferenceCitation: Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsene JP, Lommel P, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S66-76. doi: 10.1097/INF.0b013e318199f8ef.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Finland Poland France

intervention_type: Biological


title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation

acronym: STRATA

summary: The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

status: Terminated

ReferenceCitation: Gorelik L, Lerner M, Bixler S, Crossman M, Schlain B, Simon K, Pace A, Cheung A, Chen LL, Berman M, Zein F, Wilson E, Yednock T, Sandrock A, Goelz SE, Subramanyam M. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010 Sep;68(3):295-303. doi: 10.1002/ana.22128.

ReferenceCitation: Rudick RA, O'Connor PW, Polman CH, Goodman AD, Ray SS, Griffith NM, Jurgensen SA, Gorelik L, Forrestal F, Sandrock AW, Goelz SE. Assessment of JC virus DNA in blood and urine from natalizumab-treated patients. Ann Neurol. 2010 Sep;68(3):304-10. doi: 10.1002/ana.22107.

ReferenceCitation: O'Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA, Hauswirth K, Cristiano LM, Forrestal F, Duda P. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4. Erratum In: Neurology. 2014 Aug 19;83(8):773.

lead_sponsor: Biogen

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Turkey
Canada
France
Czech Republic
Hungary
Denmark
Switzerland
Belgium
Italy
United Kingdom
Sweden
Netherlands
Spain
Greece
Israel

status_simplified: Unknown


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

acronym: FACE

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

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

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: Medical Oncology Associates of Wyorning Valley, PC

location_facility: Wichita Community Clinical Oncology Program

location_facility: Center for Oncology Research and Treatment, PA

location_facility: Texas Cancer Center ( Medical City Dallas Hospital)

location_facility: Chattanooga Oncology and Hematology Assoicates, PC

location_facility: Sarah Cannon Oncology Hematology Care, Inc

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

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

location_facility: Birmingham Hematology and Oncology Associates


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

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

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

license: public-domain

license_normalized: public-domain

publisher_dissemination: Oxford University Press

lead_sponsor: Genzyme, a Sanofi Company

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


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

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

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

intervention_type: Other


title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

summary: This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy

ReferenceCitation: Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

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

ReferenceCitation: Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12.

ReferenceCitation: Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19.

lead_sponsor: UCB Pharma

location_country:
Finland
Germany
Poland
United Kingdom
Netherlands
Belgium
Spain
Czech Republic
France


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

acronym: CRYSTAL

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

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

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

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

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

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

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

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

repository_institution: PubMed Central - Europe PMC

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

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

lead_sponsor: Merck KGaA, Darmstadt, Germany

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

location_facility:
Research Site
Research Sites


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

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

status: No longer available

study_type: Expanded Access

lead_sponsor: Novartis Pharmaceuticals

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