title: A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)

acronym: TURANDOT

summary: To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

ReferenceCitation: Zhou H, Xi L, Ziemek D, O'Neil S, Lee J, Stewart Z, Zhan Y, Zhao S, Zhang Y, Page K, Huang A, Maciejewski M, Zhang B, Gorelick KJ, Fitz L, Pradhan V, Cataldi F, Vincent M, Von Schack D, Hung K, Hassan-Zahraee M. Molecular Profiling of Ulcerative Colitis Subjects from the TURANDOT Trial Reveals Novel Pharmacodynamic/Efficacy Biomarkers. J Crohns Colitis. 2019 May 27;13(6):702-713. doi: 10.1093/ecco-jcc/jjy217.

ReferenceCitation: Vermeire S, Sandborn WJ, Danese S, Hébuterne X, Salzberg BA, Klopocka M, Tarabar D, Vanasek T, Greguš M, Hellstern PA, Kim JS, Sparrow MP, Gorelick KJ, Hinz M, Ahmad A, Pradhan V, Hassan-Zahraee M, Clare R, Cataldi F, Reinisch W. Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jul 8;390(10090):135-144. doi: 10.1016/S0140-6736(17)30930-3. Epub 2017 May 17. Erratum in: Lancet. 2019 Dec 22;392(10165):2696.

lead_sponsor: Shire

location_country:
Serbia
Spain
Italy
United States
South Africa
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Slovakia
Canada
Hungary
Germany
Bulgaria
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University of North Carolina at Chapel Hill

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera -Università di Padova

location_facility: Clinical and Translational Research Institute

location_facility: Premier Medical Group Research Department - Drug

location_facility: Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva

location_facility: Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology

location_facility: Ustredna vojenska nemocnice SNP Ruzomberok

location_facility: Vanderbilt University Medical Center: IBD Clinic

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: Academic Medical Center - University of Amsterdam

location_facility: Gastroenterology Division, Rabin Medical Center, Beilinson Campus

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont

location_facility: Steinberg Diagnostic Medical Imaging Centers

location_facility: Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

location_facility: University of Nevada School of Medicine (UNSOM)

location_facility: Barnes-Jewish Hospital Radiology (X-Ray Only)

location_facility: University of Miami Hospital and Clinic - Local Lab

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa

location_facility: IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS

location_facility: KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Vanderbilt University Medical Center: Outpatient Radiology

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.

location_facility: Department of Pharmacy Investigational Drug Services

location_facility: Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department

location_facility: Vanderbilt University Medical Center: Endoscopy Lab

location_facility: Vanderbilt University Medical Center: Drug Shipment

location_facility: Vanderbilt University Medical Center: GI Clinical Research

location_facility: Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital

location_facility: SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "

location_facility: Houston Hospital for Specialized Surgery

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: University of Kentucky Chandler Medical Center

location_facility: Wojskowy Szpital Kliniczny z Poliklinika SPOZ

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: University Medical Center Groningen (UMCG)

location_facility: Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

location_facility: Office of Drs. Ranjit Andrew Singh and Jamie D. Papp

location_facility: The Oregon Clinic, PC - Gastroenterology West

location_facility: Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Weill Cornell Medical College of Cornell University

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem

location_facility: UNC Hospitals Endoscopy Center At Meadowmont

location_facility: Covance Central Laboratory Services, Inc

location_facility: Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.

location_facility: Baylor College Of Medicine - Baylor Medical Center

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)

location_facility: London Health Sciences Centre - University Hospital

location_facility: Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Hôpital Nord Service de Gastro-entérologie

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: GastroDiagnostics - Community Clinical Trials Drug


type: Other Identifier

type: EudraCT Number

title: Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

summary: The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Fraser GAM, Chanan-Khan A, Demirkan F, Santucci Silva R, Grosicki S, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Pavlovsky MA, Goy A, Mato A, Hallek M, Salman M, Tamegnon M, Sun S, Connor A, Nottage K, Schuier N, Balasubramanian S, Howes A, Cramer P. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Leuk Lymphoma. 2020 Dec;61(13):3188-3197. doi: 10.1080/10428194.2020.1795159. Epub 2020 Aug 6.

ReferenceCitation: Lavezzi SM, de Jong J, Neyens M, Cramer P, Demirkan F, Fraser G, Bartlett N, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Goy A, Ganguly S, Salman M, Howes A, Mahler M, De Nicolao G, Poggesi I. Systemic Exposure of Rituximab Increased by Ibrutinib: Pharmacokinetic Results and Modeling Based on the HELIOS Trial. Pharm Res. 2019 May 1;36(7):93. doi: 10.1007/s11095-019-2605-8.

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

ReferenceCitation: Chanan-Khan A, Cramer P, Demirkan F, Fraser G, Silva RS, Grosicki S, Pristupa A, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Pylypenko H, Loscertales J, Avigdor A, Rule S, Villa D, Samoilova O, Panagiotidis P, Goy A, Mato A, Pavlovsky MA, Karlsson C, Mahler M, Salman M, Sun S, Phelps C, Balasubramanian S, Howes A, Hallek M; HELIOS investigators. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study. Lancet Oncol. 2016 Feb;17(2):200-211. doi: 10.1016/S1470-2045(15)00465-9. Epub 2015 Dec 5.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Portugal
Russian Federation
Argentina
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Germany
Greece
Korea, Republic of
France
Colombia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


primary_purpose: Prevention

intervention_type: Biological

title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

lead_sponsor: GlaxoSmithKline

source: euctr

ReferenceCitation: Curran D, Matthews S, Rowley SD, Young JH, Bastidas A, Anagnostopoulos A, Barista I, Chandrasekar PH, Dickinson M, El Idrissi M, Heras I, Milliken ST, Monserrat Coll J, Navarro Matilla MB, Oostvogels L, Piątkowska-Jakubas B, Quiel D, Sabry W, Schwartz S, Selleslag DLD, Sullivan KM, Theunissen K, Yegin ZA, Yeh SP, Zaja F, Szer J; ZOE-HSCT Study group collaborators. Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT). Biol Blood Marrow Transplant. 2019 Dec;25(12):2474-2481. doi: 10.1016/j.bbmt.2019.07.036. Epub 2019 Aug 5.

ReferenceCitation: Bastidas A, de la Serna J, El Idrissi M, Oostvogels L, Quittet P, López-Jiménez J, Vural F, Pohlreich D, Zuckerman T, Issa NC, Gaidano G, Lee JJ, Abhyankar S, Solano C, Perez de Oteyza J, Satlin MJ, Schwartz S, Campins M, Rocci A, Vallejo Llamas C, Lee DG, Tan SM, Johnston AM, Grigg A, Boeckh MJ, Campora L, Lopez-Fauqued M, Heineman TC, Stadtmauer EA, Sullivan KM; ZOE-HSCT Study Group Collaborators. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):123-133. doi: 10.1001/jama.2019.9053. Erratum in: JAMA. 2019 Aug 27;322(8):785.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
Israel
Panama
Turkey
Malaysia
Canada
Germany
Bulgaria
Taiwan
Greece
Estonia
New Zealand
Finland
Korea, Republic of
France
Netherlands

summary: The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.


type: Registry Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

summary: The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.

status: Terminated

ReferenceCitation: Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

ReferenceCitation: Menon V, Lincoff AM, Nicholls SJ, Jasper S, Wolski K, McGuire DK, Mehta CR, Rosenstock J, Lopez C, Marcinak J, Cao C, Nissen SE; GRAND 306 Investigators. Fasiglifam-Induced Liver Injury in Patients With Type 2 Diabetes: Results of a Randomized Controlled Cardiovascular Outcomes Safety Trial. Diabetes Care. 2018 Dec;41(12):2603-2609. doi: 10.2337/dc18-0755.

lead_sponsor: Takeda

location_country:
Croatia
United Kingdom
Italy
Lithuania
Ukraine
United States
Peru
Romania
Philippines
South Africa
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Mexico
Malaysia
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Latvia
Estonia
New Zealand
Czech Republic
Thailand
Korea, Republic of
France

status_simplified: Unknown


title: A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study

lead_sponsor: Hoffmann-La Roche

design_allocation: Non-Randomized

ReferenceCitation: Oza AM, Dubois F, Hegg R, Hernández CA, Finocchiaro G, Ghiringhelli F, Zamagni C, Nick S, Irahara N, Perretti T, Colombo N. A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors. Oncologist. 2021 Dec;26(12):e2254-e2264. doi: 10.1002/onco.13971. Epub 2021 Oct 4.

location_country:
Spain
Italy
United Kingdom
Romania
South Africa
Czechia
Austria
Russian Federation
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Estonia
Korea, Republic of
France
Netherlands

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

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

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

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

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

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

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

location_facility: Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Fundación Rodolfo Padilla Padilla, A.C.; Oncology

location_facility: Altai Region Oncology Dispensory; Oncology

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Russian Research Center of Roentgenoradiology; Dept of Chemotherapy

location_facility: Hospital de Cruces; Servicio de Oncologia

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

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

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

location_facility: Universitetssjukhuset Örebro, Onkologiska kliniken

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: National Cancer Center; Medical Oncology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Addenbrooke'S Hospital; Dept of Neurosurgery

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Centre Leon Berard; Departement Oncologie Medicale

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

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

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

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

summary: This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.


title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

summary: This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Iceland
Japan
Poland
Australia
Argentina
Israel
Singapore
Sweden
Canada
Guatemala
Hungary
Germany
Taiwan
Latvia
Estonia
Finland
Korea, Republic of
France
Colombia


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

summary: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

ReferenceCitation: Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.

ReferenceCitation: Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.

ReferenceCitation: Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Italy
United States
France
Germany

location_facility: Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: Winship Cancer Institute at Emory University

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc

location_facility: Ospedale Oncologico Regionale A. Businco

location_facility: University of California, San Diego- Moores Cancer Center

location_facility: Collaborative Medical Research Corporation

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU)

location_facility: Yakima Valley Memorial Hospital / North Star Lodge

location_facility: Georgetown University Medical Center Lombardi Cancer Center


title: A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

summary: Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.

ReferenceCitation: Krug AK, Enderle D, Karlovich C, Priewasser T, Bentink S, Spiel A, Brinkmann K, Emenegger J, Grimm DG, Castellanos-Rizaldos E, Goldman JW, Sequist LV, Soria JC, Camidge DR, Gadgeel SM, Wakelee HA, Raponi M, Noerholm M, Skog J. Improved EGFR mutation detection using combined exosomal RNA and circulating tumor DNA in NSCLC patient plasma. Ann Oncol. 2018 Mar 1;29(3):700-706. doi: 10.1093/annonc/mdx765.

ReferenceCitation: Sequist LV, Soria JC, Goldman JW, Wakelee HA, Gadgeel SM, Varga A, Papadimitrakopoulou V, Solomon BJ, Oxnard GR, Dziadziuszko R, Aisner DL, Doebele RC, Galasso C, Garon EB, Heist RS, Logan J, Neal JW, Mendenhall MA, Nichols S, Piotrowska Z, Wozniak AJ, Raponi M, Karlovich CA, Jaw-Tsai S, Isaacson J, Despain D, Matheny SL, Rolfe L, Allen AR, Camidge DR. Rociletinib in EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1700-9. doi: 10.1056/NEJMoa1413654.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Australia
Poland
United States
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University of Chicago Medical Center, The Duchossois Center for Advanced Medicine

location_facility: Ohio State University, Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Providence CancerCenter Oncology and Hematology Care Clinic-Eastside Portland

location_facility: The Oncology Institute of Hope and Innovations

location_facility: University of Pittsburgh Cancer Institute (UPMC), Div. of Medical Oncology

location_facility: University of California Davis Medical Center

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Sylvester Comprehensive Cancer Center/UMHC

location_facility: University of Texas Southwestern Medical Center

location_facility: East Valley Hematology and Oncology Medical Group, Inc.

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: University of Southern California, Norris Comprehensive Cancer Center


title: A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C

summary: The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Romania
Spain
Greece
Austria
Australia
Italy
Argentina
Canada
Finland
Mexico
Netherlands
New Zealand
Korea, Republic of
United States
France
Puerto Rico
Belgium
Germany

location_facility: Toronto Digestive Disease Associates, Inc.

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

location_facility: University Of Texas Health Science Center At Houston


title: A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

summary: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

location_country:
Spain
United Kingdom
Argentina
Canada
United States
Chile
France
Peru
Mexico
Sweden


title: A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)

summary: This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O. Case-control Indian buffet process identifies biomarkers of response to Codrituzumab. BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.

ReferenceCitation: Abou-Alfa GK, Puig O, Daniele B, Kudo M, Merle P, Park JW, Ross P, Peron JM, Ebert O, Chan S, Poon TP, Colombo M, Okusaka T, Ryoo BY, Minguez B, Tanaka T, Ohtomo T, Ukrainskyj S, Boisserie F, Rutman O, Chen YC, Xu C, Shochat E, Jukofsky L, Reis B, Chen G, Di Laurenzio L, Lee R, Yen CJ. Randomized phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):289-95. doi: 10.1016/j.jhep.2016.04.004. Epub 2016 Apr 13.

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

location_facility: Hopital de L'Archet; Pole de Reference Hepatite C

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: Hôpital Saint Antoine; Service Hépathologie

location_facility: Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie

location_facility: Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: Chang Gung Memorial Foundation - Kaohsiung

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: The Clatterbridge Cancer Ctr NHS Foundation Trust

location_facility: National Cancer Institute; Ctr for Cancer Research

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

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Klinikum rechts der Isar der TU München; Klinikapotheke

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Uni Heidelberg Med. Klinik; Innere Medizin IV

location_facility: Hôpital d'Adultes; Service hépato-gastro-entérologie


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury

summary: The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord injury.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Poland
Spain
United Kingdom
Canada
United States
France
Czechia


title: A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

lead_sponsor: Genentech, Inc.

location_country:
Spain
Italy
Greece
United Kingdom
United States
France
Romania
Netherlands
Czechia

location_facility: University Hospital of Larissa; Oncology

location_facility: Azienda Ospedaliera Istituti Ospitalieri

location_facility: Prof. Dr. Th. Burghele Clin Urology Hosp

location_facility: Johns Hopkins Univ; Bunting Blaustein Cancer Center

location_facility: Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni

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

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

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

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Ospedale S. Donato; Divisione Di Reumatologia

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Queen Elizabeth Hospital; Centre for Clinical Haematology

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Sint Franciscus Gasthuis; Inwendige Geneeskunde

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

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Vu Medisch Centrum; Afdeling Longziekten

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

location_facility: St. James University Hospital; Pharmacy Department

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

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

location_facility: University Hospital of Patras Medical Oncology

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: New York Cancer and Blood Specialists - Setauket Medical Oncology

location_facility: Urology Cancer Center & GU Research Network

summary: This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.


title: A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis

summary: The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

ReferenceType: result

ReferenceCitation: Danese S, Rudziński J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.

lead_sponsor: AstraZeneca

location_country:
Poland
United Kingdom
Italy
Czech Republic
France
Germany


title: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

summary: The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].

ReferenceCitation: Jakubowiak A, Offidani M, Pégourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.

location_country:
Spain
Italy
Canada
United States
France

location_facility: Kaiser Permanente-Moanalua Medical Center

location_facility: Pikeville Medical Center Leonard Lawson Cancer Center

location_facility: Washington University School Of Medicine

location_facility: University Of Kentucky Markey Cancer Center

location_facility: Investigative Clinical Research Of Indiana, Llc

location_facility: Southern Nevada Cancer Research Foundation


title: A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL

summary: The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

lead_sponsor: MedImmune LLC

location_country:
Poland
Italy
Canada
United States
France
Israel
Belgium
Germany


title: Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

summary: The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Singh D, D'Urzo AD, Donohue JF, Kerwin EM, Molins E, Chuecos F, Ribera A, Jarreta D. An Evaluation Of Single And Dual Long-Acting Bronchodilator Therapy As Effective Interventions In Maintenance Therapy-Naïve Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 6;14:2835-2848. doi: 10.2147/COPD.S217710. eCollection 2019. Review.

ReferenceCitation: Singh D, D'Urzo AD, Chuecos F, Muñoz A, Garcia Gil E. Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol. Respir Res. 2017 May 30;18(1):106. doi: 10.1186/s12931-017-0583-0.

ReferenceCitation: Bateman ED, Chapman KR, Singh D, D'Urzo AD, Molins E, Leselbaum A, Gil EG. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir Res. 2015 Aug 2;16:92. doi: 10.1186/s12931-015-0250-2.

ReferenceCitation: Singh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, Caracta C, Gil EG, Leselbaum A. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014 Nov 18;14:178. doi: 10.1186/1471-2466-14-178.

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
Romania
South Africa
Belgium
Poland
Austria
Russian Federation
Sweden
Slovakia
Hungary
Germany
Bulgaria
Denmark
Finland
Czech Republic
Korea, Republic of
France
Netherlands

location_facility:
Almirall Investigational Site #2
Almirall Investigational Site #26
Almirall Investigational Site #21
Almirall Investigational Site #17
Almirall Investigational Site #24
Almirall Investigational Site #33
Almirall Investigational Site #16
Almirall Investigational Site #22
Almirall Investigational Site #36
Almirall Investigational Site #14
Almirall Investigational Site #32
Almirall Investigational Site #4
Almirall Investigational Site #13
Almirall Investigational Site #7
Almirall Investigational Site #23
Almirall Investigational Site #28
Almirall Investigational Site #19
Almirall Investigational Site #11
Almirall Investigational Site #6
Almirall Investigational Site #8
Almirall Investigational Site #3
Almirall Investigational Site #9
Almirall Investigational Site #12
Almirall Investigational Site #10
Almirall Investigational Site #18
Almirall Investigational Site #5
Almirall Investigational Site #34
Almirall Investigational Site #35
Almirall Investigational Site #27
Almirall Investigational Site #20
Almirall Investigational Site #25
Almirall Investigational Site #1
Almirall Investigational Site #15


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients With Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly

acronym: JAKARTA

summary:
Primary Objective:

To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI).

Secondary Objectives:

To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.
To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
To evaluate the durability of splenic response.
To evaluate the safety of IMP.

ReferenceCitation: Pardanani A, Harrison C, Cortes JE, Cervantes F, Mesa RA, Milligan D, Masszi T, Mishchenko E, Jourdan E, Vannucchi AM, Drummond MW, Jurgutis M, Kuliczkowski K, Gheorghita E, Passamonti F, Neumann F, Patki A, Gao G, Tefferi A. Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2015 Aug;1(5):643-51. doi: 10.1001/jamaoncol.2015.1590.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Taiwan
Ireland
Korea, Republic of
France

location_facility:
Investigational Site Number 826003
Investigational Site Number 840006
Investigational Site Number 372002
Investigational Site Number 620005
Investigational Site Number 440001
Investigational Site Number 840012
Investigational Site Number 380003
Investigational Site Number 440002
Investigational Site Number 643010
Investigational Site Number 643007
Investigational Site Number 642003
Investigational Site Number 840013
Investigational Site Number 616005
Investigational Site Number 376002
Investigational Site Number 158002
Investigational Site Number 076004
Investigational Site Number 620004
Investigational Site Number 826001
Investigational Site Number 643009
Investigational Site Number 158001
Investigational Site Number 380007
Investigational Site Number 620003
Investigational Site Number 124001
Investigational Site Number 372001
Investigational Site Number 250007
Investigational Site Number 642001
Investigational Site Number 250004
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 250003
Investigational Site Number 826010
Investigational Site Number 616002
Investigational Site Number 410005
Investigational Site Number 826007
Investigational Site Number 840004
Investigational Site Number 826002
Investigational Site Number 376003
Investigational Site Number 348003
Investigational Site Number 276007
Investigational Site Number 642004
Investigational Site Number 076002
Investigational Site Number 484001
Investigational Site Number 826004
Investigational Site Number 752002
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 616010
Investigational Site Number 840001
Investigational Site Number 826006
Investigational Site Number 702001
Investigational Site Number 380006
Investigational Site Number 276008
Investigational Site Number 410001
Investigational Site Number 410006
Investigational Site Number 616003
Investigational Site Number 642002
Investigational Site Number 410004
Investigational Site Number 380004
Investigational Site Number 642006
Investigational Site Number 036003
Investigational Site Number 124003
Investigational Site Number 826008
Investigational Site Number 710003
Investigational Site Number 276006
Investigational Site Number 158003
Investigational Site Number 643008
Investigational Site Number 620001
Investigational Site Number 702002
Investigational Site Number 380002
Investigational Site Number 752001
Investigational Site Number 040001
Investigational Site Number 840008
Investigational Site Number 410002
Investigational Site Number 380001
Investigational Site Number 826005
Investigational Site Number 250002
Investigational Site Number 826009
Investigational Site Number 348002
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 036001
Investigational Site Number 643005
Investigational Site Number 840009
Investigational Site Number 348007
Investigational Site Number 616006
Investigational Site Number 348006
Investigational Site Number 724001
Investigational Site Number 036005
Investigational Site Number 643001
Investigational Site Number 710002
Investigational Site Number 643004
Investigational Site Number 410007
Investigational Site Number 056001
Investigational Site Number 348001
Investigational Site Number 410003
Investigational Site Number 056003
Investigational Site Number 036004
Investigational Site Number 076001
Investigational Site Number 036002


title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]

summary: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Rabe KF, Chalmers JD, Miravitlles M, Kocks JWH, Tsiligianni I, de la Hoz A, Xue W, Singh D, Ferguson GT, Wedzicha J. Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO(®) Trials. Adv Ther. 2021 Jan;38(1):579-593. doi: 10.1007/s12325-020-01528-2. Epub 2020 Nov 11.

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

ReferenceCitation: Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. No Influence on Cardiac Arrhythmia or Heart Rate from Long-Term Treatment with Tiotropium/Olodaterol versus Monocomponents by Holter ECG Analysis in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1945-1953. doi: 10.2147/COPD.S246350. eCollection 2020.

ReferenceCitation: Andreas S, McGarvey L, Bothner U, Trampisch M, de la Hoz A, Fležar M, Buhl R, Alter P. Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1935-1944. doi: 10.2147/COPD.S246348. eCollection 2020.

ReferenceCitation: Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(®)/DYNAGITO(®) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.

ReferenceCitation: Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.

ReferenceCitation: Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(®) and OTEMTO(®) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.

ReferenceCitation: Ferguson GT, Buhl R, Bothner U, Hoz A, Voß F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.

ReferenceCitation: Maltais F, Buhl R, Koch A, Amatto VC, Reid J, Grönke L, Bothner U, Voß F, McGarvey L, Ferguson GT. β-Blockers in COPD: A Cohort Study From the TONADO Research Program. Chest. 2018 Jun;153(6):1315-1325. doi: 10.1016/j.chest.2018.01.008. Epub 2018 Jan 31.

ReferenceCitation: Buhl R, Magder S, Bothner U, Tetzlaff K, Voß F, Loaiza L, Vogelmeier CF, McGarvey L. Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2017 Jan;122:58-66. doi: 10.1016/j.rmed.2016.11.011. Epub 2016 Nov 14.

ReferenceCitation: Ferguson GT, Fležar M, Korn S, Korducki L, Grönke L, Abrahams R, Buhl R. Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. Adv Ther. 2015 Jun;32(6):523-36. doi: 10.1007/s12325-015-0218-0. Epub 2015 Jun 26.

ReferenceCitation: Buhl R, Maltais F, Abrahams R, Bjermer L, Derom E, Ferguson G, Fležar M, Hébert J, McGarvey L, Pizzichini E, Reid J, Veale A, Grönke L, Hamilton A, Korducki L, Tetzlaff K, Waitere-Wijker S, Watz H, Bateman E. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015 Apr;45(4):969-79. doi: 10.1183/09031936.00136014. Epub 2015 Jan 8. Erratum in: Eur Respir J. 2015 Jun;45(6):1763.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Japan
Portugal
Slovenia
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Canada
Guatemala
Hungary
China
Germany
Bulgaria
Denmark
Estonia
New Zealand
Finland
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: 1237.5.90001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81036 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.52007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86015 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01012 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81024 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.52003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.52001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86017 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54013 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01036 Boehringer Ingelheim Investigational Site

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intervention_type: Device


title: A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression

acronym: OVERTURE

summary: To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Brazil
Romania
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
Czech Republic
Switzerland
Sweden
United States
France
Turkey
Norway
Belgium
Japan
Germany

location_facility:
Otsuka Investigational Site 2
Otsuka Investigational Site 1
Otsuka Investigational Site
Otsuka Investigational Sites
Otuska Investigational Site


acronym: LAIF

title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

lead_sponsor: Swedish Orphan Biovitrum

ReferenceCitation: Casper C, Hascoet JM, Ertl T, Gadzinowski JS, Carnielli V, Rigo J, Lapillonne A, Couce ML, Vågerö M, Palmgren I, Timdahl K, Hernell O. Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study. PLoS One. 2016 May 31;11(5):e0156071. doi: 10.1371/journal.pone.0156071. eCollection 2016.

ReferenceCitation: Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vågerö M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.

location_country:
Poland
Spain
Italy
Russian Federation
Czech Republic
Sweden
Hungary
France
Belgium
Germany

location_facility: Swedish Orphan Biovitrum Investigational Site

summary: The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.


title: A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

summary: The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

ReferenceType: background

ReferenceCitation: Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015 Sep;3(9):692-701. doi: 10.1016/S2213-2600(15)00197-6. Epub 2015 Jul 28.

ReferenceCitation: Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.

location_country:
Poland
Spain
United Kingdom
Russian Federation
Argentina
Czech Republic
Canada
Philippines
Korea, Republic of
United States
Chile
France
Mexico
Japan
Germany


title: A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)

acronym: CAP

summary: The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

lead_sponsor: Actelion

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

location_facility: Centre Hospitalier Universitaire Vaudoise

location_facility: Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum

location_facility: CHRU de Lille, hopital Claude Huriez, Service des maladies du sang

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul

location_facility: Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Université Libre de Bruxelles Hopital Erasme

location_facility: Hanusch Krankenhaus der Gebietskrankenkasse

location_facility: Universitätsklinik für Innere Medizin Wien


title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus

summary: This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

ReferenceCitation: Mancia G, Cannon CP, Tikkanen I, Zeller C, Ley L, Woerle HJ, Broedl UC, Johansen OE. Impact of Empagliflozin on Blood Pressure in Patients With Type 2 Diabetes Mellitus and Hypertension by Background Antihypertensive Medication. Hypertension. 2016 Dec;68(6):1355-1364. Epub 2016 Oct 10.

ReferenceCitation: Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.

ipd_sharing_description: Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html

location_country:
Denmark
Estonia
Lebanon
Canada
Czech Republic
Finland
Netherlands
Sweden
United States
France
Norway
Germany

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location_facility: 1245.48.31015 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10022 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10041 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31012 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10034 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10018 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35804 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35803 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10027 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35802 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37204 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10033 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37203 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10036 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35807 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37202 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10017 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35806 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10039 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10042 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31019 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31016 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10030 Boehringer Ingelheim Investigational Site


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease

summary: This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.

ReferenceCitation: von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhász E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7.

location_country:
Poland
Australia
Czech Republic
Hungary
United States
France
Germany


title: A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared With Docetaxel in 2nd Line Subjects With Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC Stage IV)

summary: This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.

ReferenceCitation: Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC)†. Ann Oncol. 2015 May;26(5):894-901. doi: 10.1093/annonc/mdv072. Epub 2015 Feb 26.

location_country:
Spain
Italy
Greece
Hungary
Korea, Republic of
United States
France
Netherlands


title: A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

summary: The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

location_country:
Spain
Italy
Austria
Australia
Finland
Argentina
Puerto Rico
United States
France
India
South Africa
Sweden

location_facility: Oregon Center For Clinical Investigations, Inc (Occi, Inc)

location_facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: Comprehensive Clinical Development, Inc.

location_facility: Dean Foundation For Health Research & Education

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)

location_facility: Independent Psychiatric Consultants, Sc, Dba, Ipc Research

location_facility: K & S Professional Research Services, Llc

location_facility: Neuropsychiatric Research Center Of Orange County

location_facility: Atlanta Institute Of Medicine & Research

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.


title: A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

acronym: Orion

summary: To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6). pii: 18m12680. doi: 10.4088/JCP.18m12680.

ipd_sharing: No

location_country:
Poland
Serbia
Russian Federation
Canada
Ukraine
Hungary
United States
France
Romania
Germany
Slovakia


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)

acronym: PERSEUS

summary: The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

lead_sponsor: EMD Serono

location_country:
Poland
Spain
Russian Federation
Australia
Netherlands
Canada
United States
France
South Africa
Belgium
Germany
Slovakia

location_facility: Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik

location_facility: Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary

location_facility: Hôpitaux Civils de Colmar-CH Louis Pasteur

location_facility: Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie

location_facility: Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie

location_facility: State Institution of Healthcare Ivanovo Regional Oncology Dispensary

intervention_type: Other


title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

acronym: FIXTURE

summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

ReferenceCitation: Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

ReferenceCitation: Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.

ReferenceCitation: Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17.

ReferenceCitation: Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. Epub 2016 Aug 30.

ReferenceCitation: Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. Epub 2016 Aug 30.

ReferenceCitation: Gottlieb AB, Langley RG, Philipp S, Sigurgeirsson B, Blauvelt A, Martin R, Papavassilis C, Mpofu S. Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials. J Drugs Dermatol. 2015 Aug;14(8):821-33.

ReferenceCitation: Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Philippines
Belgium
Iceland
Poland
Australia
Argentina
India
Singapore
Sweden
Egypt
Canada
Guatemala
Hungary
Germany
Finland
Korea, Republic of
France
Colombia


title: An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).

summary: The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.

location_country:
Poland
Spain
Finland
Argentina
Canada
United States
France
Belgium

location_facility:
Tennessee Oncology Pllc
Local Institution
John Theurer Cancer Center
Huntsman Cancer Institute


title: A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

ReferenceCitation: Agustí A, de Teresa L, De Backer W, Zvarich MT, Locantore N, Barnes N, Bourbeau J, Crim C. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014 Mar;43(3):763-72. doi: 10.1183/09031936.00054213. Epub 2013 Oct 10.

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:
Poland
Spain
Italy
Russian Federation
Ukraine
France
Belgium
Philippines
Germany