acronym: FLAURA

title: A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

lead_sponsor: AstraZeneca

type: Other Grant/Funding Number

ReferenceCitation: Walding A, Skaltsa K, Casamayor M, Rydén A. Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions. Qual Life Res. 2022 Aug;31(8):2535-2543. doi: 10.1007/s11136-022-03088-0. Epub 2022 Jan 31. Erratum in: Qual Life Res. 2022 Mar 24;:.

ReferenceCitation: Cheng Y, He Y, Li W, Zhang HL, Zhou Q, Wang B, Liu C, Walding A, Saggese M, Huang X, Fan M, Wang J, Ramalingam SS. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021 Mar;16(2):165-176. doi: 10.1007/s11523-021-00794-6. Epub 2021 Feb 5.

ReferenceCitation: Leighl NB, Karaseva N, Nakagawa K, Cho BC, Gray JE, Hovey T, Walding A, Rydén A, Novello S. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer. 2020 Jan;125:49-57. doi: 10.1016/j.ejca.2019.11.006. Epub 2019 Dec 12.

ReferenceCitation: Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, Zhou C, Reungwetwattana T, Cheng Y, Chewaskulyong B, Shah R, Cobo M, Lee KH, Cheema P, Tiseo M, John T, Lin MC, Imamura F, Kurata T, Todd A, Hodge R, Saggese M, Rukazenkov Y, Soria JC; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50. doi: 10.1056/NEJMoa1913662. Epub 2019 Nov 21.

ReferenceCitation: Brown H, Vansteenkiste J, Nakagawa K, Cobo M, John T, Barker C, Kohlmann A, Todd A, Saggese M, Chmielecki J, Markovets A, Scott M, Ramalingam SS. Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA. J Thorac Oncol. 2020 Jan;15(1):138-143. doi: 10.1016/j.jtho.2019.09.009. Epub 2019 Oct 9.

ReferenceCitation: Gray JE, Okamoto I, Sriuranpong V, Vansteenkiste J, Imamura F, Lee JS, Pang YK, Cobo M, Kasahara K, Cheng Y, Nogami N, Cho EK, Su WC, Zhang G, Huang X, Li-Sucholeiki X, Lentrichia B, Dearden S, Jenkins S, Saggese M, Rukazenkov Y, Ramalingam SS. Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Nov 15;25(22):6644-6652. doi: 10.1158/1078-0432.CCR-19-1126. Epub 2019 Aug 22.

ReferenceCitation: Planchard D, Boyer MJ, Lee JS, Dechaphunkul A, Cheema PK, Takahashi T, Gray JE, Tiseo M, Ramalingam SS, Todd A, McKeown A, Rukazenkov Y, Ohe Y. Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 1;25(7):2058-2063. doi: 10.1158/1078-0432.CCR-18-3325. Epub 2019 Jan 18.

ReferenceCitation: Ohe Y, Imamura F, Nogami N, Okamoto I, Kurata T, Kato T, Sugawara S, Ramalingam SS, Uchida H, Hodge R, Vowler SL, Walding A, Nakagawa K. Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset. Jpn J Clin Oncol. 2019 Jan 1;49(1):29-36. doi: 10.1093/jjco/hyy179.

ReferenceCitation: Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Philippines
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Israel
Turkey
Malaysia
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Thailand
Vietnam
Korea, Republic of
France

summary: To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer


type: EudraCT Number

title: A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic

summary: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
United States
Chile
France
Germany

location_facility: University of Pittsburgh Cancer Institute Cancer Services

location_facility: George Washington University Medical Center

location_facility: Urologische Gemeinschaftspraxis Dres Stammel U. Garcia

location_facility: Istituto Nazionale Tumori Fondazione Pascale

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

lead_sponsor: Hoffmann-La Roche

source: euctr

ReferenceType: derived

ReferenceCitation: Herrera AF, Tracy S, Croft B, Opat S, Ray J, Lovejoy AF, Musick L, Paulson JN, Sehn LH, Jiang Y. Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA. Blood Adv. 2022 Mar 22;6(6):1651-1660. doi: 10.1182/bloodadvances.2021006415.

ReferenceCitation: Sehn LH, Hertzberg M, Opat S, Herrera AF, Assouline S, Flowers CR, Kim TM, McMillan A, Ozcan M, Safar V, Salles G, Ku G, Hirata J, Chang YM, Musick L, Matasar MJ. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data. Blood Adv. 2022 Jan 25;6(2):533-543. doi: 10.1182/bloodadvances.2021005794.

ReferenceCitation: Betts KA, Thuresson PO, Felizzi F, Du EX, Dieye I, Li J, Schulz M, Masaquel AS. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma. J Comp Eff Res. 2020 Oct;9(14):1003-1015. doi: 10.2217/cer-2020-0057. Epub 2020 Oct 8. Erratum in: J Comp Eff Res. 2021 Mar;10(4):337.

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

ReferenceCitation: Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, Assouline S, Kim TM, Kim WS, Ozcan M, Hirata J, Penuel E, Paulson JN, Cheng J, Ku G, Matasar MJ. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172. Epub 2019 Nov 6.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Hungary
Korea, Republic of
United States
France
Turkey
Germany
Czechia

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abt. für Hämatologie und Onkologie

location_facility: I Interni klinika; Vseobecna fakultni nemocnice

location_facility: HELIOS Klinikum Erfurt - Innere Medizin - 4. Medizinische Klinik, Hämatologie

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: KINGS COLLEGE HOSPITAL; Commercial R&D Amendments, Kings Health Partners Clinical Trials Office

location_facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

location_facility: Monash Medical Centre; Haematology Research

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Fakultní nemocnice Ostrava Klinika hematoonkologie

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: Semmelweis University, First Dept of Medicine

location_facility: Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

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

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

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.


title: Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD

summary: This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.

ReferenceCitation: Kalberg C, O'Dell D, Galkin D, Newlands A, Fahy WA. Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Drugs R D. 2016 Jun;16(2):217-27. doi: 10.1007/s40268-016-0131-2.

ipd_sharing: Yes

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
Italy
Russian Federation
Estonia
Argentina
Hungary
France
Chile
Peru
Romania
Germany
Slovakia


status: Terminated

acronym: SPECTRI

intervention_type: Other

title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

ReferenceCitation: Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.

ReferenceCitation: Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Sweden
Slovakia
Switzerland
Hungary
Germany
Denmark
France
Netherlands

location_facility: Dokuz Eylul University Medical Faculty; Department of Ophthalmology

location_facility: Hospital Perpetuo Socorro; Servicio de Oftalmología

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"

location_facility: University of Michigan, Kellogg Eye Center

location_facility: Istanbul University Istanbul Medical Faculty; Department of Ophthalmology

location_facility: A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

location_facility: St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

location_facility: Radboud University Nijmegen Medical Centre; Ophthalmology

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Macular Treatment Centre; Royal Eye Hospital

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Hospital Universitario la Fe: Servicio de Oftalmologia

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB

location_facility: University of California, Davis, Eye Center

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Retina & Vitreous Center of Southern Oregon

location_facility: Inselspital Bern, Universitätsklinik für Augenheilkunde

location_facility: Instituto Mexicano de Oftalmologia I.A.P.

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

summary: This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

status_simplified: Unknown


acronym: CHROMA

ReferenceCitation: Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Mexico
Argentina
Canada
Netherlands
Switzerland
United Kingdom
Hungary
United States
France
Peru
Belgium
Germany
Slovakia

location_facility: University Health Network Toronto Western Hospital

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Academisch Medisch Centrum Universiteit Amsterdam

location_facility: Retina-Vitreous Associates Medical Group

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: University Retina and Macula Associates, PC

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Northwestern Medical Group/Northwestern University

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

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Uni of Alabama At Birmingham Clinical Research Unit

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Radboud University Nijmegen Medical Centre; Ophthalmology

location_facility: Instituto Clinico Quirurgico de Oftalmologia - ICQO

location_facility: Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde

location_facility: CLINICA RICARDO PALMA; Oftalmologos Contreras

location_facility: The Gavin Herbert Eye Institute - UC, Irvine

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Centre Odeon; Exploration Ophtalmologique

location_facility: Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica

location_facility: FISABIO. Fundación Oftalmologica del Mediterraneo

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde

location_facility: Eye Surgeons of Richmond Inc. dba Virginia Eye Institute


type: Other Identifier

title: A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS

summary: The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).

ReferenceCitation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, García-Gutiérrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brümmendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

ReferenceCitation: Hochhaus A, Gambacorti-Passerini C, Abboud C, Gjertsen BT, Brümmendorf TH, Smith BD, Ernst T, Giraldo-Castellano P, Olsson-Strömberg U, Saussele S, Bardy-Bouxin N, Viqueira A, Leip E, Russell-Smith TA, Leone J, Rosti G, Watts J, Giles FJ; BYOND Study Investigators. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study. Leukemia. 2020 Aug;34(8):2125-2137. doi: 10.1038/s41375-020-0915-9. Epub 2020 Jun 22.

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

lead_sponsor: Pfizer

location_country:
Spain
Italy
Austria
Sweden
United States
France
Norway
Germany

location_facility: Ordensklinikum Linz Gmbh Barmherzige Schwestern

location_facility: Washington University School of Medicine

location_facility: III. Medizinische Klinik Universitaetsmedizin Mannheim

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: AOU Policlinico Consorziale di Bari - UO Ematologia con Trapianto

location_facility: RWTH Uniklinik Aachen Klinik fur Onkologie, Hamatologie und Stammzelltransplantation

location_facility: Centre Regional De Lutte Contre Le Cancer

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: A.O. Ospedale Niguarda Ca Granda - SC Ematologia

location_facility: Azienda Socio Sanitaria Territoriale - ASST Monza

location_facility: Indiana Blood and Marrow Transplantation-Clinic

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: AOU San Luigi Gonzaga SCDU Medicina Interna II ad indirizzo Ematologico

location_facility: Centre Hospitalier de Versailles (CHV)-Hopital Andre Mignot Service d'Hematologie Clinique- Oncology

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

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)


title: A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma

summary: The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

ReferenceCitation: FitzGerald JM, O'Byrne PM, Bateman ED, Barnes PJ, Zheng J, Ivanov S, Lamarca R, Larsdotter U, Emerath U, Jansen G, Puu M, Alagappan VKT, Surmont F, Reddel HK. Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies. Drug Saf. 2021 Apr;44(4):467-478. doi: 10.1007/s40264-020-01041-z. Epub 2021 Feb 6.

ReferenceCitation: Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. doi: 10.1056/NEJMoa1715275.

ReferenceCitation: O'Byrne PM, FitzGerald JM, Zhong N, Bateman E, Barnes PJ, Keen C, Almqvist G, Pemberton K, Jorup C, Ivanov S, Reddel HK. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. Trials. 2017 Jan 10;18(1):12. doi: 10.1186/s13063-016-1731-4.

ReferenceCitation: Reddel HK, Busse WW, Pedersen S, Tan WC, Chen YZ, Jorup C, Lythgoe D, O'Byrne PM. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study. Lancet. 2017 Jan 14;389(10065):157-166. doi: 10.1016/S0140-6736(16)31399-X. Epub 2016 Nov 30.

location_country:
Saudi Arabia
Spain
Ukraine
Peru
Romania
South Africa
Philippines
Czechia
Poland
Russian Federation
Australia
Mexico
Sweden
Slovakia
Brazil
Hungary
Germany
Bulgaria
New Zealand
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia


title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following a Single Oral Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment

summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Grande E, Harvey RD, You B, Batlle JF, Galbraith H, Sarantopoulos J, Ramalingam SS, Mann H, So K, Johnson M, Vishwanathan K. Pharmacokinetic Study of Osimertinib in Cancer Patients with Mild or Moderate Hepatic Impairment. J Pharmacol Exp Ther. 2019 May;369(2):291-299. doi: 10.1124/jpet.118.255919. Epub 2019 Mar 14.

location_country:
Spain
United Kingdom
Korea, Republic of
United States
France
Belgium

intervention_type: Procedure


title: A Randomized, Double-blind, Placebo-controlled, Phase III, Multi-centre Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With IPSS Intermediate-1, Intermediate 2 and High-risk Myelodysplastic Syndromes (MDS) SUPPORT: A StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine

summary: Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

ReferenceCitation: Dickinson M, Cherif H, Fenaux P, Mittelman M, Verma A, Portella MSO, Burgess P, Ramos PM, Choi J, Platzbecker U; SUPPORT study investigators. Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia. Blood. 2018 Dec 20;132(25):2629-2638. doi: 10.1182/blood-2018-06-855221. Epub 2018 Oct 10.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United States
Peru
Belgium
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Ireland
Thailand
Korea, Republic of
France


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

summary:
The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms.

Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

lead_sponsor: Gilead Sciences

location_country:
Poland
United Kingdom
Italy
Australia
New Zealand
Korea, Republic of
United States
France
Israel
Belgium
Netherlands

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Hopital Saint Louis - Service de Pneumologie

location_facility: Southampton University Hospitals NHS Trust

location_facility: Universite Liebre de Bruxelles - Hopital Erasme


title: A Phase Ib/II Randomized Study of BI 836845 in Combination With Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women With Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Taiwan
Spain
Ireland
Austria
United Kingdom
Sweden
Korea, Republic of
France
Belgium
Netherlands

location_facility: Charleroi - HOSP Grand Hôpital de Charleroi

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: CHU UCL Namur - Site De Sainte-Elisabeth

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

summary: Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer


title: A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

summary: The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

lead_sponsor: Incyte Corporation

location_country:
Spain
United Kingdom
Australia
Korea, Democratic People's Republic of
United States
Israel
France
Germany


ipd_sharing: No

acronym: VIABLE

intervention_type: Biological

title: A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

lead_sponsor: SOTIO a.s.

ReferenceCitation: Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.

ReferenceCitation: Vogelzang NJ, Beer TM, Gerritsen W, Oudard S, Wiechno P, Kukielka-Budny B, Samal V, Hajek J, Feyerabend S, Khoo V, Stenzl A, Csöszi T, Filipovic Z, Goncalves F, Prokhorov A, Cheung E, Hussain A, Sousa N, Bahl A, Hussain S, Fricke H, Kadlecova P, Scheiner T, Korolkiewicz RP, Bartunkova J, Spisek R; VIABLE Investigators. Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):546-552. doi: 10.1001/jamaoncol.2021.7298.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Czechia
Poland
Portugal
Austria
Sweden
Slovakia
Hungary
Germany
Bulgaria
Denmark
Belarus
Latvia
France
Netherlands

location_facility: Universitatsklinikum fur Urologie und Andrologie

location_facility: University Hospital Center Sisters of Charity

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Azienda Ospedialiera Universitaria Senese

location_facility: Urology Department St. Elizabeth Ziekenhuis

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria

location_facility: Specialized Hospital for Active treatment in Oncology

location_facility: Praxigemeinschaft fur Onkologie und Urologie

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E

location_facility: Cancer Care Associates St. Luke's University and Health Network

location_facility: St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust

location_facility: Eastern CT Hematology and Oncololgy Associates

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: New Jersey Hematology Oncology Associates

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: N.N. Alexandrov National Research Center

location_facility: UT Health, Internal Medicine, Division of Oncology

location_facility: Comprehensive Cancer Research Centers of Nevada

location_facility: Cliniques Universitaires Saint Luc- Urologie

location_facility: Oncology Institute of Hope and Innovation

location_facility: Winship Cancer Institute of Emory University

location_facility: Hospital Universitario Príncipe de Asturias

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: Paula Stradina Kliniska Universitates slimnica

location_facility: Klinika onkologie a radioterapie, Fakultni nemocnice

location_facility: Univ. of Miami, Sylvester Comprehensive Cancer Center

location_facility: Multifunctional Hospital for Active Treatment Serdika

location_facility: University of Kansas Cancer Center & Medical Pavilion

location_facility: Lithuanian University of Health Science Oncology Institute

location_facility: West Virginia University Mary Babb Randolph Cancer Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Northern Centre for Cancer Care, Freeman Hospital

location_facility: Urologicka ambulancia Uroexam, spol. s r.o.

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Desert Hematology Oncology Medical Group

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Urologic Consultants of Southeastern Pennsylvania

location_facility: Specialized Hospital for Active Treatment of Oncology Diseases

location_facility: California Cancer Associates for Research and Excellence

location_facility: Premier Urology Associates, LLC / AdvanceMed Research

location_facility: Clinique d'Oncologie Medicale Institut Jules Bordet

summary: The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.


primary_purpose: Prevention

title: A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

lead_sponsor: CSL Behring

ReferenceCitation: Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.

ReferenceCitation: Michael Gibson C, Korjian S, Tricoci P, Daaboul Y, Yee M, Jain P, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea DM, Deckelbaum LI, Merkely B, Zarebinski M, Ophuis TO, Harrington RA. Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I). Circulation. 2016 Dec 13;134(24):1918-1930. Epub 2016 Nov 15.

ReferenceCitation: Gibson CM, Korjian S, Tricoci P, Daaboul Y, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea D, Merkely B, Zarebinski M, Ophius TO, Harrington RA. Rationale and design of Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I): A phase 2b, randomized, placebo-controlled, dose-ranging trial to investigate the safety and tolerability of CSL112, a reconstituted, infusible, human apoA-I, after acute myocardial infarction. Am Heart J. 2016 Oct;180:22-8. doi: 10.1016/j.ahj.2016.06.017. Epub 2016 Jul 5.

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Hungary
United States
France
Israel
Germany
Bulgaria
Czechia

location_facility:
Study Site - 23007
Study Site 16234
Study Site 16213
Study Site 15004
Study Site 16147
Study Site 16102
Study Site 16100
Study Site 16179
Study Site - 23012
Study Site - 23013
Study Site 17009
Study Site 16144
Study Site 18002
Study Site 21006
Study Site 16047
Study Site - 25002
Study Site 12004
Study Site 21010
Study Site 21001
Study Site 16135
Study Site 12007
Study Site 17014
Study Site 14010
Study Site 12001
Study Site 16201
Study Site - 16168
Study Site - 23004
Study Site 18003
Study Site 19003
Study Site 18006
Study Site - 24004
Study Site 12021
Study Site 12011
Study Site 14007
Study Site 17003
Study Site 17005
Study Site 24005
Study Site - 22014
Study Site 16168
Study Site - 13003
Study Site 21009
Study Site - 23011
Study Site 16018
Study Site - 13014
Study Site 16038
Study Site 19004
Study Site - 13010
Study Site 12002
Study Site 18008
Study Site 16014
Study Site 17002
Study Site 20003
Study Site 19002
Study Site 20009
Study Site 14016
Study Site 16078
Study Site 16033
Study Site 18001
Study Site 19007
Study Site - 25001
Study Site 10002
Study Site 10005
Study Site 20002
Study Site 19008
Study Site - 23010
Study Site - 23005
Study Site - 24010
Study Site 16028
Study Site 12009
Study Site - 23009
Study Site 16003
Study Site 16166
Study Site 16039
Study Site 17011
Study Site - 24009
Study Site 19010
Study Site 21013
Study Site - 22010
Study Site 20007
Study Site 21014
Study Site 18005
Study Site - 13019
Study Site 16004
Study Site 16062
Study Site 21004
Study Site 17001
Study Site 16025
Study Site 16088
Study Site 12014
Study Site - 25004
Study Site - 22007
Study Site 17007
Study Site 12017
Study Site - 13007
Study Site 12019
Study Site 20011
Study Site 19006
Study Site 18009
Study Site - 24003
Study Site 16061
Study Site 14001
Study Site 14008
Study Site 12006
Study Site 15002
Study Site 14006
Study Site 14014
Study Site - 22006
Study Site 22009
Study Site 16024
Study Site 16031
Study Site 16208
Study Site 17006
Study Site 21015
Study Site - 23003
Study Site 19005
Study Site 16202
Study Site 16063
Study Site - 13012
Study Site 16056
Study Site 14017
Study Site 15001
Study Site 16170
Study Site 16060
Study Site 14009
Study Site 12018
Study Site 11001
Study Site 17012
Study Site - 22005
Study Site - 23002
Study Site 14003
Study Site 21003
Study Site 12008
Study Site 11004
Study Site 14012
Study Site 16016
Study Site 12012
Study Site - 23006
Study Site 14004
Study Site 20008
Study Site 20012
Study Site 12010
Study Site 12005
Study Site 17010
Study Site 21008
Study Site - 25003
Study Site - 13002
Study Site 14005
Study Site - 22013
Study Site 16022
Study Site 16017
Study Site - 23001
Study Site 16026
Study Site - 22008
Study Site 12016
Study Site 16241
Study Site 16211
Study Site - 22016
Study Site - 25005
Study Site 20006
Study Site 16015
Study Site 11002
Study Site - 22015
Study Site 20001
Study Site - 24006
Study Site - 22012
Study Site 10012
Study Site 15005
Study Site - 25008
Study Site - 13017
Study Site 16148
Study Site 21016
Study Site 21011
Study Site 16079
Study Site 10007
Study Site 15003
Study Site 16112
Study Site 14015
Study Site 16099
Study Site 10006
Study Site - 13008
Study Site 16101
Study Site 14002
Study Site 18007
Study Site 12013
Study Site 19009
Study Site 16130
Study Site 14011
Study Site 12003
Study Site 16174

summary: This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).


acronym: Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

lead_sponsor: Aradigm Corporation

ReferenceCitation: Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4). pii: 2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct.

ReferenceCitation: Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A, O'Donnell AE. Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials. Lancet Respir Med. 2019 Mar;7(3):213-226. doi: 10.1016/S2213-2600(18)30427-2. Epub 2019 Jan 15. Erratum in: Lancet Respir Med. 2019 Jan 25;:.

location_country:
Poland
Spain
Italy
Georgia
Australia
New Zealand
Canada
United Kingdom
Former Serbia and Montenegro
Hungary
Korea, Republic of
United States
France
Israel
Peru
Romania

summary: This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy (ZONDA)

summary: The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils.

ReferenceType: background

ReferenceCitation: Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 Jun 22;376(25):2448-2458. doi: 10.1056/NEJMoa1703501. Epub 2017 May 22.

ReferenceCitation: Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.

ReferenceCitation: Menzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3). pii: 00009-2019. doi: 10.1183/23120541.00009-2019. eCollection 2019 Jul.

ReferenceCitation: Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.

location_country:
Poland
Spain
Argentina
Canada
Ukraine
Korea, Republic of
United States
Chile
France
Turkey
Germany
Bulgaria


title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome

acronym: TELECAST

summary: The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

ReferenceCitation: Srirajaskanthan R, Pavel M, Kulke M, Clement D, Houchard A, Keeber L, Weickert MO. Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST. Clin Ther. 2021 Oct;43(10):1779-1785. doi: 10.1016/j.clinthera.2021.08.014. Epub 2021 Sep 28.

ReferenceCitation: Dillon JS, Kulke MH, Hörsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.

ReferenceCitation: Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Hörsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322. doi: 10.1530/ERC-17-0455. Epub 2018 Jan 12.

lead_sponsor: Lexicon Pharmaceuticals

location_country:
Spain
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
Israel
Belgium
Germany

location_facility:
Lexicon Investigative Site
Lexicon Investigational Site


title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)

summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.

ReferenceCitation: Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.

ReferenceCitation: Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.

ReferenceCitation: Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, Menter A, Philipp S, Sofen H, Tyring S, Berner BR, Visvanathan S, Pamulapati C, Bennett N, Flack M, Scholl P, Padula SJ. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.

location_country:
Finland
Canada
Sweden
United States
France
Norway
Germany

location_facility: 1311.2.35801 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10012 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.47001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10006 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.46001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10011 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10010 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10007 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.35802 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.47002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10009 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33006 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10013 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20005 Boehringer Ingelheim Investigational Site


title: Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations

summary:
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts:

Dose escalation portion to determine the MTD and/ or RP2D of futibatinib.
Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer, gastric cancer.
Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Bahleda R, Meric-Bernstam F, Goyal L, Tran B, He Y, Yamamiya I, Benhadji KA, Matos I, Arkenau HT. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Ann Oncol. 2020 Oct;31(10):1405-1412. doi: 10.1016/j.annonc.2020.06.018. Epub 2020 Jul 2.

lead_sponsor: Taiho Oncology, Inc.

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Korea, Republic of
United States
France
Japan
Germany

location_facility: University of Pittsburgh Medical Center Hillman Cancer Center

location_facility: Hospital Clinic i Provincial de Barcelona,

location_facility: Greenville Health System ITOR,Clinical Research Unit

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Wisconsin Clinical Science Center

location_facility: UOC Oncologia Medica 1 I"V - Istituto Oncologico Veneto - IRCCS

location_facility: Yonsei University, Severance Hospital (Seoul)

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: University Hospital Essen, West German Cancer Center, Department of Medical Oncology

location_facility: University of Utah, Huntsman Cancer Hospital

location_facility: Mary Crowley Cancer Research - Medical City

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Wayne State Universtity (Karmanos Cancer Institute)

location_facility: Kyoto University Hospital, Department of Clinical Pharmacology and Therapeutics

location_facility: Sidney Kimmel Cancer Center at Jefferson

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: Cancer Treatment Centers of America Zion, IL

location_facility: Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay

status_simplified: Ongoing


acronym: CheckMate 026: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 026

title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

ReferenceCitation: Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Argentina
Turkey
Mexico
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: University Of North Carolina At Chapel Hill

location_facility: New York University Clinical Cancer Center

location_facility: University Of Texas Southwestern Medical Center

summary: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy


type: Registry Identifier

title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC).

summary: This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study designed to is to determine if the combination treatment can improve progression free survival (defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first) when compared with placebo + paclitaxel.

ReferenceCitation: Owonikoko TK, Niu H, Nackaerts K, Csoszi T, Ostoros G, Mark Z, Baik C, Joy AA, Chouaid C, Jaime JC, Kolek V, Majem M, Roubec J, Santos ES, Chiang AC, Speranza G, Belani CP, Chiappori A, Patel MR, Czebe K, Byers L, Bahamon B, Li C, Sheldon-Waniga E, Kong EF, Williams M, Badola S, Shin H, Bedford L, Ecsedy JA, Bryant M, Jones S, Simmons J, Leonard EJ, Ullmann CD, Spigel DR; C14018 study investigators. Randomized Phase II Study of Paclitaxel plus Alisertib versus Paclitaxel plus Placebo as Second-Line Therapy for SCLC: Primary and Correlative Biomarker Analyses. J Thorac Oncol. 2020 Feb;15(2):274-287. doi: 10.1016/j.jtho.2019.10.013. Epub 2019 Oct 23.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Poland
Spain
Italy
Canada
Hungary
France
United States
Belgium
Germany
Czechia


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-1

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Poland
Spain
Greece
Italy
Estonia
Mexico
Canada
Czech Republic
Russian Federation
Switzerland
United Kingdom
Hungary
United States
France
Belgium
Bulgaria
Slovakia

summary: The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.


acronym: Dolomites

title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

lead_sponsor: Astellas Pharma Europe B.V.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8:CD013751. doi: 10.1002/14651858.CD013751.pub2. Review.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Croatia
Serbia
Spain
United Kingdom
Ukraine
Romania
Czechia
Montenegro
Poland
Portugal
Slovenia
Austria
Russian Federation
Israel
Slovakia
Hungary
North Macedonia
Germany
Bulgaria
Belarus
Ireland
Georgia
Latvia
Finland
France
Netherlands

location_facility:
Site UA38007
Site GE99504
Site PL48059
Site CZ42018
Site RO40004
Site UA38016
Site GE99503
Site BG35907
Site DE49057
Site UA38011
Site UA38018
Site RU70060
Site HU36029
Site BG35916
Site BY37501
Site FR33007
Site RU70011
Site GB44097
Site CZ42021
Site HU36027
Site IE35301
Site DE49073
Site FR33004
Site GB44064
Site ES34049
Site RS38103
Site GB44098
Site LV37104
Site RU70004
Site PT35132
Site MK38903
Site RU70024
Site ES34026
Site HR38504
Site PL48066
Site HR38505
Site GB44080
Site AT43009
Site PL48004
Site FR33010
Site DE49054
Site SK42116
Site SI38609
Site PL48007
Site RS38117
Site UA38017
Site GB44081
Site PT35133
Site DE49065
Site PT35131
Site CZ42008
Site ES34054
Site DE49075
Site BY37503
Site GB44102
Site GE99502
Site ME38201
Site RO40012
Site FR33062
Site IL97215
Site RU70002
Site PL48013
Site GB44006
Site GB44001
Site RU70047
Site PT35119
Site ES34010
Site UA38021
Site PT35122
Site NL31005
Site SI38619
Site SI38615
Site UA38006
Site HR38510
Site BY37502
Site PT35120
Site RO40003
Site HR38502
Site RU70003
Site ME38202
Site UA38009
Site RS38104
Site GB44086
Site GB44101
Site SI38603
Site PL48009
Site HU36008
Site PT35112
Site PL48001
Site RS38101
Site GB44082
Site RU70054
Site ES34039
Site SK42102
Site RU70014
Site BG35927
Site HU36028
Site FI35810
Site SK42109
Site MK38901
Site GB44099
Site FR33012
Site PT35118
Site UA38008
Site RS38105
Site HR38509
Site RU70001
Site RO40021
Site ES34030
Site ES34037
Site GB44100
Site UA38001
Site ES34041
Site IL97202
Site RS38102
Site SK42113
Site FR33009
Site BY37505
Site RU70006
Site BY37506
Site BY37507
Site HU36046
Site ES34017
Site LV37101
Site RU70057

summary: The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.


title: A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

summary: To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

ReferenceType: result

ReferenceCitation: Piña-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.

lead_sponsor: UCB Pharma

location_country:
Poland
Brazil
Romania
United Kingdom
Italy
Russian Federation
Mexico
Canada
Czech Republic
Hungary
United States
France
India
South Africa
Belgium
Germany


title: A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis

summary: Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

lead_sponsor: Shire

location_country:
Spain
United Kingdom
United States
Peru
Romania
Belgium
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
India
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
New Zealand
Korea, Republic of
France
Chile
Netherlands

location_facility: Hallyam University, Sacred Heart Hospital

location_facility: Gastroenterologische Praxis Prof. Hackelsberger

location_facility: Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)

location_facility: Hospital Nacional Guillermo Alemnara Irigoyen

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Sree Gokulam Medical Centre & Research Foundation

location_facility: Universidade Federal da Bahia - Hospital

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Central de Especialidades Medicas (FIDEPAZ)

location_facility: Institute of Gastronenterology & Hepatology

location_facility: Addenbrookes Hospital Department of Gastroenterology

location_facility: Center for Digestive and Liver Diseases, Inc

location_facility: Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia

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

location_facility: Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán

location_facility: Octavian Fodor Clinical Emergency Hospital

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Hospital Italiano de Mendoza, FINAMED SA

location_facility: Heilig Hart ziekenhuis vzw Roeselare-Menen


title: A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.

summary: This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.

status: Withdrawn

primary_purpose: Diagnostic

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium
Germany


title: PHASE 1/2 STUDY OF PF-06463922 (AN ALK/ROS1 TYROSINE KINASE INHIBITOR) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS

summary: Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .

ReferenceCitation: Soo RA, Huat Tan E, Hayashi H, Seto T, Lin CC, Ou SI, Kim DW, Liu G, Abbattista A, Martini JF, Hooi Wong C, Toffalorio F, Solomon BJ. Efficacy and safety of lorlatinib in Asian and non-Asian patients with ALK-positive advanced non-small cell lung cancer: Subgroup analysis of a global phase 2 trial. Lung Cancer. 2022 Jul;169:67-76. doi: 10.1016/j.lungcan.2022.05.012. Epub 2022 May 23.

ReferenceCitation: Ou SI, Solomon BJ, Shaw AT, Gadgeel SM, Besse B, Soo RA, Abbattista A, Toffalorio F, Wiltshire R, Bearz A. Continuation of Lorlatinib in ALK-Positive NSCLC Beyond Progressive Disease. J Thorac Oncol. 2022 Apr;17(4):568-577. doi: 10.1016/j.jtho.2021.12.011. Epub 2022 Jan 10.

ReferenceCitation: Chen J, Ruiz-Garcia A, James LP, Peltz G, Thurm H, Clancy J, Hibma J. Lorlatinib Exposure-Response Analyses for Safety and Efficacy in a Phase I/II Trial to Support Benefit-Risk Assessment in Non-Small Cell Lung Cancer. Clin Pharmacol Ther. 2021 Nov;110(5):1273-1281. doi: 10.1002/cpt.2228. Epub 2021 Jun 26.

ReferenceCitation: Chen J, O'Gorman MT, James LP, Klamerus KJ, Mugundu G, Pithavala YK. Pharmacokinetics of Lorlatinib After Single and Multiple Dosing in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: Results from a Global Phase I/II Study. Clin Pharmacokinet. 2021 Oct;60(10):1313-1324. doi: 10.1007/s40262-021-01015-z. Epub 2021 May 3.

ReferenceCitation: Peters S, Shaw AT, Besse B, Felip E, Solomon BJ, Soo RA, Bearz A, Gadgeel SM, Lin CC, Kao S, Seto T, Masters ET, Abbattista A, Clancy JS, Thurm H, Reisman A, Peltz G, Ross Camidge D. Impact of lorlatinib on patient-reported outcomes in patients with advanced ALK-positive or ROS1-positive non-small cell lung cancer. Lung Cancer. 2020 Jun;144:10-19. doi: 10.1016/j.lungcan.2020.02.011. Epub 2020 Mar 10.

ReferenceCitation: Bauer TM, Shaw AT, Johnson ML, Navarro A, Gainor JF, Thurm H, Pithavala YK, Abbattista A, Peltz G, Felip E. Brain Penetration of Lorlatinib: Cumulative Incidences of CNS and Non-CNS Progression with Lorlatinib in Patients with Previously Treated ALK-Positive Non-Small-Cell Lung Cancer. Target Oncol. 2020 Feb;15(1):55-65. doi: 10.1007/s11523-020-00702-4.

ReferenceCitation: Shaw AT, Solomon BJ, Chiari R, Riely GJ, Besse B, Soo RA, Kao S, Lin CC, Bauer TM, Clancy JS, Thurm H, Martini JF, Peltz G, Abbattista A, Li S, Ou SI. Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2019 Dec;20(12):1691-1701. doi: 10.1016/S1470-2045(19)30655-2. Epub 2019 Oct 25.

ReferenceCitation: Solomon BJ, Besse B, Bauer TM, Felip E, Soo RA, Camidge DR, Chiari R, Bearz A, Lin CC, Gadgeel SM, Riely GJ, Tan EH, Seto T, James LP, Clancy JS, Abbattista A, Martini JF, Chen J, Peltz G, Thurm H, Ou SI, Shaw AT. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018 Dec;19(12):1654-1667. doi: 10.1016/S1470-2045(18)30649-1. Epub 2018 Nov 6. Erratum in: Lancet Oncol. 2019 Jan;20(1):e10.

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

ReferenceCitation: Shaw AT, Friboulet L, Leshchiner I, Gainor JF, Bergqvist S, Brooun A, Burke BJ, Deng YL, Liu W, Dardaei L, Frias RL, Schultz KR, Logan J, James LP, Smeal T, Timofeevski S, Katayama R, Iafrate AJ, Le L, McTigue M, Getz G, Johnson TW, Engelman JA. Resensitization to Crizotinib by the Lorlatinib ALK Resistance Mutation L1198F. N Engl J Med. 2016 Jan 7;374(1):54-61. doi: 10.1056/NEJMoa1508887. Epub 2015 Dec 23.

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

location_facility: Washington University School of Medicine

location_facility: Rockefeller Patient Pavilion - Memorial Sloan Kettering

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: Hospital Universitari de la Vall D'Hebron Edificio General. Planta Baja. UITM. Servicio de Oncologia

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Sarah Cannon Research Institute (Pharmacy)

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: CHU de Rennes - Hôpital Pontchaillou - CIC Inserm

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Institut Gustave Roussy- Pharmacie-Unite Essais Cliniques

location_facility: Institut Gustave Roussy (comite poumon-pneumologie)

location_facility: National University Hospital Medical Centre

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

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Unita di Farmacologia Clinica e Nuovi Farmaci

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT-O)

location_facility: Washington University Infusion Center Pharmacy


title: Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

summary: This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United Kingdom
Canada
United States
France
Germany

location_facility: St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis

location_facility: Northwestern Center for Clinical Research

location_facility: Midwest Orthopedics at Rush University Medical Center

location_facility: Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department

location_facility: Centre Hospitalier Lyon-Sud, Service de Rhumatologie

location_facility: Southampton General Hospital, MRC Environmental Epidemiology Unit

location_facility: Maidstone General Hospital & Tunbridge Wells NHS Trust

location_facility: Arthritis & Osteoporosis Center of Maryland

location_facility: CHU Hôpital Trousseau Service de Rhumatologie

location_facility: Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research

location_facility: Orthopedic Center for Joint Replacement and Sports

intervention_type: Device


title: Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

lead_sponsor: Pfizer

location_country:
Denmark
Australia
Canada
United States
France
South Africa
Iceland
Norway
Sweden


title: Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507

summary: The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.

study_type: Observational

time_perspective: Prospective

lead_sponsor: MedImmune LLC

location_country:
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Washington University, Dermatology Clinical Trials Unit

location_facility: Hospital Saint-Louis Service de Dermatologie 1

location_facility: Hospital Haut Leveque CHU Sud -Service de Dermatologie

location_facility: Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt

location_facility: Atlanta Dermatology, Vein & Research Center, LLC

location_facility: Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)

location_facility: Capital District Health Authority, QE II Health Sciences Center


title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares

summary: The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

ReferenceCitation: Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.

ReferenceCitation: Bandyopadhyay S, Connolly SE, Jabado O, Ye J, Kelly S, Maldonado MA, Westhovens R, Nash P, Merrill JT, Townsend RM. Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial. Lupus Sci Med. 2017 Jul 28;4(1):e000206. doi: 10.1136/lupus-2017-000206. eCollection 2017.

ReferenceCitation: Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, Bae SC, Sigal L, Becker JC, Kelly S, Raghupathi K, Li T, Peng Y, Kinaszczuk M, Nash P. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Oct;62(10):3077-87. doi: 10.1002/art.27601.

lead_sponsor: Bristol-Myers Squibb

location_country:
Taiwan
Brazil
United Kingdom
Italy
Austria
Australia
Mexico
Canada
Korea, Republic of
United States
France
Puerto Rico
South Africa
Belgium
Germany

location_facility: Kentuckiana Center For Better Bone And Joint Health


title: A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures

summary: The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

ReferenceCitation: Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.

ReferenceCitation: Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.

ReferenceCitation: Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Spain
Ukraine
United States
Belgium
South Africa
Poland
Russian Federation
Australia
Argentina
India
Israel
Mexico
Norway
Canada
Hungary
Taiwan
New Zealand
Finland
Thailand
Korea, Republic of
France
Chile
Netherlands


title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

summary: The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

ReferenceCitation: Jones RL, Herzog TJ, Patel SR, von Mehren M, Schuetze SM, Van Tine BA, Coleman RL, Knoblauch R, Triantos S, Hu P, Shalaby W, McGowan T, Monk BJ, Demetri GD. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med. 2021 Jun;10(11):3565-3574. doi: 10.1002/cam4.3903. Epub 2021 May 7.

ReferenceCitation: Krasner CN, Poveda A, Herzog TJ, Vermorken JB, Kaye SB, Nieto A, Claret PL, Park YC, Parekh T, Monk BJ. Patient-reported outcomes in relapsed ovarian cancer: results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone. Gynecol Oncol. 2012 Oct;127(1):161-7. doi: 10.1016/j.ygyno.2012.06.034. Epub 2012 Jul 2.

ReferenceCitation: Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Park YC, Parekh TV, Poveda AM. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: overall survival analysis. Eur J Cancer. 2012 Oct;48(15):2361-8. doi: 10.1016/j.ejca.2012.04.001. Epub 2012 Apr 26.

location_country:
Poland
Taiwan
Brazil
Hong Kong
Spain
United Kingdom
Russian Federation
Australia
Netherlands
Argentina
Canada
Sweden
Korea, Republic of
United States
Chile
China
France
Belgium
Singapore
Germany


title: A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer

summary: This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.

ReferenceCitation: Boussen H, Cristofanilli M, Zaks T, DeSilvio M, Salazar V, Spector N. Phase II study to evaluate the efficacy and safety of neoadjuvant lapatinib plus paclitaxel in patients with inflammatory breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3248-55. doi: 10.1200/JCO.2009.21.8594. Epub 2010 Jun 7.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
United Kingdom
Australia
New Zealand
Canada
Tunisia
United States
Israel
France


title: Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

summary:
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

ReferenceCitation: Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13.

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Brazil
Spain
Russian Federation
Argentina
United States
France
South Africa
Turkey
Romania
Philippines
Bulgaria


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

summary: A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
Spain
Italy
United Kingdom
United States
Peru
South Africa
Philippines
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
India
Canada
Hungary
Germany
Taiwan
New Zealand
Finland
Thailand
Korea, Republic of
France
Netherlands
Pakistan


title: A Randomized, Two-Cohort Phase II Study of Two Doses of BMS-275183 Given on a Weekly Schedule in Patients With Pre-Treated Non-Small Cell Lung Cancer

summary: The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this treatment will also be studied.

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium
Netherlands

location_facility:
Local Insitution
Local Institution


title: A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

summary: This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
United Kingdom
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
Switzerland
Guatemala
Hungary
Puerto Rico
United States
Chile
France
Panama
Belgium
Germany


title: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

summary: The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

status: Approved for marketing

study_type: Expanded Access

ReferenceCitation: Reichardt P, Kang YK, Rutkowski P, Schuette J, Rosen LS, Seddon B, Yalcin S, Gelderblom H, Williams CC Jr, Fumagalli E, Biasco G, Hurwitz HI, Kaiser PE, Fly K, Matczak E, Chen L, Lechuga MJ, Demetri GD. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405-13. doi: 10.1002/cncr.29220. Epub 2015 Jan 13. Erratum in: Cancer. 2019 Mar 1;125(5):821.

ReferenceCitation: Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. doi: 10.1093/annonc/mdq696. Epub 2011 Feb 2.

location_country:
Spain
Italy
United Kingdom
Venezuela
United States
Belgium
Poland
Hong Kong
Austria
Australia
Argentina
India
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands


title: Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

summary: The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.

ReferenceCitation: Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC β inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.

lead_sponsor: Chromaderm, Inc.

location_country:
Denmark
Poland
Taiwan
Brazil
Portugal
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
United States
France
India
Mexico
Germany

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


title: Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

summary: BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

ReferenceCitation: Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, Singer JW. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470-2045(12)70212-7. Epub 2012 May 30. Erratum in: Lancet Oncol. 2012 Jul;13(7):e285.

lead_sponsor: CTI BioPharma

location_country:
Poland
Romania
United Kingdom
Italy
Russian Federation
Estonia
Argentina
Ecuador
Ukraine
Hungary
Uruguay
United States
Costa Rica
France
India
Mexico
Panama
Germany
Peru
Bulgaria

location_facility: Klinika Hematologii, Onkologii i Chorob Wewnetrznych

location_facility: Research Insitute of Hematology and Blood Transfusion

location_facility: Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy

location_facility: Azienda Ospedaliera Pisanan "Santana Chiara"

location_facility: Tartu University Clinics, Hematology Oncology Clinic

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS

location_facility: State Medical Institution Altai Territorial Oncological Center

location_facility: Ospedale Oncolgoico Regionale della Basilicata

location_facility: Hopitaux Universitaires de Strabourg - Hopital de Hautepierre

location_facility: Policlinico S. Orsola, Instituto di Ematologia

location_facility: State Institution: Hematological Research Center under the Russian Academy of Medical Sciences

location_facility: Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal

location_facility: Zhtomyr O.F. Gerbachevsky Regional Hospital

location_facility: University General Hospital for Active Treatment "St. Marina" Clinic of Hematology

location_facility: Bhagwan Mahaveer Cancer Hospital & Research Center

location_facility: Institutul Oncologic "Ion Chiricuta" Oncologie Medicala

location_facility: St. Petersburg State Medical Institution: Municipal Hospital #31

location_facility: State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center

location_facility: State Research Institution: Research Institute of Oncology

location_facility: Beatson Oncology Centre, Western Infirmary

location_facility: Watson Clinic for Cancer Care and Research

location_facility: State Institution: Moscow Regional Research Clinical institute n.a. M.F.

location_facility: University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology

location_facility: Indo-American Cancer Institute & Research Center

location_facility: St. Petersburg State Medical univ. n.a. I.P. Pavlov

location_facility: Universitatklinik des Saarlandes, Innere Medzin I

location_facility: FUNDALEU - fundacion para combatir le Leucernia

location_facility: Complejo Hospitalario "Arnulfo Arias Madrid

location_facility: Institute of Blood Pathology & Transfusion Medicine under the UAMS

location_facility: Central Research Rontgenological and Radiological Institute

location_facility: Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie

location_facility: St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II

location_facility: Azienda ospedaliera Pisana "Santa Chiara"

location_facility: State Medical Institution: Clinical Oncological Center

location_facility: Medical Radiological Research Center under the Russian academey of Medical Sciences

location_facility: State Medical Institution Replubican Oncological Center

location_facility: Universita degli Studi Perugia Policlinico Monteluce


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

summary: A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.

ReferenceCitation: Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
United States
France
Singapore
Belgium
Netherlands