title: GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

summary:
After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

ReferenceType: background

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ReferenceCitation: Ono M, Hara H, Kawashima H, Gao C, Wang R, Wykrzykowska JJ, Piek JJ, Garg S, Hamm C, Steg PG, Valgimigli M, Windecker S, Vranckx P, Onuma Y, Serruys PW. Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial. EuroIntervention. 2022 Aug 5;18(5):e377-e388. doi: 10.4244/EIJ-D-21-00870.

ReferenceCitation: Gragnano F, Zwahlen M, Vranckx P, Heg D, Schmidlin K, Hamm C, Steg PG, Gargiulo G, McFadden EP, Onuma Y, Chichareon P, Benit E, Möllmann H, Janssens L, Leonardi S, Zurakowski A, Arrivi A, Van Geuns RJ, Huber K, Slagboom T, Calabrò P, Serruys PW, Jüni P, Valgimigli M, Windecker S; GLOBAL LEADERS Investigators [Link]. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2022 May 17;11(10):e024291. doi: 10.1161/JAHA.121.024291. Epub 2022 Mar 1.

ReferenceCitation: Westra J, Eftekhari A, Renkens M, Mejía-Rentería H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH. Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up. Int J Cardiovasc Imaging. 2022 Jan 18. doi: 10.1007/s10554-022-02522-1. [Epub ahead of print]

ReferenceCitation: Vranckx P, Valgimigli M, Odutayo A, Serruys PW, Hamm C, Steg PG, Heg D, Mc Fadden EP, Onuma Y, Benit E, Janssens L, Diletti R, Ferrario M, Huber K, Räber L, Windecker S, Jüni P; GLOBAL LEADERS Investigators. Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.

ReferenceCitation: Gao C, Tomaniak M, Takahashi K, Kawashima H, Wang R, Hara H, Ono M, Montalescot G, Garg S, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, van Geuns RJ, Hamm C, Steg PG, Onuma Y, Angiolillo DJ, Serruys PW. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial. Cardiovasc Diabetol. 2020 Oct 16;19(1):179. doi: 10.1186/s12933-020-01153-x.

ReferenceCitation: Kawashima H, Tomaniak M, Ono M, Wang R, Hara H, Gao C, Takahashi K, Sharif F, Thury A, Suryapranata H, Walsh S, Cotton J, Carrie D, Sabate M, Steinwender C, Leibundgut G, Wykrzykowska J, de Winter RJ, Garg S, Hamm C, Steg PG, Jüni P, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW. Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS). Am J Cardiol. 2021 Jan 1;138:1-10. doi: 10.1016/j.amjcard.2020.09.057. Epub 2020 Oct 13.

ReferenceCitation: Gao C, Takahashi K, Garg S, Hara H, Wang R, Kawashima H, Ono M, Montalescot G, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, Hamm C, Steg PG, Storey R, van Geuns RJ, Tao L, Onuma Y, Serruys PW. Regional variation in patients and outcomes in the GLOBAL LEADERS trial. Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.

ReferenceCitation: Hara H, Takahashi K, Kogame N, Tomaniak M, Kerkmeijer LSM, Ono M, Kawashima H, Wang R, Gao C, Wykrzykowska JJ, de Winter RJ, Neumann FJ, Plante S, Lemos Neto PA, Garg S, Jüni P, Vranckx P, Windecker S, Valgimigli M, Hamm C, Steg PG, Onuma Y, Serruys PW. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2020 Sep;13(9):e009177. doi: 10.1161/CIRCINTERVENTIONS.120.009177. Epub 2020 Aug 25.

ReferenceCitation: Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Jüni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, Serruys PW; GLOBAL LEADERS Trial Investigators. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. Circ Cardiovasc Qual Outcomes. 2020 Aug;13(8):e006660. doi: 10.1161/CIRCOUTCOMES.120.006660. Epub 2020 Jul 30.

ReferenceCitation: Ono M, Chichareon P, Tomaniak M, Kawashima H, Takahashi K, Kogame N, Modolo R, Hara H, Gao C, Wang R, Walsh S, Suryapranata H, da Silva PC, Cotton J, Koning R, Akin I, Rensing BJWM, Garg S, Wykrzykowska JJ, Piek JJ, Jüni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial. Clin Res Cardiol. 2020 Sep;109(9):1125-1139. doi: 10.1007/s00392-020-01604-1. Epub 2020 Jan 31.

ReferenceCitation: Tomaniak M, Chichareon P, Klimczak-Tomaniak D, Takahashi K, Kogame N, Modolo R, Wang R, Ono M, Hara H, Gao C, Kawashima H, Rademaker-Havinga T, Garg S, Curzen N, Haude M, Kochman J, Gori T, Montalescot G, Angiolillo DJ, Capodanno D, Storey RF, Hamm C, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW, Anderson R. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clin Res Cardiol. 2020 Jul;109(7):930-943. doi: 10.1007/s00392-019-01586-9. Epub 2020 Jan 10.

ReferenceCitation: Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernández Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, Serruys PW; GLOBAL LEADERS Study Investigators. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):222-230. doi: 10.1093/ehjcvp/pvz052.

ReferenceCitation: Tomaniak M, Chichareon P, Modolo R, Takahashi K, Chang CC, Kogame N, Spitzer E, Buszman PE, van Geuns RM, Valkov V, Steinwender C, Geisler T, Prokopczuk J, Sabaté M, Zmudka K, Rademaker-Havinga T, Tijssen JGP, Jüni P, Hamm C, Steg PG, Onuma Y, Vranckx P, Valgimigli M, Windecker S, Baber U, Anderson R, Dominici M, Serruys PW. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial. EuroIntervention. 2020 Apr 3;15(18):e1605-e1614. doi: 10.4244/EIJ-D-19-00699.

ReferenceCitation: Chichareon P, Modolo R, Kerkmeijer L, Tomaniak M, Kogame N, Takahashi K, Chang CC, Komiyama H, Moccetti T, Talwar S, Colombo A, Maillard L, Barlis P, Wykrzykowska J, Piek JJ, Garg S, Hamm C, Steg PG, Jüni P, Valgimigli M, Windecker S, Onuma Y, Mehran R, Serruys PW. Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):21-29. doi: 10.1001/jamacardio.2019.4296.

ReferenceCitation: Takahashi K, Serruys PW, Chichareon P, Chang CC, Tomaniak M, Modolo R, Kogame N, Magro M, Chowdhary S, Eitel I, Zweiker R, Ong P, Ottesen MM, Tijssen JGP, Wykrzykowska JJ, de Winter RJ, Garg S, Stoll HP, Hamm C, Steg PG, Onuma Y, Valgimigli M, Vranckx P, Carrie D, Windecker S. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI. J Am Coll Cardiol. 2019 Oct 22;74(16):2015-2027. doi: 10.1016/j.jacc.2019.08.997.

ReferenceCitation: Tomaniak M, Chichareon P, Onuma Y, Deliargyris EN, Takahashi K, Kogame N, Modolo R, Chang CC, Rademaker-Havinga T, Storey RF, Dangas GD, Bhatt DL, Angiolillo DJ, Hamm C, Valgimigli M, Windecker S, Steg PG, Vranckx P, Serruys PW; GLOBAL LEADERS Trial Investigators. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial. JAMA Cardiol. 2019 Nov 1;4(11):1092-1101. doi: 10.1001/jamacardio.2019.3355.

ReferenceCitation: Serruys PW, Tomaniak M, Chichareon P, Modolo R, Kogame N, Takahashi K, Chang CC, Spitzer E, Walsh SJ, Adlam D, Hildick-Smith D, Édes I, van de Harst P, Krackhardt F, Tijssen JGP, Rademaker-Havinga T, Garg S, Steg PG, Hamm C, Jüni P, Vranckx P, Onuma Y, Verheugt FWA. Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial. EuroIntervention. 2019 Dec 20;15(12):e1090-e1098. doi: 10.4244/EIJ-D-19-00202.

ReferenceCitation: Leonardi S, Franzone A, Piccolo R, McFadden E, Vranckx P, Serruys P, Benit E, Liebetrau C, Janssens L, Ferrario M, Zurakowski A, van Geuns RJ, Dominici M, Huber K, Slagboom T, Buszman P, Bolognese L, Tumscitz C, Bryniarski K, Aminian A, Vrolix M, Petrov I, Garg S, Naber C, Prokopczuk J, Hamm C, Steg G, Heg D, Juni P, Windecker S, Valgimigli M. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). BMJ Open. 2019 Mar 9;9(3):e026053. doi: 10.1136/bmjopen-2018-026053.

lead_sponsor: ECRI bv

location_country:
Denmark
Poland
Brazil
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
Hungary
France
Singapore
Belgium
Germany
Bulgaria

location_facility: Research centre Villingen - Schwenningen, 4919


status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment

study_completion_date_type: Actual

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Léna H, Popat S, Ahn JS, Dansin E, Mitry E, Müller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14.

ReferenceCitation: Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.

ReferenceCitation: Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. Epub 2016 Oct 31. Erratum in: J Clin Oncol. 2017 May 10;35(14):1631.

enrollment_type: Actual

location_country:
Denmark
Taiwan
Luxembourg
Spain
Italy
Russian Federation
Australia
Netherlands
United Kingdom
Sweden
Korea, Republic of
United States
France
Singapore
Belgium
Germany

location_facility: National University Hospital; Investigational Medicine Unit

location_facility: Hospital Regional Universitario de Malaga

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

location_facility: Midwestern Regional Medical Center; Office of Research

location_facility: Maastricht University Medical Centre; Afdeling Klinische Farmacie en Toxicologie

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement

location_facility: Hôpital Nord - AP-HM Marseille#; Gastroenterology and Hepatology

location_facility: CHU de Grenoble - Hôpital Nord; Service d'Oncologie Thoracique

location_facility: Seoul National University Bundang Hospital

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Charité Campus Virchow-Klinikum; Department of Cardiology

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: Severance Hospital, Yonsei University Health System; Pharmacy

location_facility: Royal Marsden Hospital;Dept of Haematology Oncology Research

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: Columbia University Medical Center; Department of Hematology/Oncology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: University Hospitals Case Medical Center

location_facility: UCLA Cancer Center; Premiere Oncology, A Medical Corporation

location_facility: Washington University; Wash Uni. Sch. Of Med

summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.

lead_sponsor_type: industriel

status_simplified: Completed


title: A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

summary: This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

design_allocation: Randomized

ReferenceCitation: Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.

lead_sponsor: Boehringer Ingelheim

location_country:
Serbia
Spain
United Kingdom
United States
Peru
Philippines
Russian Federation
Turkey
Mexico
Malaysia
Egypt
Brazil
Lebanon
Canada
Guatemala
Germany
Taiwan
Czech Republic
Thailand
Korea, Republic of
France

location_facility: 1276.1.10041 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44004 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.82009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10016 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20010 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.63003 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.95002 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.96004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63006 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.95001 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.55003 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.49002 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.44006 Boehringer Ingelheim Investigational Site

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location_facility: 1276.1.44005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10014 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34034 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34048 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10042 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10036 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34051 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10025 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10034 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10028 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10033 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70015 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10044 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34027 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.60003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70016 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10024 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10045 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10035 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49014 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70018 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10027 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51003 Boehringer Ingelheim Investigational Site


acronym: STRATUS

title: A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

lead_sponsor: Celgene

ReferenceCitation: Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Röllig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.

ReferenceCitation: Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.

ReferenceCitation: Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.

ReferenceCitation: Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. Epub 2016 Jun 7.

location_country:
Denmark
Poland
Portugal
Spain
Greece
Austria
Estonia
Ireland
Finland
Italy
Netherlands
Switzerland
Sweden
France
Turkey
United Kingdom
Belgium
Norway
Germany
Slovakia

location_facility: Abt Haematologie - Onkologie / Allg. Krankenhaus Altona

location_facility: Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette

location_facility: Belfast City Hospital Haematology Department

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: University Hospital Bratislava - Hospital Ss Cyril and Methodius

location_facility: Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Service Hemato-Immunologie Hopital St Louis

location_facility: Hospital Geral de Santo António - Serviço de Hematologia Clínica

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Universitatsklinik MuensterMedizinische Klinik A

location_facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

location_facility: Hospital Clinico Universitario De Santiago De Compostela

location_facility: Cork University HospitalHaematology Consultant

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I

location_facility: Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii

location_facility: Charite, Campus Benjamin Franklin Universitatsmedizin Berlin

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Oslo University Hospital, Rikshospitalet HF

summary:
The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.

In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.

The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.


title: High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)

summary:
This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified > 12 months at diagnosis).

The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®).

In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned.

Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted.

Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.

After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour.

Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour.

The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed.

The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Ladenstein R, Valteau-Couanet D, Brock P, Yaniv I, Castel V, Laureys G, Malis J, Papadakis V, Lacerda A, Ruud E, Kogner P, Garami M, Balwierz W, Schroeder H, Beck-Popovic M, Schreier G, Machin D, Pötschger U, Pearson A. Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study. J Clin Oncol. 2010 Jul 20;28(21):3516-24. doi: 10.1200/JCO.2009.27.3524. Epub 2010 Jun 21.

ReferenceCitation: Ladenstein R, Pötschger U, Pearson ADJ, Brock P, Luksch R, Castel V, Yaniv I, Papadakis V, Laureys G, Malis J, Balwierz W, Ruud E, Kogner P, Schroeder H, de Lacerda AF, Beck-Popovic M, Bician P, Garami M, Trahair T, Canete A, Ambros PF, Holmes K, Gaze M, Schreier G, Garaventa A, Vassal G, Michon J, Valteau-Couanet D; SIOP Europe Neuroblastoma Group (SIOPEN). Busulfan and melphalan versus carboplatin, etoposide, and melphalan as high-dose chemotherapy for high-risk neuroblastoma (HR-NBL1/SIOPEN): an international, randomised, multi-arm, open-label, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):500-514. doi: 10.1016/S1470-2045(17)30070-0. Epub 2017 Mar 2.

ReferenceCitation: Ladenstein R, Pötschger U, Valteau-Couanet D, Luksch R, Castel V, Yaniv I, Laureys G, Brock P, Michon JM, Owens C, Trahair T, Chan GCF, Ruud E, Schroeder H, Beck Popovic M, Schreier G, Loibner H, Ambros P, Holmes K, Castellani MR, Gaze MN, Garaventa A, Pearson ADJ, Lode HN. Interleukin 2 with anti-GD2 antibody ch14.18/CHO (dinutuximab beta) in patients with high-risk neuroblastoma (HR-NBL1/SIOPEN): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Dec;19(12):1617-1629. doi: 10.1016/S1470-2045(18)30578-3. Epub 2018 Nov 12.

ReferenceCitation: Morgenstern DA, Pötschger U, Moreno L, Papadakis V, Owens C, Ash S, Pasqualini C, Luksch R, Garaventa A, Canete A, Elliot M, Wieczorek A, Laureys G, Kogner P, Malis J, Ruud E, Beck-Popovic M, Schleiermacher G, Valteau-Couanet D, Ladenstein R. Risk stratification of high-risk metastatic neuroblastoma: A report from the HR-NBL-1/SIOPEN study. Pediatr Blood Cancer. 2018 Nov;65(11):e27363. doi: 10.1002/pbc.27363. Epub 2018 Jul 17.

ReferenceCitation: Berbegall AP, Bogen D, Pötschger U, Beiske K, Bown N, Combaret V, Defferrari R, Jeison M, Mazzocco K, Varesio L, Vicha A, Ash S, Castel V, Coze C, Ladenstein R, Owens C, Papadakis V, Ruud E, Amann G, Sementa AR, Navarro S, Ambros PF, Noguera R, Ambros IM. Heterogeneous MYCN amplification in neuroblastoma: a SIOP Europe Neuroblastoma Study. Br J Cancer. 2018 May;118(11):1502-1512. doi: 10.1038/s41416-018-0098-6. Epub 2018 May 14.

ReferenceCitation: Mueller I, Ehlert K, Endres S, Pill L, Siebert N, Kietz S, Brock P, Garaventa A, Valteau-Couanet D, Janzek E, Hosten N, Zinke A, Barthlen W, Varol E, Loibner H, Ladenstein R, Lode HN. Tolerability, response and outcome of high-risk neuroblastoma patients treated with long-term infusion of anti-GD(2) antibody ch14.18/CHO. MAbs. 2018 Jan;10(1):55-61. doi: 10.1080/19420862.2017.1402997. Epub 2017 Dec 5.

ReferenceCitation: Ladenstein R, Pötschger U, Valteau-Couanet D, Luksch R, Castel V, Ash S, Laureys G, Brock P, Michon JM, Owens C, Trahair T, Chi Fung Chan G, Ruud E, Schroeder H, Beck-Popovic M, Schreier G, Loibner H, Ambros P, Holmes K, Castellani MR, Gaze MN, Garaventa A, Pearson ADJ, Lode HN. Investigation of the Role of Dinutuximab Beta-Based Immunotherapy in the SIOPEN High-Risk Neuroblastoma 1 Trial (HR-NBL1). Cancers (Basel). 2020 Jan 28;12(2). pii: E309. doi: 10.3390/cancers12020309.

ReferenceCitation: Bellini A, Pötschger U, Bernard V, Lapouble E, Baulande S, Ambros PF, Auger N, Beiske K, Bernkopf M, Betts DR, Bhalshankar J, Bown N, de Preter K, Clément N, Combaret V, Font de Mora J, George SL, Jiménez I, Jeison M, Marques B, Martinsson T, Mazzocco K, Morini M, Mühlethaler-Mottet A, Noguera R, Pierron G, Rossing M, Taschner-Mandl S, Van Roy N, Vicha A, Chesler L, Balwierz W, Castel V, Elliott M, Kogner P, Laureys G, Luksch R, Malis J, Popovic-Beck M, Ash S, Delattre O, Valteau-Couanet D, Tweddle DA, Ladenstein R, Schleiermacher G. Frequency and Prognostic Impact of ALK Amplifications and Mutations in the European Neuroblastoma Study Group (SIOPEN) High-Risk Neuroblastoma Trial (HR-NBL1). J Clin Oncol. 2021 Oct 20;39(30):3377-3390. doi: 10.1200/JCO.21.00086. Epub 2021 Jun 11.

ReferenceCitation: Holmes K, Potschger U, Pearson ADJ, Sarnacki S, Cecchetto G, Gomez-Chacon J, Squire R, Freud E, Bysiek A, Matthyssens LE, Metzelder M, Monclair T, Stenman J, Rygl M, Rasmussen L, Joseph JM, Irtan S, Avanzini S, Godzinski J, Bjornland K, Elliott M, Luksch R, Castel V, Ash S, Balwierz W, Laureys G, Ruud E, Papadakis V, Malis J, Owens C, Schroeder H, Beck-Popovic M, Trahair T, Forjaz de Lacerda A, Ambros PF, Gaze MN, McHugh K, Valteau-Couanet D, Ladenstein RL; International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN). Influence of Surgical Excision on the Survival of Patients With Stage 4 High-Risk Neuroblastoma: A Report From the HR-NBL1/SIOPEN Study. J Clin Oncol. 2020 Sep 1;38(25):2902-2915. doi: 10.1200/JCO.19.03117. Epub 2020 Jul 8.

ReferenceCitation: Viprey VF, Gregory WM, Corrias MV, Tchirkov A, Swerts K, Vicha A, Dallorso S, Brock P, Luksch R, Valteau-Couanet D, Papadakis V, Laureys G, Pearson AD, Ladenstein R, Burchill SA. Neuroblastoma mRNAs predict outcome in children with stage 4 neuroblastoma: a European HR-NBL1/SIOPEN study. J Clin Oncol. 2014 Apr 1;32(10):1074-83. doi: 10.1200/JCO.2013.53.3604. Epub 2014 Mar 3.

lead_sponsor: St. Anna Kinderkrebsforschung

location_country:
Denmark
Poland
Portugal
Slovenia
Greece
Austria
Australia
Ireland
Italy
Spain
Switzerland
United Kingdom
Hungary
France
Israel
Belgium
Norway
Sweden
Slovakia
Czechia

location_facility: Edinburgh Royal Hospital for Sick Children

location_facility: Glasgow Royal Hospital for Sick Children

location_facility: Azienda Ospedaliera Universitaria di Parma-Oncoematologia Pediatrica

location_facility: Clinica di Oncoematologia Pediatrica Padova

location_facility: Univ.Klinik f. Kinder-u. Jugendheilkunde Innsbruck

location_facility: Schneider Children's Medical Center of Israel

location_facility: Children's University Hospital in Lublin

location_facility: Sec. Univ. degli Studi di Napoli - Policlinico

location_facility: Aberdeen: Royal Aberdeen Children's Hospital

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Univ.-Klinik für Kinder- und Jugendheilkunde Graz

location_facility: Liverpool: Alder Hey Children's Hospital

location_facility: Istituto per l'Infanzia "Burlo Garofolo"

location_facility: Upper Silesian Centre of Child and Mother's Care

location_facility: University Children's Hospital Ljubljana

status_simplified: Ongoing


title: A Multicenter, Open Label, Randomized Phase II Trial of the MEK Inhibitor Pimasertib or Dacarbazine in Previously Untreated Subjects With N-Ras Mutated Locally Advanced or Metastatic Malignant Cutaneous Melanoma

summary: This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.

ReferenceCitation: Lebbé C, Dutriaux C, Lesimple T, Kruit W, Kerger J, Thomas L, Guillot B, Braud F, Garbe C, Grob JJ, Loquai C, Ferraresi V, Robert C, Vasey P, Conry R, Isaacs R, Espinosa E, Schueler A, Massimini G, Dréno B. Pimasertib Versus Dacarbazine in Patients With Unresectable NRAS-Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover. Cancers (Basel). 2020 Jun 29;12(7). pii: E1727. doi: 10.3390/cancers12071727.

lead_sponsor: EMD Serono

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
New Zealand
Switzerland
Sweden
United States
France
Israel
South Africa
Belgium
Germany

location_facility: Please contact the US Medical Information in


acronym: coBRIM

title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

ReferenceCitation: Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Oct 30. doi: 10.1007/s40264-022-01248-2. [Epub ahead of print]

ReferenceCitation: Ascierto PA, Dréno B, Larkin J, Ribas A, Liszkay G, Maio M, Mandalà M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Atkinson V, Dutriaux C, Garbe C, Hsu J, Jones S, Li H, McKenna E, Voulgari A, McArthur GA. 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study. Clin Cancer Res. 2021 Oct 1;27(19):5225-5235. doi: 10.1158/1078-0432.CCR-21-0809.

ReferenceCitation: Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dréno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib ± cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

ReferenceCitation: de la Cruz-Merino L, Di Guardo L, Grob JJ, Venosa A, Larkin J, McArthur GA, Ribas A, Ascierto PA, Evans JTR, Gomez-Escobar A, Barteselli G, Eng S, Hsu JJ, Uyei A, Dréno B. Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study. J Transl Med. 2017 Jun 24;15(1):146. doi: 10.1186/s12967-017-1246-0.

ReferenceCitation: Dréno B, Ribas A, Larkin J, Ascierto PA, Hauschild A, Thomas L, Grob JJ, Koralek DO, Rooney I, Hsu JJ, McKenna EF, McArthur GA. Incidence, course, and management of toxicities associated with cobimetinib in combination with vemurafenib in the coBRIM study. Ann Oncol. 2017 May 1;28(5):1137-1144. doi: 10.1093/annonc/mdx040.

ReferenceCitation: Ascierto PA, McArthur GA, Dréno B, Atkinson V, Liszkay G, Di Giacomo AM, Mandalà M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Yan Y, Wongchenko M, Chang I, Hsu JJ, Koralek DO, Rooney I, Ribas A, Larkin J. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016 Sep;17(9):1248-60. doi: 10.1016/S1470-2045(16)30122-X. Epub 2016 Jul 30.

ReferenceCitation: Larkin J, Ascierto PA, Dréno B, Atkinson V, Liszkay G, Maio M, Mandalà M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Sovak MA, Chang I, Choong N, Hack SP, McArthur GA, Ribas A. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014 Nov 13;371(20):1867-76. doi: 10.1056/NEJMoa1408868. Epub 2014 Sep 29.

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
New Zealand
Russian Federation
Switzerland
Sweden
Hungary
United States
France
Israel
United Kingdom
Belgium
Norway
Germany
Czechia

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: London Health Sciences Centre · Victoria Hospital;Department of Pediatrics

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology

location_facility: Centre Hospitalier Universitaire de Grenoble - Albert Michallon

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Institut Jules Bordet; Department of Medical Oncology

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: FSBSI "N. N. Blokhin Russian Cancer Research Center"

location_facility: BC Cancer Agency Vancouver Island Cancer Centre

location_facility: Rabin Medical Center-Beilinson Campus;Hematology-Oncology

location_facility: Uni of Kansas Medical Center; Dept of Neurology

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: Hospital General Universitario de Valencia

location_facility: University of California Davis Health System

location_facility: McGill University Health Centre/Glen Site / Royal Victoria Hospital

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Klinikum der Ludwigs-Maximilians-Universitaet Muenchen

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: TSBHI Altai Territorial oncological dispensary

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Rhode Island Hospital; Investigational Services

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

location_facility: Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Lismore Base Hospital; Cancer Care & Haematology Unit

location_facility: Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: The Ottawa Hospital Cancer Center; General Campus

location_facility: Dartmouth-Hitchcock Medical Center; Department of Medicine

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Northwestern Center For Clinical Research

location_facility: U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

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

location_facility: Peter MacCallum Cancer Centre-East Melbourne

summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.


title: A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy

acronym: BEYOND

summary: The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

ipd_sharing: Yes

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

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Spain
Armenia
Italy
United Kingdom
Lithuania
Ukraine
Kazakhstan
Belgium
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Turkey
Norway
Sweden
Slovakia
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Belarus
Greece
Georgia
Ireland
Latvia
Finland
France
Netherlands


title: An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary: The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

ReferenceCitation: Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019 Jan;7(1):60-68. doi: 10.1016/S2213-2600(18)30339-4. Epub 2018 Sep 14.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Portugal
Russian Federation
Australia
India
Israel
Turkey
Mexico
Canada
China
Germany
Greece
Ireland
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: General Hospital of Shenyang Military Region

location_facility: Kobe City Medical Center General Hospital

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Saitama Cardiovascular and Respiratory Center

location_facility: General Hospital of Ningxia Medical University

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

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: University Hospital of Heraklion, University Pulmonology Cl

location_facility: Center Hospital of the National Center for Global Health and Medicine

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

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Mehta Hospital & Cardiopulmonary Care Centre

location_facility: Scientific Research Institute of Pulmonology

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Xiangya Hospital, Central South University

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: National Allergy Asthma Bronchitis Institute, Kolkata

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

location_facility: Athens Hospital of Chest Diseases "Sotiria"

location_facility: National Hospital Organization Himeji Medical Center


title: A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.

summary: Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

status: Active, not recruiting

ReferenceCitation: Garcia-Manero G, Almeida A, Giagounidis A, Platzbecker U, Garcia R, Voso MT, Larsen SR, Valcarcel D, Silverman LR, Skikne B, Santini V. Design and rationale of the QUAZAR Lower-Risk MDS (AZA-MDS-003) trial: a randomized phase 3 study of CC-486 (oral azacitidine) plus best supportive care vs placebo plus best supportive care in patients with IPSS lower-risk myelodysplastic syndromes and poor prognosis due to red blood cell transfusion-dependent anemia and thrombocytopenia. BMC Hematol. 2016 May 3;16:12. doi: 10.1186/s12878-016-0049-5. eCollection 2016.

ReferenceCitation: Garcia-Manero G, Santini V, Almeida A, Platzbecker U, Jonasova A, Silverman LR, Falantes J, Reda G, Buccisano F, Fenaux P, Buckstein R, Diez Campelo M, Larsen S, Valcarcel D, Vyas P, Giai V, Olíva EN, Shortt J, Niederwieser D, Mittelman M, Fianchi L, La Torre I, Zhong J, Laille E, Lopes de Menezes D, Skikne B, Beach CL, Giagounidis A. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes. J Clin Oncol. 2021 May 1;39(13):1426-1436. doi: 10.1200/JCO.20.02619. Epub 2021 Mar 25.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Australia
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Germany
Denmark
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: Baskent University Medical Faculty Adana Practice and Research Center

location_facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

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

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

location_facility: Princess Margaret Hospital University Health Network

location_facility: Uniwersytet Jagiellonski Collegium Medicum

location_facility: Robert H Lurie Comprehensive Cancer Center NW Univ

location_facility: Nottingham City Hospital - Dept of Haematology

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: AUSL LE1 - Vito Fazzii Hospital Medical Oncology Department

location_facility: University Hospitals of Cleveland Case Medical Center

location_facility: Haematoloy and Oncology Clinics of Australia

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Txagorritxu - Hospital Universitario de Álava

location_facility: Hospital Angeles Lomas - Consultorio 830

location_facility: Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

location_facility: U.O. Ematologia. Ospedale Oncologico di Riferimento Regionale Armando Businco

location_facility: Opsedale Maggiore Policlinico and University

location_facility: Tower Hematology/Oncology Medical Group and Tower Cancer Research Found

location_facility: ULSBA (Unidade Local de Saúde do Baixo Alentejo, EPE) - Hospital de Beja

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Az. Osp. SS.Antonio e Biagio - SC Ematologia

location_facility: Hospital Universitario "Dr. Jose E. Gonzalez"

location_facility: Institute Paoli-Calmettes Service Haematology

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: Queens Centre for Oncology & Haematology

location_facility: Royal Prince Alfred Hospital, Sydney Cancer Centre

location_facility: Royal Liverpool University Hospital, Prescot Street

location_facility: Hematology and Oncology Specialists, LLC

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Attikon General University Hospital of Athens

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Specjalistyczny Szpital Miejski im. M. Kopernika w Toruniu

location_facility: VA Commonwealth University Massey Cancer Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Complejo Hospitalario Universitario de Granada

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Seoul St Marys Hospital College of Medicine The Catholic University of Korea

location_facility: Icahn School of Medicine at Mount Sinai Medical Center

location_facility: SU/Sahlgrenska, Section of Haematology and Coagulation

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: University of Louisville, J.G. Brown Cancer Center

location_facility: McGill University, Dept. Oncology Clinical Research Program

location_facility: Oslo University Hospital, Rikshospitalet HF

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Azienda Ospedaliera San Giovanni Battista

location_facility: University General Hospital of Heraklion

location_facility: Phoebe Cancer Center of Phoebe Putney Memorial Hospital

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: University of Alberta Hospital Adult Hematology Research

location_facility: University of Southern California Norris Cancer Center

intervention_type: Other


title: A Phase II, Multi-center, Randomised, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Lauriad® 50 μg and 100 μg Mucoadhesive Buccal Tablet (MBT) Applied Once Daily to Those of Placebo in the Prevention and Treatment of Chemoradiation Therapy Induced Oral Mucositis in Patients With Head and Neck Cancer

lead_sponsor: Onxeo

location_country:
Spain
Switzerland
Hungary
United States
France
Germany

location_facility: Washington University School of medecine

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: California Cancer Associates for Researche and Excellence

location_facility: Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.

location_facility: Carolinas Medical Center- Carolinas Health Care System

location_facility: University of Oklahoma Health Sciences Center

location_facility: Universitatsklinikum Freiburg Klinik fur Strahlentherapie

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

summary: The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.


acronym: LUX-Head & Neck 1

title: A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy

ReferenceCitation: Cohen EEW, Licitra LF, Burtness B, Fayette J, Gauler T, Clement PM, Grau JJ, Del Campo JM, Mailliez A, Haddad RI, Vermorken JB, Tahara M, Guigay J, Geoffrois L, Merlano MC, Dupuis N, Krämer N, Cong XJ, Gibson N, Solca F, Ehrnrooth E, Machiels JH. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer. Ann Oncol. 2017 Oct 1;28(10):2526-2532. doi: 10.1093/annonc/mdx344.

ReferenceCitation: Clement PM, Gauler T, Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Cohen EE, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Vermorken JB; LUX-H&N 1 investigators. Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial. Ann Oncol. 2016 Aug;27(8):1585-93. doi: 10.1093/annonc/mdw151. Epub 2016 Apr 15.

ReferenceCitation: Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Vermorken JB, Clement PM, Gauler T, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Cohen EE; LUX-H&N 1 investigators. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):583-94. doi: 10.1016/S1470-2045(15)70124-5. Epub 2015 Apr 16.

location_country:
Denmark
Brazil
Spain
Greece
Austria
Italy
Mexico
Argentina
Russian Federation
Switzerland
Sweden
United States
France
Israel
South Africa
Belgium
Japan
Germany
Czechia

location_facility: 1200.43.08105 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.97203 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08110 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03903 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02701 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03301 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03204 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00703 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00110 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04907 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04906 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08106 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00704 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04902 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03910 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03406 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03005 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03901 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04101 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00103 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04305 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03905 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00705 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02704 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03309 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04901 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03403 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05503 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02702 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03401 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05507 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03312 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03907 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08113 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05506 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03909 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04301 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04203 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03004 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03202 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05504 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08103 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.97201 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00113 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03316 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03201 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05502 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03310 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00107 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03305 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03908 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03307 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03405 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03002 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03902 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08102 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00102 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03203 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03304 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08104 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03314 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03404 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08107 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.97204 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00710 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05402 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04501 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00106 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08108 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03306 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00707 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04602 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00709 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04102 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08112 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04904 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03317 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03904 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03906 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08114 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08109 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04903 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00105 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04909 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05505 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04905 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03303 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05501 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05202 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05403 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04908 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08111 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04202 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03302 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03402 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00109 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00706 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02703 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05401 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04201 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04303 Boehringer Ingelheim Investigational Site

summary: This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate


title: Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003

summary: The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

ReferenceCitation: Moreau P, Weisel KC, Song KW, Gibson CJ, Saunders O, Sternas LA, Hong K, Zaki MH, Dimopoulos MA. Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS). Leuk Lymphoma. 2016 Dec;57(12):2839-2847. Epub 2016 May 13.

ReferenceCitation: Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055-1066. doi: 10.1016/S1470-2045(13)70380-2. Epub 2013 Sep 3.

ReferenceCitation: Morgan G, Palumbo A, Dhanasiri S, Lee D, Weisel K, Facon T, Delforge M, Oriol A, Zaki M, Yu X, Sternas L, Jacques C, Akehurst R, Offner F, Dimopoulos MA. Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone. Br J Haematol. 2015 Mar;168(6):820-3. doi: 10.1111/bjh.13227. Epub 2014 Nov 18.

location_country:
Denmark
Spain
Greece
Italy
Australia
Netherlands
Canada
Russian Federation
Switzerland
United Kingdom
Sweden
France
Belgium
Germany
Czechia

location_facility: CHRU de Lille - Service des maladies du sang

location_facility: Universitätsklinikum Ulm - Klinik fur Innere Medizin III

location_facility: Princess Alexandra Hospital - Haematology

location_facility: Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

location_facility: State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

location_facility: Ospedale San Luigi AO Luigi Gonzaga - Hematology

location_facility: Royal Wolverhampton Hospitals Trust - Research and Development

location_facility: Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

location_facility: Royal Prince Alfred Hospital - Institute of Haematology

location_facility: Charles University Hospital - Internal Medicine

location_facility: St Bartholomew's Hospital - Medical Oncology

location_facility: Askepios Klinik Altona-Abteilung Hamatologie und Internistische Onkologie

location_facility: University of Athens - Alexandra Hospital

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hôpitaux Universitaire de Genève - Oncologie

location_facility: Royal Adelaide Hospital - SA Pathology Haematology

location_facility: Universitatsklinikum Carl Gustav Carus-Medizinische Klinik und Poliklinik I

location_facility: Freeman Hospital - Northern Centre for Cancer Care

location_facility: Royal hallamshire Hospital - Haematology

location_facility: Centre Hospitalier Départemental Vendée - Onco-hematologie

location_facility: AO Universitaria San Martino - hematooncology

location_facility: Cliniques Universitaires ULC de Mont-Godinne - Hematology

location_facility: Princess Margaret Hospital, University Health Network

location_facility: Centre Hospitalier de la côte basque - Hematologie

location_facility: Karolinska University Hospital Huddinge - Center of hematology

location_facility: Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

location_facility: Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

location_facility: Royal Bournemouth Hospital - Haematology

location_facility: Ospedale Guglielmo da Saliceto - hematooncology

location_facility: Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie Westdeutsches Tumorzentrum

location_facility: Hospital Germans Trias i Pujol - Hematology

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

location_facility: St James's University Hospital - Haematology

location_facility: Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

location_facility: Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

location_facility: Peter McCallum Cancer Institute - Directorate of Cancer Medicine

location_facility: Hôpital Saint Louis - Immuno-hematologie

location_facility: King's College Hospital - Haematology Clinical Trials

location_facility: CHU Angers - Service des maladies du sang

location_facility: Hôpital Bretonneau - Hématologie & Thérapie cellulaire

location_facility: Sahlgrenska Hospital, University of Goteborg - Hematology

location_facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

location_facility: Royal Marsden NHS Foundation Trust - Haematology

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie Service des maladies du sang

location_facility: Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

location_facility: Russian Research Institute of Hematology and Blood Transfusion - Hematology

location_facility: Hospital Universitario Marqués de Valdecilla - Hematology

location_facility: Hematological Research Center under the Russian Academy of Medical Sciences - Hematology & BMT

location_facility: Hospital Clinic i Provincial de Barcelona - Hematology

location_facility: Inselspital, Institut für Medizinische Onkologie

location_facility: The Alfred Hospital - Malignant Haematology & Stem Cell Transplantation

location_facility: Universita degli Studi di Padova - Clinical & Experimental Medicine

location_facility: British Columbia Cancer Agency, Vancouver Centre

location_facility: Centre Hospitalier Lyon sud - Hematologie

location_facility: Karolinska University Hospital Solna- medicine

location_facility: CHU Saint Antoine - Service des maladies du sang

location_facility: Nottingham City Hospital - Centre for Clinical Haematology

location_facility: Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

location_facility: Frankston Hospital-Peninsula Health - Oncology Day Unit

location_facility: A.O.U. San Giovanni Battista - Hematology


title: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

acronym: Prospect

summary: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

ReferenceCitation: Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.

lead_sponsor: Bavarian Nordic

location_country:
Denmark
Poland
Spain
United Kingdom
Russian Federation
Australia
Estonia
Canada
Netherlands
Puerto Rico
United States
France
Israel
Belgium
Iceland
Germany

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: James A Haley Veteran Affairs Medical Center

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: St. Josephs Healthcare Hamilton Research Ethics Board

location_facility: Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries

location_facility: University Hospitals Case Medical Center

location_facility: Centre Hospitalier Universitaire de Quebec Hotel Dieu

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine

location_facility: Orenburg Regional Clinical Oncology Center

location_facility: National Cancer Institute - Center for Cancer Research

location_facility: Urologic Consultants of Southeaster PA LLP

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: White River Junction Veterans Affairs Medical Center

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Central Texas Veterans Health Care System

location_facility: Delaware Valley Urology LLC - Westhampton

location_facility: Presbyterian Hospital Center for Cancer Research

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Middelheim

location_facility: Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o.

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Stavropol Regional Clinical Oncology Dispensary

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Moscow Research Oncology Institute n.a. P.A.Gertsen

location_facility: Leeds Teaching Hospitals NHS Trust, St James's University Hospital

location_facility: Centre Hospitalier de l'Universite de Montreal

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

location_facility: Institut Jean Godinot - Centre de lutte contre le cancer

location_facility: Hospital Universitario Fundación Alcorcón

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

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

location_facility: Monash Medical Centre - Moorabbin Campus

location_facility: Plymouth Hospitals NHS Trust, Derriford Hospital

location_facility: James H. Quillen Veterans Affairs Medical Center

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: St. Petersburg Medical Academy of Postgraduate Education

intervention_type: Biological


title: A Phase 3, Muticenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone Versus High-dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

acronym: NIMBUS

summary: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.

ReferenceCitation: Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. Epub 2016 Jun 7.

ReferenceCitation: Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Knop S, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel J. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Haematologica. 2016 Jul;101(7):872-8. doi: 10.3324/haematol.2015.137083. Epub 2016 Apr 14.

ReferenceCitation: Dimopoulos MA, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Spencer A, Knop S, Bahlis NJ, Renner C, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel JF. Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone. Haematologica. 2015 Oct;100(10):1327-33. doi: 10.3324/haematol.2014.117077. Epub 2015 Aug 6.

ReferenceCitation: San Miguel JF, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Renner C, Bahlis NJ, Yu X, Teasdale T, Sternas L, Jacques C, Zaki MH, Dimopoulos MA. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. Haematologica. 2015 Oct;100(10):1334-9. doi: 10.3324/haematol.2015.125864. Epub 2015 Jul 9.

ReferenceCitation: Weisel K, Dimopoulos M, Song KW, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Gibson CJ, Zaki M, Jacques C, San Miguel J. Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. Clin Lymphoma Myeloma Leuk. 2015 Sep;15(9):519-30. doi: 10.1016/j.clml.2015.05.007. Epub 2015 Jun 6.

ReferenceCitation: Song KW, Dimopoulos MA, Weisel KC, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Monzini MS, Zaki M, Jacques C, San Miguel J. Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma. Haematologica. 2015 Feb;100(2):e63-7. doi: 10.3324/haematol.2014.112557. Epub 2014 Nov 25.

location_country:
Denmark
Spain
Greece
Italy
Australia
Netherlands
Canada
Russian Federation
Switzerland
United Kingdom
Sweden
United States
France
Belgium
Germany
Czechia

location_facility: Royal Victoria Hospital McGill Department of Oncology(RVH)

location_facility: Department of Hematology Hematology Centre

location_facility: Univerita La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: State Educational Institution, Saint Petersburg State Medical University

location_facility: State Institution Hematological Research, Centre of Russian Academy of Medical Science

location_facility: State Institution Moscow Regional Research Clinical Institute

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: Servizio di Ematologia, A.O. - Arcispedale S.Maria Nuova

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

location_facility: Azienda Ospedaliera San Giovanni Battista

location_facility: Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Royal Hallamshire HospitalSheffield Teaching Hospitals NHS Trust


title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

acronym: SEAMLESS

summary: This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

ReferenceCitation: Kantarjian HM, Begna KH, Altman JK, Goldberg SL, Sekeres MA, Strickland SA, Arellano ML, Claxton DF, Baer MR, Gautier M, Berman E, Seiter K, Solomon SR, Schiller GJ, Luger SM, Butrym A, Gaidano G, Thomas XG, Montesinos P, Rizzieri DA, Quick DP, Venugopal P, Gaur R, Maness LJ, Kadia TM, Ravandi F, Buyse ME, Chiao JH. Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS). Cancer. 2021 Dec 1;127(23):4421-4431. doi: 10.1002/cncr.33828. Epub 2021 Aug 23.

ipd_sharing: No

lead_sponsor: Cyclacel Pharmaceuticals, Inc.

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Switzerland
Sweden
Hungary
United States
France
Belgium
Germany

location_facility: Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin

location_facility: The University of Chicago Medical Center

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu

location_facility: University of Lodz N. Copernicus Memorial Hospital

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Westchester Hematology Oncology Group, PC

location_facility: Skåne Universitetssjukhus Univ Hospital Lund

location_facility: St. Francis Medical Group Oncology and Hematology Specialists

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: John Theurer Cancer Center at the Hackensack University Medical Center

location_facility: Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Shands Cancer Hospital at University of Florida

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: University of Alabama Comprehensive Cancer Center

location_facility: Kings College Hospital and Guys and St Thomas' Hospital

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Winship Cancer Institute, Emory University

location_facility: IHT Instytut Hematologii I Transfuzjologii w Warszawie

location_facility: University of Maryland Greenbaum Cancer Center

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: University of Iowa Hospitals and Clinics

location_facility: Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku

location_facility: Centre Hospitalier de Saint-Brieuc Yves Ie Foll

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg


title: A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

summary: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

ReferenceCitation: Möller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.

lead_sponsor: AstraZeneca

location_country:
Croatia
Poland
Brazil
Romania
Serbia
Spain
Russian Federation
Argentina
Ukraine
Hungary
France
Chile
South Africa
Colombia
Germany
Bulgaria
Slovakia