title: A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

lead_sponsor: Genentech, Inc.

ReferenceCitation: Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13.

location_country:
Taiwan
Serbia
Spain
Korea, Republic of
United States
France

location_facility: Taipei Medical University -Shuang Ho Hospital

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

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

location_facility: Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Clinical Hospital Center Bezanijska Kosa; Physical Medicine and Rehabilitation

location_facility: Centro Medico Quironsalud Sagrado Corazon

location_facility: Hopital Nord AP-HM; Service Clinique des bronches allergies et sommeil

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: National Cheng Kung University Hospital; Internal Medicine

location_facility: Seoul National University Bundang Hospital

summary: This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.


ipd_sharing: No

status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

study_completion_date_type: Actual

lead_sponsor: Agios Pharmaceuticals, Inc.

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Al-Samkari H, Galactéros F, Glenthøj A, Rothman JA, Andres O, Grace RF, Morado-Arias M, Layton DM, Onodera K, Verhovsek M, Barcellini W, Chonat S, Judge MP, Zagadailov E, Xu R, Hawkins P, Beynon V, Gheuens S, van Beers EJ; ACTIVATE Investigators. Mitapivat versus Placebo for Pyruvate Kinase Deficiency. N Engl J Med. 2022 Apr 14;386(15):1432-1442. doi: 10.1056/NEJMoa2116634.

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

enrollment_type: Actual

location_country:
Denmark
Brazil
Spain
Italy
United Kingdom
Netherlands
Canada
Thailand
Switzerland
Korea, Republic of
United States
France
Turkey
Japan
Germany
Czechia

location_facility: Hospital U. Vall d'Hebron Servicio de Hematología Clínica

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Hospital Clinico Universitario Virgen de la Arricaxa

location_facility: The Royal Liverpool and Broadgreen University

location_facility: Department of Paediatrics and Thalassaemia Center, Faculty of Medicine Siriraj

location_facility: Institute of Hematology and Blood Transfusion

location_facility: AOU Policlinico, Università della Campania "Luigi Vanvitelli"

location_facility: Toronto General Hospital, University Health Network

location_facility: Wayne State University School of Medicine, Children's Hospital of Michigan

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Kansai Medical University, Department of Pediatrics, Hirakata Hospital

location_facility: University of Copenhagen, Herlev Hospital

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Primary Children's Hospital Univ. of Utah

location_facility: McMaster University - Health Sciences Centre

location_facility: The Children's Hospital Corporation d/b/a Boston's Children Hospital

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Hospital Central da Faculdade de Medicina USP Cidade Universitaria

summary: Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

lead_sponsor: Jazz Pharmaceuticals

type: EudraCT Number

ReferenceCitation: Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, Morse AM, Šonka K, Thorpy MJ, Mignot E, Chandler P, Parvataneni R, Black J, Sterkel A, Chen D, Skobieranda F, Bogan RK. Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Lancet Neurol. 2022 Jan;21(1):53-65. doi: 10.1016/S1474-4422(21)00368-9.

location_country:
Poland
Spain
United Kingdom
Finland
France
United States
Belgium
Czechia

location_facility: Ohio Sleep Medicine and Neuroscience Institute

location_facility: Southern California Institute for Respiratory Diseases, Inc.

location_facility: Hospital Vithas Nuestra Señora de America

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: SleepCare Research Institute d/b/a Clinical Research

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Montefiore Medical Center/Sleep-Wake Disorders Center

location_facility: lnstytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej

summary: This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.


ipd_sharing: Yes

title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

lead_sponsor: LEO Pharma

ReferenceCitation: Soehoel A, Larsen MS, Timmermann S. Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clin Pharmacol Drug Dev. 2022 Aug;11(8):910-921. doi: 10.1002/cpdd.1113. Epub 2022 Jun 7.

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

location_country:
Poland
United Kingdom
Australia
Netherlands
Canada
United States
France
Belgium
Japan
Germany

location_facility:
Leo Pharma Investigationel Site
LEO Pharma Investigational Site
Leo Pharma Investigational Site

summary:
Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.

To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.


acronym: CheckMate 9UT

intervention_type: Biological

title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
Hong Kong
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
United States
Chile
China
France
Mexico
Turkey
Netherlands

location_facility:
Local Institution - 0047
USC Norris Comprehensive Cancer Center
Local Institution - 0094
Local Institution - 0022
Hopital Claude Huriez
Laura & Isaac Perlmutter Cancer Center
Local Institution - 0148
Local Institution - 0056
Local Institution - 0036
Local Institution - 0078
Houston Methodist Hospital
University Of Minnesota
Local Institution - 0057
Local Institution - 0040
Local Institution - 0062
Deleware Valley Urology, LLC
Local Institution - 0048
Local Institution - 0125
Local Institution - 0005
Local Institution - 0021
Local Institution - 0154
Local Institution - 0137
Local Institution - 0144
Local Institution - 0003
Local Institution - 0080
Local Institution - 0143
Local Institution - 0141
Hopital Foch
Local Institution - 0087
Local Institution - 0023
Local Institution - 0151
Local Institution - 0073
Urology San Antonio Research, Pa
Urology Clinics Of North Texas, Pa
Local Institution - 0028
Local Institution - 0001
Local Institution - 0020
Local Institution - 0136
Medical University Of South Carolina
Local Institution - 0081
Local Institution - 0150
Wichita Urology Group
Local Institution - 0086
Local Institution - 0013
Local Institution
Local Institution - 0002
Local Institution - 0058
Cryptex Investigacion Clinica Sa de Cv
Local Institution - 0077
Hopital Pellegrin
Nouvel Hopital Civil Chru De Strasbourg
Instituto Oncologico De Cordoba
Local Institution - 0072
Local Institution - 0116
Local Institution - 0084

summary: A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.


title: An Open-Label Phase 1/2a Study of the Safety and Efficacy of Melflufen and Dexamethasone in Combination With Either Bortezomib or Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma

acronym: ANCHOR

summary: This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma following 1-4 lines of prior therapy. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab and are required to be IMiD refractory to be enrolled to the bortezomib regimen, and to not have any prior exposure to daratumumab or other antiCD-38 mAb to be enrolled to the daratumumab regimen.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Oncopeptides AB

location_country:
United States
France
Spain
Czechia

location_facility: Centre Hospitalier Universitaire Institut Gustave Roussy

location_facility: Hospital Universitai Germans Trias i Pujol

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Hospital Universitario Marques de Valdecilla

status_simplified: Unknown


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Identifier

type: Registry Identifier

ReferenceCitation: Dicpinigaitis PV, Birring SS, Blaiss M, McGarvey LP, Morice AH, Pavord ID, Satia I, Smith JA, La Rosa C, Li Q, Nguyen AM, Schelfhout J, Tzontcheva A, Muccino D. Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough. Ann Allergy Asthma Immunol. 2022 May 13:S1081-1206(22)00406-9. doi: 10.1016/j.anai.2022.05.003. Online ahead of print.

ReferenceCitation: McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X(3) receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.

location_country:
Denmark
Poland
Taiwan
Spain
United Kingdom
Argentina
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Peru
Turkey
Japan
Czechia

location_facility: Sher Allergy Specialists/Center For Cough ( Site 0078)

location_facility: National Hospital Organization Fukuoka Hospital ( Site 1552)

location_facility: Terada Clinic Respiratory Medicine & General Practice ( Site 1565)

location_facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)

location_facility: MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)

location_facility: Incheon St. Mary s Hospital ( Site 2200)

location_facility: Konkuk University Medical Center ( Site 2205)

location_facility: Seoul National University Hospital ( Site 2210)

location_facility: Changhua Christian Hospital ( Site 2403)

location_facility: Hopital Arnaud de Villeneuve ( Site 0905)

location_facility: National Hospital Organization Disaster Medical Center ( Site 1558)

location_facility: NZOZCentrum Medyczne Kermed ( Site 1905)

location_facility: Yokohama City Minato Red Cross Hospital ( Site 1506)

location_facility: Taichung Veterans General Hospital ( Site 2401)

location_facility: Medinova Lakeside Dedicated Research Centre ( Site 2710)

location_facility: Nagoya City University Hospital ( Site 1528)

location_facility: JA Niigatakoseiren Niigata Medical Center ( Site 1522)

location_facility: Hospital Chancay y Servicios Basicos de Salud ( Site 1810)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 1503)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0900)

location_facility: Bernstein Clinical Research Center, LLC ( Site 0005)

location_facility: Osaka Habikino Medical Center ( Site 1546)

location_facility: CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)

location_facility: CEMEDIC - Centro de Especialidades Medicas ( Site 0304)

location_facility: National Clinical Research-Richmond, Inc. ( Site 0073)

location_facility: Q & T Research Sherbrooke Inc. ( Site 0512)

location_facility: Intermountain Clinical Research ( Site 0033)

location_facility: F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)

location_facility: Florida Pulmonary Research Institute, LLC ( Site 0019)

location_facility: Hillel Yaffe Medical Center ( Site 1303)

location_facility: Centrum Medyczne Pratia Bydgoszcz ( Site 1418)

location_facility: National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)

location_facility: Juntendo University Hospital ( Site 1578)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)

location_facility: Hallym University Sacred Heart Hospital ( Site 2208)

location_facility: CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)

location_facility: Pulmonary Associates of Richmond Inc. ( Site 0101)

location_facility: Charlottesville Medical Research Center, LLC ( Site 0006)

location_facility: Clinical Research of Gastonia ( Site 0043)

location_facility: National Hospital Organization Tokyo National Hospital ( Site 1557)

location_facility: Biosolutions Clinical Research Center ( Site 0070)

location_facility: Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)

location_facility: Hiroshima Allergy & Respiratory Clinic ( Site 1529)

location_facility: Prywatny Gabinet Internistyczno ( Site 1928)

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)

location_facility: InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)

location_facility: Mainland Medical Research Institute ( Site 0003)

location_facility: Kawaguchi Respiratory Clinic ( Site 1504)

location_facility: Hospital Privado Universitario de Cordoba ( Site 0313)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 2309)

location_facility: Ishikawa Prefectural Central Hospital ( Site 1554)

location_facility: Kamei Internal Medicine and Respiratory Clinic ( Site 1509)

location_facility: Centrum Medyczne Pratia Gdynia ( Site 1910)

location_facility: Asociacion Civil por la Salud ( Site 1805)

location_facility: Center for Clinical Trials, LLC ( Site 0059)

location_facility: Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)

location_facility: Tokyo Metropolitan Geriatric Hospital ( Site 1577)

location_facility: Centro Medico Privado de Reumatologia ( Site 0309)

location_facility: Idaimae Minamiyojo Int Clinic ( Site 1521)

location_facility: Centrum Medyczne Pratia Czestochowa ( Site 1926)

location_facility: National Taiwan University Hospital ( Site 2400)

location_facility: Plicni stredisko Teplice s. r. o ( Site 0700)

location_facility: Pharmaceutical Research & Consulting, Inc. ( Site 0029)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 2215)

location_facility: Hospital Clinico Universitario de Santiago ( Site 2303)

location_facility: Sirius Clinical Research, LLC ( Site 0102)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 1574)

location_facility: Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)

location_facility: Well Pharma Medical Research, Corp. ( Site 0093)

location_facility: Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)

location_facility: Korea University Guro Hospital ( Site 2213)

location_facility: Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 1539)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)

location_facility: Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)

location_facility: Hospital Nacional Adolfo Guevara Velasco ( Site 1808)

location_facility: Vital Prospects Clinical Research Institute, PC ( Site 0037)

location_facility: National Hospital Organization Minami-Okayama Medical Center ( Site 1553)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 2611)

location_facility: Midwest Allergy Sinus Asthma, SC ( Site 0081)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1206)

location_facility: I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)

location_facility: Far Eastern Memorial Hospital ( Site 2402)

location_facility: Research Solutions of Arizona PC ( Site 0036)

location_facility: Chang Gung Medical Foundation - Keelung Branch ( Site 2404)

location_facility: Prywatny Gabinet Specjalistyczny ( Site 1927)

location_facility: Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)

location_facility: Cotton-O'Neil Clinical Research Center ( Site 0052)

location_facility: Investigaciones en Patologias Respiratorias ( Site 0325)

location_facility: Pneumologie Varnsdorf S.R.O. ( Site 0706)

location_facility: Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)

location_facility: Clinical Research Institute LLC ( Site 0004)

location_facility: Wonju Severance Christian Hospital ( Site 2214)

location_facility: The Center for Pharmaceutical Research PC ( Site 0016)

location_facility: MUDr. I. Cierna Peterova s.r.o. ( Site 0707)

location_facility: Kanazawa University Hospital ( Site 1536)

location_facility: Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)

location_facility: Tokyo Medical University Hachioji Medical Center ( Site 1569)

location_facility: 167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)

location_facility: National Hospital Organization Ehime Medical Center ( Site 1556)

location_facility: Chaim Sheba Medical Center. ( Site 1304)

summary: The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.


primary_purpose: Prevention

acronym: MENACWY CONJ-069 (V59_78)

title: Immunogenicity, Reactogenicity and Safety Study of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) When Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Vir Singh P, Tiberi P, Di Domenico GF, Romolini V, Mzolo T, Costantini M, Akhund T, Basile V, Lattanzi M, Pellegrini M. Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis. Drug Saf. 2022 Nov 11. doi: 10.1007/s40264-022-01242-8. [Epub ahead of print]

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Brazil
Spain
Russian Federation
Estonia
Finland
France
South Africa
Turkey
Mexico

summary:
MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.

The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.


title: A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

summary: The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
Spain
United Kingdom
France
United States
Israel
Japan
Germany
Czechia

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

location_facility: University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic

location_facility: Avera Medical Group - Oncology & Hematology

location_facility: Cancer Center of Central Connecticut - Southington

location_facility: UF Health Cancer Center at Orlando Health

status_simplified: Ongoing


title: A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs

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

ReferenceCitation: Coyne DW, Singh AK, Lopes RD, Bailey CK, DiMino TL, Huang C, Connaire J, Rastogi A, Kim SG, Orias M, Shah S, Patel V, Cobitz AR, Wanner C. Three Times Weekly Dosing of Daprodustat versus Conventional Epoetin for Treatment of Anemia in Hemodialysis Patients: ASCEND-TD: A Phase 3 Randomized, Double-Blind, Noninferiority Trial. Clin J Am Soc Nephrol. 2022 Aug 2. pii: CJN.00550122. doi: 10.2215/CJN.00550122. [Epub ahead of print]

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
Korea, Republic of
United States
France
Romania

summary: This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.


acronym: ATLAS

title: A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

lead_sponsor: Clovis Oncology, Inc.

ReferenceCitation: Grivas P, Loriot Y, Morales-Barrera R, Teo MY, Zakharia Y, Feyerabend S, Vogelzang NJ, Grande E, Adra N, Alva A, Necchi A, Rodriguez-Vida A, Gupta S, Josephs DH, Srinivas S, Wride K, Thomas D, Simmons A, Loehr A, Dusek RL, Nepert D, Chowdhury S. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS). BMC Cancer. 2021 May 24;21(1):593. doi: 10.1186/s12885-021-08085-z.

location_country:
Spain
Italy
United Kingdom
United States
France
Germany

location_facility: University of California, Los Angeles (UCLA)

location_facility: Saint John's Health Center - John Wayne Cancer Institute (JWCI)

location_facility: University of Washington / Seattle Cancer Care Alliance

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: University of Virginia, Emily Couric Clinical Center

location_facility: Urologische und Kinderurologische Universitätsklinik im Malteser

location_facility: Northwest Cancer Specialists P.C. (USO - US Oncology)

location_facility: Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)

location_facility: Hospital Universitari Vall d'Hebron de Barcelona

location_facility: New York Oncology Hematology, P.C. (USO - US Oncology)

location_facility: IRCCS Ospedale San Raffaele - Medical Oncology Dept

location_facility: University of California San Diego (UCSD), Moores Cancer Center

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard

location_facility: University of Maryland, Marlene and Stewart Greenebaum Cancer Center

location_facility: Minnesota Oncology Hematology P.A. (USO - US Oncology)

location_facility: Sarah Cannon Research Institute - United Kingdom - London Office

location_facility: University of New Mexico UNM Cancer Research and Treatment Center

location_facility: Eastern Connecticut Hematology & Oncology Associates (ECHO)

location_facility: Medstar Georgetown University Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Miami Cancer Institute, Baptist Health South Florida

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: University of Texas, UT Health Science Center

location_facility: Guy's & St. Thomas' Hospital (London Oncology Clinic)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau

location_facility: Azienda Ospedaliera Universitaria Federico II Oncologia Medica

location_facility: Comprehensive Cancer Centers of Nevada (CCCN)

location_facility: Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS

location_facility: The University of Iowa and Holden Comprehensive Cancer Center

location_facility: Universitatsklinikum Munster / Urologie und Kinderurologie

location_facility: Froedtert & Medical College of Wisconsin

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra

summary: The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.


status: Recruiting

acronym: A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930

title: A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP])

lead_sponsor: Baxalta now part of Shire

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

enrollment_type: Anticipated

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Switzerland
United States
France
Japan
Germany

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

summary:
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can occur. People who have TTP may bleed underneath the skin forming purple bruises or purpura, or from the surface of the skin. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them leading to lower than normal number of red blood cells.

A lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in blood clotting, causes TTP. The enzyme breaks up another blood protein called von Willebrand factor that clumps together with platelets to form blood clots. Some people are born with this condition, others get the condition during their life. Many people who born with TTP experience frequent flareups that need to be treated right away. If not treated It can be fatal or cause lasting damage, such as brain damage or a stroke. BAX 930 is a medicine that replaces ADAMTS13 and can prevent or control TTP flareups, called TTP events.

The main aim of this study is to compare the number of TTP events in people born with severe TTP when they treated with BAX 930 versus when they are treated with the standard treatment. Treatment will be given in 2 ways:

BAX 930 or standard treatment given to prevent TTP events from happening.
BAX 930 or standard treatment given to control an acute TTP event when it happens, according to the clinic's standard practice.

Both BAX 930 and standard treatment are given slowly through a vein (infusion).

At the first visit, the study doctor will check if you can participate in the study. If you are eligible and enter the study, you will follow an assigned schedule and either start with BAX 930 (Period 1) and then switch to standard treatment (Period 2) or start with standard treatment (Period 1) and then switch to BAX 930 (Period 2). Everyone will be treated with BAX 930 again for Period 3. Each Period will last approximately 6 months.

If you enter the study to control an acute TTP event, you will follow a schedule receiving either BAX 930 or standard care to treat your acute TTP event. Once the acute TTP event has gotten better, you can decide to continue in the study and be given treatment to prevent TTP events from happening, following the schedule above.

Another study's aim is to assess side effects from treatment with BAX 930 and standard treatment. To do that, the study doctor will ask you questions about your health at each study visit.

The study doctors will also check how long BAX 930 stays in the blood of the participants, over time. They will do this from blood samples taken after participants receive their specific infusions of BAX 930. This will happen at different times during the study.

1 month after all treatment has been completed, participants will visit the clinic for a final check-up.


title: An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

ReferenceCitation: Ruhayel SD, Valvi S. Daratumumab in T-cell acute lymphoblastic leukaemia: A case report and review of the literature. Pediatr Blood Cancer. 2021 May;68(5):e28829. doi: 10.1002/pbc.28829. Epub 2020 Nov 27. Review.

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

location_facility: Charite-Universitätsmedizin Berlin - Berlin

location_facility: University of Utah Primary Children's Medical Center

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: New York University Langone Medical Center

location_facility: Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita

location_facility: Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center

location_facility: Washington Univeristy School of Medicine/ Pediatrics

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

summary: The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.


title: A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion

summary:
The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults.

Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.

ipd_sharing_description: Takeda does not provide access to Individual Participant Data when a study is in a very limited (small) study population due to participant privacy concerns such as potential reidentification of study participants.

location_country:
Spain
Austria
Hungary
United States
France

location_facility: Gulf States Hemophilia and Thrombophilia Center City

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Medical University of South Carolina (MUSC)

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Hospital Regional Universitario de Malaga


title: A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 28-week Treatment Period as Adjunctive Therapy to Antipsychotic Treatment for the Prevention of Relapse in Patients With Schizophrenia.

summary: The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

lead_sponsor: Boehringer Ingelheim

location_country:
Taiwan
Spain
Canada
Korea, Republic of
United States
France
Japan

location_facility: National Hospital Organization Hizen Psychiatric Medical Center

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: Chatham-Kent Clinical Trials Research Centre

location_facility: National Center Neurology and Psychiatry

location_facility: Seoul National University Bundang Hospital

location_facility: National Center for Global Health and Medicine Kohnodai Hospital

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: IUSMM Institut Universitaire en Sante Mentale de Montreal

location_facility: St. Charles Psychiatric Associates & Midwest Research Group

location_facility: Centre for Addiction and Mental Health (CAMH)

location_facility: Orange County Neuropsychiatric Research Center LLC

location_facility: Hospital Universitario Marqués de Valdecilla


title: A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

summary: Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses [up to 750 micrograms (µg)] compared with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in this double-blind study. Subjects will be randomized to receive different doses of nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

ReferenceType: background

ReferenceCitation: Fahy WA, Homayoun-Valiani F, Cahn A, Robertson J, Templeton A, Meeraus WH, Wilson R, Lowings M, Marotti M, West SL, Tabberer M, Hessel EM. Nemiralisib in Patients with an Acute Exacerbation of COPD: Placebo-Controlled, Dose-Ranging Study. Int J Chron Obstruct Pulmon Dis. 2021 Jun 3;16:1637-1646. doi: 10.2147/COPD.S309320. eCollection 2021.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site

location_country:
Poland
Romania
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
Mexico
Germany


title: A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

summary: The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

ReferenceCitation: Najarian D, Sanga P, Wang S, Lim P, Singh A, Robertson MJ, Cohen K, Schotte A, Milz R, Venkatasubramanian R, T'Jollyn H, Walling DP, Galderisi S, Gopal S. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251. doi: 10.1093/ijnp/pyab071.

location_country:
Spain
Italy
Ukraine
United States
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Malaysia
Brazil
Hungary
Bulgaria
Taiwan
Korea, Republic of
France

location_facility: Centro de Estudios Clinicos y Especialidades Medicas, S.C.

location_facility: CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

location_facility: Psychiatricka ambulance, MUDr. Marta Holanova

location_facility: St-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

location_facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

location_facility: CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

location_facility: Selcuk University, Medical School, Department of Psychiatry

location_facility: Sverdlovsk Regional Clinical Psychiatric Hospital

location_facility: Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'

location_facility: Nizny Novgorod clinical psychiatric hospital 1

location_facility: C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Centre for Mental Health Prof.N.Shipkovenski EOOD

location_facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

location_facility: Psychiatricka ambulance MUDr. Simona Papezova

location_facility: Clinica Psichiatrica - Università di Cagliari

location_facility: Abdurrah Yurtarslan Training and Research Hospital

location_facility: Saratov Regional Psychiatric hospital named after St. Sofia

location_facility: Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

location_facility: Kyiv Territorial Medical Incorporation 'Psychiatry'

location_facility: Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

location_facility: Ankara Numune Research and Training Hospital

location_facility: Jehangir Clinical Development Center Pvt Ltd

location_facility: State Psychiatric HospitalDr.Georgi Kissiov

location_facility: MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

location_facility: Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

location_facility: Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny

location_facility: Józsefvarosi Szent Kozma Egészségügyi Központ

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o.

location_facility: Sakarya University Medical Faculty Psychiatry Department

location_facility: Psychiatric Clinical hospital 1 named after N.A. Alekseev

location_facility: Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea

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

location_facility: CNCE Odesa regional psychiatric hospital #2 Odesa regional council

location_facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales

location_facility: Deva Institute of Health Care and Research Pvt Ltd

location_facility: Ruschel Medicina e Pesquisa Clínica Ltda

location_facility: Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski

location_facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

location_facility: California Pharmaceutical Research Institute, Inc.

location_facility: Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky

location_facility: Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie

location_facility: Psychoneurological Dispensary of Frunzensky District

location_facility: University of Pennsylvania Medical Center

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Juan Schrönen - Western Cape South Africa

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

location_facility: Mental Health Center Prof. Dr. Ivan Temkov

intervention_type: Other


title: Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

acronym: MiMe-A

summary:
Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.

Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage:

Platinum-refractory esophageal adenocarcinoma (ADC)
Platinum-refractory esophageal squamous cell carcinoma (SCC)
Platinum-refractory cholangiocarcinoma
Platinum-refractory and progressive after immunotherapy urothelial cancer
Platinum-refractory endometrial cancer

lead_sponsor: Jules Bordet Institute

location_country: France Belgium

location_facility: Hôpital universitaire de Strasbourg - ICANS

location_facility: IUCT Oncopole - Institut Claudius Regaud


title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

acronym: CheckMate 9KD

summary: The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

ReferenceCitation: Fizazi K, Retz M, Petrylak DP, Goh JC, Perez-Gracia J, Lacombe L, Zschäbitz S, Burotto M, Mahammedi H, Gravis G, Bastos DA, McCune SL, Vázquez Limón JC, Kwan EM, Castellano D, Fléchon A, Saad F, Grimm MO, Shaffer DR, Armstrong AJ, Bhagavatheeswaran P, Amin NP, Ünsal-Kaçmaz K, Wang X, Li J, Loehr A, Pachynski RK. Nivolumab plus rucaparib for metastatic castration-resistant prostate cancer: results from the phase 2 CheckMate 9KD trial. J Immunother Cancer. 2022 Aug;10(8). pii: e004761. doi: 10.1136/jitc-2022-004761.

ReferenceCitation: Fizazi K, González Mella P, Castellano D, Minatta JN, Rezazadeh Kalebasty A, Shaffer D, Vázquez Limón JC, Sánchez López HM, Armstrong AJ, Horvath L, Bastos DA, Amin NP, Li J, Unsal-Kacmaz K, Retz M, Saad F, Petrylak DP, Pachynski RK. Nivolumab plus docetaxel in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer: results from the phase II CheckMate 9KD trial. Eur J Cancer. 2022 Jan;160:61-71. doi: 10.1016/j.ejca.2021.09.043. Epub 2021 Nov 18.

location_country:
Brazil
Spain
Australia
Mexico
Argentina
Canada
United States
Chile
France
Colombia
Germany

location_facility: Northwest Georgia Oncology Centers, P.C.


acronym: SPARK

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease

lead_sponsor: Biogen

ReferenceCitation: Lang AE, Siderowf AD, Macklin EA, Poewe W, Brooks DJ, Fernandez HH, Rascol O, Giladi N, Stocchi F, Tanner CM, Postuma RB, Simon DK, Tolosa E, Mollenhauer B, Cedarbaum JM, Fraser K, Xiao J, Evans KC, Graham DL, Sapir I, Inra J, Hutchison RM, Yang M, Fox T, Budd Haeberlein S, Dam T; SPARK Investigators. Trial of Cinpanemab in Early Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):408-420. doi: 10.1056/NEJMoa2203395.

ReferenceCitation: Hutchison RM, Evans KC, Fox T, Yang M, Barakos J, Bedell BJ, Cedarbaum JM, Brys M, Siderowf A, Lang AE. Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial. BMC Neurol. 2021 Nov 23;21(1):459. doi: 10.1186/s12883-021-02470-8.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Spain
Italy
Austria
United Kingdom
Canada
United States
France
Israel
Germany

location_facility: University of Kansas Medical Center Research Institute

location_facility: Montreal Neurological Institute Clinical Research Unit

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Booth Gardner Parkinson's Care Center at Evergreen Health

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: University of California San Francisco Medical Center

location_facility: Parkinson's Disease and Movement Disorders Centerf

location_facility: St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute

location_facility: Rocky Mountain Movement Disorders Center, PC

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: Seconda Università degli Studi di Napoli

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Northwestern University PD and Movement Disorders Center

summary:
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score.

The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.


title: A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of Amcenestrant (SAR439859), Administered Orally as Monotherapy, Then in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer

summary:
Primary Objectives:

Dose Escalation:

To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib
To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy

Safety Run-In:

- To confirm the RD of amcenestrant in combination with alpelisib

Dose Expansion:

Antitumor activity using objective response rate (ORR)
Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib

Secondary Objectives:

Overall safety profile of amcenestrant monotherapy and in combination
Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib
Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS)
Time to first tumor response
Residual ER availability with positron emission tomography (PET) scan [(18)F] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant
Food effect on PK of amcenestrant
Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol

ReferenceCitation: Bardia A, Chandarlapaty S, Linden HM, Ulaner GA, Gosselin A, Cartot-Cotton S, Cohen P, Doroumian S, Paux G, Celanovic M, Pelekanou V, Ming JE, Ternès N, Bouaboula M, Lee JS, Bauchet AL, Campone M. AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer. Nat Commun. 2022 Jul 15;13(1):4116. doi: 10.1038/s41467-022-31668-8.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Poland
Portugal
Spain
Italy
United Kingdom
Canada
France
United States
Belgium
Czechia

location_facility:
Investigational Site Number :6200001
Investigational Site Number :6160004
Investigational Site Number :2030003
Investigational Site Number :2500005
Investigational Site Number :3800001
Investigational Site Number :7240007
Investigational Site Number :3800003
Investigational Site Number :2500003
Investigational Site Number :8400001
Investigational Site Number :7240002
Investigational Site Number :1240004
Investigational Site Number :8400102
Investigational Site Number :8400002
Investigational Site Number :2030001
Investigational Site Number :2500002
Investigational Site Number :6200003
Investigational Site Number :3800004
Investigational Site Number :0560001
Investigational Site Number :3800002
Investigational Site Number :7240001
Investigational Site Number :6200002
Investigational Site Number :1240002
Investigational Site Number :2500004
Investigational Site Number :8260003
Investigational Site Number :8400005
Investigational Site Number :1240003
Investigational Site Number :8400003
Investigational Site Number :2500001
Investigational Site Number :2030002
Investigational Site Number :8260002
Investigational Site Number :6160001


title: A Prospective, Double-masked, Randomized, Multicenter, Active-controlled, Parallel-group, 6-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to GANFORT® (Bimatoprost 0.03% / Timolol 0.5%) Ophthalmic Solution in Subjects With Elevated Intraocular Pressure (MERCURY 3)

summary: The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure

lead_sponsor: Aerie Pharmaceuticals

location_country:
Poland
Spain
Italy
Austria
Latvia
United Kingdom
Hungary
France
Belgium
Germany
Czechia

location_facility: Department of Ophthalmology Clinical Johannes Gutenberg-University Mainz

location_facility: Queen Mary Hospital, King's College Hospital NHS

location_facility: Institut Catala de retina (ICR) Glaucoma and Investigation Department

location_facility: Hospital Universitario Reina Sofía de Córdoba

location_facility: Dept. Ophthalmology, San Raffaele Hospital

location_facility: Glaucoma center Oční klinika VFN a 1. LF UK

location_facility: Ophthalmic Clinic DiNOGMI University Hospital San Martino

location_facility: Northwest Anglia NHS Foundation trust Hinchingbrooke Hospital

location_facility: P.Stradins Clinical University Hospital, Ophthalmology Clinic

location_facility: ASST Santi Paolo e Carlo - Ophthalmic Clinic

location_facility: Riga East University hospital, In-patient Department "Biķernieki", Ophthalmology Clinic

location_facility: Hospital Clinico Universitario Lozano Blesa Zaragoza Ophthalmology department

location_facility: City Hospitals Sunderland NHS Foundation Trust Sunderland Eye Infirmary

location_facility: Department of Diagnostics and Microsurgery of Glaucoma

location_facility: Hospital Universitario Miguel Servet Ophthalmology Department

location_facility: Ophthalmology Service - Batiment R Hospital de la Croix-Rousse

location_facility: Centre ophtalmologique Pole vision val d'ouest

location_facility: University of Debrecen, Clinical Center, Ophthalmology Department

location_facility: University Medical Center Freiburg, Eye Center,Killianstr.5, Freiburg i. Breisgau

location_facility: Ophthalmology Department Hospital Universitario Rio Hortega

location_facility: Signes Ozolinas Doctor Practice in Ophthalmology

location_facility: Hospital Universitario de Torrevieja Ophthalmology Department

location_facility: CHU de Nantes-Hospital Hotel Dieu Ophthalmology Service

location_facility: Universitats-Augenklinik, Studienzentrum/Clinical Trials in Opthalmology (CTO)

location_facility: Guy's & St Thomas' NHS Foundation Trust Glaucoma Research Area

location_facility: University of Szeged, Department of Ophthalmology

location_facility: Department of Medicine and Surgery University of Parma

location_facility: Department of Ophthalmology Semmelweis University

location_facility: Military Institute of Medicine Klinika Okulistyki

location_facility: State Hospital - University Medical Center Academical Department of Ophthalmology

location_facility: Cambridge University Hospitals NHS Trust

location_facility: UZ Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven

location_facility: Ophthalmology department Necker University Hospital-Enfants Malades

location_facility: Professor K. Gibinski University Clinical Centre

location_facility: Ophthamic Clinic of the University of Pavia, IRCCS Foundation San Matteo Policlinic

location_facility: Hospital Universitario Virgen Macarena Ophthalmology Department

location_facility: Ophthalmology Service Centre Francois Xavier Michelet CHU Pellegrin

location_facility: S.C.U Oculistica, Azienda Ospedaliero Universitaria, Città della Salute e della Scienza

location_facility: Hospital General del S.A.S. de Jerez de la Frontera

location_facility: University Eye Hospital Tuebingen, STC eyetrial at the center for Ophthalmolgy

location_facility: Ophthalmology Department, Queen Alexandra Hospital

location_facility: Mid-Cheshire Hospitals NHS Foundation Trust

location_facility: Politecnico Gianbattista Rossi AOUI Ospedale Borgo Roma

location_facility: Hospital General de Catalunya Ophthalmology Department

location_facility: Markusovszky University Teaching Hospital


title: BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

lead_sponsor: Bayer

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
United Kingdom
Canada
Finland
Switzerland
Sweden
Hungary
France
Israel
Belgium
Norway
Germany
Czechia

location_facility: Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Instituto Português de Oncologia Francisco Gentil - Coimbra

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Universitätsklinik Gießen und Marburg GmbH

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Helse Bergen HF Haukeland universitetssjukehus

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Szent-Gyorgyi Albert Orvostudomanyi Egyetem

location_facility: Peterfy Sandor utcai Korhaz - Rendelointezet

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: Universitätsmedizin der Georg-August-Universität Göttingen

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: IRCCS Ist Neurologico Nazionale C.Mondino

location_facility: Klinikum der Universität München Grosshadern

summary:
The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.

This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.


title: A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia

acronym: PANTHER

summary: The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).

ReferenceCitation: Adès L, Girshova L, Doronin VA, Díez-Campelo M, Valcárcel D, Kambhampati S, Viniou NA, Woszczyk D, De Paz Arias R, Symeonidis A, Anagnostopoulos A, Munhoz EC, Platzbecker U, Santini V, Fram RJ, Yuan Y, Friedlander S, Faller DV, Sekeres MA. Pevonedistat plus azacitidine vs azacitidine alone in higher-risk MDS/chronic myelomonocytic leukemia or low-blast-percentage AML. Blood Adv. 2022 Sep 13;6(17):5132-5145. doi: 10.1182/bloodadvances.2022007334.

lead_sponsor: Takeda

location_country:
Poland
Brazil
Spain
Greece
Italy
Australia
Mexico
Canada
Russian Federation
United Kingdom
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Turkey
Czechia

location_facility: University of North Carolina at Chapel Hill

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Weill Cornell Medical Center - Monitoring Location

location_facility: Rocky Mountain Cancer Centers (Longmont) - USOR

location_facility: New Jersey Hematology Oncology Associates LLC

location_facility: Chonnam National University Hwasun Hospital

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii I Transplantologii, Budynek Centrum Medycyny N

location_facility: North-West Federal Medical Research Center n.a. V.A. Almazov

location_facility: Rocky Mountain Cancer Centers (Williams) - USOR

location_facility: Presbyterian Saint Lukes Medical Center Laboratory

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc

location_facility: Rocky Mountain Cancer Centers (Denver) - USOR

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Rocky Mountain Cancer Centers (Colorado Springs) - USOR

location_facility: Tennessee Oncology - GALLATIN - SCRI - PPDS

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Tennessee Oncology SKYLINE - SCRI - PPDS

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

location_facility: Baptist Health System (N Kendall) - USOR

location_facility: Oncology Hematology Care, Inc - Fairfield

location_facility: Rocky Mountain Cancer Centers (Thornton) - USOR

location_facility: Kobe City Medical Center General Hospital

location_facility: Florida Cancer Specialists - NORTH - SCRI - PPDS

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: Marien Hospital Akademisches Lehrkrankenhaus

location_facility: Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR

location_facility: Texas Oncology - San Antonio Medical Center - USOR

location_facility: Rocky Mountain Cancer Centers (Littleton) - USOR

location_facility: Tennessee Oncolgy - BAPTIST - SCRI - PPDS

location_facility: Universidade Federal do Rio de Janeiro - UFRJ

location_facility: ICO lHospitalet Hospital Duran i Reynals

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Arizona Oncology Associates (Wilmot HOPE) - USOR

location_facility: Saint Alphonsus Caldwell Cancer Care Center

location_facility: Arizona Oncology Associates (Orange HOPE) - USOR

location_facility: Tennessee Oncology - DICKSON - SCRI - PPDS

location_facility: Rocky Mountain Cancer Centers (Parker) - USOR

location_facility: Tennessee Oncology - SUMMIT - SCRI - PPDS

location_facility: Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital

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

location_facility: Rocky Mountain Cancer Centers (Lakewood) - USOR

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Winship Cancer Institute, Emory University

location_facility: Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Capital Humano para Investigacion Clinica SC

location_facility: Rocky Mountain Cancer Centers (Pueblo) - USOR

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

location_facility: Rocky Mountain Cancer Centers (Lone Tree) - USOR

location_facility: University of Miami Miller School of Medicine

location_facility: Compassionate Cancer Care Medical Group Inc

location_facility: Tennessee Oncology - SHELBYVILLE - SCRI - PPDS

location_facility: Sarah Cannon Center for Blood Centers - SCRI - PPDS

location_facility: Rocky Mountain Cancer Centers (Aurora) - USOR

location_facility: Greenville Health System Cancer Institute

location_facility: Arizona Oncology Associates (Rudasill HOPE) - USOR

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Tennessee Oncology - MURFREESBORO - SCRI - PPDS

location_facility: IRCCS Centro Di Riferimento Oncologico Della Basilicata

location_facility: Tennessee Oncology - SMYRNA - SCRI - PPDS

location_facility: Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR

location_facility: Complejo Asistencial Universitario de Leon

location_facility: University of Texas Southwestern Medical Center

location_facility: Rocky Mountain Cancer Centers (Boulder) - USOR

location_facility: Tennessee Oncology - FRANKLIN - SCRI - PPDS

location_facility: Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS

location_facility: Tennessee Oncology - LEBANON - SCRI - PPDS

location_facility: Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS

location_facility: Southeastern Regional Medical Center - CTCA - PPDS


title: A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

lead_sponsor: AbbVie

ReferenceCitation: Dalton KM, Krytska K, Lochmann TL, Sano R, Casey C, D'Aulerio A, Khan QA, Crowther GS, Coon C, Cai J, Jacob S, Kurupi R, Hu B, Dozmorov M, Greninger P, Souers AJ, Benes CH, Mossé YP, Faber AC. Venetoclax-based Rational Combinations are Effective in Models of MYCN-amplified Neuroblastoma. Mol Cancer Ther. 2021 Aug;20(8):1400-1411. doi: 10.1158/1535-7163.MCT-20-0710. Epub 2021 Jun 4.

ReferenceCitation: Place AE, Goldsmith K, Bourquin JP, Loh ML, Gore L, Morgenstern DA, Sanzgiri Y, Hoffman D, Zhou Y, Ross JA, Prine B, Shebley M, McNamee M, Farazi T, Kim SY, Verdugo M, Lash-Fleming L, Zwaan CM, Vormoor J. Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies. Future Oncol. 2018 Sep;14(21):2115-2129. doi: 10.2217/fon-2018-0121. Epub 2018 Mar 29.

location_country:
United Kingdom
Australia
Netherlands
Canada
Switzerland
United States
France
Germany

location_facility: CHU Toulouse - Hôpital des enfants /ID# 163727

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161729

location_facility: Dana-Farber Cancer Institute /ID# 163440

location_facility: AP-HM - Hopital de la Timone /ID# 161465

location_facility: Kinderspital Zurich - Eleonorenstiftung /ID# 163037

location_facility: Children's Healthcare of Atlan /ID# 161552

location_facility: St Jude Children's Research Hospital /ID# 163447

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 161730

location_facility: Cincinnati Children's Hospital /ID# 161550

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 162938

location_facility: Children's Hospital Colorado /ID# 161551

location_facility: Great Ormond Street Hospital for Children /ID# 169238

location_facility: Universitaetsklinikum Freiburg /ID# 164206

location_facility: Medical College of Wisconsin /ID# 163461

location_facility: Women and Childrens Hospital /ID# 163147

location_facility: AP-HP - Hopital Armand-Trousseau /ID# 163728

location_facility: Univ California, San Francisco /ID# 163460

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444

location_facility: Queensland Children's Hospital /ID# 163146

location_facility: Children's Hospital of Philadelphia /ID# 163445

summary: An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.


title: Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis

acronym: OPTIMUM-LT

summary: The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

lead_sponsor: Actelion

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Czechia
Poland
Portugal
Russian Federation
Israel
Turkey
Mexico
Sweden
Bosnia and Herzegovina
Canada
Hungary
Germany
Bulgaria
Belarus
Greece
Georgia
Latvia
Finland
France

location_facility: State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin

location_facility: State Budgetary Healthcare Institution Kursk Region Kursk Regional Clinical Hospital

location_facility: NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna

location_facility: Military Medical Academy, Multiprofile Hospital for Active Treatment -Sofia

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Federal Scientific Clinical Center of Physico-Chemical Medicine

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Public Institution Vinnitsa O.I. Yuschenko Regional Neuropsychiatric Hospital

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'

location_facility: Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.

location_facility: Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'

location_facility: Siberian District Medical Center of Federal Medical-Biological Agency

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: WroMedica I.Bielicka, A.Strzałkowska s.c.

location_facility: Limited Liability Company 'Neuro Global'

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: Perm State Medical Academy n.a. E. A. Vagner

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska EAD

location_facility: Kharkiv Postgrad Academy, Dept of Neurology #1 At Hosp #7

location_facility: Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Nuam

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Rīgas Austrumu klīniskā universitātes slimnīca

location_facility: Public Non-Profit Enterprise: Lviv City Clinical Hospital #5

location_facility: Clinical Research Center sp. z o.o MEDIC-R s.k.

location_facility: O.F. Herbachevskyi Regional Clinical Hospital

location_facility: Josephson Wallack Munshower Neurology, PC

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Hospital Regional Universitario de Malaga

location_facility: National Research Center for Radiation Medicine

location_facility: The Research Center of Southern California, LLC

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy

location_facility: Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb

location_facility: St Ivan Rilski University Multiprofile Hospital For Active Treatment

location_facility: Municipal health care institution Chernihiv Regional Hospital

location_facility: Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu'

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Public Non-profit Enterprise: Chernihiv City Hospital #4 under Chernihiv City Council

location_facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied


title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Adaptive Dose-Finding Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

ReferenceCitation: Savitz A, Wajs E, Zhang Y, Xu H, Etropolski M, Thase ME, Drevets WC. Efficacy and Safety of Seltorexant as Adjunctive Therapy in Major Depressive Disorder: A Phase 2b, Randomized, Placebo-Controlled, Adaptive Dose-Finding Study. Int J Neuropsychopharmacol. 2021 Dec 8;24(12):965-976. doi: 10.1093/ijnp/pyab050.

location_country:
Russian Federation
Finland
Ukraine
United States
France
Japan
Germany
Bulgaria

location_facility: National Center for Global Health and Medicine, Kohnodai hospital

location_facility: Neurologische Praxis Dr. Schoell & Kollegen

location_facility: CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU

location_facility: Poltava O.F. Maltsev RC Psychiatric Hospital Dept #9 (Ad-P Dept) HSEIU Ukrainian MSA

location_facility: St-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

location_facility: CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

location_facility: Clinical Psychiatry Hospital n.a. N.N. Solodovnikov

location_facility: Sverdlov Regional Psychiatric Clinical Hospital

location_facility: Velocity Clinical Research, Hallandale Beach

location_facility: CI Odesa Regional Medical Center of Mental Health

location_facility: Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

location_facility: City Psychiatric Hospital of St. Nikolay Chudotvorets

location_facility: Synergy Clinical Research Center Of Escondido

location_facility: Mental Health Center - Veliko Tarnovo EOOD

location_facility: CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'

location_facility: Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: CNCE Odesa regional psychiatric hospital #2 Odesa regional council

location_facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

location_facility: California Pharmaceutical Research Institute, Inc.

location_facility: Closed corporation 'Scientific Center of Personalized Psychiatry'

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia

location_facility: Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)

location_facility: SHI Arkhangelsk Regional Clinical Psychiatric Hospital

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez

location_facility: University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

location_facility: Medical and Rehabilitation Research Center Phoenix

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: State Psychiatric Hospital - Tzarev Brod

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: Mental Health Center Prof. Dr. Ivan Temkov

summary: The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.


title: A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

summary: CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.

lead_sponsor: Checkpoint Therapeutics, Inc.

location_country:
Poland
Spain
Russian Federation
New Zealand
Australia
Thailand
Ukraine
France
South Africa


title: A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

acronym: EPITOPE

summary: The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

lead_sponsor: DBV Technologies

location_country:
United Kingdom
Ireland
Australia
Netherlands
Canada
United States
France
Germany

location_facility: Ann & Robert H. Lurie Children's Hospital of CHicago

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

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Riley Hospital for Children at Indiana University

location_facility: Baylor College of Medicine - Texas Children's Hospital

location_facility: University of California School of Medicine

location_facility: The University of North Carolina - Chapell Hill

location_facility: University of California, Rady Children's Hospital


title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma

summary:
Primary Objectives:

To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.
To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria.

Secondary Objectives:

To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS).
To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination.
To assess the immunogenicity of isatuximab and cemiplimab when given in combination.

location_country:
Brazil
Spain
Greece
Italy
Australia
Canada
Hungary
United States
France
Czechia

location_facility:
Investigational Site Number 2500002
Investigational Site Number 8400003
Investigational Site Number 0360003
Investigational Site Number 2030001
Investigational Site Number 2500003
Investigational Site Number 3800002
Investigational Site Number 2500001
Investigational Site Number 1240003
Investigational Site Number 8400004
Investigational Site Number 2500005
Investigational Site Number 1240005
Investigational Site Number 0760003
Investigational Site Number 0360002
Investigational Site Number 1240001
Investigational Site Number 7240003
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 2500004
Investigational Site Number 0760004
Investigational Site Number 3000001
Investigational Site Number 3800003
Investigational Site Number 2030003
Investigational Site Number 0360001
Investigational Site Number 3800005
Investigational Site Number 2030002
Investigational Site Number 3480002
Investigational Site Number 0760001
Investigational Site Number 7240002
Investigational Site Number 7240006
Investigational Site Number 3800001
Investigational Site Number 7240004
Investigational Site Number 7240005


title: A Phase-2 Study To Determine Efficacy and Safety of Luspatercept in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With or Without Red Blood Cell-Transfusion Dependence

summary: This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.

lead_sponsor: Celgene

location_country:
United States
Italy
United Kingdom
France

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: University of Texas Health Science Center at San Antonio

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Mid Florida Hematology and Oncology Centers, PA

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


title: A Phase 1 / 2 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

summary: This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.

ReferenceType: result

ReferenceCitation: Perets R, Bar J, Rasco DW, Ahn MJ, Yoh K, Kim DW, Nagrial A, Satouchi M, Lee DH, Spigel DR, Kotasek D, Gutierrez M, Niu J, Siddiqi S, Li X, Cyrus J, Chackerian A, Chain A, Altura RA, Cho BC. Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer. Ann Oncol. 2021 Mar;32(3):395-403. doi: 10.1016/j.annonc.2020.11.020. Epub 2020 Dec 2.

ReferenceCitation: Cho BC, Yoh K, Perets R, Nagrial A, Spigel DR, Gutierrez M, Kim DW, Kotasek D, Rasco D, Niu J, Satouchi M, Ahn MJ, Lee DH, Maurice-Dror C, Siddiqi S, Ren Y, Altura RA, Bar J. Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer. Lung Cancer. 2021 Sep;159:162-170. doi: 10.1016/j.lungcan.2021.07.009. Epub 2021 Jul 18.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Spain
Greece
Italy
Australia
New Zealand
Canada
Sweden
Korea, Republic of
United States
Chile
China
France
Israel
Japan
South Africa

location_facility: Fundacion Arturo Lopez Perez ( Site 5601)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 2701)

location_facility: Hospital Universitario Virgen de la Macarena ( Site 3402)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4801

location_facility: Severance Hospital Yonsei University Health System ( Site 0008)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 3405)

location_facility: Banner MD Anderson Cancer Center ( Site 0013)

location_facility: McGill University Health Centre ( Site 1101)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 3903)

location_facility: Regional General Hospital of Athens "Laiko" ( Site 3001)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 3905)

location_facility: Melanoma Institute Australia ( Site 0017)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 3403)

location_facility: Ashford Cancer Centre Research ( Site 0012)

location_facility: Hospital General Universitario de Valencia ( Site 3404)

location_facility: Chongqing Cancer Hospital-Phase 1 Unite ( Site 5004)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 3302)

location_facility: Seoul National University Hospital ( Site 0007)

location_facility: Canterbury District Health Board ( Site 0023)

location_facility: Princess Margaret Cancer Centre ( Site 1104)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 3907)

location_facility: National Cancer Center Hospital East ( Site 0014)

location_facility: Tennessee Oncology Nashville ( Site 0004)

location_facility: Beijing Cancer hospital-Digestive Oncology ( Site 5001)

location_facility: Skanes Universitetssjukhus Lund. ( Site 4601)

location_facility: Cairns and Hinterland Hospital and Health Service ( Site 0020)

location_facility: Sunnybrook Research Institute ( Site 1103)

location_facility: Cancercare Rondebosch Oncology ( Site 2706)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0021)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 5003)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 3307)

location_facility: Hospital Clinic i Provincial de Barcelona ( Site 3401)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 4803)

location_facility: Sheba Medical Center - Cancer Center ( Site 0002)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1102)

location_facility: Blacktown Hospital. Western Sydney local health district ( Site 0009)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 2704)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)

location_facility: South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

location_facility: Inova Schar Cancer Institute ( Site 1001)


title: A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

acronym: SERENADE

summary:
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.

The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

location_country:
Denmark
Poland
Brazil
Spain
United Kingdom
Austria
Russian Federation
Argentina
Sweden
Hungary
United States
France
Israel
Romania
Germany
Bulgaria
Czechia

location_facility: Washington University School of Medicine

location_facility: Specialized Hospital for Active Treatment in Cardiology - Pleven

location_facility: Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III

location_facility: Federal State Budget Scientific Institution

location_facility: Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika

location_facility: University of North Carolina (UNC) - School of Medicine

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Vascular Medicine Institute University Of Pittsburgh

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Herzzentrum Uniklinik Köln Klinik III für Innere Medizin

location_facility: General University Hospital II.department of Internal Medicine-cardiology and angiology

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: State Healthcare Institution, Regional Clinical Cardiology Dispensary

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: Instituto de Moléstias Cardiovasculares Tatuí

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Maestri E Kormann Consultoria Médico- Científica Ltda

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: Multiprofile Hospital for Active Treatment - National Heart Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: State Autonomous Healthcare Institution Of Yaroslavl Region

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie


title: A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

acronym: PROPEL

summary:
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy.

The study is comprised of two groups; dose optimization and dose expansion cohorts.

Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC)

The dose expansion cohort will include first-line NSCLC patients.

ipd_sharing: Undecided

lead_sponsor: Nektar Therapeutics

location_country:
Spain
Italy
Australia
United States
France
Germany

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Washington University School of Medicine in St. Louis

location_facility: Southern Illinois University (SIU) School of Medicine

location_facility: New York University Langone Medical Center

location_facility: Froedtert & the Medical College of Wisconsin Froedtert Hospital

location_facility: Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)

location_facility: Augusta University - Augusta University Medical Center

location_facility: Highlands Oncology Group, PA - North Hills

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Park Nicollet - Frauenshuh Cancer Center

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Hospital Universitari i Politècnic La Fe