title: A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study

acronym: SIDEROS-E

summary: The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

family: Buyse

full_name: Gunnar M Buyse

given: Gunnar M

family: Voit

full_name: Thomas Voit

given: Thomas

family: Schara

full_name: Ulrike Schara

given: Ulrike

family: Straathof

full_name: Chiara S M Straathof

given: Chiara S M

family: D'Angelo

full_name: M Grazia D'Angelo

given: M Grazia

family: Bernert

full_name: Günther Bernert

given: Günther

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Finkel

full_name: Richard S Finkel

given: Richard S

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

family: McDonald

full_name: Craig M McDonald

given: Craig M

family: Rummey

full_name: Christian Rummey

given: Christian

family: Meier

full_name: Thomas Meier

journal_name: The Lancet

ReferenceCitation: McDonald CM, Meier T, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Spagnolo P, Buyse GM; DELOS Study Group. Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2016 Aug;26(8):473-80. doi: 10.1016/j.nmd.2016.05.008. Epub 2016 May 12.

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Mayer OH, Spagnolo P, Meier T, McDonald CM; DELOS Study Group. Treatment effect of idebenone on inspiratory function in patients with Duchenne muscular dystrophy. Pediatr Pulmonol. 2017 Apr;52(4):508-515. doi: 10.1002/ppul.23547. Epub 2016 Aug 29.

ReferenceCitation: Mayer OH, Leinonen M, Rummey C, Meier T, Buyse GM; DELOS Study Group. Efficacy of Idebenone to Preserve Respiratory Function above Clinically Meaningful Thresholds for Forced Vital Capacity (FVC) in Patients with Duchenne Muscular Dystrophy. J Neuromuscul Dis. 2017;4(3):189-198. doi: 10.3233/JND-170245.

lead_sponsor: Santhera Pharmaceuticals

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

location_facility: Children's Hospital Boston, Harvard Medical School, Department of Neurology

location_facility: Servizio di Cardiomiologia e Genetica Medica AOU Università degli Studi della Campania Luigi Vanvitelli

location_facility: Clinical Research Facility Level 6 Leazes Wing Royal Victoria Infirmary

location_facility: Dipartimento di Clinica Neurologica e Psichiatrica dell'Eta Evolutiva della Fondazione IRCCS "C. Mondino" di Pavia

location_facility: Centro Clinico NEMO (NEuroMuscular Omnicentre), Niguarda Hospital

location_facility: Hospital La Fe de Valencia Avinguda de Fernando Abril Martorell Servicio de Neurologia Torre D

location_facility: Center for Integrative Rare Disease Research, Rare Disease Research, LLC

location_facility: Banner University of Arizona Medical Center

location_facility: Hôpital des enfants, Pédiatrie Neurologie et infectiologie Pôle enfants

location_facility: Hôpital Hôtel Dieu, Service Explorations Fonctionnelles - Centre de Référence de Maladies Neuromusculaires rares

location_facility: Gillette Children's Specialty Healthcare

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital

location_facility: UCL, National Hospital for Neurology and Neurosurgery

location_facility: Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System

location_facility: Center for neuromuscular disorders, Universitäts-Kinderspital beider Basel (UKBB)

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac, Département de pédiatrie - neuropédiatrie

location_facility: U.O. Malattie Neuromuscolari, Istituto Giannina Gaslini

location_facility: University of Alabama - Birmingham, Child Health Research

location_facility: Children's Hospital of Philadelphia, Division of Pulmonology

location_facility: Hospital Sant Joan de Deu Neuropediatra, Unidad de patologia nueromuscular, Servicio de Neurologia

location_facility: I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20, 2ème étage

location_facility: Scientific Coordinator Nemo Sud Clinical CenterAOU Policlinico "G. Martino"

location_facility: University of Iowa, Department of Pediatrics

location_facility: Center for neuromuscular disorders, Dr. v. Haunersche Kinderklinik, Universität München

location_facility: Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Great Ormond Street Hospital for Children

location_facility: UC Davis Department of Physical Medicine and Rehabilitation

location_facility: Reparto Di Neurologia dell'Osperdale Di Padova

location_facility: University Medical Center Hamburg - Eppendorf, Department of Paediatrics


title: Limiting AKI Progression In Sepsis (LAPIS): A Phase 4, Multicenter, Randomized Controlled Trial of Biomarker-guided Delivery of Kidney-sparing Care Measures in Sepsis Subjects at Risk of Developing AKI

acronym: LAPIS

summary: Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Molinari L, Heskia F, Peerapornratana S, Ronco C, Guzzi L, Toback S, Birch R, Beyhaghi H, Kwan T, Kampf JP, Yealy DM, Kellum JA; Sapphire and Protocolized Care for Early Septic Shock (ProCESS) Investigators. Limiting Acute Kidney Injury Progression In Sepsis: Study Protocol and Trial Simulation. Crit Care Med. 2021 Oct 1;49(10):1706-1716. doi: 10.1097/CCM.0000000000005061.

family: Molinari

full_name: Luca Molinari

given: Luca

sequence: first

family: Heskia

full_name: Fabienne Heskia

given: Fabienne

sequence: additional

family: Peerapornratana

full_name: Sadudee Peerapornratana

given: Sadudee

family: Ronco

full_name: Claudio Ronco

given: Claudio

family: Guzzi

full_name: Louis Guzzi

given: Louis

family: Toback

full_name: Seth Toback

given: Seth

family: Birch

full_name: Robert Birch

given: Robert

family: Beyhaghi

full_name: Hadi Beyhaghi

given: Hadi

family: Kwan

full_name: Thomas Kwan

family: Kampf

full_name: J. Patrick Kampf

given: J. Patrick

family: Yealy

full_name: Donald M. Yealy

given: Donald M.

family: Kellum

full_name: John A. Kellum

given: John A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: BioMérieux

location_country:
Germany
United States
Belgium
France

location_facility: LSU Health Sciences Center, 1541 Kings Highway

location_facility: Universitatsklinikum Munster, Albert-Schweitzer-Campus 1

location_facility: Hôpital Erasme, Soins Intensifs, Route de Lennik 808

location_facility: AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10

location_facility: Memorial Sloan Kettering Cancer Center, 1275 York Avenue

location_facility: Hopital Cochin, 27 Rue Du Faubourg Saint Jacques

location_facility: CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel

location_facility: Brigham and Womens Hospital, 75 Francis Street

location_facility: Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque

location_facility: University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110

location_facility: Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting

summary: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

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

lead_sponsor: Pfizer

location_country:
Italy
Brazil
France
Greece
Russian Federation
Spain
Colombia

location_facility: BUZ UR First Republican Clinical Hospital under the Ministry of Healthcare of Udmurt Republic UR

location_facility: E.S.E. Hospital Universitario San Jorge de Pereira

location_facility: Aou Citta Della Salute E Della Scienza Scdu Malattie Infettive 2

location_facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa

location_facility: Asst Spedali Civili Brescia and Universita Degli Studi di Brescia

location_facility: Croix-Rousse hospital, Hospices Civils de Lyon

location_facility: AORN Ospedali dei Colli - Ospedale Monaldi

location_facility: AHEPA General University Hospital of Thessaloniki

location_facility: Republican Clinical Hospital named after G.G. Kuvatova

intervention_type: Drug

status_simplified: Completed


type: EudraCT Number

title: A Phase 1 Study of BOS172738 in Patients With Advanced Solid Tumors With RET Gene Alterations Including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC)

summary: This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.

status: Active, not recruiting

primary_purpose: Treatment

lead_sponsor: Boston Pharmaceuticals

location_country:
Hong Kong
France
Belgium
Spain
United States
Korea, Republic of
Taiwan

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: START MADRID-FJD, Hospital Fundación Jiménez Díaz

location_facility: Seoul National University Bundang Hospital

location_facility: Severance Hospital, Yonsei University College of Medicine


title: A Phase 1b Open-Label Study Assessing the Pharmacokinetics, Tolerability, and Safety of Oral Trimetazidine in Subjects With Acute-on-Chronic Liver Failure

acronym: TRUST

summary: The study will assess the pharmacokinetics (PK), tolerability, and safety of oral trimetazidine administered to subjects with AD (ACLF Grade 0) or with ACLF Grade 1 or 2.

status: Suspended

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Martin Pharmaceuticals

location_country: Austria France Belgium Spain Germany

location_facility: Hospital Marques de Valdecilla Santander

location_facility: Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin I

status_simplified: Unknown


ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Switzerland
France
Poland
Israel
Singapore
Belgium
Russian Federation
New Zealand
Spain
Turkey
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

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

location_facility: Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Hopital Timone Adultes; Oncologie Medicale Et Usp

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

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

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: National Cancer Centre; Medical Oncology

location_facility: University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

ipd_sharing: Yes

source: euctr

title: An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors

summary: This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on patients with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.


location_country: Sweden Netherlands France Czechia Poland Norway Spain Denmark Germany

location_facility: Fakultni nemocnice Ostrava; Klinika hematoonkologie

location_facility: Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze - 1; Lekarska Fakulta - I

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

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Uniwersytet Medyczny im.Karola Marcinkowskiego w Poznaniu

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: Medical University School; Dept. of Haematology

title: A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma

summary: This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety run-in phase of the study. Once the dose levels have demonstrated acceptable safety during this phase, randomization will begin for all treatment arms (Arms A, B, and C).


title: Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

acronym: PIPACRegis

summary: Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Graversen M, Detlefsen S, Bjerregaard JK, Pfeiffer P, Mortensen MB. Peritoneal metastasis from pancreatic cancer treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC). Clin Exp Metastasis. 2017 Jun;34(5):309-314. doi: 10.1007/s10585-017-9849-7. Epub 2017 May 17.

ReferenceCitation: Grass F, Vuagniaux A, Teixeira-Farinha H, Lehmann K, Demartines N, Hübner M. Systematic review of pressurized intraperitoneal aerosol chemotherapy for the treatment of advanced peritoneal carcinomatosis. Br J Surg. 2017 May;104(6):669-678. doi: 10.1002/bjs.10521. Review.

ReferenceCitation: Hübner M, Teixeira Farinha H, Grass F, Wolfer A, Mathevet P, Hahnloser D, Demartines N. Feasibility and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:6852749. doi: 10.1155/2017/6852749. Epub 2017 Feb 26.

ReferenceCitation: Teixeira Farinha H, Grass F, Kefleyesus A, Achtari C, Romain B, Montemurro M, Demartines N, Hübner M. Impact of Pressurized Intraperitoneal Aerosol Chemotherapy on Quality of Life and Symptoms in Patients with Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:4596176. doi: 10.1155/2017/4596176. Epub 2017 Feb 21.

ReferenceCitation: Tempfer CB, Hartmann F, Hilal Z, Rezniczek GA. Intraperitoneal cisplatin and doxorubicin as maintenance chemotherapy for unresectable ovarian cancer: a case report. BMC Cancer. 2017 Jan 6;17(1):26. doi: 10.1186/s12885-016-3004-8.

ReferenceCitation: Girshally R, Demtröder C, Albayrak N, Zieren J, Tempfer C, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) as a neoadjuvant therapy before cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. World J Surg Oncol. 2016 Sep 27;14(1):253.

ReferenceCitation: Graversen M, Pfeiffer P, Mortensen MB. [Treatment of peritoneal carcinomatosis with pressurized intraperitoneal aerosol chemotherapy]. Ugeskr Laeger. 2016 May 23;178(21). pii: V11150928. Review. Danish.

ReferenceCitation: Robella M, Vaira M, De Simone M. Safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) associated with systemic chemotherapy: an innovative approach to treat peritoneal carcinomatosis. World J Surg Oncol. 2016 Apr 29;14:128. doi: 10.1186/s12957-016-0892-7.

ReferenceCitation: Tempfer CB, Rezniczek GA, Ende P, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy with Cisplatin and Doxorubicin in Women with Peritoneal Carcinomatosis: A Cohort Study. Anticancer Res. 2015 Dec;35(12):6723-9.

ReferenceCitation: Nadiradze G, Giger-Pabst U, Zieren J, Strumberg D, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Low-Dose Cisplatin and Doxorubicin in Gastric Peritoneal Metastasis. J Gastrointest Surg. 2016 Feb;20(2):367-73. doi: 10.1007/s11605-015-2995-9. Epub 2015 Oct 28.

ReferenceCitation: Demtröder C, Solass W, Zieren J, Strumberg D, Giger-Pabst U, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis. Colorectal Dis. 2016 Apr;18(4):364-71. doi: 10.1111/codi.13130.

ReferenceCitation: Hübner M, Teixeira H, Boussaha T, Cachemaille M, Lehmann K, Demartines N. [PIPAC--Pressurized intraperitoneal aerosol chemotherapy. A novel treatment for peritoneal carcinomatosis]. Rev Med Suisse. 2015 Jun 17;11(479):1325-30. French.

ReferenceCitation: Odendahl K, Solass W, Demtröder C, Giger-Pabst U, Zieren J, Tempfer C, Reymond MA. Quality of life of patients with end-stage peritoneal metastasis treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). Eur J Surg Oncol. 2015 Oct;41(10):1379-85. doi: 10.1016/j.ejso.2015.06.001. Epub 2015 Jun 21.

ReferenceCitation: Tempfer CB, Solass W, Buerkle B, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in a woman with pseudomyxoma peritonei: A case report. Gynecol Oncol Rep. 2014 Oct 18;10:32-5. doi: 10.1016/j.gore.2014.10.001. eCollection 2014 Dec.

ReferenceCitation: Giger-Pabst U, Solass W, Buerkle B, Reymond MA, Tempfer CB. Low-dose pressurized intraperitoneal aerosol chemotherapy (PIPAC) as an alternative therapy for ovarian cancer in an octogenarian patient. Anticancer Res. 2015 Apr;35(4):2309-14.

ReferenceCitation: Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.

ReferenceCitation: Sabaila A, Fauconnier A, Huchon C. [Pressurized intraperitoneal aerosol chemotherapy (PIPAC): a new way of administration in peritoneal carcinomatosis of ovarian cancer]. Gynecol Obstet Fertil. 2015 Jan;43(1):66-7. doi: 10.1016/j.gyobfe.2014.11.012. Epub 2014 Dec 15. French.

ReferenceCitation: Tempfer CB, Solass W, Reymond MA. Pressurized intraperitoneal chemotherapy (PIPAC) in women with gynecologic malignancies: a review. Wien Med Wochenschr. 2014 Dec;164(23-24):519-28. doi: 10.1007/s10354-014-0312-y. Epub 2014 Sep 24. Review.

ReferenceCitation: Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.

ReferenceCitation: Solass W, Kerb R, Mürdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.

ReferenceCitation: Kurtz F, Struller F, Horvath P, Solass W, Bösmüller H, Königsrainer A, Reymond MA. Feasibility, Safety, and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastasis: A Registry Study. Gastroenterol Res Pract. 2018 Oct 24;2018:2743985. doi: 10.1155/2018/2743985. eCollection 2018.

name: Dept. of General Surgery, Karls-Eberhard University Tübingen, Germany

family: Kurtz

full_name: Florian Kurtz

given: Florian

family: Struller

full_name: Florian Struller

family: Horvath

full_name: Philipp Horvath

given: Philipp

name: Institute of Pathology, Karls-Eberhard University Tübingen, Germany

family: Solass

full_name: Wiebke Solass

given: Wiebke

family: Bösmüller

full_name: Hans Bösmüller

given: Hans

family: Königsrainer

full_name: Alfred Königsrainer

given: Alfred

name: National Center for Pleura and Peritoneum, Comprehensive Cancer Center South-Western Germany, Tübingen, Stuttgart, Germany

family: Reymond

full_name: Marc A. Reymond

given: Marc A.

currency_apc_doaj: USD

journal_name: Gastroenterology Research and Practice

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

ipd_sharing_description: Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany

lead_sponsor: Sabine Rhode

location_country:
Italy
Austria
Switzerland
Spain
France
Poland
Singapore
Argentina
Australia
Belgium
Russian Federation
Denmark
Germany

location_facility:
Roffo Cancer Institute
Gersten Institute for Cancer Research
University Hospital Odense
Peter MacCallum Cancer Centre
Hospices civils de Lyon
University Hospital Tübingen
F. Łukaszczyk Oncology Centre
Centre du Cancer
Hospital de Pilar
National University Hospital
University Hospital Gent (UZ Gent)
IRCC Torino Candiolo
Centre Hospitalier Universitaire
SALK - Salzburger Landeskliniken
University Hospital Lausanne CHUV

intervention_type: Combination Product


type: Other Identifier

title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

summary: The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).

ReferenceCitation: Zoulim F, Lenz O, Vandenbossche JJ, Talloen W, Verbinnen T, Moscalu I, Streinu-Cercel A, Bourgeois S, Buti M, Crespo J, Manuel Pascasio J, Sarrazin C, Vanwolleghem T, Shukla U, Fry J, Yogaratnam JZ. JNJ-56136379, an HBV Capsid Assembly Modulator, Is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients With Chronic Infection. Gastroenterology. 2020 Aug;159(2):521-533.e9. doi: 10.1053/j.gastro.2020.04.036. Epub 2020 Apr 25.

family: Zoulim

full_name: Fabien Zoulim

given: Fabien

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Vandenbossche

full_name: Joris J. Vandenbossche

given: Joris J.

family: Talloen

full_name: Willem Talloen

given: Willem

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Moscalu

full_name: Iurie Moscalu

given: Iurie

family: Streinu-Cercel

full_name: Adrian Streinu-Cercel

given: Adrian

family: Bourgeois

full_name: Stefan Bourgeois

given: Stefan

family: Buti

full_name: Maria Buti

given: Maria

family: Crespo

full_name: Javier Crespo

given: Javier

family: Manuel Pascasio

full_name: Juan Manuel Pascasio

given: Juan

family: Sarrazin

full_name: Christoph Sarrazin

given: Christoph

family: Vanwolleghem

full_name: Thomas Vanwolleghem

given: Thomas

family: Shukla

full_name: Umesh Shukla

given: Umesh

family: Fry

full_name: John Fry

given: John

family: Yogaratnam

full_name: Jeysen Z. Yogaratnam

given: Jeysen Z.

journal_name: Gastroenterology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Vandenbossche J, Jessner W, van den Boer M, Biewenga J, Berke JM, Talloen W, De Zwart L, Snoeys J, Yogaratnam J. Pharmacokinetics, Safety and Tolerability of JNJ-56136379, a Novel Hepatitis B Virus Capsid Assembly Modulator, in Healthy Subjects. Adv Ther. 2019 Sep;36(9):2450-2462. doi: 10.1007/s12325-019-01017-1. Epub 2019 Jul 2. Erratum in: Adv Ther. 2020 Mar 4;:.

full_name: Joris Vandenbossche

given: Joris

family: Jessner

full_name: Wolfgang Jessner

given: Wolfgang

family: van den Boer

full_name: Maarten van den Boer

given: Maarten

location_country:
France
Bulgaria
Malaysia
Georgia
Romania
Belgium
Spain
Moldova, Republic of
Germany
Taiwan


ReferenceCitation: Schwartz DA, Peyrin-Biroulet L, Lasch K, Adsul S, Danese S. Efficacy and Safety of 2 Vedolizumab Intravenous Regimens for Perianal Fistulizing Crohn's Disease: ENTERPRISE Study. Clin Gastroenterol Hepatol. 2021 Sep 29. pii: S1542-3565(21)01042-9. doi: 10.1016/j.cgh.2021.09.028. [Epub ahead of print]

family: Schwartz

full_name: David A. Schwartz

given: David A.

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Lasch

full_name: Karen Lasch

given: Karen

family: Adsul

full_name: Shashi Adsul

given: Shashi

family: Danese

full_name: Silvio Danese

given: Silvio

journal_name: Clinical Gastroenterology and Hepatology

title: Efficacy and Safety of 2 Vedolizumab Intravenous Regimens for Perianal Fistulizing Crohn’s Disease: ENTERPRISE Study

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Takeda

location_country:
Italy
Netherlands
France
Spain
United States
United Kingdom
Canada

acronym: ENTERPRISE

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Nottingham University Hospitals NHS Trust

type: Registry Identifier

title: A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)

summary: The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).


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.

lead_sponsor: Janssen Research & Development, LLC

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

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

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Cancer Center of Central Connecticut - Southington

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

location_facility: Centro de Pesquisa do Instituto do Câncer- Hospital São Vicente de Paulo

location_facility: Avera Medical Group - Oncology & Hematology

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

location_facility: Hospital do Servidor Publico Estadual - IAMSPE

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


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

lead_sponsor: GlaxoSmithKline

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

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

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.


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.

family: Grivas

full_name: P. Grivas

given: P.

family: Loriot

full_name: Y. Loriot

given: Y.

family: Morales-Barrera

full_name: R. Morales-Barrera

given: R.

family: Teo

full_name: M. Y. Teo

given: M. Y.

family: Zakharia

full_name: Y. Zakharia

family: Feyerabend

full_name: S. Feyerabend

given: S.

family: Vogelzang

full_name: N. J. Vogelzang

given: N. J.

family: Grande

full_name: E. Grande

given: E.

family: Adra

full_name: N. Adra

given: N.

family: Alva

full_name: A. Alva

given: A.

family: Necchi

full_name: A. Necchi

family: Rodriguez-Vida

full_name: A. Rodriguez-Vida

family: Gupta

full_name: S. Gupta

family: Josephs

full_name: D. H. Josephs

given: D. H.

family: Srinivas

full_name: S. Srinivas

family: Wride

full_name: K. Wride

given: K.

family: Thomas

full_name: D. Thomas

given: D.

family: Simmons

full_name: A. Simmons

family: Loehr

full_name: A. Loehr

family: Dusek

full_name: R. L. Dusek

given: R. L.

family: Nepert

full_name: D. Nepert

family: Chowdhury

full_name: S. Chowdhury

currency_apc_doaj: GBP

journal_name: BMC Cancer

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

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

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

location_country:
Italy
United States
France
Spain
Germany
United Kingdom

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra

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

location_facility: University of Texas, UT Health Science Center

location_facility: Universitatsklinikum Munster / Urologie und Kinderurologie

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

location_facility: Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS

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

location_facility: University of Virginia, Emily Couric Clinical Center

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

location_facility: The University of Iowa and Holden Comprehensive Cancer Center

location_facility: University of Utah, Huntsman Cancer Institute

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

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

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

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliera Universitaria Federico II Oncologia Medica

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Comprehensive Cancer Centers of Nevada (CCCN)

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

location_facility: Medstar Georgetown University Medical Center

location_facility: Froedtert & Medical College of Wisconsin

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

location_facility: Hospital Universitari Vall d'Hebron de Barcelona

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Eastern Connecticut Hematology & Oncology Associates (ECHO)

location_facility: IRCCS Ospedale San Raffaele - Medical Oncology Dept

location_facility: University of California, Los Angeles (UCLA)

location_facility: Miami Cancer Institute, Baptist Health South Florida

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

location_facility: University of Washington / Seattle Cancer Care Alliance

location_facility: Urologische und Kinderurologische Universitätsklinik im Malteser

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

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

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

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

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.


title: An Exploratory Phase II, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Pertuzumab and Herceptin (Trastuzumab) in Patients With HER2-Positive Metastatic Breast Cancer

summary: This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab will be administered at the same schedule the participant was following before entry into the study. An additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks. These participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.

location_country:
Italy
France
Spain
Canada
United Kingdom


title: A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

summary: This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.

location_country:
United States
France


ReferenceCitation: Dohil R, Fidler M, Barshop BA, Gangoiti J, Deutsch R, Martin M, Schneider JA. Understanding intestinal cysteamine bitartrate absorption. J Pediatr. 2006 Jun;148(6):764-9.

ReferenceCitation: Fidler MC, Barshop BA, Gangoiti JA, Deutsch R, Martin M, Schneider JA, Dohil R. Pharmacokinetics of cysteamine bitartrate following gastrointestinal infusion. Br J Clin Pharmacol. 2007 Jan;63(1):36-40.

ReferenceCitation: Levtchenko EN, van Dael CM, de Graaf-Hess AC, Wilmer MJ, van den Heuvel LP, Monnens LA, Blom HJ. Strict cysteamine dose regimen is required to prevent nocturnal cystine accumulation in cystinosis. Pediatr Nephrol. 2006 Jan;21(1):110-3. Epub 2005 Oct 27.

ReferenceCitation: Langman CB, Greenbaum LA, Grimm P, Sarwal M, Niaudet P, Deschenes G, Cornelissen EA, Morin D, Cochat P, Elenberg E, Hanna C, Gaillard S, Bagger MJ, Rioux P. Quality of life is improved and kidney function preserved in patients with nephropathic cystinosis treated for 2 years with delayed-release cysteamine bitartrate. J Pediatr. 2014 Sep;165(3):528-33.e1. doi: 10.1016/j.jpeds.2014.05.013. Epub 2014 Jun 16.

family: Langman

full_name: Craig B. Langman

given: Craig B.

family: Greenbaum

full_name: Larry A. Greenbaum

given: Larry A.

family: Grimm

full_name: Paul Grimm

given: Paul

family: Sarwal

full_name: Minnie Sarwal

given: Minnie

family: Niaudet

full_name: Patrick Niaudet

given: Patrick

family: Deschenes

full_name: Georges Deschenes

given: Georges

family: Cornelissen

full_name: Elisabeth A.M. Cornelissen

given: Elisabeth A.M.

family: Morin

full_name: Denis Morin

given: Denis

family: Cochat

full_name: Pierre Cochat

given: Pierre

family: Elenberg

full_name: Ewa Elenberg

given: Ewa

family: Hanna

full_name: Christian Hanna

given: Christian

family: Gaillard

full_name: Segolene Gaillard

given: Segolene

family: Bagger

full_name: Mary Jo Bagger

given: Mary Jo

family: Rioux

full_name: Patrice Rioux

given: Patrice

journal_name: The Journal of Pediatrics

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

version: acceptedVersion

title: Quality of Life is Improved and Kidney Function Preserved in Patients with Nephropathic Cystinosis Treated for 2 Years with Delayed-Release Cysteamine Bitartrate

lead_sponsor: Horizon Pharma USA, Inc.

location_facility: California Pacific Medical Center (CPMC) Research Institute

location_facility: Texas Children's Hospital/Baylor University

location_facility: Radboud University Nijmegen Medical Center

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

location_facility: Hôpital Arnaud Villeneuve - CHU Montpellier

title: A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients With Cystinosis

summary: Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. Cysteamine bitartrate delayed-release capsules (RP103) is a formulation of cysteamine bitartrate that is being studied to see if it can be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.


ReferenceCitation: Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Göran-Ericzon B, Phillips S, Tweddle L, Karas A, Brown M, Fischer L; TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators; TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators. Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients. Clin Infect Dis. 2015 Apr 1;60(7):997-1006. doi: 10.1093/cid/ciu1128. Epub 2014 Dec 17.

family: Saliba

full_name: Faouzi Saliba

given: Faouzi

name: Charite Universitätsmedizin, Berlin, Germany

family: Pascher

full_name: Andreas Pascher

given: Andreas

family: Cointault

full_name: Olivier Cointault

given: Olivier

name: St Luc University Hospital, Université catholique de Louvain, Brussels, Belgium

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

name: Hospital Clinic i Provincial, Barcelona, Spain

family: Cervera

full_name: Carlos Cervera

given: Carlos

family: De Waele

full_name: Jan J. De Waele

given: Jan J.

family: Cillo

full_name: Umberto Cillo

given: Umberto

name: Semmelweis University, Budapest, Hungary

family: Langer

full_name: Róbert M. Langer

given: Róbert M.

name: Azienda Ospedaliero Universitaria Misericordia, Udine, Italy

family: Lugano

full_name: Manuela Lugano

given: Manuela

name: Karolinska University Hospital, Huddinge, Sweden

family: Göran-Ericzon

full_name: Bo Göran-Ericzon

given: Bo

name: Astellas Pharma Europe, Leiden, The Netherlands

family: Phillips

full_name: Stephen Phillips

given: Stephen

name: Astellas Pharma Europe Medical Affairs, Chertsey, United Kingdom

family: Tweddle

full_name: Lorraine Tweddle

given: Lorraine

family: Karas

full_name: Andreas Karas

name: Astellas Pharma Global Medical Affairs, Northbrook, Illinois

family: Brown

full_name: Malcolm Brown

given: Malcolm

name: University Medical Center Hamburg-Eppendorf, Germany

family: Fischer

full_name: Lutz Fischer

given: Lutz

family: Pratschke

full_name: Johann Pratschke

given: Johann

family: Decruyenaere

full_name: Johan Decruyenaere

given: Johan

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Michielsen

full_name: Peter Michielsen

given: Peter

family: Neuhaus

full_name: Peter Neuhaus

name: for the TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators

repository_institution: University of Padua - Padua Research Archive

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

title: Randomized Trial of Micafungin for the Prevention of Invasive Fungal Infection in High-Risk Liver Transplant Recipients

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Italy
Austria
Sweden
Saudi Arabia
Spain
France
Romania
Hungary
Belgium
Ireland
Russian Federation
Portugal
Germany
United Kingdom

title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients

summary: Prevention of invasive fungal infection in high risk patients following liver transplant.


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.

status: Terminated

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


title: A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

summary: Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing

lead_sponsor: Clavis Pharma

location_country:
Italy
United States
France
Norway
Germany
United Kingdom

location_facility: Department of Internal Medicine Klinikum der Johann Wolfgang Goethe-Universität Medizinische Klinik II

location_facility: Mew York Medical College, Division of Oncology

location_facility: Hematology Service, Hôpital Beaujon and Hôpital Avicenne

location_facility: Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan

location_facility: Westfälische Wilhelms-Universität Münster Medizinische Klinik und Polikinik Innere Medizin A

location_facility: Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna

location_facility: Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata

location_facility: Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd.

location_facility: Department of Hematology, Ullevål University Hospital, University of Oslo

location_facility: University Hospital Benjamin Franklin Med.Clinic III

location_facility: Centre Hospitalier Universitaire, CHU de Lyon, Service d'Hematologie Clinique


title: Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours

summary: The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

lead_sponsor: AstraZeneca

location_country:
Sweden
United Kingdom
France
Hungary
Spain
Czech Republic
Portugal


title: A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction

summary: To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Italy
France
Greece
Israel
Russian Federation
Spain
Canada
United Kingdom


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, 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. 2021 Nov 18. pii: S0959-8049(21)01144-8. doi: 10.1016/j.ejca.2021.09.043. [Epub ahead of print]

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: González Mella

full_name: Pablo González Mella

given: Pablo

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Minatta

full_name: Jose N. Minatta

given: Jose N.

family: Rezazadeh Kalebasty

full_name: Arash Rezazadeh Kalebasty

given: Arash

family: Shaffer

full_name: David Shaffer

given: David

family: Vázquez Limón

full_name: Juan C. Vázquez Limón

given: Juan C.

family: Sánchez López

full_name: Héctor M. Sánchez López

given: Héctor M.

family: Armstrong

full_name: Andrew J. Armstrong

given: Andrew J.

family: Horvath

full_name: Lisa Horvath

given: Lisa

family: Bastos

full_name: Diogo A. Bastos

given: Diogo A.

family: Amin

full_name: Neha P. Amin

given: Neha P.

family: Li

full_name: Jia Li

given: Jia

family: Unsal-Kacmaz

full_name: Keziban Unsal-Kacmaz

given: Keziban

family: Retz

full_name: Margitta Retz

given: Margitta

family: Saad

full_name: Fred Saad

given: Fred

family: Petrylak

full_name: Daniel P. Petrylak

given: Daniel P.

family: Pachynski

full_name: Russell K. Pachynski

given: Russell K.

journal_name: European Journal of Cancer

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Integrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Columbia University Medical Center (Cumc)

location_facility: Centro de Investigacion Clinica Bradford Hill

location_facility: Desert Hematology Oncology Medical Group

location_facility: PERSONAL Oncologia de Precisao e Personalizada

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: Praxisklinik Fuer Haematologie Und Onkologie

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Washington University School Of Medicine


title: An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON).

acronym: HUDSON

summary: This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Austria
Germany
France
Korea, Republic of
Israel
Spain
United States
Canada


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.

family: Hutchison

full_name: R. Matthew Hutchison

given: R. Matthew

family: Evans

full_name: Karleyton C. Evans

given: Karleyton C.

family: Fox

full_name: Tara Fox

given: Tara

family: Yang

full_name: Minhua Yang

given: Minhua

family: Barakos

full_name: Jerome Barakos

given: Jerome

family: Bedell

full_name: Barry J. Bedell

given: Barry J.

family: Cedarbaum

full_name: Jesse M. Cedarbaum

given: Jesse M.

family: Brys

full_name: Miroslaw Brys

given: Miroslaw

family: Siderowf

full_name: Andrew Siderowf

given: Andrew

family: Lang

full_name: Anthony E. Lang

given: Anthony E.

journal_name: BMC Neurology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson’s disease trial

lead_sponsor: Biogen

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

acronym: SPARK

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

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

location_facility: Northwestern University PD and Movement Disorders Center

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

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

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Seconda Università degli Studi di Napoli

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Montreal Neurological Institute Clinical Research Unit

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

location_facility: Parkinson's Disease and Movement Disorders Centerf

location_facility: Rocky Mountain Movement Disorders Center, PC

location_facility: University of Kansas Medical Center Research Institute

location_facility: University of Pittsburgh Medical Center Health System

location_facility: University of California San Francisco Medical Center

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

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

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

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

location_facility:
Investigational Site Number 3800001
Investigational Site Number 8260002
Investigational Site Number 8400003
Investigational Site Number 3800003
Investigational Site Number 2030002
Investigational Site Number 8400102
Investigational Site Number 2500002
Investigational Site Number 8400004
Investigational Site Number 8400001
Investigational Site Number 8260003
Investigational Site Number 2030003
Investigational Site Number 7240002
Investigational Site Number 1240002
Investigational Site Number 2500003
Investigational Site Number 2030001
Investigational Site Number 6200001
Investigational Site Number 6200003
Investigational Site Number 1240004
Investigational Site Number 3800004
Investigational Site Number 3800002
Investigational Site Number 2500001
Investigational Site Number 2500004
Investigational Site Number 7240007
Investigational Site Number 0560001
Investigational Site Number 8400002
Investigational Site Number 1240003
Investigational Site Number 6200002
Investigational Site Number 7240001
Investigational Site Number 8260001
Investigational Site Number 8400005
Investigational Site Number 1240005
Investigational Site Number 6160001
Investigational Site Number 2500005
Investigational Site Number 6160004


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

location_facility: Dept. Ophthalmology, San Raffaele Hospital

location_facility: Cambridge University Hospitals NHS Trust

location_facility: Hospital Clinico Universitario Lozano Blesa Zaragoza Ophthalmology department

location_facility: Department of Diagnostics and Microsurgery of Glaucoma

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

location_facility: Hospital Universitario Virgen Macarena Ophthalmology Department

location_facility: P.Stradins Clinical University Hospital, Ophthalmology Clinic

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

location_facility: Markusovszky University Teaching Hospital

location_facility: Department of Ophthalmology Clinical Johannes Gutenberg-University Mainz

location_facility: Northwest Anglia NHS Foundation trust Hinchingbrooke Hospital

location_facility: Se Ophthamic Clinic of the University of Pavia

location_facility: ASST Santi Paolo e Carlo - Ophthalmic Clinic

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

location_facility: CHU de Nantes-Hospital Hotel Dieu Ophthalmology Service

location_facility: Ophthalmology department Necker University Hospital-Enfants Malades

location_facility: Military Institute of Medicine Klinika Okulistyki

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

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

location_facility: Hospital Universitario de Torrevieja Ophthalmology Department

location_facility: Professor K. Gibinski University Clinical Centre

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

location_facility: Ophthalmic Clinic DiNOGMI University Hospital San Martino

location_facility: Ophthalmology Service Centre Francois Xavier Michelet CHU Pellegrin

location_facility: Hospital General de Catalunya Ophthalmology Department

location_facility: Department of Ophthalmology Semmelweis University

location_facility: University of Debrecen, Clinical Center, Ophthalmology Department

location_facility: Ophthalmology Department Hospital Universitario Rio Hortega

location_facility: City Hospitals Sunderland NHS Foundation Trust Sunderland Eye Infirmary

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

location_facility: Hospital Universitario Miguel Servet Ophthalmology Department

location_facility: Hospital Universitario Reina Sofía de Córdoba/C.P.E Carlos Castilla del Pino

location_facility: Centre ophtalmologique Pole vision val d'ouest

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

location_facility: Signes Ozolinas Doctor Practice in Ophthalmology

location_facility: Politecnico Gianbattista Rossi AOUI Ospedale Borgo Roma

location_facility: Ophthalmology Department, Queen Alexandra Hospital

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

location_facility: University of Szeged, Department of Ophthalmology

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

location_facility: Mid-Cheshire Hospitals NHS Foundation Trust

location_facility: Department of Medicine and Surgery University of Parma


title: Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

acronym: PsABIOnd

summary: The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Italy
Austria
Sweden
France
Russian Federation
Spain
Germany
United Kingdom

location_facility: Akademiskt Specialistcentrum centrum för reumatologi

location_facility: North-Western State Medical University named I.I. Mechnikov

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Immunologisches Zentrum Vogelsang-Gommern GmbH

location_facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

location_facility: FGBU Research Institute of Rheumatology named V.A.Nasonova

location_facility: Evang. Krankenhaus Gemein. Betriebgesm. Mbh

location_facility: The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

location_facility: Ospedale Regionale Cardarelli-Università degli Studi del Mol

location_facility: Praxis Prim. Priv.Doz. Dr. Burkhard Leeb

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

location_facility: Praxis fur Klinische Studien und Praxis fur Orthopadie

location_facility: Bakoulev Scientific Center For Cardiovascular Surgery Rams

location_facility: Schwerpunktpraxis für Rheumatologie und Klinische Immunologi


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).

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.

lead_sponsor: Millennium Pharmaceuticals, Inc.

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

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

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

location_facility: Affiliated Hospital of Nantong University

location_facility: IRCCS Centro Di Riferimento Oncologico Della Basilicata

location_facility: Rocky Mountain Cancer Centers (Longmont) - USOR

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

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

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Oncology Hematology Care, Inc - Fairfield

location_facility: Tennessee Oncology - LEBANON - SCRI - PPDS

location_facility: Capital Humano para Investigacion Clinica SC

location_facility: Rocky Mountain Cancer Centers (Lakewood) - USOR

location_facility: Tianjin Medical University General Hospital

location_facility: Southeastern Regional Medical Center - CTCA - PPDS

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

location_facility: Tennessee Oncolgy - BAPTIST - SCRI - PPDS

location_facility: Rocky Mountain Cancer Centers (Pueblo) - USOR

location_facility: Tennessee Oncology - MURFREESBORO - SCRI - PPDS

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

location_facility: Tennessee Oncology SKYLINE - SCRI - PPDS

location_facility: Arizona Oncology Associates (Orange HOPE) - USOR

location_facility: Saint Alphonsus Caldwell Cancer Care Center

location_facility: Rocky Mountain Cancer Centers (Aurora) - USOR

location_facility: Universidade Federal do Rio de Janeiro - UFRJ

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Arizona Oncology Associates (Rudasill HOPE) - USOR

location_facility: Tennessee Oncology - SMYRNA - SCRI - PPDS

location_facility: Tennessee Oncology - SUMMIT - SCRI - PPDS

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

location_facility: Arizona Oncology Associates (Wilmot HOPE) - USOR

location_facility: Tennessee Oncology - SHELBYVILLE - SCRI - PPDS

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Xuanwu Hospital Capital Medical University

location_facility: ICO lHospitalet Hospital Duran i Reynals

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

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

location_facility: Tennessee Oncology - FRANKLIN - SCRI - PPDS

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Rocky Mountain Cancer Centers (Parker) - USOR

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Marien Hospital Akademisches Lehrkrankenhaus

location_facility: Rocky Mountain Cancer Centers (Thornton) - USOR

location_facility: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

location_facility: Tennessee Oncology - GALLATIN - SCRI - PPDS

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

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

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Winship Cancer Institute, Emory University

location_facility: Greenville Health System Cancer Institute

location_facility: The Affiliated Hospital of Xuzhou Medical Univeristy

location_facility: Nanfang Hospital Southern Medical University

location_facility: Rocky Mountain Cancer Centers (Littleton) - USOR

location_facility: University of North Carolina at Chapel Hill

location_facility: Texas Oncology - San Antonio Medical Center - USOR

location_facility: Chinese PLA General Hospital (301 Hospital)

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

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

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

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

location_facility: Florida Cancer Specialists - NORTH - SCRI - PPDS

location_facility: Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS

location_facility: Rocky Mountain Cancer Centers (Denver) - USOR

location_facility: First Affiliated Hospital of Soochow University

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Baptist Health System (N Kendall) - USOR

location_facility: Compassionate Cancer Care Medical Group Inc

location_facility: Rocky Mountain Cancer Centers (Williams) - USOR

location_facility: New Jersey Hematology Oncology Associates LLC

location_facility: Presbyterian Saint Lukes Medical Center Laboratory

location_facility: Rocky Mountain Cancer Centers (Boulder) - USOR

location_facility: Complejo Asistencial Universitario de Salamanca H. Clinico

location_facility: University of Miami Miller School of Medicine

location_facility: Kobe City Medical Center General Hospital

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: Karadeniz Technical University Faculty of Medicine

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

location_facility: Weill Cornell Medical Center - Monitoring Location

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

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: Tennessee Oncology - DICKSON - SCRI - PPDS

location_facility: University of Texas Southwestern Medical Center

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


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.

family: Dalton

full_name: Krista M. Dalton

given: Krista M.

family: Krytska

full_name: Kateryna Krytska

given: Kateryna

family: Lochmann

full_name: Timothy L. Lochmann

given: Timothy L.

family: Sano

full_name: Renata Sano

given: Renata

family: Casey

full_name: Colleen Casey

given: Colleen

family: D'Aulerio

full_name: Alessia D'Aulerio

given: Alessia

family: Khan

full_name: Qasim A. Khan

given: Qasim A.

family: Crowther

full_name: Giovanna Stein Crowther

given: Giovanna Stein

family: Coon

full_name: Colin Coon

given: Colin

family: Cai

full_name: Jinyang Cai

given: Jinyang

family: Jacob

full_name: Sheeba Jacob

given: Sheeba

family: Kurupi

full_name: Richard Kurupi

given: Richard

family: Hu

full_name: Bin Hu

given: Bin

family: Dozmorov

full_name: Mikhail Dozmorov

given: Mikhail

family: Greninger

full_name: Patricia Greninger

given: Patricia

family: Souers

full_name: Andrew J. Souers

given: Andrew J.

family: Benes

full_name: Cyril H. Benes

given: Cyril H.

family: Mossé

full_name: Yael P. Mossé

given: Yael P.

family: Faber

full_name: Anthony C. Faber

given: Anthony C.

journal_name: Molecular Cancer Therapeutics

publisher: American Association for Cancer Research (AACR)

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.

name: Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Boston, MA, USA

family: Place

full_name: Andrew E Place

given: Andrew E

name: School of Medicine, Emory University, Atlanta, GA, USA

family: Goldsmith

full_name: Kelly Goldsmith

given: Kelly

name: Cancer Research Center, University Children's Hospital & Children's Research Center, Zurich, Switzerland

family: Bourquin

full_name: Jean-Pierre Bourquin

given: Jean-Pierre

name: Department of Pediatrics, Benioff Children's Hospital & the Helen Diller Comprehensive Cancer Center, University of California, San Francisco, CA, USA

family: Loh

full_name: Mignon L Loh

given: Mignon L

name: School of Medicine & Children's Hospital Colorado, University of Colorado, Aurora, CO, USA

family: Gore

name: Department of Paediatrics, Hospital for Sick Children & University of Toronto, Toronto, ON, Canada

name: Genentech Inc., South San Francisco, CA, USA

name: Department of Pediatric Oncology/Hematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, & Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands

name: Wolfson Childhood Cancer Research Centre, Northern Institute for Cancer Research, Newcastle University & Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

repository_institution: University of Zurich - Zurich Open Repository and Archive

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

location_facility: Women and Childrens Hospital /ID# 163147

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

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

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

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

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

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

location_facility: Children's Hospital Colorado /ID# 161551

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

location_facility: Dana-Farber Cancer Institute /ID# 163440

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

location_facility: Universitaetsklinikum Freiburg /ID# 164206

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

location_facility: Univ California, San Francisco /ID# 163460

location_facility: Medical College of Wisconsin /ID# 163461

location_facility: Queensland Children's Hospital /ID# 163146

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

location_facility: Kinderspital Zurich - Eleonorenstiftung /ID# 163037

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

location_facility: Cincinnati Children's Hospital /ID# 161550

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

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

location_facility: The Research Center of Southern California, LLC

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

location_facility: Hospital Regional Universitario de Malaga

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

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: O.F. Herbachevskyi Regional Clinical Hospital

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

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

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

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

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

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

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

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

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

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

location_facility: St Ivan Rilski University Multiprofile Hospital For Active Treatment

location_facility: Pauls Stradins Clinical University Hospital

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: National Research Center for Radiation Medicine

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

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

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

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna

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

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

location_facility: CRI Centro Regiomontano de Investigacion SC

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

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

location_facility: Federal Scientific Clinical Center of Physico-Chemical Medicine

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

location_facility: Municipal health care institution Chernihiv Regional Hospital

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Josephson Wallack Munshower Neurology, PC

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

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

location_facility: H. Santo António - Centro Hospitalar do Porto

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

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska EAD

location_facility: Limited Liability Company 'Neuro Global'

location_facility: Rīgas Austrumu klīniskā universitātes slimnīca

location_facility: Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu'


title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

summary:
Primary Objective:

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions

Secondary Objective:

To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures
To evaluate the safety and tolerability of SAR441344
To evaluate pharmacokinetics of SAR441344

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://www.clinicalstudydatarequest.com/

location_country:
Germany
France
Czechia
Bulgaria
Spain
Turkey
United States
Canada
Ukraine

location_facility:
Investigational Site Number :8400007
Investigational Site Number :8040002
Investigational Site Number :8040010
Investigational Site Number :2760005
Investigational Site Number :7920001
Investigational Site Number :8400002
Investigational Site Number :2030002
Investigational Site Number :1240001
Investigational Site Number :7240002
Investigational Site Number :2030001
Investigational Site Number :2030003
Investigational Site Number :1000001
Investigational Site Number :8040005
Investigational Site Number :8040006
Investigational Site Number :2030004
Investigational Site Number :7920002
Investigational Site Number :8400004
Investigational Site Number :1000003
Investigational Site Number :7240003
Investigational Site Number :8040003
Investigational Site Number :2500003
Investigational Site Number :2760001
Investigational Site Number :8040008
Investigational Site Number :8040004
Investigational Site Number :7920004
Investigational Site Number :1000002
Investigational Site Number :2030005
Investigational Site Number :2500002
Investigational Site Number :2500006
Investigational Site Number :8400001
Investigational Site Number :2500007


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

summary: The purpose of this study is to assess the safety, efficacy, and tolerability of BMS-986165 compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if BMS-986165 is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

location_country:
United States
Mexico
France
Poland
Argentina
Australia
Russian Federation
Germany
Taiwan

location_facility: Charité Universitaetsmedizin Berlin-Klinik für Dermatologie Venerologie und Allerologie

location_facility: Hôpital Tenon-Dermatology and allergology


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 States
Netherlands
Germany
France
Ireland
Australia
Canada
United Kingdom

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

location_facility: University of California School of Medicine

location_facility: University of California, Rady Children's Hospital

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

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Riley Hospital for Children at Indiana University

location_facility: The University of North Carolina - Chapell Hill

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

intervention_type: Biological


title: An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

acronym: SOTERIA

summary: This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in PAH.

lead_sponsor: Acceleron Pharma Inc.

location_country:
France
Israel
Australia
Spain
United States

location_facility: The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital

location_facility: Centre Hospitalier, Universitaire de Saint Etienne

location_facility: Centre Hospitalier, Universitaire de Bicêtre

location_facility: Hospital Universitario Marques de Valdecilla


title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

summary:
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML).

The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy.

The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
United States
Canada
France

location_facility: Mt. Sinai Medical Center Division of Hematology/Oncology

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Princess Margaret Hospital University Health Network