title: Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases

lead_sponsor: Baxalta now part of Shire

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

location_country:
Denmark
United Kingdom
Greece
France
Sweden
Slovakia
Czechia

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: Univerzitna Nemocnica Klinika detí a dorastu

location_facility: University Hospital of Wales Heath Park Clinical Research Facility

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: The Great North Children's Hospital Royal Victoria Infirmary

location_facility: Fakultni nemocnice Brno Odd. Detska klinika

location_facility: Dept. of Pediatric Oncology/Hematology/Immunology-Skånes Universitetssjukhus

location_facility: Hospices Civils de Lyon - Hôpitaux Est - IHOP

summary: The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary Immunodeficiency Diseases (PIDD)


type: EudraCT Number

type: Other Identifier

title: Phase I, International, Multicentre, Open-label, Non-randomised, Non-comparative Study of Intravenously Administered S64315, a Mcl-1 Inhibitor, in Patients With Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)

summary: The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Australia
United States
Spain
France

location_facility: Patient Care Location: Smilow Cancer Hospital at Yale

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Hospital Universitario Vall d' Hebron/VHIO Hematology Department

location_facility: The University of Texas MD Anderson Cancer Center, Department of Leukemia, Division of Cancer Medicine

location_facility: The Alfred Hospital Department of Haematology

location_facility: Hospital Universitario La Fe Hematology Department

location_facility: Institut Paoli-Calmettes Departement d'Hématologie

location_facility: Royal Melbourne Hospital, Department of Clinical Haematology and BMT Service

location_facility: Hôpital Saint-Antoine Département d'Hematologie Clinique et de Thérapie cellulaire

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: VMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

acronym: VMI-CFA

summary: The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.

lead_sponsor: ID3 Medical

location_country: France Belgium

location_facility:
Clinique Rhone Durance
ZNA Stuivenberg
CHU de Nantes
Imelda Hospital
AZ Sint-Blasius
CHU de Clermont-Ferrand
OLV Ziekenhuis Aalst

intervention_type: Device


title: A Phase Ib/II, Open-label, Multi-center Study of INC280 in Combination With PDR001 or PDR001 Single Agent in Advanced Hepatocellular Carcinoma.

summary: The purpose of this study of INC280 and PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent or in combination with INC280 administered orally in adult patients with advanced hepatocellular carcinoma (HCC).

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Hong Kong
Italy
Canada
Korea, Republic of
France
China
Germany


title: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

summary: The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

ReferenceType: derived

ReferenceCitation: Tchétché D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Søndergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231.

ReferenceCitation: Reichenspurner H, Schaefer A, Schäfer U, Tchétché D, Linke A, Spence MS, Søndergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060.

ipd_sharing: No

lead_sponsor: Edwards Lifesciences

location_country:
Denmark
United Kingdom
Italy
Australia
Netherlands
New Zealand
Switzerland
France
Germany

location_facility: Erasmus University Medical Center Rotterdam

location_facility: LMU - Klinikum der Universitaet Muenchen

location_facility: Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania

location_facility: Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH

location_facility: Universitair Medical Center (UMC) Utrecht


title: An Open-Label, Multicenter, Dose-Escalation Phase IB Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Selicrelumab (CD40 Agonist) in Combination With Atezolizumab (Anti PD-L1) in Patients With Locally Advanced and/or Metastatic Solid Tumors

lead_sponsor: Hoffmann-La Roche

source: euctr

location_country:
Denmark
Spain
Canada
United States
France
Netherlands

location_facility: Jewish General Hospital / McGill University

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

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

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

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

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

summary: This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of Selicrelumab administered in combination with Atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants will be followed up for survival until death or loss of follow-up after the last visit or withdrawal of consent.


title: A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects With Long QT Syndrome Type 3

summary: The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (OLE) phase.

status: Terminated

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Italy
Netherlands
Canada
United States
Israel
France
Germany

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Barts and The London School of Medicine and Dentistry

status_simplified: Unknown


acronym: TOLEDO

title: Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment

lead_sponsor: Britannia Pharmaceuticals Ltd.

design_allocation: Randomized

ReferenceCitation: Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Lockhart D, Staines H, Lees A. Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study. Parkinsonism Relat Disord. 2021 Feb;83:79-85. doi: 10.1016/j.parkreldis.2020.12.024. Epub 2021 Jan 12.

ReferenceCitation: Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Spivey K, Vel S, Staines H, Lees A. Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2018 Sep;17(9):749-759. doi: 10.1016/S1474-4422(18)30239-4. Epub 2018 Jul 25.

location_country:
Denmark
Spain
United Kingdom
Austria
Netherlands
France
Germany

location_facility: Donauspital / SMZ-Ost, Abteilung für Neurologie, Sekretariat (Stock 1, Ebene 4)

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Schön Klinik München Schwabing / Neurologie und Klinische Neurophysiologie

location_facility: Newcastle University, Clinical Ageing Research Unit (CARU)

location_facility: Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Neurologisches Fachkrankenhausfür Bewegungsstörungen / Parkinson

location_facility: CHU Toulouse, Hôpital Purpan, Centre d'Investigation Clinique

location_facility: Medizinische Universität Graz / Univ. Klinik für Neurologie

location_facility: Bispebjerg University Hospital, Movement Disorder Centre

summary:
The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment.

The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.


title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

summary: This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

ReferenceCitation: Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, Stephan C, Massetto B, Gaggar A, Ni L, Svarovskaia E, Brainard D, Subramanian GM, McHutchison JG, Puoti M, Rockstroh JK; PHOTON-2 study team. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet. 2015 Mar 21;385(9973):1098-106. doi: 10.1016/S0140-6736(14)62483-1. Epub 2015 Feb 4.

ReferenceCitation: Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.

location_country:
Spain
Italy
United Kingdom
Australia
France
Germany


title: A Phase 1b Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With CD20-Positive B-Cell Non Hodgkin Lymphoma (NHL)

summary: The purpose of this study is to identify if, and at what dose, ibrutinib may be administered with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to document responses of this combination in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

ReferenceCitation: Younes A, Thieblemont C, Morschhauser F, Flinn I, Friedberg JW, Amorim S, Hivert B, Westin J, Vermeulen J, Bandyopadhyay N, de Vries R, Balasubramanian S, Hellemans P, Smit JW, Fourneau N, Oki Y. Combination of ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for treatment-naive patients with CD20-positive B-cell non-Hodgkin lymphoma: a non-randomised, phase 1b study. Lancet Oncol. 2014 Aug;15(9):1019-26. doi: 10.1016/S1470-2045(14)70311-0. Epub 2014 Jul 17.

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
France


title: A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome

summary: The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).

location_country:
Spain
United Kingdom
Netherlands
Canada
United States
France
South Africa
Germany


type: Registry Identifier

title: A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

summary: The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.

ReferenceType: result

ReferenceCitation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.

ReferenceCitation: Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28.

ReferenceCitation: Locatelli F, Mauz-Koerholz C, Neville K, Llort A, Beishuizen A, Daw S, Pillon M, Aladjidi N, Klingebiel T, Landman-Parker J, Medina-Sanson A, August K, Sachs J, Hoffman K, Kinley J, Song S, Song G, Zhang S, Suri A, Gore L. Brentuximab vedotin for paediatric relapsed or refractory Hodgkin's lymphoma and anaplastic large-cell lymphoma: a multicentre, open-label, phase 1/2 study. Lancet Haematol. 2018 Oct;5(10):e450-e461. doi: 10.1016/S2352-3026(18)30153-4.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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: Millennium Pharmaceuticals, Inc.

location_country:
Spain
Italy
United Kingdom
Netherlands
United States
France
Mexico
Germany


title: An Open-label, Single-arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AUY922 in Combination With Trastuzumab Standard Therapy as Second-line Treatment in Patients With HER2-positive Advanced Gastric Cancer

summary: This study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line.

location_country:
Spain
Italy
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: University of Texas/MD Anderson Cancer Center UT SC

location_facility: University of California at Los Angeles UCLA LeConte Location


title: A Multicenter, Open-label, Dose Ranging Study to Determine the Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Intravenously or Subcutaneously to Adult Asthmatic Subjects With Elevated Blood Eosinophil Levels

summary: A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Estonia
United States
Germany
France

intervention_type: Biological


title: A Longitudinal 2-year Bone Marrow Study of Eltrombopag Olamine (SB-497115-GR) in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

summary: A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.

ReferenceCitation: Wong RS, Bakshi K, Brainsky A. Thrombophilia in patients with chronic immune thrombocytopenia. Scand J Clin Lab Invest. 2015 Jan;75(1):13-7. doi: 10.3109/00365513.2014.962597. Epub 2014 Oct 9.

location_country:
Hong Kong
Italy
Russian Federation
Czech Republic
Hungary
Korea, Republic of
United States
France
India
Germany
Pakistan


title: A Phase 1/2, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-Interleukin 6 (IL-6) Monoclonal Antibody, in Subjects With Solid Tumors

summary: The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.

lead_sponsor: Centocor, Inc.

location_country:
United Kingdom
Spain
United States
France
Belgium


title: A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma

summary: The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).

ReferenceCitation: Gronchi A, Bui BN, Bonvalot S, Pilotti S, Ferrari S, Hohenberger P, Hohl RJ, Demetri GD, Le Cesne A, Lardelli P, Pérez I, Nieto A, Tercero JC, Alfaro V, Tamborini E, Blay JY. Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Ann Oncol. 2012 Mar;23(3):771-776. doi: 10.1093/annonc/mdr265. Epub 2011 Jun 3.

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

location_country:
Germany
United States
France


title: A Ph I/IIa Rand Placebo Ctrl, S-Blind Multictr Dose-Esc Study of SC Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Pts With CD4 T Lymphocyte Counts 101-400 Cells-/mm(3) and Plasma HIV RNA Less Than 50 Copies/mL After at Least 12 M of HAART

summary:
This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T cells. If this study shows that IL-7 is safe, additional studies will be done to see if it can improve the function or numbers of T-cells in HIV-infected persons.

HIV-infected persons who have been receiving HAART therapy for at least 12 months before enrolling in the study and have been stable on this treatment for at least 3 months before enrollment may be eligible for this study.

Participants have about 10 clinic visits over 3 months. They receive three injections of IL-7, one injection a week for 3 consecutive weeks. The injections are given as a shot under the skin in the arm or leg. On the day of each injection, the participant stays in the clinic for up to 8 hours or longer for observation and collection of blood samples. Three additional visits (one every 3 months) may be scheduled.

During the study visits the following may be done:

Medical history, physical examination, blood tests every visit.
Electrocardiogram (EKG) at study days 0 (day of first dose), 1, 7 (day of second dose), 14 (day of third dose) and 21.
Chest x-ray study on day 21.
Blood sample collections at frequent intervals during the first 96 hours after the first dose administration. A catheter (thin plastic tube) may be put into a vein in the arm and left in place to allow several blood samples to be drawn without repeated needle sticks.
Urine tests several times during the study.

ReferenceType: background

ReferenceCitation: Stebbing J, Gazzard B, Douek DC. Where does HIV live? N Engl J Med. 2004 Apr 29;350(18):1872-80. Review.

ReferenceCitation: Battegay M, Nüesch R, Hirschel B, Kaufmann GR. Immunological recovery and antiretroviral therapy in HIV-1 infection. Lancet Infect Dis. 2006 May;6(5):280-7. Review.

ReferenceCitation: Douek DC, Picker LJ, Koup RA. T cell dynamics in HIV-1 infection. Annu Rev Immunol. 2003;21:265-304. Epub 2001 Dec 19. Review.

lead_sponsor: Cytheris SA

location_country:
United States
Italy
Canada
France

location_facility: Hopital Henri Mendor-Service d'Immunologie Clinique

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma

summary: The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.

status: Withdrawn

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
Germany
United States
Spain
France

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


title: Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.

ReferenceCitation: Lutz MP, Van Cutsem E, Wagener T, Van Laethem JL, Vanhoefer U, Wils JA, Gamelin E, Koehne CH, Arnaud JP, Mitry E, Husseini F, Reichardt P, El-Serafi M, Etienne PL, Lingenfelser T, Praet M, Genicot B, Debois M, Nordlinger B, Ducreux MP; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group. J Clin Oncol. 2005 Dec 20;23(36):9250-6.

ReferenceCitation: Lutz MP, Ducreux M, Wagener T, et al.: Docetaxel/gemcitabine or docetaxel/cisplatin in advanced pancreatic carcinoma: a randomized phase II study of the EORTC-GI group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-498, 2002.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Poland
United Kingdom
France
Turkey
Belgium
Netherlands
Germany
Egypt

location_facility: Hermann-Holthusen Institute for Radiotherapy

location_facility: Dokuz Eylul University School of Medicine

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Universitaetsklinik und Strahlenklinik - Essen


title: A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer

summary: The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).

status: Recruiting

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
United States
United Kingdom
France

location_facility: Center for Cancer Research National Cancer Institute

location_facility: University College London Hospitals NHSFT

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: Sidney Kimmel Cancer Center - Jefferson Health

status_simplified: Ongoing


title: The CROCO Study: CROhn's Disease COhort Study

acronym: CROCO

summary: The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn's Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.

primary_purpose: Diagnostic

lead_sponsor: GLSMED Learning Health S.A.

location_country:
Denmark
Portugal
Romania
Spain
Italy
United Kingdom
France
Malta
Belgium
Cyprus
Czechia

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: IBD Clinical and Research Clinic, ISCARE

location_facility: Claude Huriez Hospital, Lille University

location_facility: Hospital Alvaro Cunqueiro - Área Sanitária de Vigo

location_facility: Hull University Teaching Hospitals NHS Trust

intervention_type: Diagnostic Test


title: Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination With Tremelimumab in Pediatric Patients With Advanced Solid Tumors and Hematological Malignancies.

summary: The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

status: Active, not recruiting

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

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Netherlands
United States
France
Germany


title: FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

summary:
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Manoharan G, Grube E, Van Mieghem NM, Brecker S, Fiorina C, Kornowski R, Danenberg H, Ruge H, Thiele H, Lancellotti P, Søndergaard L, Tamburino C, Oh JK, Fan Y, Windecker S. Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study. EuroIntervention. 2020 Nov 20;16(10):850-857. doi: 10.4244/EIJ-D-20-00279.

lead_sponsor: Medtronic Cardiovascular

location_country:
Denmark
Slovenia
Italy
Austria
Netherlands
Spain
Finland
United Kingdom
Switzerland
France
Israel
Belgium
Norway
Germany

location_facility: Royal Victoria Hospital - Belfast Health and Social Care Trust

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Deutsches Herzzentrum München Klinik an der TU München

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Hospital Universitario Central de Asturias

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: AOU Presidio Gaspare Rodolico Policlinico

location_facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital

location_facility: Hospital Universitario Virgen de la Victoria


title: A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Eichler H, Jiménez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupančić-Šalek S, Oldenburg J, Chowdary P. Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. Blood Adv. 2022 Jun 14;6(11):3422-3432. doi: 10.1182/bloodadvances.2021006403.

ReferenceCitation: Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jiménez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Spain
Italy
United Kingdom
Thailand
Ukraine
Sweden
United States
France
Turkey
Japan
Germany

summary: This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.


title: A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.

ReferenceCitation: Massard C, Cassier PA, Azaro A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of crenigacestat (LY3039478) in combination with gemcitabine and cisplatin or gemcitabine and carboplatin in patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol. 2022 Oct;90(4):335-344. doi: 10.1007/s00280-022-04461-z. Epub 2022 Aug 28.

ReferenceCitation: Azaro A, Massard C, Tap WD, Cassier PA, Merchan J, Italiano A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of the Notch inhibitor crenigacestat (LY3039478) in combination with other anticancer target agents (taladegib, LY3023414, or abemaciclib) in patients with advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1089-1098. doi: 10.1007/s10637-021-01094-6. Epub 2021 Mar 8.

location_country:
Denmark
United States
Spain
France

location_facility: University of Texas MD Anderson Cancer Center


title: Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment

summary: A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.

lead_sponsor: Cardionovum GmbH

location_country: Germany France Belgium

location_facility:
Klinikum Arnsberg
ZNA Stuivenberg
ZOL (Ziekenhuis Oost-Limburg)
UZ Leuven
CHU Bordeaux
CHU Cermont-Ferrand
CH Mont-de-Marsan
AZ Sint-Jan
Jessa hospital


acronym: iMATRIXcobi

title: A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Cobimetinib In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

ReferenceCitation: Trippett T, Toledano H, Campbell Hewson Q, Verschuur A, Langevin AM, Aerts I, Howell L, Gallego S, Rossig C, Smith A, Patel D, Pereira LR, Cheeti S, Musib L, Hutchinson KE, Devlin C, Bernardi R, Geoerger B. Cobimetinib in Pediatric and Young Adult Patients with Relapsed or Refractory Solid Tumors (iMATRIX-cobi): A Multicenter, Phase I/II Study. Target Oncol. 2022 May;17(3):283-293. doi: 10.1007/s11523-022-00888-9. Epub 2022 Jun 17.

location_country:
Spain
Italy
United Kingdom
United States
Israel
France
Germany

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Hospital Infantil Universitario Nino Jesus

summary: This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.


title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

summary: This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.

ReferenceCitation: Vij R, Nath R, Afar DEH, Mateos MV, Berdeja JG, Raab MS, Guenther A, Martínez-López J, Jakubowiak AJ, Leleu X, Weisel K, Wong S, Gulbranson S, Sheridan JP, Reddy A, Paiva B, Singhal A, San-Miguel JF, Moreau P. First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2308-2317. doi: 10.1158/1078-0432.CCR-19-1431. Epub 2020 Jan 22.

lead_sponsor: AbbVie

location_facility: Universitaetsklinikum Heidelberg /ID# 140046

location_facility: Clinica Universitaria de Navarra /ID# 141411

location_facility: CHU de la miletrie, Centre d'investigation clinique /ID# 147542

location_facility: Hospital Clinic de Barcelona /ID# 141643

location_facility: The Sarah Cannon Research Institute /ID# 135814

location_facility: University of Michigan Medical Center /ID# 139402

location_facility: The University of Chicago Medical Center /ID# 139403

location_facility: Universitaetsklinikum Tuebingen /ID# 141074

location_facility: Hospital Universitario 12 de Octubre /ID# 140878

location_facility: CHRU de Lille, Hopital Claude Huriez /ID# 133634

location_facility: Universitaetsklinikum Wuerzburg /ID# 141533

location_facility: Universitaetklinikum Dresden /ID# 141860

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 141534

location_facility: Hospital Universitario de la Princesa /ID# 140881

location_facility: Hospital Clinico Universitario Salamanca /ID# 140880

location_facility: Washington University School of Medicine /ID# 135708

location_facility: CHU de Nantes, Hotel Dieu - HME /ID# 133633


title: A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Azacitidine and to Compare Azacitidine to Historical Controls in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome or Juvenile Myelomonocytic Leukemia Before Hematopoietic Stem Cell Transplantation

lead_sponsor: Celgene

ReferenceCitation: Niemeyer CM, Flotho C, Lipka DB, Starý J, Rössig C, Baruchel A, Klingebiel T, Micalizzi C, Michel G, Nysom K, Rives S, Schmugge Liner M, Zecca M, Schönung M, Baumann I, Nöllke P, Benettaib B, Biserna N, Poon J, Simcock M, Patturajan M, Menezes D, Gaudy A, van den Heuvel-Eibrink MM, Locatelli F. Response to upfront azacitidine in juvenile myelomonocytic leukemia in the AZA-JMML-001 trial. Blood Adv. 2021 Jul 27;5(14):2901-2908. doi: 10.1182/bloodadvances.2020004144.

location_country:
Denmark
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Switzerland
Sweden
France
Belgium
Germany
Czechia

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Hematology, Oncology and clinical immunology / Heinrich-Heine-University

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: St. Anna Kinderkrebsforschung, CHILDREN'S CANCER RESEARCH INSTITUTE

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

location_facility: Hospital Infantil Universitario Nino Jesus

summary:
Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT).

Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR; JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data.

Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population.

Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped.


title: A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)

acronym: TiLE

summary: The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.

primary_purpose: Other

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Denmark
Spain
Italy
United Kingdom
Canada
Sweden
France
Norway
Germany

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Montichiari Università degli studi di Bresca

location_facility: Birmingham Women's Health Care NHS Trust

location_facility: Laboratoire Alphabio & Institut de Médecine de la Reproducti


title: A Multiarm, Open-label, Phase 1b Study of MLN2480 (an Oral A-, B-, and CRAF Inhibitor) in Combination With MLN0128 (an Oral mTORC 1/2 Inhibitor), or Alisertib (an Oral Aurora A Kinase Inhibitor), or Paclitaxel, or Cetuximab, or Irinotecan, in Adult Patients With Advanced Nonhematologic Malignancies

summary: The primary purpose of this study is to determine the safety profile and the maximum tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 + cetuximab, and MLN2480 + irinotecan in participants with advanced nonhematologic malignancies.

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.

location_country:
United Kingdom
United States
Spain
France

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Massachusetts General Hospital Cancer Center


title: Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts

acronym: INTEGRATE

summary: The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.

ReferenceCitation: Robaeys G, Christensen S, Lucidarme D, Arain A, Bruggmann P, Kunkel J, Keim S, Jäkel M, DeMasi R, Liu C, Lonjon-Domanec I, Foster GR. Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study. Infect Dis Ther. 2017 Jun;6(2):265-275. doi: 10.1007/s40121-017-0158-x. Epub 2017 May 5.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
United Kingdom
Netherlands
Switzerland
France
Belgium
Germany


title: Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

acronym: DIRECT II

summary:
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

lead_sponsor: Svelte Medical Systems, Inc.

location_country: Netherlands Switzerland Sweden France Belgium Germany Czechia

location_facility: University Medical Center Utrecht, Department of Cardiology

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer


title: Neo Randomized Heart Failure Study

summary: The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

status: Unknown status

ReferenceCitation: Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.

ReferenceCitation: Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Müller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.

ReferenceCitation: Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.

lead_sponsor: CVRx, Inc.

location_country: Germany Canada Italy France

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Azienda Ospedaliera Spedali Riuniti Di Bergamo

location_facility: University Hospital of Schleswig-Holstein, Kiel Campus

location_facility: Immanuel Hospital Bernau-Heart Center Brandenburg

location_facility: Azienda Ospedaliero Universitaria Opedali


title: Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)

acronym: EFFORTLESS

summary: The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.

ReferenceCitation: Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.

ReferenceCitation: Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.

ReferenceCitation: Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kääb S, Murgatroyd F, Reeve HL, Carter N, Boersma L; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Portugal
Spain
Italy
United Kingdom
Netherlands
New Zealand
France
Germany
Czechia

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Azienda Ospedaliero Universitaria Padova

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Ludwig-Maximilians-Universität München, Campus Großhadern


title: A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

acronym: AVANT

summary: The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

location_country:
Denmark
Canada
United Kingdom
France


title: International Report on Routine Practice of Sensor-enabled Pump Therapy

summary: The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.

ipd_sharing_description: Nørgaard K et al. Routine sensor-augmented pump therapy in type 1 diabetes: the INTERPRET study. Diabetes Technol Ther. 2013 Apr;15(4):273-80. doi: 10.1089/dia.2012.0288. Epub 2013 Feb 25.

lead_sponsor: Medtronic Diabetes

location_country: Denmark Poland Serbia Slovenia Italy Austria Spain Lithuania Hungary France Israel Belgium Sweden Slovakia

location_facility: Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp

location_facility: LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I

location_facility: Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz


title: The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants

summary: The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.

ReferenceCitation: Laube M, Amann E, Uhlig U, Yang Y, Fuchs HW, Zemlin M, Mercier JC, Maier RF, Hummler HD, Uhlig S, Thome UH. Inflammatory Mediators in Tracheal Aspirates of Preterm Infants Participating in a Randomized Trial of Inhaled Nitric Oxide. PLoS One. 2017 Jan 3;12(1):e0169352. doi: 10.1371/journal.pone.0169352. eCollection 2017.

ReferenceCitation: Durrmeyer X, Hummler H, Sanchez-Luna M, Carnielli VP, Field D, Greenough A, Van Overmeire B, Jonsson B, Hallman M, Mercier JC, Marlow N, Johnson S, Baldassarre J; European Union Nitric Oxide Study Group. Two-year outcomes of a randomized controlled trial of inhaled nitric oxide in premature infants. Pediatrics. 2013 Sep;132(3):e695-703. doi: 10.1542/peds.2013-0007. Epub 2013 Aug 12.

ReferenceCitation: Mercier JC, Hummler H, Durrmeyer X, Sanchez-Luna M, Carnielli V, Field D, Greenough A, Van Overmeire B, Jonsson B, Hallman M, Baldassarre J; EUNO Study Group. Inhaled nitric oxide for prevention of bronchopulmonary dysplasia in premature babies (EUNO): a randomised controlled trial. Lancet. 2010 Jul 31;376(9738):346-54. doi: 10.1016/S0140-6736(10)60664-2. Epub 2010 Jul 23.

ipd_sharing_description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT00551642) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

lead_sponsor: Mallinckrodt

location_country:
Spain
Italy
United Kingdom
Netherlands
Finland
Sweden
France
Belgium
Germany

location_facility: Astrid Lindgrens barnsjukjus, Karolinska Unviersritets sjukhuset-Solna

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: Centre Hospitalier Intercommunal de Creteil


title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma

summary: This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma

lead_sponsor: Novartis Pharmaceuticals

location_country:
Australia
United States
Spain
France

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.

location_facility: St. Vincent's Comprehensive Cancer Center

intervention_type: Combination Product


title: A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

summary: Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

lead_sponsor: Cumberland Pharmaceuticals

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Finland
France
Belgium
Germany


title: An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage

summary: This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Spain
Russian Federation
Australia
Czech Republic
Hungary
France
Israel
Belgium


title: A Multicentre, Stratified, Randomised, Double Blind, Parallel Group Trial to Evaluate Whether a Treatment Strategy Based on Aiming for Total Control Results in Better AHR Than a Treatment Strategy Based on Maintaining Well Control

summary: This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.

lead_sponsor: GlaxoSmithKline

location_country: Spain Italy Latvia Estonia Netherlands Finland Sweden France Belgium Germany


title: A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months

summary: This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.

lead_sponsor: AstraZeneca

location_country:
United States
France


title: A Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) Amyloidosis

summary: The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.

ReferenceCitation: Safety, Tolerability and Pharmacokinetic Profile of FibrillexTM (Anti-AA Amyloid Agent) in Healthy and Renal Impaired Subjects. Garceau D., Gurbindo C., Laurin J. Neurochem Inc. Reference: Proceedings from the IXth International Symposium on Amyloidosis , 2001 (Budapest, Hungary)

ReferenceCitation: Dember LM, Hawkins PN, Hazenberg BP, Gorevic PD, Merlini G, Butrimiene I, Livneh A, Lesnyak O, Puéchal X, Lachmann HJ, Obici L, Balshaw R, Garceau D, Hauck W, Skinner M; Eprodisate for AA Amyloidosis Trial Group. Eprodisate for the treatment of renal disease in AA amyloidosis. N Engl J Med. 2007 Jun 7;356(23):2349-60.

lead_sponsor: Bellus Health Inc

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Finland
Lithuania
United States
Israel
France
Turkey
Netherlands

location_facility: Ciutad Sanitària y Universitària de Bellvitge, Servicio de Reumatologia, Hospitalet de Llobregat

location_facility: Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology

location_facility: Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,

location_facility: Royal Free and University College Medical School, Department of Medicine, National Amyloidosis Centre

location_facility: Italian Group for Systemic Amyloidosis, Biotechnology Research Laboratories, IRCCS Policlinico San Matteo, Internal Medicine and Medical Oncology

location_facility: Hôpital Cochin, Centre de Recherche et d'Explorations Fonctionnelles

location_facility: Okregowy Szpital Kolejowy, Zaklad Reumatologii

location_facility: Hôpital Claude Huriez, Service de médecine Interne, Clinique Médicale A

location_facility: University Hospital Groningen, Department of Medicine, Division of Rheumatology

location_facility: Centre Hospitalier du Mans, Service de Rhumatologie

location_facility: Hospital Clinic I Provincial de Barcelona, Jefe del Departamento de Reumatologia

location_facility: Hospital Universitario Germans Trias I Pujol, Servicio de Reumatologia

location_facility: Heller Institute of Medical Research, Sheba Medical Center

location_facility: Marmara University Medical School Hospital, Department of Rheumatology

location_facility: Hospital Clinico San Carlos de Madrid, Servicio de Reumatologia


title: Gemtuzumab Ozogamicin (CMA-676) Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia: An EORTC-LG Pilot Phase II Study

summary:
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without chemotherapy in treating older patients who have acute myeloid leukemia.

ReferenceCitation: Seedhouse CH, Grundy M, White P, Li Y, Fisher J, Yakunina D, Moorman AV, Hoy T, Russell N, Burnett A, Pallis M; National Cancer Research Network. Sequential influences of leukemia-specific and genetic factors on p-glycoprotein expression in blasts from 817 patients entered into the National Cancer Research Network acute myeloid leukemia 14 and 15 trials. Clin Cancer Res. 2007 Dec 1;13(23):7059-66.

ReferenceCitation: Amadori S, Suciu S, Willemze R, et al.: Up-front window trial of gemtuzumab ozogamicin (GO) in previously untreated elderly patients with AML: an EORTC leukemia group study. [Abstract] Blood 104 (11): A-877, 2004.

ReferenceCitation: Amadori S, Suciu S, Willemze R, Mandelli F, Selleslag D, Stauder R, Ho A, Denzlinger C, Leone G, Fabris P, Muus P, Vignetti M, Hagemeijer A, Beeldens F, Anak O, De Witte T; EORTC leukemia group; GIMEMA leukemia group. Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups. Haematologica. 2004 Aug;89(8):950-6.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Croatia Italy Austria Netherlands France Belgium Germany

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.

ReferenceCitation: Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S, Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 Jul;45(10):1807-14. doi: 10.1016/j.ejca.2009.04.016. Epub 2009 May 4.

ReferenceCitation: Keilholz U, Suciu S, Bedikian AY, et al.: LDH is a prognostic factor in stage IV melanoma patients (pts) but is a predictive factor only for bcl2 antisense treatment efficacy: re-analysis of GM301 and EORTC18951 randomized trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-8552, 485s, 2007.

ReferenceCitation: Keilholz U, Eggermont AM. The role of interleukin-2 in the management of stage IV melanoma: the EORTC melanoma cooperative group program. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S99-103.

ReferenceCitation: Schmidt H, Suciu S, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, von der Maase H, Eggermont AM, Keilholz U; American Joint Committee on Cancer Stage IV Melanoma; EORTC 18951. Pretreatment levels of peripheral neutrophils and leukocytes as independent predictors of overall survival in patients with American Joint Committee on Cancer Stage IV Melanoma: results of the EORTC 18951 Biochemotherapy Trial. J Clin Oncol. 2007 Apr 20;25(12):1562-9.

ReferenceCitation: Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U. Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer. 2006 Nov;42(17):2991-5. Epub 2006 Oct 4.

ReferenceCitation: Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55.

ReferenceCitation: Keilholz U, Punt CJ, Gore M, et al.: Dacarbazine, cisplatin and interferon alpha with or without interleukin-2 in advanced melanoma: interim analysis of EORTC trial 18951. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2043, 530a, 1999.

location_country:
Portugal
United Kingdom
Italy
Austria
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Instituto Portugues de Oncologia do Porto


title: A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

summary: The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

study_start_date_type: Anticipated

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Australia
United States
Chile
France
Belgium

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

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center


title: A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

lead_sponsor: Tyra Biosciences, Inc

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC)

location_facility: Duke Cancer Institute (DCI) - Duke Cancer Center

location_facility: Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville

location_facility: Seattle Cancer Care Alliance (SCCA) - South Lake Union

location_facility: NEXT Madrid - Hospital Universitario Quironsalud Madrid

location_facility: Southern Oncology Research Unit Pty Ltd.

location_facility: Institut de Cancerologie de L'Ouest (ICO)

location_facility: Vall d'Hebron Institut d'Oncologia (VHIO)

location_facility: Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

location_facility: NEXT Barcelona - Hospital Quironsalud Barcelona

location_facility: Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala)


title: A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients With BRCA Mutations and Early Stage HER2-Negative Breast Cancer

acronym: OlympiaN

summary:
This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems.

Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy.

Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.

location_country:
Spain
Italy
Austria
Australia
United Kingdom
United States
France
Israel
Belgium
Germany


title: A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)

summary: The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

location_country:
Poland
United Kingdom
United States
France
Germany

location_facility: University of Utah MidValley Dermatology

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Psoriasis Treatment Center of Central NJ

location_facility: Keck School of Medicine of University of Southern California

location_facility: Dermatology Clinical Research Center of San Antonio

intervention_type: Other


title: A Phase 1b Study of JNJ-75276617 in Combination With AML Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

summary: The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
Australia
United States
France
Germany

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: University College London Hospitals NHSFT

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: ASST Grande Ospedale Metropolitano Niguarda


title: A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

summary: A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.

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 requests 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:
United Kingdom
Spain
Canada
United States
France


title: A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

acronym: FRONTIER 2

summary: The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

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

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

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

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Atlanta Dermatology, Vein & Research Center

location_facility: Seoul National University Bundang Hospital


title: A Phase 2A, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of PTC518 in Subjects With Huntington's Disease

summary: The primary goal of this study is to evaluate the safety and pharmacodynamic effects of PTC518 and placebo in participants with HD.

lead_sponsor: PTC Therapeutics

location_country:
United Kingdom
Australia
Netherlands
United States
France
Germany

location_facility: Columbia University, G.H. Sergievsky Center

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: The University of Texas Health Science Center at Houston; McGovern Medical School

location_facility: Hôpital Universitaire de Marseille Hôpital de la Timone

location_facility: UCL Queen Square Institute of Neurology National Hospital for Neurology and Neurosurgery

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Cardiff University Schools of Medicine and Biosciences

location_facility: University of Washington Department of Neurology


title: A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)

summary: A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren's syndrome (NEPTUNUS-1)

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

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

location_country:
Poland
Portugal
Spain
Austria
United States
France
Germany
Czechia


title: Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non- Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions

summary: The purpose of the study in Part 1 (dose escalation) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and in Part 2 (dose expansion) is to determine the safety of Erdafitinib Intravesical Delivery System administered at the RP2D(s).

location_country:
Spain
Netherlands
Korea, Republic of
United States
France
Germany

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

location_facility: Levine Cancer Institute, Carolinas HealthCare System


title: A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

acronym: ATHENA-SSc-ILD

summary: The purpose of this study is to assess the safety and efficacy of PRA023 in participants with SSc-ILD .

lead_sponsor: Prometheus Biosciences, Inc.

location_country:
Poland
Spain
Italy
Australia
Switzerland
Hungary
United States
France
Israel
Belgium
Netherlands

location_facility:
Prometheus Biosciences Selected Center
Prometheus Biosciences Selected Site
Prometheus Biosciences Call Center


title: A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

summary: The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).

location_country:
Spain
Italy
United Kingdom
Canada
United States
France

location_facility: The Ohio State University Wexner Medical Center James Cancer Hospital

location_facility: Massachusetts General Hospital-Medical Oncology

location_facility: University of Alabama at Birmingham-Medicine

location_facility: University of Cincinnati Medical Center-University of Cincinnati Cancer Center


acronym: HIMALAYA

title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label Extension

lead_sponsor: Sanofi

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

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
United States
France
China
Belgium
Japan
Germany

location_facility: Mount Sinai Beth Israel Medical Center-Site Number:8400002

location_facility: University of Pennsylvania-Site Number:8400021

location_facility: University of Colorado-Site Number:8400025

location_facility: University of California Irvine-Site Number:8400012

location_facility: AdventHealth Medical Group - Neurology at Winter Park-Site Number:8400006

location_facility: Massachusetts General Hospital-Site Number:8400001

location_facility: Thomas Jefferson University Hospital-Site Number:8400014

location_facility: Froedtert Hospital & Medical College of Wisconsin-Site Number:8400010

summary:
This is a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy, safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in male and female participants,18 to 80 years of age with ALS followed by an openlabel, longterm extension period.

Study ACT16970 consists of 2 parts (A and B) as follows:

Part A is a 24 week, double blind, placebo controlled part, preceded by a screening period of up to 4 weeks before Day 1.

On Day 1 of Part A, participants will be randomized in a 2:1 ratio to the SAR443820 treatment arm or matching placebo arm as listed below:

Treatment arm: SAR443820, BID
Placebo arm: Placebo, BID

Randomization will be stratified by the geographic region of the study site, region of ALS onset (bulbar vs other areas), use of riluzole (yes vs no), and use of edaravone (yes vs no). Participants will attend inclinic study assessments at baseline (Day 1), Week 2, Week 4, Week 8, Week 16, and Week 24, and will receive a phone call at Week 12 and Week 20. All ongoing participants in Part A will rollover to Part B. The Week 24 Visit is the end of Part A and the beginning of Part B.

Part B is an open label, longterm extension period that starts from the end of Part A (Week 24) and continues up to Week 106. The objectives of Part B are to further determine the safety and efficacy of longterm SAR443820 treatment. The treatment assignment of participants in Part A will remain blinded to Investigators, participants, and site personnel until the end of Part B. Every participant ,except those who discontinued Investigational Medicinal Product (IMP) treatment permanently in Part A, will receive BID oral tablets of SAR443820 in Part B.


title: A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer

summary: This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Japan
Poland
Portugal
Austria
Australia
Argentina
Israel
Mexico
Canada
Hungary
China
Germany
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: Heartlands Hospital-Oncology Research ( Site 2604)

location_facility: Isala, locatie Zwolle-Poli Longziekten ( Site 1612)

location_facility: Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)

location_facility: Medizinische Universität Graz ( Site 0504)

location_facility: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)

location_facility: West China Hospital Sichuan University ( Site 2903)

location_facility: Aichi Cancer Center Hospital ( Site 3016)

location_facility: Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)

location_facility: Maastricht UMC+-Pulmonary disease ( Site 1602)

location_facility: Kanazawa University Hospital ( Site 3006)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0013)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)

location_facility: Beijing Peking Union Medical College Hospital ( Site 2921)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)

location_facility: Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)

location_facility: Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)

location_facility: H.R.U Málaga - Hospital General-Oncology ( Site 2104)

location_facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 0410)

location_facility: iCan Oncology Center Centro Medico AVE ( Site 0406)

location_facility: LungenClinic Grosshansdorf-Onkologie ( Site 0903)

location_facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 3015)

location_facility: Okayama University Hospital ( Site 3011)

location_facility: Fudan University Shanghai Cancer Center ( Site 2908)

location_facility: Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané

location_facility: Rambam Health Care Campus-Oncology ( Site 1301)

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)

location_facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)

location_facility: Medische Centrum Leeuwarden ( Site 1619)

location_facility: European Interbalkan Medical Center ( Site 1000)

location_facility: Los Angeles Hematology Oncology Medical Group ( Site 0006)

location_facility: Chungnam national university hospital-Department of Internal Medicine ( Site 2802)

location_facility: Jeroen Bosch Hospital-Pulmonology ( Site 1605)

location_facility: Japanese Foundation for Cancer Research ( Site 3003)

location_facility: University of Virginia Cancer Center ( Site 0019)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 2702)

location_facility: Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)

location_facility: Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)

location_facility: Fujian Provincial Cancer Hospital-oncology department ( Site 2904)

location_facility: Korea University Guro Hospital-Internal Medicine ( Site 2803)

location_facility: Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)

location_facility: Zhejiang Cancer Hospital-Oncology ( Site 2919)

location_facility: Niigata Cancer Center Hospital ( Site 3005)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 3013)

location_facility: Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)

location_facility: Hospital Provincial del Centenario ( Site 0205)

location_facility: Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)

location_facility: Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)

location_facility: Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)

location_facility: Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)

location_facility: Shanghai Chest Hospital-Oncology department ( Site 2900)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 1300)

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)

location_facility: Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 3012)

location_facility: Hattiesburg Clinic Hematology/Oncology ( Site 0003)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)

location_facility: CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)

location_facility: Kepler Universitätsklinikum ( Site 0507)

location_facility: Jilin Cancer Hospital-GCP office ( Site 2909)

location_facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)

location_facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)

location_facility: SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)

location_facility: Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1302)

location_facility: Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)

location_facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)

location_facility: National Cancer Center Hospital East ( Site 3002)

location_facility: The First Affiliated Hospital of Soochow University ( Site 2913)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 0001)

location_facility: Kansai Medical University Hospital ( Site 3009)

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)

location_facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)

location_facility: Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)

location_facility: Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)

location_facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)


title: A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

acronym: FRONTIER 1

summary: Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

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

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Atlanta Dermatology, Vein & Research Center

location_facility: Seoul National University Bundang Hospital


title: A Phase 3, Multicenter, Multinational, Randomized, Double-blind, Double-dummy, Active-comparator Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3 (GD3) Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ERT)

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Argentina
Canada
Hungary
United States
France
China
Germany

location_facility: Children's Hospital of Philadelphia - Investigational Site Number: 8400004

location_facility: Yale University School of Medicine - Investigational Site Number: 8400003

location_facility: Lysosomal and Rare Disorders Research and Treatment Center, Inc - Investigational Site Number: 8400001

location_facility: University of Iowa - Investigational Site Number: 8400002

summary: This is a parallel arm, Phase 3, double-blind, double-dummy, active-comparator, 2 arm study to evaluate the efficacy and safety of daily oral venglustat versus intravenous Cerezyme infusions every two weeks for improvement or stabilization of the neurological manifestations and maintenance of systemic disease stability in participants aged ≥12 and <18 years and adult patients with Gaucher disease Type 3 (GD3) who have been treated with Enzyme Replacement Therapy (ERT) for at least 3 years.


title: A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

summary: The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

lead_sponsor: Biohaven Pharmaceuticals, Inc.

location_country:
United Kingdom
United States
Canada
France

location_facility: Centre d'Investigation Clinique - Equipe Mobile d'Aide à l'Investigation

location_facility: Neurology Offices of South Florida, PLLC

location_facility: Clinical Investigation Specialists, Inc.

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: Alliance for Multispecialty Research, LLC

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: Mirtorabi Medicine Professional Corporation

location_facility: Montefiore Medical Center; Headache Center


title: A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer

summary: Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with rising PSA values on abiraterone.

lead_sponsor: Arvinas Androgen Receptor, Inc.