title: Phase II Study of Cabozantinib in Patients With Gastrointestinal Stromal Tumor (GIST) Who Progressed During Neoadjuvant, Adjuvant or Palliative Therapy With Imatinib and Sunitinib

summary:
The study is a multi-center, multi-national, open label, single arm Phase II study of single-agent cabozantinib. The objective of the study is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors.

Patient will receive cabozantinib until they experience no further benefit from the treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon investigator's discretion, provided no other criteria for treatment withdrawal are met.

ReferenceCitation: Kyriazoglou A, Jespers P, Vandecavaye V, Mir O, Kasper B, Papai Z, Blay JY, Italiano A, Zaffaroni F, Litière S, Nzokirantevye A, Schöffski P. Exploratory analysis of tumor imaging in a Phase 2 trial with cabozantinib in gastrointestinal stromal tumor: lessons learned from study EORTC STBSG 1317 'CaboGIST'. Acta Oncol. 2022 Jun;61(6):663-668. doi: 10.1080/0284186X.2022.2068967. Epub 2022 Apr 28.

ReferenceCitation: Schöffski P, Mir O, Kasper B, Papai Z, Blay JY, Italiano A, Benson C, Kopeckova K, Ali N, Dileo P, LeCesne A, Menge F, Cousin S, Wardelmann E, Wozniak A, Marreaud S, Litiere S, Zaffaroni F, Nzokirantevye A, Vanden Bempt I, Gelderblom H. Activity and safety of the multi-target tyrosine kinase inhibitor cabozantinib in patients with metastatic gastrointestinal stromal tumour after treatment with imatinib and sunitinib: European Organisation for Research and Treatment of Cancer phase II trial 1317 'CaboGIST'. Eur J Cancer. 2020 Jul;134:62-74. doi: 10.1016/j.ejca.2020.04.021. Epub 2020 May 26.

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

location_country:
United Kingdom
Hungary
France
Belgium
Germany
Czechia

location_facility: Military Hospital - State Health Centre (3769)

location_facility: Royal Marsden Hospital - Chelsea, London (613)

location_facility: Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital (622)


type: EudraCT Number

title: A Two-part, Multicentre, International Phase I and II Trial Assessing the Safety and Efficacy of the Hsp90 Inhibitor Ganetespib in Combination With Paclitaxel Weekly in Women With High-grade Serous, High-grade Endometrioid, or Undifferentiated, Platinum-resistant Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

summary: Epithelial ovarian cancer (EOC) is the most lethal gynaecological malignancy causing 41900 deaths annually in Europe. The predominance of aggressive Type II tumours, which are characterised by a high frequency of p53 mutations, and primary or acquired resistance to platinum-based chemotherapy profoundly contribute to the high mortality rate. With current standard therapy the median overall survival of metastatic platinum-resistant (Pt-R) ovarian cancer patients is only 14 month. There is a pressing need for more effective, innovative treatment strategies to particularly improve survival in this subgroup of EOC patients. This is a drug strategy targeting a central driver of tumour aggressiveness and metastatic ability, namely mutant p53, via an innovative new Hsp90 (heat shock protein 90) inhibition mechanism. The most advanced, second-generation Hsp90 inhibitor will be used, Ganetespib. The first part (Phase I) of the GANNET53 trial will test the safety of Ganetespib in a new combination with standard chemotherapy (Paclitaxel weekly) in Pt-R EOC patients. The second part (randomised Phase II) will examine the efficacy of Ganetespib in combination with standard chemotherapy versus standard chemotherapy alone in EOC patients with Pt-R tumours.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Medical University Innsbruck

location_country: Austria Germany France Belgium

location_facility: Katholieke Universiteit Leuven, Dept. of Gynaecologic Oncology

location_facility: Universitätsmedizin Berlin Charité, Dept. for Gynecology

location_facility: Assistance Publique - Hôpitaux de Paris Medical Oncology Department

location_facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung / Knappschaft GmbH Department of Gynaecologic Oncology

location_facility: Medical University Innsbruck, Department for Gynaecology and Obstetrics

location_facility: Universitätsklinikum Hamburg-Eppendorf Dept. of Gynecology and Gynecologic Oncology

location_facility: Centre de lutte contre le cancer Francois Baclesse

location_facility: University Hospital Carl Gustav Carus Dresden, Department of Gynaecology and Obstetrics

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


status: Completed

title: Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma

type: Other Identifier

source: euctr

location_country:
France
Italy
United Kingdom
Belgium

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori (704)

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)

location_facility: CHU de Dijon - Centre Georges-Francois-Leclerc (229)

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)

summary: Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia

lead_sponsor: Janssen Research & Development, LLC

location_country:
Denmark
Spain
United Kingdom
Netherlands
France
Belgium
Germany

summary: The purpose of this study is to examine the safety and efficacy of decitabine in sequential administration with cytarabine in children with relapsed or refractory acute myeloid leukemia (AML).


title: A Prospective, Open Label, Multicenter, Partially Randomized, Safety Study of One Cycle of Promethera HepaStem in Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN) Paediatric Patients.

summary:
The purpose of this study is to assess the safety and to appraise the efficacy of one cycle of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in paediatric patients suffering from CN or UCD.

The study duration: 12 months starting from the day of treatment: 6 months active surveillance and 6 months observation post-infusion.

ReferenceType: derived

ReferenceCitation: Coppin LCF, Smets F, Ambroise J, Sokal EEM, Stéphenne X. Infusion-related thrombogenesis by liver-derived mesenchymal stem cells controlled by anticoagulant drugs in 11 patients with liver-based metabolic disorders. Stem Cell Res Ther. 2020 Feb 7;11(1):51. doi: 10.1186/s13287-020-1572-7.

lead_sponsor: Promethera Therapeutics

location_country:
United Kingdom
Italy
France
Israel
Belgium

location_facility: Rambam Medical Center, Meyer Children's Hospital

location_facility: Ospedale Pediatrico Bambino Gesu di Roma

location_facility: Schneider Children's Medical Center of israel

intervention_type: Biological


title: Virtue® Male Sling European Study

summary: This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

ipd_sharing: No

lead_sponsor: Coloplast A/S

location_country:
Spain
Italy
Ireland
Netherlands
United Kingdom
France
Belgium
Germany

location_facility: Fundacio Puigvert - Universitat Autonoma de Barcelona

location_facility: Centre Hospitalier Universitaire Henri Mondor

intervention_type: Device


title: A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib at 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

summary: The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

lead_sponsor: AB Science

location_country: Spain Hungary India France Bulgaria Czechia

location_facility: University of Debrecen Medical and Health Science Center


title: HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups

summary: The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.

ReferenceType: background

ReferenceCitation: Kim YG. Anticoagulation during haemodialysis in patients at high-risk of bleeding. Nephrology (Carlton). 2003 Oct;8 Suppl:S23-7. Review.

ReferenceCitation: European Best Practice Guidelines Expert Group on Hemodialysis, European Renal Association. Section V. Chronic intermittent haemodialysis and prevention of clotting in the extracorporal system. Nephrol Dial Transplant. 2002;17 Suppl 7:63-71.

ReferenceCitation: Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. Epub 2007 Dec 21.

ReferenceCitation: Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75.

ReferenceCitation: Yixiong Z, Jianping N, Yanchao L, Siyuan D. Low dose of argatroban saline flushes anticoagulation in hemodialysis patients with high risk of bleeding. Clin Appl Thromb Hemost. 2010 Aug;16(4):440-5. doi: 10.1177/1076029609334628. Epub 2009 Oct 14.

ReferenceCitation: Laville M, Dorval M, Fort Ros J, Fay R, Cridlig J, Nortier JL, Juillard L, Dębska-Ślizień A, Fernández Lorente L, Thibaudin D, Franssen C, Schulz M, Moureau F, Loughraieb N, Rossignol P. Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis. Kidney Int. 2014 Dec;86(6):1260-7. doi: 10.1038/ki.2014.225. Epub 2014 Jul 9.

ReferenceCitation: Rossignol P, Dorval M, Fay R, Ros JF, Loughraieb N, Moureau F, Laville M. Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial. Trials. 2013 Jun 1;14:163. doi: 10.1186/1745-6215-14-163.

lead_sponsor: Baxter Healthcare Corporation

location_country:
Poland
Spain
United Kingdom
Canada
France
Belgium
Netherlands

location_facility: Hospital Universitary German Trias i Pujol

intervention_type: Other


title: An Extension Protocol for Participants of Genzyme-Sponsored Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea

acronym: Extension

summary: To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Vericel Corporation

location_country:
Poland
United Kingdom
Sweden
France
Norway
Netherlands
Czechia

location_facility: University Medical Centre of Utrecht, Department of Orthopaedics

location_facility: Orthopaedic & Traumatology of Motor Organs, Independent Public Clinic Hospital

location_facility: Hôpital d'instruction des Armées Robert Picqué

location_facility: University Hospital Na Bulovce- Department of Orthopaedic Surgery Postgraduate Medical Institute

location_facility: Regional Centre of Knee Surgery & Arthroscopy, Regional Hospital of Traumatologic Surgery

location_facility: University of Oxford, Nuffield Dept. of Orthopaedic Surgery


title: An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence

summary: The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.

lead_sponsor: Galderma R&D

location_country: Spain Italy Finland Canada France Norway Germany

location_facility: University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza

location_facility: CHU de Rouen 1 rue Germont service de chirurgie et digestive

location_facility: Univ. degli Studi di Padova Hospital Clinica Chirurgica

location_facility: Klinik für Allgemein- und Vizeralchirurgie


title: A Phase 2, Randomized, Open-Label Trial of GS-9256 Plus GS-9190 Alone and in Combination With Ribavirin for 28 Days in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0112)

summary:
This a phase 2, randomized, open-label trial of GS-9256 plus GS-9190, two oral anti HCV drugs, for 28 days with and without ribavirin (RIBA) and with pegylated interferon (PEG)/RIBA in adults with chronic Hepatitis C virus (HCV). In Part A, approximately thirty (30) subjects 18-70 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of the two treatment groups (GS-9256 plus GS-9190 or GS-9256 plus GS-9190 plus RIBA). In Part B, an additional fifteen (15) subjects will receive 75 mg GS-9256 BID plus 40 mg GS-9190 BID in combination with PEG/RIBA. After the 28-day treatment period, subjects will receive PEG/RIBA as standard of care (SOC).

Following randomization, subjects will return for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 28 day treatment phase. During the treatment phase, subjects will receive oral study drugs twice daily for 28 days and PEG once weekly for Part B. Subjects then receive PEG/RIBA as local SOC starting on Day 28 (not provided as part of the study). Following completion of the 28-day treatment phase, subjects will be followed for approximately 72 weeks.

lead_sponsor: Gilead Sciences

location_country:
Germany
France
United Kingdom
Belgium


title: A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

acronym: SY

summary: Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

ReferenceType: result

ReferenceCitation: Voskanyan L, García-Feijoó J, Belda JI, Fea A, Jünemann A, Baudouin C; Synergy Study Group. Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014 Feb;31(2):189-201. doi: 10.1007/s12325-014-0095-y. Epub 2014 Jan 23.

lead_sponsor: Glaukos Corporation

location_country: Spain Italy Austria Armenia France Germany


title: A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer

summary: This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Bracco Diagnostics, Inc

location_country:
United Kingdom
Italy
Austria
Netherlands
France
Belgium
Germany

location_facility: Imperial College NHS Trust - Charing Cross

location_facility: Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"

intervention_type: Procedure


title: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800, an S1P1 Receptor Agonist, Administered for 6 Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis

summary: This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis.

lead_sponsor: Actelion

location_country: Serbia Austria Hungary France Germany

location_facility: UNIVERSITY OF DEBRECEN Department of dermatology

location_facility: Clinical Centre of Nis Clinic of Dermato-venerology

location_facility: Klinik für Dermatologie Venerologie und Allergologie

location_facility: CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie

location_facility: Department of Dermatology University Hospital Johannes Gutenberg-University Mainz

location_facility: Veszprem County Csolnoky Ferenc Hospital Dermatology Department

location_facility: Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie

location_facility: Dermatologie, Hôpital Purpan Universtité Paul Sabatier

location_facility: University of Szeged Department of dermatology and allergology

location_facility: Semmelweis Universtity Dept. dermato-venerology and skin oncology

location_facility: Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud

location_facility: University Clinic Münster Clinic and Policlinic for skin diseases


title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)

summary: Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

enrollment_type: Anticipated

ReferenceCitation: Zerbib F, Bruley des Varannes S, Roman S, Tutuian R, Galmiche JP, Mion F, Tack J, Malfertheiner P, Keywood C. Randomised clinical trial: effects of monotherapy with ADX10059, a mGluR5 inhibitor, on symptoms and reflux events in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Apr;33(8):911-21. doi: 10.1111/j.1365-2036.2011.04596.x. Epub 2011 Feb 14.

lead_sponsor: Addex Pharma S.A.

location_facility:
Lyon
Nantes
Dresden
Wien
Berlin
Gorlitz
Magdeburg 13
Leipzig
Madgeburg 12
Bordeaux
Leuven


title: A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.

summary: The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.

ReferenceCitation: Löwenberg B, Muus P, Ossenkoppele G, Rousselot P, Cahn JY, Ifrah N, Martinelli G, Amadori S, Berman E, Sonneveld P, Jongen-Lavrencic M, Rigaudeau S, Stockman P, Goudie A, Faderl S, Jabbour E, Kantarjian H. Phase 1/2 study to assess the safety, efficacy, and pharmacokinetics of barasertib (AZD1152) in patients with advanced acute myeloid leukemia. Blood. 2011 Dec 1;118(23):6030-6. doi: 10.1182/blood-2011-07-366930. Epub 2011 Oct 5.

lead_sponsor: AstraZeneca

location_country:
Netherlands
United States
Italy
France


title: An Open Label, Multicenter Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial Hypertension

summary: The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.

ReferenceCitation: Beghetti M, Haworth SG, Bonnet D, Barst RJ, Acar P, Fraisse A, Ivy DD, Jais X, Schulze-Neick I, Galiè N, Morganti A, Dingemanse J, Kusic-Pajic A, Berger RM. Pharmacokinetic and clinical profile of a novel formulation of bosentan in children with pulmonary arterial hypertension: the FUTURE-1 study. Br J Clin Pharmacol. 2009 Dec;68(6):948-55. doi: 10.1111/j.1365-2125.2009.03532.x.

location_country:
United Kingdom
Italy
Netherlands
Switzerland
United States
France
Germany

location_facility: The Children's Hospital Cardiac Care Center


title: An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1

acronym: FUTURE 2

summary: The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.

ReferenceCitation: Berger RM, Haworth SG, Bonnet D, Dulac Y, Fraisse A, Galiè N, Ivy DD, Jaïs X, Miera O, Rosenzweig EB, Efficace M, Kusic-Pajic A, Beghetti M. FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion. Int J Cardiol. 2016 Jan 1;202:52-8. doi: 10.1016/j.ijcard.2015.08.080. Epub 2015 Aug 9. Erratum in: Int J Cardiol. 2016 Nov 15;223:1072-1073.


title: Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.

ReferenceCitation: Leahy M, Ray-Coquard I, Verweij J, Le Cesne A, Duffaud F, Hogendoorn PC, Fowst C, de Balincourt C, di Paola ED, van Glabbeke M, Judson I, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a phase II study from the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Jan;43(2):308-15. Epub 2006 Nov 13.

ReferenceCitation: Leahy MG, Blay JY, Verweij J, et al.: EORTC 62011: phase II trial of brostallicin for soft tissue sarcoma. [Abstract] Eur J Cancer Suppl 1 (5): S209, A-694, 2003.

location_country:
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: Daniel Den Hoed Cancer Center at Erasmus University Medical Center

location_facility: Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital


title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.

location_country:
Poland
United Kingdom
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

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

location_facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

intervention_type: Radiation


title: Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.

ReferenceCitation: Smyth JF, Aamdal S, Awada A, Dittrich C, Caponigro F, Schöffski P, Gore M, Lesimple T, Djurasinovic N, Baron B, Ravic M, Fumoleau P, Punt CJ; EORTC New Drug Development and Melanoma Groups. Phase II study of E7070 in patients with metastatic melanoma. Ann Oncol. 2005 Jan;16(1):158-61.

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

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


title: Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy.

location_country:
Slovenia
United Kingdom
Austria
France
Israel
Belgium
Germany

location_facility: Schneider Children's Medical Center of Israel


ipd_sharing: Yes

status: Recruiting

acronym: TH HBV ASO-001

title: A Phase 2, Single-blinded, Randomised, Controlled Multi-country Study to Evaluate the Safety, Reactogenicity, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide (ASO) Against Chronic Hepatitis B (CHB) Followed by Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy

study_completion_date_type: Anticipated

lead_sponsor: GlaxoSmithKline

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

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Thailand
France
Singapore
Belgium
Philippines
Germany
Bulgaria

summary: This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA treatment for CHB. The aim is to quantify the efficacy of sequential therapy as well as to determine an added value of sequential therapy over GSK3228836 therapy in CHB patients treated with NAs. In addition, the study will assess the effect of different treatment durations of GSK3228836 (12 or 24 weeks) prior to initiating GSK3528869A treatment.

status_simplified: Ongoing


title: An Open-label, Single-arm, Multicenter Pilot Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Pegcetacoplan in Patients With Transplant-associated Thrombotic Microangiopathy (TA-TMA) After Hematopoietic Stem Cell Transplantation (HSCT)

summary: The purpose of the study is to assess PK, Pharmacodynamics (PD), Efficacy and safety of pegcetacoplan in patients with TA-TMA after HSCT.

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Spain
Italy
Greece
United States
France

location_facility:
Luca Castagna, MD
Ryotaro Nakamura, MD
Panagiotis Tsirigotis, MD
Giovanni Grillo, MD
Flore Sicre de Fontbrune, MD
Rafael Francisco Duarte Palomino, MD
Hassan AlKhateeb, MD
Michael Loschi, MD
Simona Sica, MD
Madiha Iqbal
Jerome Cornillon, MD
Antonio Risitano, MD
Elisabetta Terruzi, MD
Ioanna Sakellari, MD
Ioannis Baltadakis, MD


title: Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors

lead_sponsor: EMD Serono Research & Development Institute, Inc.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

location_country:
Canada
Korea, Republic of
United States
France
Germany

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

location_facility: CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique

location_facility: Severance Hospital, Yonsei University Health System

summary: This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended Avelumab and Lenvatinib dose for expansion. Dose Expansion Part 2 will assess the efficacy of Avelumab in combination with Lenvatinib by Progression-free Survival in participants with pre-defined primary central nervous system (CNS) tumors.


title: Multi-centre Retrospective Study to Describe the Use and Outcomes of ECP in Combination With New Treatment Protocols in Acute and Chronic GvHD

summary:
Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects. Additionally ECP has been shown to allow tapering of steroids and immunosuppressant agents which should be a goal of GvHD therapy.

ECP has been used for the management of GvHD since first described in 1994 and as its use has continued over the decades. The treatment was incorporated into a number of guidelines as a second line therapy in steroid refractory or steroid dependent GvHD patients. As well as being used in addition and after steroids, it is also used in combination with CNI Inhibitors, MMF and other immunosuppressant agents.

However, despite the current widespread use of ECP in the treatment of patients with GvHD, clinical data from randomized studies is limited and small prospective and retrospective trials are the main evidence base .This is also the case for other commonly used immunosuppressant agents, which have been used in GvHD since ECP was introduced.

The systematic review concluded that ECP is an effective therapy for oral, skin, and liver SR-cGVHD, with modest activity in lung and gastrointestinal SR-cGVHD.

In the USA Ibrutinib is the only FDA approved agent for second line cGvHD therapy once steroid therapy has failed and Ruxolitinib had been approved in the USA for the treatment of steroid refractory GvHD.

While studies have shown the effectiveness and safety of ECP in GvHD treatment, there is limited data to show how it is being used in combination with the recently approved agents.

Using existing registry data targeting centres where the newer agents are being used and enhancing the capture of treatment data we believe we can undertake a larger scale study, which will include the new treatment protocols. The aim of the current study is to improve the evidence basis on the potential benefit of ECP use as treatment of GVHD.

status: Active, not recruiting

time_perspective: Retrospective

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Denmark
Poland
Romania
Spain
Greece
Italy
Russian Federation
United Kingdom
Sweden
France
Israel
Turkey
Belgium
Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: ICO-Hospital Universitari Germans Trias i Pujol

location_facility: First State Pavlov Medical University of St. Petersburg

location_facility: University Hospital Birmingham NHS Trust


title: A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

summary: The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Netherlands
United States
Spain
France

location_facility: Columbia University Medical Center, Herbert Irving Pavilion


title: An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma

summary: This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. RO7425781 will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of RO7425781 (Part 1) and a randomized dose expansion of RO7425781 (Part 2).

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

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Korea, Republic of
France
Belgium

location_facility: Clinica Universitaria de Navarra; Servicio de Hematologia

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

location_facility: CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

location_facility: Instituto Clinico Humanitas; Med Onc & Hemat

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"


title: Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens

lead_sponsor: Menarini Group

location_country:
Poland
Spain
Italy
Netherlands
United States
France
Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Azienda Socio Sanitaria Territoriale Niguarda

summary: Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer.


title: A Double-blind, Placebo Controlled, Randomized, Phase II Study Evaluating the Efficacy and Safety of Capmatinib and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations

lead_sponsor: Novartis Pharmaceuticals

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.

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

location_facility: Massachusetts General Hospital Liver and Kidney TX

summary: A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations


title: Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection

summary: Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection

lead_sponsor: ExThera Medical Europe BV

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

location_facility:
Hôpital Erasme
Medisch Spectrum Twente
Medizinische Hochschule Hannover
Universitätsmedizin Greifswald
University Hospital, Pisa
A.Gemelli University Hospital
Nouvel Hopital Civil
Ziekenhuis Gelderse Vallei
Middelheim Hospital
CHU Bocage Central
Universität Witten-Herdecke
Jagiellonia University
Royal Surrey NHS Foundation Trust
Hospital Universitari Vall d'Hebron
Azienda Usl Toscana Centro
Medical University of Innsbruck
Klinikum Aschaffenburg-Alzenau
Hospices Civils de Lyon
University Hospital Frankfurt
Vivantes Klinikum Neukölln
Universität Rostock
Hospital Clinico San Carlos
Universitätsklinikum Essen (AöR)
Städtisches Klinikum Braunschweig GmbH
Asklepios Hospital St. Georg


title: A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

summary: A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

lead_sponsor: SOTIO Biotech AG

location_country:
United States
France
Spain
Czechia

location_facility: Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče


title: A Phase II Two Cohort Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases

summary: This study will evaluate the efficacy and safety of cobimetinib plus atezolizumab in participants with BRAFV600 wild-type melanoma with central nervous system (CNS) metastases and of cobimetinib plus atezolizumab and vemurafenib in BRAFV600 mutation-positive melanoma patients with CNS metastases.

ReferenceCitation: Dummer R, Queirolo P, Abajo Guijarro AM, Hu Y, Wang D, de Azevedo SJ, Robert C, Ascierto PA, Chiarion-Sileni V, Pronzato P, Spagnolo F, Mujika Eizmendi K, Liszkay G, de la Cruz Merino L, Tawbi H. Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2022 Sep;23(9):1145-1155. doi: 10.1016/S1470-2045(22)00452-1. Epub 2022 Aug 5.

location_country: Brazil Spain Italy Latvia Switzerland Hungary France Germany

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie

location_facility: Onkologikoa - Instituto Oncológico de Donostia

location_facility: Universitätsspital Zürich; USZ Flughafen / H13-7-609

location_facility: Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly


title: An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination, in Patients With Advanced Solid/Metastatic Tumours.

summary: A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer or advanced solid tumours.

ReferenceCitation: Eickhoff N, Bergman AM, Zwart W. Homing in on a Moving Target: Androgen Receptor Cistromic Plasticity in Prostate Cancer. Endocrinology. 2022 Oct 11;163(11). pii: bqac153. doi: 10.1210/endocr/bqac153.

lead_sponsor: CellCentric Ltd.

location_country:
Spain
United Kingdom
Sweden
United States
France
Netherlands

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

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center


type: Other Grant/Funding Number

type: Registry Identifier

title: Randomised Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Radiotherapy for Women With Early Stage Endometrial Cancer: PORTEC-4a Trial

summary: This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

ReferenceCitation: Nero C, Ciccarone F, Pietragalla A, Duranti S, Daniele G, Scambia G, Lorusso D. Adjuvant Treatment Recommendations in Early-Stage Endometrial Cancer: What Changes With the Introduction of The Integrated Molecular-Based Risk Assessment. Front Oncol. 2021 Sep 1;11:612450. doi: 10.3389/fonc.2021.612450. eCollection 2021. Review.

ReferenceCitation: van den Heerik ASVM, Horeweg N, Nout RA, Lutgens LCHW, van der Steen-Banasik EM, Westerveld GH, van den Berg HA, Slot A, Koppe FLA, Kommoss S, Mens JWM, Nowee ME, Bijmolt S, Cibula D, Stam TC, Jurgenliemk-Schulz IM, Snyers A, Hamann M, Zwanenburg AG, Coen VLMA, Vandecasteele K, Gillham C, Chargari C, Verhoeven-Adema KW, Putter H, van den Hout WB, Wortman BG, Nijman HW, Bosse T, Creutzberg CL. PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer. Int J Gynecol Cancer. 2020 Dec;30(12):2002-2007. doi: 10.1136/ijgc-2020-001929. Epub 2020 Oct 12.

ReferenceCitation: Wortman BG, Bosse T, Nout RA, Lutgens LCHW, van der Steen-Banasik EM, Westerveld H, van den Berg H, Slot A, De Winter KAJ, Verhoeven-Adema KW, Smit VTHBM, Creutzberg CL; PORTEC Study Group. Molecular-integrated risk profile to determine adjuvant radiotherapy in endometrial cancer: Evaluation of the pilot phase of the PORTEC-4a trial. Gynecol Oncol. 2018 Oct;151(1):69-75. doi: 10.1016/j.ygyno.2018.07.020. Epub 2018 Aug 3.

ipd_sharing_description: Specifics will be decided and made public on website at a later stage, most probably from 5 years after final publication onwards

lead_sponsor: Leiden University Medical Center

location_country: Ireland Austria Netherlands Switzerland France Belgium Germany Czechia

location_facility: CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague

location_facility: CancerTrials Ireland - St Luke's Hospital (SLRON SLH)

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: CancerTrials Ireland - St James Hospital (SLRON SJH)


title: TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients With Coronary MultiVessel Disease and Aortic Valve Stenosis

acronym: TCW

summary: The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

ipd_sharing: Undecided

lead_sponsor: Maatschap Cardiologie Zwolle

location_country: Denmark Poland Portugal Spain Greece Austria Netherlands France Germany Slovakia

location_facility: Hospital Clinico Universitario San Carlos

location_facility: University Hospital Frankfurt - Goethe University

location_facility: Rigshospitalet, Copenhagen University Hospital

location_facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH


title: Post-Market Clinical Investigation of the Clareon® IOL

summary: The primary purpose of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL) compared to historical safety and performance endpoint (SPE) rates as reported in EN ISO 11979-7:2014. The secondary purpose of this study is to evaluate the refractive outcomes obtained with up to 3 years follow-up in eyes implanted with the Clareon® IOL.

lead_sponsor: Alcon Research

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
France
Germany


title: A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

lead_sponsor: Iltoo Pharma

ReferenceCitation: Humrich JY, Cacoub P, Rosenzwajg M, Pitoiset F, Pham HP, Guidoux J, Leroux D, Vazquez T, Riemekasten G, Smolen JS, Tsokos G, Klatzmann D. Low-dose interleukin-2 therapy in active systemic lupus erythematosus (LUPIL-2): a multicentre, double-blind, randomised and placebo-controlled phase II trial. Ann Rheum Dis. 2022 Aug 16. pii: annrheumdis-2022-222501. doi: 10.1136/ard-2022-222501. [Epub ahead of print]

location_country: Portugal Romania Spain Italy Austria France Mauritius Mexico Germany Bulgaria

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Azienda Osp. Univ. Seconda Università di Napoli

location_facility: University Multiprofile Hospital for Active Treatment

location_facility: Centro Integral en Reumatología S.A. de C.V.

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

summary: The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.


title: Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

acronym: TRUST

summary:
This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial.

All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study.

TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.

ReferenceCitation: Reuss A, du Bois A, Harter P, Fotopoulou C, Sehouli J, Aletti G, Guyon F, Greggi S, Mosgaard BJ, Reinthaller A, Hilpert F, Schade-Brittinger C, Chi DS, Mahner S. TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7). Int J Gynecol Cancer. 2019 Oct;29(8):1327-1331. doi: 10.1136/ijgc-2019-000682. Epub 2019 Aug 15.

lead_sponsor: AGO Study Group

location_country:
Denmark
United Kingdom
Italy
Austria
Sweden
United States
France
Germany

location_facility: European Institute of Oncology; Gynecologic Cancer Surgery

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli

location_facility: Fondazione IRCCS Istituto Nazionale Tumori - Milan

location_facility: Imperial College London, Hammersmith Hospital, Surgery&Cancer

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München

location_facility: Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie

location_facility: Klinikum rechts der Isar, Frauen- und Poliklinik

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie


title: A Phase II Multicenter Study Comparing the Efficacy of the Oral Angiogenesis Inhibitor Nintedanib With the Intravenous Cytotoxic Compound Ifosfamide for Treatment of Patients With Advanced Metastatic Soft Tissue Sarcoma After Failure of Systemic Non-oxazaphosporine-based First Line Chemotherapy for Inoperable Disease "ANITA"

acronym: ANITA

summary:
This is a prospective, multicentric, randomized, open label Phase II trial investigating whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after failure of first line chemotherapy prolongs progression-free survival.

The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival when compared with ifosfamide.

Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in terms of progression-free survival rate at 12 weeks, overall survival, objective response rate, patient benefit rate, response duration, total duration of treatment with nintedanib safety, Health related Quality of Life and Health Economics.

Exploratory objectives include an analysis of putative predictive biomarkers for the anti-tumor effects of the investigational agent nintedanib.treatment.

ReferenceCitation: Schöffski P, Toulmonde M, Estival A, Marquina G, Dudzisz-Śledź M, Brahmi M, Steeghs N, Karavasilis V, de Haan J, Wozniak A, Cousin S, Domènech M, Bovée JVMG, Charon-Barra C, Marreaud S, Litière S, De Meulemeester L, Olungu C, Gelderblom H. Randomised phase 2 study comparing the efficacy and safety of the oral tyrosine kinase inhibitor nintedanib with single agent ifosfamide in patients with advanced, inoperable, metastatic soft tissue sarcoma after failure of first-line chemotherapy: EORTC-1506-STBSG "ANITA". Eur J Cancer. 2021 Jul;152:26-40. doi: 10.1016/j.ejca.2021.04.015. Epub 2021 May 29.

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

location_country:
Poland
Spain
United Kingdom
Lithuania
France
Belgium
Netherlands

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Royal Marsden Hospital - Chelsea, London (613)

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Cliniques Universitaires Saint-Luc (121)

location_facility: Vilnius University Hospital Santariskiu Santaros Clinics Klinikos (9453)

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (301)

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre


summary: The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

ReferenceCitation: Verzini F, Cieri E, Kahlberg A, Sternbach Y, Heijmen R, Ouriel K, Robaina S, Azizzadeh A. A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms. J Vasc Surg. 2021 Oct;74(4):1125-1134.e2. doi: 10.1016/j.jvs.2021.04.018. Epub 2021 Apr 20.

ReferenceCitation: Azizzadeh A, Desai N, Arko FR 3rd, Panneton JM, Thaveau F, Hayes P, Dagenais F, Lei L, Verzini F. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg. 2019 Nov;70(5):1399-1408.e1. doi: 10.1016/j.jvs.2019.01.067. Epub 2019 May 21.

lead_sponsor: Medtronic Cardiovascular

location_country:
Denmark
United Kingdom
Italy
Canada
France
Netherlands

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Università di Perugia - Ospedale S.M. Della Misericordia

location_facility: IRCCS Ca' Granda Ospendale Maggiore Policlinico

location_facility: Imperial College Healthcare NHS Trust - St Mary's Hospital

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve


acronym: ICONIC

title: Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome

lead_sponsor: Mirum Pharmaceuticals, Inc.

ReferenceCitation: Kamath BM, Goldstein A, Howard R, Garner W, Vig P, Marden JR, Billmyer E, Anderson A, Kirson N, Jacquemin E, Gonzales E. Maralixibat treatment response in Alagille syndrome is associated with improved health-related quality of life. J Pediatr. 2022 Sep 10. pii: S0022-3476(22)00791-0. doi: 10.1016/j.jpeds.2022.09.001. [Epub ahead of print]

ReferenceCitation: Gonzales E, Hardikar W, Stormon M, Baker A, Hierro L, Gliwicz D, Lacaille F, Lachaux A, Sturm E, Setchell KDR, Kennedy C, Dorenbaum A, Steinmetz J, Desai NK, Wardle AJ, Garner W, Vig P, Jaecklin T, Sokal EM, Jacquemin E. Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study. Lancet. 2021 Oct 30;398(10311):1581-1592. doi: 10.1016/S0140-6736(21)01256-3. Epub 2021 Oct 28.

location_country:
Poland
Spain
United Kingdom
Australia
France
Belgium

location_facility: The Children's Memorial Health Institute

location_facility: Hospital Universitario La Paz- Hospital Materno Infantil

location_facility: Paediatric Liver Center, Kings College Hospital

summary: This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as maralixibat or MRX).


title: A Phase 2 Multicenter, Open-label Study to Determine the Efficacy and Safety of Pomalidomide (CC-4047) in Combination With Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Moderate or Severe Renal Impairment Including Subjects Undergoing Hemodialysis

lead_sponsor: Celgene

ReferenceCitation: Li Y, Wang X, O'Mara E, Dimopoulos MA, Sonneveld P, Weisel KC, Matous J, Siegel DS, Shah JJ, Kueenburg E, Sternas L, Cavanaugh C, Zaki M, Palmisano M, Zhou S. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function. Clin Pharmacol. 2017 Nov 8;9:133-145. doi: 10.2147/CPAA.S144606. eCollection 2017.

ReferenceCitation: Dimopoulos M, Weisel K, van de Donk NWCJ, Ramasamy K, Gamberi B, Streetly M, Offidani M, Bridoux F, de la Rubia J, Mateos MV, Ardizzoia A, Kueenburg E, Collins S, Di Micco A, Rosettani B, Li Y, Bacon P, Sonneveld P. Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial. J Clin Oncol. 2018 Jul 10;36(20):2035-2043. doi: 10.1200/JCO.2017.76.1742. Epub 2018 Feb 2.

location_country:
Spain
Italy
Austria
Greece
Netherlands
United Kingdom
France
Germany

location_facility: Oxford Radcliffe Hospital ICRF Medical Oncology Unit

location_facility: Ospedale Maggiore Policlinico Mangiagalli Regina Elena

location_facility: CEIC Hospital Universitario de Salamanca

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: St Thomas' HospitalGuy's Hospital Dept. of Haematology

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: Queen Elizabeth Hospital UHB NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Ospedali

location_facility: Daniel den Hoed Kliniek Medical Oncology, Erasmus MC

location_facility: Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie

location_facility: Alexandra Hospital, University of Athens

summary: The primary purpose of the study is to determine the safety and efficacy and to generate PK and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.


title: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)

acronym: CRIB

summary: The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.

primary_purpose: Other

ReferenceCitation: Mariette X, Förger F, Abraham B, Flynn AD, Moltó A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13.

lead_sponsor: UCB BIOSCIENCES, Inc.

location_country:
Netherlands
United States
Switzerland
France


title: An Exploratory, Blinded, Randomized, Placebo-controlled Study in Subjects With Depressive Disorder to Investigate the Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced (Partial) Symptoms Response

summary: The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped.

lead_sponsor: Janssen Research & Development, LLC

location_country: Netherlands France Spain Belgium


title: A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Korea, Republic of
United States
France
Norway
Japan
Netherlands

location_facility: Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5

summary:
The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.

The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.


title: An Open Label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

summary: The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).

ReferenceCitation: Krejcik J, Frerichs KA, Nijhof IS, van Kessel B, van Velzen JF, Bloem AC, Broekmans MEC, Zweegman S, van Meerloo J, Musters RJP, Poddighe PJ, Groen RWJ, Chiu C, Plesner T, Lokhorst HM, Sasser AK, Mutis T, van de Donk NWCJ. Monocytes and Granulocytes Reduce CD38 Expression Levels on Myeloma Cells in Patients Treated with Daratumumab. Clin Cancer Res. 2017 Dec 15;23(24):7498-7511. doi: 10.1158/1078-0432.CCR-17-2027. Epub 2017 Oct 12.

ReferenceCitation: Plesner T, Arkenau HT, Gimsing P, Krejcik J, Lemech C, Minnema MC, Lassen U, Laubach JP, Palumbo A, Lisby S, Basse L, Wang J, Sasser AK, Guckert ME, de Boer C, Khokhar NZ, Yeh H, Clemens PL, Ahmadi T, Lokhorst HM, Richardson PG. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood. 2016 Oct 6;128(14):1821-1828. doi: 10.1182/blood-2016-07-726729. Epub 2016 Aug 16.

location_country:
Denmark
United Kingdom
United States
France
Netherlands


title: Phase Ib / II Study of BAY 1000394 in Combination With Cisplatin / Etoposide or Carboplatin / Etoposide as First-line Therapy in Subjects With Extensive Disease Small Cell Lung Cancer

lead_sponsor: Bayer

location_country:
Korea, Republic of
United States
France

summary:
This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.

The study will also assess how the drug is metabolized by the body and changes in tumor size.

BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.


title: A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

summary: The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).

ReferenceCitation: Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suárez-Fariñas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.

ReferenceCitation: Tsianakas A, Luger TA, Radin A. Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. Br J Dermatol. 2018 Feb;178(2):406-414. doi: 10.1111/bjd.15905. Epub 2018 Jan 11.

lead_sponsor: Regeneron Pharmaceuticals

location_country: Poland Hungary France Germany Czechia


title: An Explorative, Randomized, Placebo-controlled, DB, Parallel-group Trial, to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Subjects With GERD & With Persistent Symptoms Despite Taking a Stable Dose of PPIs

lead_sponsor: Shire

ReferenceCitation: Tack J, Zerbib F, Blondeau K, des Varannes SB, Piessevaux H, Borovicka J, Mion F, Fox M, Bredenoord AJ, Louis H, Dedrie S, Hoppenbrouwers M, Meulemans A, Rykx A, Thielemans L, Ruth M. Randomized clinical trial: effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment. Neurogastroenterol Motil. 2015 Feb;27(2):258-68. doi: 10.1111/nmo.12484. Epub 2014 Dec 21.

location_country:
United Kingdom
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Wingate Institute of Neurogastroenterology

location_facility: Queen's Medical Center (Nottingham University Hospital)

location_facility: Inselspital Bern (Bern University Hopsital)

location_facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot

summary: The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.


title: A Phase I, Open, Dose Escalation Trial With BI 836826 in Patients With Advanced Chronic Lymphocytic Leukaemia

summary: Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial. The trial will examine whether monotherapy with BI 836826 is safe and tolerable at escalating dose levels.

lead_sponsor: Boehringer Ingelheim

location_country: Germany France Belgium

location_facility: CTR Investigation Clinique, onco, Montpellier


title: A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol® With Placebo in Patients With Constipation Associated With Irritable Bowel Syndrome (IBS)

summary: Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.

ReferenceCitation: Attar A, Lémann M, Ferguson A, Halphen M, Boutron MC, Flourié B, Alix E, Salmeron M, Guillemot F, Chaussade S, Ménard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30.

lead_sponsor: Norgine

location_country:
Poland
United Kingdom
Italy
Czech Republic
Sweden
France
Germany

location_facility: Katedra i Klinika Gastroenterologii i Hepatologii


title: An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma

summary:
Purpose of the study:

The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.

Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.

Overall, participation in the study will help determine the following:

Find out if patients receiving Sorafenib will live longer
Find out if Sorafenib helps to slow the worsening of kidney cancer
Find out if Sorafenib has an effect on the tumours

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Switzerland
Sweden
France
Belgium
Germany


title: A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)

summary: The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.

primary_purpose: Prevention

lead_sponsor: Warner Chilcott

location_country:
United Kingdom
Australia
Argentina
Canada
Switzerland
France
Germany


title: An Open, Randomised, Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus, Mycophenolate Mofetil and Daclizumab Against Tacrolimus, Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation

acronym: TWIST

summary: The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Taiwan
Romania
United Kingdom
Italy
Czech Republic
Sweden
Hungary
France
Israel
South Africa
Turkey
Belgium
Germany


title: Phase 2 Clinical Trial of Bi-weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer

summary: Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.

lead_sponsor: Eisai Inc.

location_country:
Russian Federation
Argentina
Ukraine
Peru
United States
France


title: A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

summary:
Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).

This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients).

Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.

ReferenceCitation: Crosara IC, Mélot C, Preiser JC. A J-shaped relationship between caloric intake and survival in critically ill patients. Ann Intensive Care. 2015 Dec;5(1):37. doi: 10.1186/s13613-015-0079-3. Epub 2015 Nov 5.

ReferenceCitation: Preiser JC, Devos P, Ruiz-Santana S, Mélot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chioléro R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.

lead_sponsor: University of Liege

location_country: Spain Switzerland France Israel Belgium Netherlands Germany

location_facility: Centre Hospitalier Universitaire de Liège


title: A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer

summary:
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.

location_country: France Switzerland Belgium

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF)

acronym: BEAT PERS-AF

summary: BEAT AF is a randomized controlled trial aiming to assess the efficacy and the safety of pulsed field energy in persistent AF ablation

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Bordeaux

location_country: Austria France Belgium Germany Czechia

location_facility: Institute for Clinical and Experimental Medicine


acronym: SAkuraBonsai

title: SAkuraBonsai: Clinical, Imaging And Biomarker Open-Label Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention

lead_sponsor: Hoffmann-La Roche

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

location_country:
Turkey
United States
Italy
France

location_facility: University of Texas Southwestern Medical Center

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Hacettepe University Medical Faculty; Neurology

summary: Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar)


title: Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)

acronym: BEAT PAROX-AF

summary: BEAT AF is a randomized controlled trial aiming to demonstrate that pulsed field energy is faster, more effective and safer (tissue selectivity) than RF for paroxysmal AF ablation


title: Prospective Longitudinal Study of Neurological Disease Trajectory in Children Living With Late-Infantile or Juvenile Onset of GM1 or GM2 Gangliosidosis

acronym: PRONTO

summary: The study aims to characterize prospectively longitudinal progression of neurological domains in GM1 and GM2 Gangliosidosis patients with high-quality standards (GCP compliant).

lead_sponsor: Azafaros A.G.

location_country:
Brazil
United Kingdom
Italy
United States
France
Germany

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: LMU - Klinikum der Universitaet Muenchen - Neurologische Klinik und Poliklinik

location_facility: Hôpital des Enfants - CHU Toulouse Purpan

location_facility: Universtitäsklinikum Giessen und Marburg

location_facility: Armand-Trousseau Children's Hospital - CHU Paris Est


title: An Open-label, First-in-human, Dose-escalation Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS)

summary: This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.

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

lead_sponsor: Sanofi

location_country:
Australia
United States
Netherlands
France

location_facility: MD Anderson Cancer Center-Site Number:8400001


title: An Open-Label, Randomized, Phase 2, Umbrella Study to Investigate the Biological Rational of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy

acronym: Optimus

summary: This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
United States
Italy
France

location_facility: Hopital Europeen Georges Pompidou (Hegp)

location_facility: Ohio State University Medical Center Division of H

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

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari


title: A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase II Trial Investigating the Efficacy and Safety of Trimodulin (BT588) as add-on Therapy to Standard of Care in Adult Subjects With Severe COVID-19

acronym: ESsCOVID

summary:
The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19.

Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.

lead_sponsor: Biotest

location_country:
Russian Federation
France
Brazil
Spain

location_facility:
Investigational site # 3304
Investigational Site # 3401
Investigational site # 0709
Investigational site # 5503
Investigational site # 5505
Investigational site # 0706
Investigational site # 5501
Investigational site # 0707
Investigational Site # 3301
Investigational site # 3305
Investigational site # 0711
Investigational site # 5502
Investigational site # 0708
Investigational Site # 0704
Investigational Site # 3402
Investigational site # 0702
Investigational site # 0701


title: A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013.

ReferenceCitation: Deng JZ, Rustandi RR, Barbacci D, Swartz AR, Gulasarian A, Loughney JW. Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification. Hum Gene Ther. 2022 Jul;33(13-14):765-775. doi: 10.1089/hum.2022.013. Epub 2022 Jun 1.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Taiwan
Portugal
Spain
Italy
Canada
Hungary
United States
France
Israel
Norway
Peru
Japan
Germany

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0161)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

location_facility: Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 0172)

location_facility: Orszagos Onkologiai Intezet ( Site 0070)

location_facility: Princess Margaret Cancer Centre ( Site 0031)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0072)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0145)

location_facility: China Medical University Hospital ( Site 0144)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0181

location_facility: National Cancer Center Hospital East ( Site 0166)

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0191)

location_facility: Universitaetsklinikum Tuebingen ( Site 0171)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 0162)

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 0192)

location_facility: National Taiwan University Hospital ( Site 0141)

location_facility: Clinica Universitaria de Navarra ( Site 0122)

location_facility: Providence Portland Medical Center ( Site 0001)

location_facility: Centre Hospitalier Lyon-Sud ( Site 0055)

location_facility: Hospital Universitari Vall d Hebron ( Site 0121)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 0146)

location_facility: National Cheng Kung University Hospital ( Site 0142)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0032)


title: An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms

summary: The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.

ReferenceCitation: Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. Review.

ReferenceCitation: Lantigua H, Ortega-Gutierrez S, Schmidt JM, Lee K, Badjatia N, Agarwal S, Claassen J, Connolly ES, Mayer SA. Subarachnoid hemorrhage: who dies, and why? Crit Care. 2015 Aug 31;19:309. doi: 10.1186/s13054-015-1036-0.

ReferenceCitation: Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.

ReferenceCitation: Steiner T, Juvela S, Unterberg A, Jung C, Forsting M, Rinkel G; European Stroke Organization. European Stroke Organization guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage. Cerebrovasc Dis. 2013;35(2):93-112. doi: 10.1159/000346087. Epub 2013 Feb 7. Review.

ReferenceCitation: Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.

ipd_sharing_description: No plan to share IPD.

lead_sponsor: Corindus Inc.

location_country: Spain Austria Australia Canada Switzerland France

location_facility: CHU Montpellier - Hôpital Gui de Chauliac

location_facility: University Clinical Hospital of Valladolid


title: A Phase I Open Label First in Human Dose Escalation of the Immunoproteasome Inhibitor M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone in Participants With Relapsed Refractory Multiple Myeloma

summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed Refractory Multiple Myeloma (RRMM).

ReferenceCitation: Sanderson MP, Friese-Hamim M, Walter-Bausch G, Busch M, Gaus S, Musil D, Rohdich F, Zanelli U, Downey-Kopyscinski SL, Mitsiades CS, Schadt O, Klein M, Esdar C. M3258 Is a Selective Inhibitor of the Immunoproteasome Subunit LMP7 (β5i) Delivering Efficacy in Multiple Myeloma Models. Mol Cancer Ther. 2021 Aug;20(8):1378-1387. doi: 10.1158/1535-7163.MCT-21-0005. Epub 2021 May 27.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
United States
France

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Georgetown University Medical Center- Research Parent


title: A First-in-Human Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of JNJ-74699157 in Participants With Advanced Solid Tumors Harboring the KRAS G12C Mutation

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JNJ-74699157 in participants with advanced solid tumors harboring a kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation (Part 1: Dose escalation) and to determine the safety and preliminary antitumor activity of JNJ-74699157 at the RP2D regimen in participants with advanced solid tumors harboring a KRAS G12C mutation (Part 2: Dose expansion).

ReferenceCitation: Wang J, Martin-Romano P, Cassier P, Johnson M, Haura E, Lenox L, Guo Y, Bandyopadhyay N, Russell M, Shearin E, Lauring J, Dahan L. Phase I Study of JNJ-74699157 in Patients with Advanced Solid Tumors Harboring the KRAS G12C Mutation. Oncologist. 2022 Jul 5;27(7):536-e553. doi: 10.1093/oncolo/oyab080.

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

lead_sponsor: Janssen Research & Development, LLC

location_facility: H. Lee Moffitt Cancer & Research Institute


title: International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours

acronym: SALUS

summary: Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

time_perspective: Other

lead_sponsor: Advanced Accelerator Applications

location_country:
United States
Portugal
United Kingdom
France

location_facility: The Ohio State University Wexner Medical Center

location_facility: Oregon Health & Sciences University Hospital


title: An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax, a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia (AML).

summary: The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.

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
France

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: The Alfred Hospital Department of Haematology

location_facility: The University of Texas MD Anderson Cancer Center, Houston, TX

intervention_type: Combination Product


title: A Phase 2, Single-arm, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or With Other Aggressive B-Cell Malignancies

acronym: TRANSCENDWORLD

summary: The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

lead_sponsor: Celgene

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Switzerland
France
Belgium
Japan
Germany

location_facility: Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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


acronym: PNEU-WAY

title: A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Adults Infected With HIV (PNEU-WAY)

ReferenceCitation: Mohapi L, Pinedo Y, Osiyemi O, Supparatpinyo K, Ratanasuwan W, Molina JM, Dagan R, Tamms G, Sterling T, Zhang Y, Pedley A, Hartzel J, Kan Y, Hurtado K, Musey L, Simon JK, Buchwald UK; V114-018 (PNEU-WAY) study group. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. AIDS. 2022 Mar 1;36(3):373-382. doi: 10.1097/QAD.0000000000003126.

location_country:
Thailand
Peru
United States
France
South Africa

location_facility: Investigaciones Medicas en Salud - INMENSA ( Site 0041)

location_facility: Saint Hope Foundation, Inc. ( Site 0009)

location_facility: Chris Hani Baragwanath Hospital ( Site 0122)

location_facility: Siriraj Hosp (Prev&Social Med). ( Site 0183)

location_facility: Research Institute for Health. ( Site 0182)

location_facility: Triple O Research Institute, P.A. ( Site 0011)

location_facility: The Crofoot Research Center, Inc. ( Site 0002)

summary: This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.