title: A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK3640254 in HIV-1 Infected Treatment-Naïve Adults

summary: Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.

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

lead_sponsor: ViiV Healthcare

location_country:
Italy
United States
South Africa
France
Spain
Germany


title: A Multicentre, Open-label, Three-arm Randomised Phase II Trial Assessing the Safety and Efficacy of the HSP90 Inhibitor Ganetespib in Combination With Carboplatin Followed by Maintenance Treatment With Niraparib Versus Ganetespib Plus Carboplatin Followed by Ganetespib and Niraparib Versus Carboplatin in Combination With Standard Chemotherapy Followed by Niraparib Maintenance Treatment in Platinum-sensitive Ovarian Cancer Patients

acronym: EUDARIO

summary:
This study will be performed in women with platinum-sensitive, high-grade serous, high-grade endometrioid, undifferentiated epithelial ovarian cancer, carcinosarcoma, fallopian tube or primary peritoneal cancer (proven by central histo-pathological review).

A total of 120 subjects will be randomized (1:1:1) to three different treatment arms: (A) Standard arm (arm A): Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) // (B) First experimental arm (arm B): Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) // (C) Second experimental arm (arm C): Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w).

Chemotherapy treatment will be given for 6 cycles, maintenance treatment with Ganetespib will be given for a maximum of 9 months or until disease progression, maintenance treatment with Niraparib can continue until disease progression.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Universitaire Ziekenhuizen Leuven

location_country: Italy Austria France Belgium Germany

location_facility: Kliniken Essen Mitte, Evang. Huyssens- Stiftung/Knappschaft GmbH

location_facility: Fondazione IRCCS Istituto Nazionale dei tumori Milano

location_facility: Centre de lutte contre le cancer Francois Baclesse

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: Osse Registry for Patients With Lipodystrophy Run by the European Consortium of Lipodystrophies (ECLip)

acronym: ECLip Registry

summary:
Given the lack of knowledge on lipodystrophies, the medical and social responsibility for the persons affected by it calls for the monitoring of the progression over long periods of time. Sensible clinical and basic research into rare diseases such as lipodystrophy is only possible in multi-location networks with sufficient case numbers. Also, reliable information on the incidence of certain manifestation patterns, health status, etc. is of utmost importance for health care and health policy in this rare disease.

Therefore, the European Consortium of Lipodystrophies (ECLip), an association of European experts on lipodystrophy, has launched a registry (OSSE) for lipodystrophies which is committed to help to improve the research conditions by consolidating this kind of information in a registry.

status: Recruiting

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: von Schnurbein J, Adams C, Akinci B, Ceccarini G, D'Apice MR, Gambineri A, Hennekam RCM, Jeru I, Lattanzi G, Miehle K, Nagel G, Novelli G, Santini F, Santos Silva E, Savage DB, Sbraccia P, Schaaf J, Sorkina E, Tanteles G, Vantyghem MC, Vatier C, Vigouroux C, Vorona E, Araújo-Vilar D, Wabitsch M. European lipodystrophy registry: background and structure. Orphanet J Rare Dis. 2020 Jan 15;15(1):17. doi: 10.1186/s13023-020-1295-y.

ipd_sharing: Yes

ipd_sharing_description: Researches participating in the ECLip registry and third parties independently can request to perform research with the data.

lead_sponsor: University of Ulm

location_country:
Italy
Austria
United Kingdom
Netherlands
Spain
Cyprus
France
Poland
Hungary
Russian Federation
Portugal
Turkey
Germany
Slovenia

location_facility: University of Cambridge Metabolic Research Laboratories

location_facility: Endocrinology Unit, Department of Clinical and Medical science, S. Orsola-Malpighi Hospital , University of Bologna

location_facility: Med. Klinik B für Gastroenterologie und Hepatologie, Universitätsklinikum Münster

location_facility: Abel Salazar Biomedical Sciences Institute - University of Porto

location_facility: Dokuz Eylul University School of Medicine

location_facility: Academic Medical Center, University of Amsterdam

location_facility: Institute of Human Genetics, Martin Luther University Halle-Wittenberg

location_facility: Department of Internal Medicine (Endocrinology and Nephrology), University of Leipzig

location_facility: University of Szeged, Department of Internal Medicine

location_facility: Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

location_facility: Tor Vergata University - Policlinico of Tor Vergata

location_facility: Endocrine Unit of University Hospital of Pisa

location_facility: Cyprus Institute of Neurology & Genetics

location_facility: Pierre et Marie Curie School of Medicine, Sorbonne University

location_facility: University Medical Center Ljubljana - Clinical Institute of Medical Genetics


type: EudraCT Number

title: An International Multicentre, Open-Label First in Human Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Antitumour Activity of 177Lu-3BP-227 for the Treatment of Subjects With Solid Tumours Expressing Neurotensin Receptor 1

summary:
This study was being conducted to advance new treatment for patients with metastatic or locally advanced cancers expressing Neurotensin receptor 1 (NTSR1). This study was a first administration of a radioactive drug called 177Lu-3BP-227 to patients under controlled conditions of a clinical study. The purpose of this study is to evaluate how safe this investigational drug is as well to verify how well it is tolerated by patients after several intravenous administrations. In addition, the effect of the study drug on tumoral lesions and how it distributes throughout the body and at which rate it is removed from the body was evaluated. Since 177Lu-3BP-227 is a radio-labelled drug, it will also be measured how the emitted radiation is distributed throughout the body (dosimetry).

The study consisted of a phase I dose escalation part. The study originally planned to include a phase II study however due to early termination (not due to safety concerns) the study did not progress to phase II and was stopped during phase I. For the phase I dose escalation part, it was anticipated that approximately 30 subjects will be included, in up to six escalation steps. No expansion cohorts were implemented.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Ipsen

location_country:
Switzerland
Netherlands
France
Belgium
United States

location_facility: The University of Texas MD Anderson Cancer Center

lead_sponsor_type: industriel

status_simplified: Unknown


title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

summary:
A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.

Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.

ipd_sharing: No

lead_sponsor: Medi-Tate Ltd.

location_country: Italy Austria Switzerland France Australia Spain Germany

location_facility: Sydney Adventist Hospital Clinical School of the University of Sydney

location_facility: Azienda Ospedaliera Universitaria San Martino

intervention_type: Device


title: A Modular, Multi-arm, Multi-part, First Time in Patient Study to Evaluate the Safety and Tolerability of OMO-1, Alone and in Combination With Anti-cancer Treatments, in Patients With Locally Advanced, Unresectable or Metastatic Solid Malignancies

summary: This is a modular, first time in patient, open-label, multicentre study of OMO-1, administered orally, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies.

design_allocation: Non-Randomized

lead_sponsor: Octimet Oncology N.V.

location_country:
Netherlands
France
Belgium
United States
United Kingdom

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University of Oxford, Department of Oncology

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: UMCU Universitair Medisch Centrum Utrecht


status: Completed

primary_purpose: Other

location_country: Italy Netherlands France Czechia Poland Germany

acronym: EASYKID

location_facility: ORN Santobono-Pausilipon Padiglione Santobono

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

location_facility: Uniwersytecki Szpital Dziecięcy w Lublinie

location_facility: Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Uniwersytecki Szpital Dziecięcy w Krakowie

location_facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 6 Śląskiego

source: euctr

title: Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (Eziclen/Izinova®) in Paediatric Subjects Undergoing Colonoscopy: a Phase III, Multicentre, Randomised, Comparative Study Versus Klean-Prep® (PEG-Electrolytes), Administered on the Day Before Colonoscopy, Investigator-blinded, Non-inferiority in Adolescents of 12 to 17 Years of Age (Inclusive) >40 kg

summary: The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight >40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.

status_simplified: Completed


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
France
Czechia
Thailand
Israel
Spain
Denmark
Korea, Republic of

title: A Phase II, Open Label, Multi-center, Multi-arm Study of Ceritinib in Patients With Advanced Solid Tumors and Hematological Malignancies Characterized by Genetic Abnormalities of Anaplastic Lymphoma Kinase (ALK)

summary: This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).


ReferenceType: derived

ReferenceCitation: Novak G, Streffer JR, Timmers M, Henley D, Brashear HR, Bogert J, Russu A, Janssens L, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study. Alzheimers Res Ther. 2020 May 14;12(1):58. doi: 10.1186/s13195-020-00614-5.

family: Novak

full_name: Gerald Novak

given: Gerald

sequence: first

family: Streffer

full_name: Johannes Rolf Streffer

given: Johannes Rolf

sequence: additional

family: Timmers

full_name: Maarten Timmers

given: Maarten

family: Henley

full_name: David Henley

given: David

family: Brashear

full_name: H. Robert Brashear

given: H. Robert

family: Bogert

full_name: Jennifer Bogert

given: Jennifer

family: Russu

full_name: Alberto Russu

given: Alberto

family: Janssens

full_name: Luc Janssens

given: Luc

family: Tesseur

full_name: Ina Tesseur

given: Ina

family: Tritsmans

full_name: Luc Tritsmans

family: Van Nueten

full_name: Luc Van Nueten

family: Engelborghs

full_name: Sebastiaan Engelborghs

given: Sebastiaan

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license_normalized: no license

repository_institution: Vrije Universiteit Brussel - VUBIR

repository_normalized: vubissmart

evidence: oa repository (via pmcid lookup)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square
vubissmart

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square
Vrije Universiteit Brussel - VUBIR

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer’s disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study

location_country: Sweden Netherlands France Belgium Spain Germany

title: A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer's Disease Spectrum

summary: The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.


title: Bifurcation Lesion Analysis and STenting / BLAST

acronym: BLAST

summary: The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram alone. Additionally, this study is to determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term procedural outcome vs. bifurcation stenting with only angiographic guidance in native coronary arteries.

lead_sponsor: Volcano Corporation

location_country:
Italy
United Kingdom
Netherlands
France
Poland
Denmark
United States
Latvia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Kardiologisk laboratorium/B-lab Skejby Sygehus

location_facility: Saint Luke's Hospital-Mid America Heart Institute

location_facility: St. Thomas Hospital Cardiothoracic Centre

location_facility: Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista al Torino Departp Emodinamica Universitaria


type: Other Identifier

title: A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects With Early Alzheimer's Disease

summary: The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 during 6 months of treatment in participants with early (predementia) alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention span, and problem solving skills are followed by severe apraxias and a global loss of cognitive abilities]).


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: 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.

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Mir

full_name: Olivier Mir

given: Olivier

family: Kasper

full_name: Bernd Kasper

given: Bernd

family: Papai

full_name: Zsuzsanna Papai

given: Zsuzsanna

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Benson

full_name: Charlotte Benson

given: Charlotte

family: Kopeckova

full_name: Katerina Kopeckova

given: Katerina

family: Ali

full_name: Nasim Ali

given: Nasim

family: Dileo

full_name: Palma Dileo

given: Palma

family: LeCesne

full_name: Axel LeCesne

given: Axel

family: Menge

full_name: Franka Menge

given: Franka

family: Cousin

full_name: Sophie Cousin

given: Sophie

family: Wardelmann

full_name: Eva Wardelmann

given: Eva

family: Wozniak

full_name: Agnieszka Wozniak

given: Agnieszka

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: Litiere

full_name: Saskia Litiere

given: Saskia

family: Zaffaroni

full_name: Facundo Zaffaroni

given: Facundo

family: Nzokirantevye

full_name: Axelle Nzokirantevye

given: Axelle

family: Vanden Bempt

full_name: Isabelle Vanden Bempt

given: Isabelle

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

title: 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’

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

location_country:
France
Czechia
Hungary
Belgium
Germany
United Kingdom

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

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)


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.

lead_sponsor: Medical University Innsbruck

location_country: Austria Germany Belgium France

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

location_facility: Katholieke Universiteit Leuven, Dept. of Gynaecologic Oncology

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

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: Centre de lutte contre le cancer Francois Baclesse

location_facility: Universitätsmedizin Berlin Charité, Dept. for Gynecology

location_facility: Medical University Innsbruck, Department for Gynaecology and Obstetrics


location_country:
Italy
United Kingdom
Belgium
France

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

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori (704)

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

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

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

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: Janssen Research & Development, LLC

location_country:
Netherlands
France
Belgium
Spain
Denmark
Germany
United Kingdom

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

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.

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.

family: Coppin

full_name: Louise C. F. Coppin

given: Louise C. F.

family: Smets

full_name: Françoise Smets

given: Françoise

family: Ambroise

full_name: Jérome Ambroise

given: Jérome

family: Sokal

full_name: Etienne E. M. Sokal

given: Etienne E. M.

family: Stéphenne

full_name: Xavier Stéphenne

given: Xavier

journal_name: Stem Cell Research & Therapy

lead_sponsor: Promethera Biosciences

location_country:
Italy
France
Israel
Belgium
United Kingdom

location_facility: Schneider Children's Medical Center of israel

location_facility: Ospedale Pediatrico Bambino Gesu di Roma

location_facility: Rambam Medical Center, Meyer Children's Hospital

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.

lead_sponsor: Coloplast A/S

location_country:
Italy
Netherlands
France
Ireland
Belgium
Spain
Germany
United Kingdom

location_facility: Fundacio Puigvert - Universitat Autonoma de Barcelona

location_facility: Centre Hospitalier Universitaire Henri Mondor


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: India France Czechia Bulgaria Hungary Spain

location_facility: University of Debrecen Medical and Health Science Center


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.

lead_sponsor: Vericel Corporation

location_country:
Sweden
Netherlands
Poland
France
Czechia
Norway
United Kingdom

location_facility: University Medical Centre of Utrecht, Department of Orthopaedics

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

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

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

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

location_facility: Hôpital d'instruction des Armées Robert Picqué

intervention_type: Procedure


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: Q-Med AB

location_country: Italy Finland France Norway Spain Germany Canada

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

location_facility: Univ. degli Studi di Padova Hospital Clinica Chirurgica

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

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
United Kingdom
Belgium
France


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.

family: Voskanyan

full_name: Lilit Voskanyan

given: Lilit

family: García-Feijoó

full_name: Julián García-Feijoó

given: Julián

family: Belda

full_name: Jose I. Belda

given: Jose I.

family: Fea

full_name: Antonio Fea

given: Antonio

family: Jünemann

full_name: Anselm Jünemann

given: Anselm

family: Baudouin

full_name: Christophe Baudouin

given: Christophe

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

publisher_dissemination: Springer

publisher_group: Springer

title: Prospective, Unmasked Evaluation of the iStent® Inject System for Open-Angle Glaucoma: Synergy Trial

lead_sponsor: Glaukos Corporation

location_country: Italy Armenia Austria France Spain 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.

primary_purpose: Diagnostic

lead_sponsor: Bracco Diagnostics, Inc

location_country:
Italy
Austria
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: Imperial College NHS Trust - Charing Cross

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


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: Austria Serbia France Hungary Germany

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

location_facility: Dermatologie, Hôpital Purpan Universtité Paul Sabatier

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

location_facility: UNIVERSITY OF DEBRECEN Department of dermatology

location_facility: University Clinic Münster Clinic and Policlinic for skin diseases

location_facility: Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie

location_facility: Klinik für Dermatologie Venerologie und Allergologie

location_facility: University of Szeged Department of dermatology and allergology

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

location_facility: Veszprem County Csolnoky Ferenc Hospital Dermatology Department

location_facility: Clinical Centre of Nis Clinic of Dermato-venerology

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


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.

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.

family: Zerbib

full_name: F. Zerbib

given: F.

family: Bruley des Varannes

full_name: S. Bruley des Varannes

given: S.

family: Roman

full_name: S. Roman

family: Tutuian

full_name: R. Tutuian

given: R.

family: Galmiche

full_name: J.-P. Galmiche

family: Mion

full_name: F. Mion

family: Tack

full_name: J. Tack

given: J.

family: Malfertheiner

full_name: P. Malfertheiner

given: P.

family: Keywood

full_name: C. Keywood

given: C.

journal_name: Alimentary Pharmacology & Therapeutics

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Addex Pharma S.A.

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


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.

name: Erasmus University Medical Center, Rotterdam, The Netherlands;

family: Löwenberg

full_name: Bob Löwenberg

given: Bob

name: Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;

family: Muus

full_name: Petra Muus

given: Petra

name: Vrije Universiteit Medical Center, Amsterdam, The Netherlands;

family: Ossenkoppele

full_name: Gert Ossenkoppele

given: Gert

name: Hôpital André Mignot, Versailles, France;

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

name: Clinique Universitaire d'Hématologie, Grenoble, France;

family: Cahn

full_name: Jean-Yves Cahn

given: Jean-Yves

name: Centre Hospitalier Universitaire Angers, Angers, France;

family: Ifrah

full_name: Norbert Ifrah

given: Norbert

name: Policlinico S. Orsola University Hospital, Bologna, Italy;

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

name: Tor Vergata University Hospital, Rome, Italy;

family: Amadori

full_name: Sergio Amadori

given: Sergio

name: Memorial Sloan-Kettering Cancer Center, New York, NY;

family: Berman

full_name: Ellin Berman

given: Ellin

family: Sonneveld

full_name: Pieter Sonneveld

given: Pieter

family: Jongen-Lavrencic

full_name: Mojca Jongen-Lavrencic

given: Mojca

family: Rigaudeau

full_name: Sophie Rigaudeau

given: Sophie

name: AstraZeneca, Macclesfield, United Kingdom; and

family: Stockman

full_name: Paul Stockman

given: Paul

family: Goudie

full_name: Alison Goudie

given: Alison

name: The University of Texas M. D. Anderson Cancer Center, Houston, TX

family: Faderl

full_name: Stefan Faderl

given: Stefan

family: Jabbour

full_name: Elias Jabbour

given: Elias

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology


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.

family: Beghetti

full_name: Maurice Beghetti

given: Maurice

family: Haworth

full_name: Sheila G. Haworth

given: Sheila G.

family: Bonnet

full_name: Damien Bonnet

given: Damien

family: Barst

full_name: Robyn J. Barst

given: Robyn J.

family: Acar

full_name: Philippe Acar

family: Fraisse

full_name: Alain Fraisse

given: Alain

family: Ivy

full_name: Dunbar D. Ivy

given: Dunbar D.

family: Jais

full_name: Xavier Jais

given: Xavier

family: Schulze-Neick

full_name: Ingram Schulze-Neick

given: Ingram

family: GaliÃ¨

full_name: Nazzareno GaliÃ¨

given: Nazzareno

family: Morganti

full_name: Adele Morganti

given: Adele

family: Dingemanse

full_name: Jasper Dingemanse

given: Jasper

family: Kusic-Pajic

full_name: Andjela Kusic-Pajic

given: Andjela

family: Berger

full_name: Rolf M. F. Berger

given: Rolf M. F.

journal_name: British Journal of Clinical Pharmacology

location_country:
Italy
United States
Switzerland
Netherlands
France
Germany
United Kingdom

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.

full_name: Rolf M.F. Berger

given: Rolf M.F.

family: Dulac

full_name: Yves Dulac

given: Yves

family: Galiè

full_name: Nazzareno Galiè

full_name: D. Dunbar Ivy

given: D. Dunbar

family: Jaïs

full_name: Xavier Jaïs

family: Miera

full_name: Oliver Miera

given: Oliver

family: Rosenzweig

full_name: Erika B. Rosenzweig

given: Erika B.

family: Efficace

full_name: Michela Efficace

given: Michela

journal_name: International Journal of Cardiology

publisher_normalized: Elsevier


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:
Netherlands
France
Belgium
Germany
United Kingdom

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

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

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:
Switzerland
Netherlands
Poland
France
Belgium
Germany
United Kingdom

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

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

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Cancer Research Centre at Weston Park Hospital

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

location_facility: Centre Hospitalier Universitaire Vaudois

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

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:
Italy
Austria
Switzerland
France
Norway
Belgium
Portugal
Germany
United Kingdom

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

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


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:
Austria
United Kingdom
France
Israel
Belgium
Germany
Slovenia

location_facility: Schneider Children's Medical Center of Israel


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.

time_perspective: Retrospective

lead_sponsor: European Society for Blood and Marrow Transplantation

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

location_facility: Azienda Ospedaliero Universitaria Policlinico Bari

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: First State Pavlov Medical University of St. Petersburg

location_facility: ICO-Hospital Universitari Germans Trias i Pujol

location_facility: University Hospital Birmingham NHS Trust

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: Azienda Ospedaliero Universitaria Pisana


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

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

location_facility: Instituto Clinico Humanitas; Med Onc & Hemat

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

location_facility: Clinica Universitaria de Navarra; Servicio de Hematologia

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

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

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

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


lead_sponsor: Menarini Group

location_country:
Italy
United States
Netherlands
France
Poland
Spain
Germany

location_facility: Azienda Socio Sanitaria Territoriale Niguarda

location_facility: MultiCare Health System Institute for Research and Innovation

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

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital Clinico Universitario de Valencia

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

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.


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

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: Massachusetts General Hospital Liver and Kidney TX

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

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:
Italy
Austria
Netherlands
France
Poland
Belgium
Spain
Germany
United Kingdom

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


title: Randomised, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Tolerability of EPA-FFA Gastro-resistant Capsules, in Patients With Familial Adenomatous Polyposis (FAP)

summary: 2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.

lead_sponsor: S.L.A. Pharma AG

location_country: Italy Netherlands France Czechia Israel Spain

location_facility: Istituto Nazionale Tumori Fondazione G.Pascale

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: University of Bologna and St.Orsola-Malpighi Hospital

location_facility: Hospital Clinico Universitario Lozana Blesa

location_facility: Hospital General Universitario de Alicante

location_facility: Centro di Riferimento Oncologico di aviano


title: Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.

acronym: LiverScreen

summary: Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography

status: Enrolling by invitation

lead_sponsor: Judit Pich Martínez

location_country:
Netherlands
Croatia
France
Spain
Denmark
Germany
United Kingdom

location_facility: Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers


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.

location_country: Italy Brazil Switzerland France Hungary Spain Germany Latvia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

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

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

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

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

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

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

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

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Onkologikoa - Instituto Oncológico de Donostia

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


type: Other Grant/Funding Number

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: This open-label Phase 2 study will evaluate the safety and efficacy of modified T cells (JCAR017) administered to adult patients with aggressive B-cell non-Hodgkin lymphoma (NHL). The study will also help determine how long the modified T cells stay in the patient's body. Furthermore, changes in the patient's quality of life will be described. Phase 2 (autologous T cells expressing anti-CD19 chimeric antigen receptor) (DLBCL NOS [de novo or tFL], follicular lymphoma Grade 3B [FL3B], high grade B-cell Lymphoma [HGBL] and primary central nervous system lymphoma [PCNSL]).

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.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Ernst

full_name: Moritz Ernst

given: Moritz

family: Oeser

full_name: Annika Oeser

given: Annika

family: Besiroglu

full_name: Burcu Besiroglu

given: Burcu

family: Caro-Valenzuela

full_name: Julia Caro-Valenzuela

given: Julia

name: Department of Surgery; Mayo Clinic; Rochester Minnesota USA

family: Abd El Aziz

full_name: Mohamed Abd El Aziz

given: Mohamed

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department I of Internal Medicine; University Hospital of Cologne; Cologne Germany

family: Borchmann

full_name: Peter Borchmann

given: Peter

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

family: Goldkuhle

full_name: Marius Goldkuhle

given: Marius

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Celgene

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

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

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori


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.

family: Nero

full_name: Camilla Nero

given: Camilla

family: Ciccarone

full_name: Francesca Ciccarone

given: Francesca

family: Pietragalla

full_name: Antonella Pietragalla

given: Antonella

family: Duranti

full_name: Simona Duranti

given: Simona

family: Daniele

full_name: Gennaro Daniele

given: Gennaro

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Lorusso

full_name: Domenica Lorusso

given: Domenica

currency_apc_doaj: USD

journal_name: Frontiers in Oncology

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

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.

family: van den Heerik

full_name: Anne Sophie V M van den Heerik

given: Anne Sophie V M

family: Horeweg

full_name: Nanda Horeweg

given: Nanda

family: Nout

full_name: Remi A Nout

given: Remi A

family: Lutgens

full_name: Ludy C H W Lutgens

given: Ludy C H W

family: van der Steen-Banasik

full_name: Elzbieta M van der Steen-Banasik

given: Elzbieta M

family: Westerveld

full_name: G Henrike Westerveld

given: G Henrike

family: van den Berg

full_name: Hetty A van den Berg

given: Hetty A

family: Slot

full_name: Annerie Slot

given: Annerie

family: Koppe

full_name: Friederike L A Koppe

given: Friederike L A

family: Kommoss

full_name: Stefan Kommoss

journal_name: International Journal of Gynecologic Cancer

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

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

location_country: Austria Switzerland Netherlands France Czechia Ireland Belgium Germany

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

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

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

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck


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:
Italy
Netherlands
France
Australia
Spain
Germany
United Kingdom


lead_sponsor: Iltoo Pharma

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

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

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

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

location_facility: Azienda Osp. Univ. Seconda Università di Napoli

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: University Multiprofile Hospital for Active Treatment

ipd_sharing: Undecided

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)

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.

family: Reuss

full_name: Alexander Reuss

given: Alexander

family: du Bois

full_name: Andreas du Bois

given: Andreas

family: Harter

full_name: Philipp Harter

given: Philipp

family: Fotopoulou

full_name: Christina Fotopoulou

given: Christina

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

family: Aletti

full_name: Giovanni Aletti

family: Guyon

full_name: Frederic Guyon

given: Frederic

family: Greggi

full_name: Stefano Greggi

given: Stefano

family: Mosgaard

full_name: Berit Jul Mosgaard

given: Berit Jul

family: Reinthaller

full_name: Alexander Reinthaller

family: Hilpert

full_name: Felix Hilpert

given: Felix

family: Schade-Brittinger

full_name: Carmen Schade-Brittinger

given: Carmen

family: Chi

full_name: Dennis S Chi

given: Dennis S

family: Mahner

full_name: Sven Mahner

given: Sven

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO‐OVAR OP7)

lead_sponsor: AGO Study Group

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

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

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

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

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

location_facility: Hôpital Européen Georges Pompidou (HEGP)

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

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

location_facility: Fondazione IRCCS Istituto Nazionale Tumori - Milan

location_facility: European Institute of Oncology; Gynecologic Cancer Surgery


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.

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Estival

full_name: Anna Estival

given: Anna

family: Marquina

full_name: Gloria Marquina

given: Gloria

family: Dudzisz-Śledź

full_name: Monika Dudzisz-Śledź

given: Monika

family: Brahmi

full_name: Mehdi Brahmi

given: Mehdi

family: Steeghs

full_name: Neeltje Steeghs

given: Neeltje

family: Karavasilis

full_name: Vasilios Karavasilis

given: Vasilios

family: de Haan

full_name: Jacco de Haan

given: Jacco

family: Wozniak

full_name: Agnieszka Wozniak

given: Agnieszka

family: Cousin

full_name: Sophie Cousin

given: Sophie

family: Domènech

full_name: Marta Domènech

given: Marta

family: Bovée

full_name: Judith V.M.G. Bovée

given: Judith V.M.G.

family: Charon-Barra

full_name: Céline Charon-Barra

given: Céline

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: Litière

full_name: Saskia Litière

given: Saskia

family: De Meulemeester

full_name: Laura De Meulemeester

given: Laura

family: Olungu

full_name: Christine Olungu

given: Christine

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: 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”

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

location_country:
Netherlands
Poland
France
Lithuania
Belgium
Spain
United Kingdom

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

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Cliniques Universitaires Saint-Luc (121)

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

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

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


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: 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.

family: Azizzadeh

full_name: Ali Azizzadeh

given: Ali

family: Desai

full_name: Nimesh Desai

given: Nimesh

family: Arko

full_name: Frank R. Arko

given: Frank R.

suffix: III

family: Panneton

full_name: Jean M. Panneton

given: Jean M.

family: Thaveau

full_name: Fabien Thaveau

given: Fabien

family: Hayes

full_name: Paul Hayes

given: Paul

family: Dagenais

full_name: Francois Dagenais

given: Francois

family: Lei

full_name: Lanyu Lei

given: Lanyu

family: Verzini

full_name: Fabio Verzini

given: Fabio

journal_name: Journal of Vascular Surgery

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

lead_sponsor: Medtronic Cardiovascular

location_country:
Italy
Netherlands
France
Denmark
Canada
United Kingdom

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: IRCCS Ca' Granda Ospendale Maggiore Policlinico

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

location_facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

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

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

location_facility: London Health Sciences Centre - Victoria Hospital

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


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.

family: Gonzales

full_name: Emmanuel Gonzales

given: Emmanuel

family: Hardikar

full_name: Winita Hardikar

given: Winita

family: Stormon

full_name: Michael Stormon

given: Michael

family: Baker

full_name: Alastair Baker

given: Alastair

family: Hierro

full_name: Loreto Hierro

given: Loreto

family: Gliwicz

full_name: Dorota Gliwicz

given: Dorota

family: Lacaille

full_name: Florence Lacaille

given: Florence

family: Lachaux

full_name: Alain Lachaux

given: Alain

family: Sturm

full_name: Ekkehard Sturm

given: Ekkehard

family: Setchell

full_name: Kenneth D R Setchell

given: Kenneth D R

family: Kennedy

full_name: Ciara Kennedy

given: Ciara

family: Dorenbaum

full_name: Alejandro Dorenbaum

given: Alejandro

family: Steinmetz

full_name: Jana Steinmetz

given: Jana

full_name: Nirav K Desai

given: Nirav K

family: Wardle

full_name: Andrew J Wardle

given: Andrew J

family: Garner

full_name: Will Garner

given: Will

family: Vig

full_name: Pamela Vig

given: Pamela

family: Jaecklin

full_name: Thomas Jaecklin

given: Thomas

family: Sokal

full_name: Etienne M Sokal

given: Etienne M

family: Jacquemin

full_name: Emmanuel Jacquemin

journal_name: The Lancet

lead_sponsor: Mirum Pharmaceuticals, Inc.

location_country:
France
Poland
Belgium
Australia
Spain
United Kingdom

acronym: ICONIC

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

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

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).


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:
Italy
Austria
Netherlands
France
Greece
Spain
Germany
United Kingdom

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

location_facility: CEIC Hospital Universitario de Salamanca

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

location_facility: Oxford Radcliffe Hospital ICRF Medical Oncology Unit

location_facility: Alexandra Hospital, University of Athens

location_facility: Azienda Ospedaliero Universitaria Ospedali

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: Ospedale Maggiore Policlinico Mangiagalli Regina Elena

location_facility: Queen Elizabeth Hospital UHB NHS Foundation Trust

location_facility: Daniel den Hoed Kliniek Medical Oncology, Erasmus MC

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

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.

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.

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Förger

full_name: Frauke Förger

given: Frauke

family: Abraham

full_name: Bincy Abraham

given: Bincy

family: Flynn

full_name: Ann D Flynn

given: Ann D

family: Moltó

full_name: Anna Moltó

given: Anna

family: Flipo

full_name: René-Marc Flipo

given: René-Marc

family: van Tubergen

full_name: Astrid van Tubergen

given: Astrid

family: Shaughnessy

full_name: Laura Shaughnessy

given: Laura

family: Simpson

full_name: Jeff Simpson

given: Jeff

family: Teil

full_name: Marie Teil

given: Marie

family: Helmer

full_name: Eric Helmer

given: Eric

family: Wang

full_name: Maggie Wang

given: Maggie

family: Chakravarty

full_name: Eliza F Chakravarty

given: Eliza F

journal_name: Annals of the Rheumatic Diseases

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

lead_sponsor: UCB BIOSCIENCES, Inc.

location_country:
United States
France
Switzerland
Netherlands


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: Spain Belgium France Netherlands


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

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

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

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.

family: Krejcik

full_name: Jakub Krejcik

given: Jakub

family: Frerichs

full_name: Kris A. Frerichs

given: Kris A.

family: Nijhof

full_name: Inger S. Nijhof

given: Inger S.

family: van Kessel

full_name: Berris van Kessel

given: Berris

family: van Velzen

full_name: Jeroen F. van Velzen

given: Jeroen F.

family: Bloem

full_name: Andries C. Bloem

given: Andries C.

family: Broekmans

full_name: Marloes E.C. Broekmans

given: Marloes E.C.

family: Zweegman

full_name: Sonja Zweegman

given: Sonja

family: van Meerloo

full_name: Johan van Meerloo

given: Johan

family: Musters

full_name: René J.P. Musters

given: René J.P.

family: Poddighe

full_name: Pino J. Poddighe

given: Pino J.

family: Groen

full_name: Richard W.J. Groen

given: Richard W.J.

family: Chiu

full_name: Christopher Chiu

given: Christopher

family: Plesner

full_name: Torben Plesner

given: Torben

family: Lokhorst

full_name: Henk M. Lokhorst

given: Henk M.

family: Sasser

full_name: A. Kate Sasser

given: A. Kate

family: Mutis

full_name: Tuna Mutis

given: Tuna

family: van de Donk

full_name: Niels W.C.J. van de Donk

given: Niels W.C.J.

journal_name: Clinical Cancer Research

version: acceptedVersion

publisher: American Association for Cancer Research (AACR)

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.

name: Vejle Hospital and University of Southern Denmark, Vejle, Denmark;

name: Sarah Cannon Research Institute, University College London, London, United Kingdom;

name: Department of Haematology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;

name: Department of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands;

name: LeBow Institute for Myeloma Therapeutics, Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;

name: Myeloma Unit, Division of Hematology, University of Turin, Turin, Italy;

name: Janssen Research & Development, LLC, Raritan, NJ;

name: Janssen Research & Development, LLC, Spring House, PA;

name: Janssen Biologics, Leiden, The Netherlands; and

name: Department of Hematology, Vrije Universiteit Medical Center, Amsterdam, The Netherlands

repository_institution: University College London - UCL Discovery

location_country:
Netherlands
France
Denmark
United States
United Kingdom


lead_sponsor: Bayer

location_country:
United States
Korea, Republic of
France

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

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.

family: Beck

full_name: Lisa A. Beck

given: Lisa A.

family: Thaçi

full_name: Diamant Thaçi

given: Diamant

family: Hamilton

full_name: Jennifer D. Hamilton

given: Jennifer D.

family: Graham

full_name: Neil M. Graham

given: Neil M.

family: Bieber

full_name: Thomas Bieber

given: Thomas

family: Rocklin

full_name: Ross Rocklin

given: Ross

family: Ming

full_name: Jeffrey E. Ming

given: Jeffrey E.

family: Ren

full_name: Haobo Ren

given: Haobo

family: Kao

full_name: Richard Kao

given: Richard

family: Simpson

full_name: Eric Simpson

given: Eric

family: Ardeleanu

full_name: Marius Ardeleanu

given: Marius

family: Weinstein

full_name: Steven P. Weinstein

given: Steven P.

family: Pirozzi

full_name: Gianluca Pirozzi

given: Gianluca

family: Guttman-Yassky

full_name: Emma Guttman-Yassky

given: Emma

family: Suárez-Fariñas

full_name: Mayte Suárez-Fariñas

given: Mayte

family: Hager

full_name: Melissa D. Hager

given: Melissa D.

family: Stahl

full_name: Neil Stahl

given: Neil

family: Yancopoulos

full_name: George D. Yancopoulos

given: George D.

family: Radin

full_name: Allen R. Radin

given: Allen R.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis

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.

name: Department of Dermatology; University of Münster; Münster Germany

family: Tsianakas

full_name: A. Tsianakas

given: A.

family: Luger

full_name: T.A. Luger

name: Regeneron Pharmaceuticals Inc.; Tarrytown NY U.S.A.


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.

name: Universitair Ziekenhuis Leuven Leuven Belgium

family: Tack

full_name: J. Tack

given: J.

name: CHU de Bordeaux Hôpital Saint André Bordeaux France

family: Zerbib

full_name: F. Zerbib

given: F.

family: Blondeau

full_name: K. Blondeau

given: K.

name: Institut des Maladies de l'Appareil Digestif du Centre Hospitalier Universitaire de Nantes Nantes France

family: Varannes

full_name: S. B. Varannes

given: S. B.

name: Cliniques Universitaires Saint‐Luc Brussels Belgium

family: Piessevaux

full_name: H. Piessevaux

given: H.

name: Kantonsspital St Gallen St Gallen Switzerland

family: Borovicka

full_name: J. Borovicka

name: Hospices Civils de Lyon Digestive Physiology University Lyon Lyon France

family: Mion

full_name: F. Mion

name: Division of Gastroenterology and Hepatology University Hospital Zürich Zurich Switzerland

family: Fox

full_name: M. Fox

given: M.

name: Academic Medical Center Amsterdam The Netherlands

family: Bredenoord

full_name: A. J. Bredenoord

given: A. J.

name: CUB Hôpital Erasme Université Libre de Bruxelles Brussels Belgium

family: Louis

full_name: H. Louis

family: Dedrie

full_name: S. Dedrie

given: S.

family: Hoppenbrouwers

full_name: M. Hoppenbrouwers

family: Meulemans

full_name: A. Meulemans

family: Rykx

full_name: A. Rykx

family: Thielemans

full_name: L. Thielemans

given: L.

family: Ruth

full_name: M. Ruth

journal_name: Neurogastroenterology & Motility

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Randomized clinical trial: effect of the 5‐ HT 4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment

location_country:
Switzerland
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: Inselspital Bern (Bern University Hopsital)

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

location_facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot

location_facility: Wingate Institute of Neurogastroenterology

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

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.