title: High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)

summary:
This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified > 12 months at diagnosis).

The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®).

In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned.

Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted.

Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.

After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour.

Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour.

The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed.

The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval.

ReferenceCitation: Ladenstein R, Valteau-Couanet D, Brock P, Yaniv I, Castel V, Laureys G, Malis J, Papadakis V, Lacerda A, Ruud E, Kogner P, Garami M, Balwierz W, Schroeder H, Beck-Popovic M, Schreier G, Machin D, Pötschger U, Pearson A. Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study. J Clin Oncol. 2010 Jul 20;28(21):3516-24. doi: 10.1200/JCO.2009.27.3524. Epub 2010 Jun 21.

name: From St. Anna Children's Hospital; Children's Cancer Research Institute; Austrian Institute of Technology, Vienna, Austria; Institut Gustave Roussy, Villejuif, France; Great Ormond Street Hospital, London; The Children's Cancer and Leukaemia Group, University of Leicester, Leicester; Royal Marsden Hospital, Sutton, United Kingdom; Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Hospital Universitario Infantil La Fe, Valencia, Spain; Ghent University Hospital, Ghent, Belgium;...

family: Ladenstein

full_name: Ruth Ladenstein

given: Ruth

family: Valteau-Couanet

full_name: Dominique Valteau-Couanet

given: Dominique

family: Brock

full_name: Penelope Brock

given: Penelope

family: Yaniv

full_name: Isaac Yaniv

given: Isaac

family: Castel

full_name: Victoria Castel

given: Victoria

family: Laureys

full_name: Geneviève Laureys

given: Geneviève

family: Malis

full_name: Josef Malis

given: Josef

family: Papadakis

full_name: Vassilios Papadakis

given: Vassilios

family: Lacerda

full_name: Ana Lacerda

given: Ana

family: Ruud

full_name: Ellen Ruud

given: Ellen

family: Kogner

full_name: Per Kogner

given: Per

family: Garami

full_name: Miklos Garami

given: Miklos

family: Balwierz

full_name: Walentyna Balwierz

given: Walentyna

family: Schroeder

full_name: Henrik Schroeder

given: Henrik

family: Beck-Popovic

full_name: Maja Beck-Popovic

given: Maja

family: Schreier

full_name: Günter Schreier

given: Günter

family: Machin

full_name: David Machin

given: David

family: Pötschger

full_name: Ulrike Pötschger

given: Ulrike

family: Pearson

full_name: Andrew Pearson

given: Andrew

journal_name: Journal of Clinical Oncology

title: Randomized Trial of Prophylactic Granulocyte Colony-Stimulating Factor During Rapid COJEC Induction in Pediatric Patients With High-Risk Neuroblastoma: The European HR-NBL1/SIOPEN Study

ReferenceCitation: Ladenstein R, Pötschger U, Pearson ADJ, Brock P, Luksch R, Castel V, Yaniv I, Papadakis V, Laureys G, Malis J, Balwierz W, Ruud E, Kogner P, Schroeder H, de Lacerda AF, Beck-Popovic M, Bician P, Garami M, Trahair T, Canete A, Ambros PF, Holmes K, Gaze M, Schreier G, Garaventa A, Vassal G, Michon J, Valteau-Couanet D; SIOP Europe Neuroblastoma Group (SIOPEN). Busulfan and melphalan versus carboplatin, etoposide, and melphalan as high-dose chemotherapy for high-risk neuroblastoma (HR-NBL1/SIOPEN): an international, randomised, multi-arm, open-label, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):500-514. doi: 10.1016/S1470-2045(17)30070-0. Epub 2017 Mar 2.

full_name: Andrew D J Pearson

given: Andrew D J

ReferenceCitation: Ladenstein R, Pötschger U, Valteau-Couanet D, Luksch R, Castel V, Yaniv I, Laureys G, Brock P, Michon JM, Owens C, Trahair T, Chan GCF, Ruud E, Schroeder H, Beck Popovic M, Schreier G, Loibner H, Ambros P, Holmes K, Castellani MR, Gaze MN, Garaventa A, Pearson ADJ, Lode HN. Interleukin 2 with anti-GD2 antibody ch14.18/CHO (dinutuximab beta) in patients with high-risk neuroblastoma (HR-NBL1/SIOPEN): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Dec;19(12):1617-1629. doi: 10.1016/S1470-2045(18)30578-3. Epub 2018 Nov 12.

ReferenceCitation: Morgenstern DA, Pötschger U, Moreno L, Papadakis V, Owens C, Ash S, Pasqualini C, Luksch R, Garaventa A, Canete A, Elliot M, Wieczorek A, Laureys G, Kogner P, Malis J, Ruud E, Beck-Popovic M, Schleiermacher G, Valteau-Couanet D, Ladenstein R. Risk stratification of high-risk metastatic neuroblastoma: A report from the HR-NBL-1/SIOPEN study. Pediatr Blood Cancer. 2018 Nov;65(11):e27363. doi: 10.1002/pbc.27363. Epub 2018 Jul 17.

name: Paediatric Haematology/Oncology; Hospital for Sick Children and University of Toronto; Toronto Canada

name: Paediatric Haematology/Oncology; Great Ormond Street Hospital and UCL Institute of Child Health; London UK

name: Studies and Statistics on Integrated Research and Projects; St Anna Kinderkrebsforschung; Vienna Austria

name: Paediatric Haematology/Oncology; Hospital Nino Jesús; Madrid Spain

name: Paediatric Haematology/Oncology; Agia Sofia Children's Hospital; Athens Greece

name: Paediatric Haematology/Oncology; Our Lady's Children's Hospital; Crumlin Dublin Ireland

name: Paediatric Haematology/Oncology; Schneider Children's Medical Center of Israel; Petah Tikva Israel

name: Department of Paediatric and Adolescent Oncology; Institut Gustav Roussy; Viellejuif France

name: Dipartimento di Ematologia e Onco-ematologia Pediatrica; Fondazione IRCCS Istituto Nazionale dei Tumori; Milan Italy

name: Paediatric Oncology; Istituto Giannia Gaslini; Genova Italy

name: Pediatric Oncology Unit; Hospital Universitario y Politecnico La Fe; Valencia Spain

name: Paediatric Oncology; Leeds Teaching Hospital NHS Trust; Leeds UK

name: Department of Pediatric Oncology and Hematology; Institute of Pediatrics; Jagiellonian University Medical College; Krakow Poland

name: Department of Pediatric Hematology/Oncology and Stem Cell Transplantation University Hospital Ghent; Ghent Belgium

name: Department of Women's and Children's Health, Karolinska Institutet; Astrid Lindgren Children's Hospital; Karolinska University Hospital; Stockholm Sweden

name: Department of Pediatric Hematology and Oncology; University Hospital Motol; Prague Czech Republic

name: Department of Paediatric Medicine; Rikshospitalet; Oslo University Hospital; Oslo Norway

name: Department of Pediatrics and Pediatric Surgery; Pediatric Haematology Oncology Unit; University Hospital Lausanne; Lausanne Switzerland

name: Department of Paediatrics; Institut Curie; Paris France

name: Paediatric Haematology/Oncology; St Anna Kinderspital and St Anna Kinderkrebforschung; Vienna Austria

ReferenceCitation: Berbegall AP, Bogen D, Pötschger U, Beiske K, Bown N, Combaret V, Defferrari R, Jeison M, Mazzocco K, Varesio L, Vicha A, Ash S, Castel V, Coze C, Ladenstein R, Owens C, Papadakis V, Ruud E, Amann G, Sementa AR, Navarro S, Ambros PF, Noguera R, Ambros IM. Heterogeneous MYCN amplification in neuroblastoma: a SIOP Europe Neuroblastoma Study. Br J Cancer. 2018 May;118(11):1502-1512. doi: 10.1038/s41416-018-0098-6. Epub 2018 May 14.

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Mueller I, Ehlert K, Endres S, Pill L, Siebert N, Kietz S, Brock P, Garaventa A, Valteau-Couanet D, Janzek E, Hosten N, Zinke A, Barthlen W, Varol E, Loibner H, Ladenstein R, Lode HN. Tolerability, response and outcome of high-risk neuroblastoma patients treated with long-term infusion of anti-GD(2) antibody ch14.18/CHO. MAbs. 2018 Jan;10(1):55-61. doi: 10.1080/19420862.2017.1402997. Epub 2017 Dec 5.

name: Department of Pediatric Oncology, University Medicine Greifswald, Greifswald, Germany

name: Great Ormond Street Hospital, Department of Pediatric Hematology and Oncology, London, United Kingdom

name: Department of Pediatric Hematology and Oncology, Gaslini Institute, Genova Italy

name: Department of Pediatric and Adolescent Oncology Villejuif, Gustave Roussy Université Paris-Sud, France

name: Department of Radiology and Nuclear Medicine, University Medicine Greifswald, Greifswald, Germany

name: Department of Pediatric Surgery, University Medicine Greifswald, Greifswald, Germany

name: St. Anna Children's Hospital, Department of Pediatric Hematology and Oncolgoy, Vienna, Austria

title: Tolerability, response and outcome of high-risk neuroblastoma patients treated with long-term infusion of anti-GD2 antibody ch14.18/CHO

ReferenceCitation: Ladenstein R, Pötschger U, Valteau-Couanet D, Luksch R, Castel V, Ash S, Laureys G, Brock P, Michon JM, Owens C, Trahair T, Chi Fung Chan G, Ruud E, Schroeder H, Beck-Popovic M, Schreier G, Loibner H, Ambros P, Holmes K, Castellani MR, Gaze MN, Garaventa A, Pearson ADJ, Lode HN. Investigation of the Role of Dinutuximab Beta-Based Immunotherapy in the SIOPEN High-Risk Neuroblastoma 1 Trial (HR-NBL1). Cancers (Basel). 2020 Jan 28;12(2). pii: E309. doi: 10.3390/cancers12020309.

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

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

ReferenceCitation: Holmes K, Pötschger U, Pearson ADJ, Sarnacki S, Cecchetto G, Gomez-Chacon J, Squire R, Freud E, Bysiek A, Matthyssens LE, Metzelder M, Monclair T, Stenman J, Rygl M, Rasmussen L, Joseph JM, Irtan S, Avanzini S, Godzinski J, Björnland K, Elliott M, Luksch R, Castel V, Ash S, Balwierz W, Laureys G, Ruud E, Papadakis V, Malis J, Owens C, Schroeder H, Beck-Popovic M, Trahair T, Forjaz de Lacerda A, Ambros PF, Gaze MN, McHugh K, Valteau-Couanet D, Ladenstein RL; International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN). Influence of Surgical Excision on the Survival of Patients With Stage 4 High-Risk Neuroblastoma: A Report From the HR-NBL1/SIOPEN Study. J Clin Oncol. 2020 Sep 1;38(25):2902-2915. doi: 10.1200/JCO.19.03117. Epub 2020 Jul 8.

name: Paediatric Surgery, St George’s Hospital London and Royal Marsden Hospital, Sutton, United Kingdom

name: Institute of Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom

name: Department of Pediatric Surgery, Necker Enfants–Malades Hospital, Assistance Publique Hôpitaux de Paris, University de Paris, Paris, France

name: Pediatric Surgery, Department of Women’s and Children’s Health, University of Padua, Padua, Italy

name: Paediatric Oncology, Paediatric Surgical Oncology Unit, Hospital Universitario La FE, Valencia, Spain

name: Paediatric Oncology, Leeds Teaching Hospital, Leeds, United Kingdom

name: Schneider Children’s Medical Center of Israel, Petach, Tikvah, Israel

name: Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

name: Department of Pediatric Surgery, University Children’s Hospital, Kraków, Poland

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name: Paediatric Surgery, Medical University of Vienna, Vienna, Austria

name: Oslo University Hospital Rikshospitalet, Oslo, Norway

name: Karolinska University Hospital, Stockholm, Sweden

name: University Hospital Motol, Prague, Czech Republic

name: Department of Surgical Gastroenterology A, Odense University Hospital, Odense, Denmark

name: University Hospital Lausanne, Lausanne, Switzerland

name: Sorbonne University, Department of Visceral and Neonatal Pediatric Surgery, Armand Trousseau Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France

name: Pediatric Surgery Unit, IRCCS Istituto Giannina Gaslini, Genoa, Italy

name: Department of Paediatric Surgery, Marciniak Hospital, and Department of Paediatric Traumatology and Emergency Medicine, Wroclaw Medical University, Wroclaw, Poland

name: Paediatric Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy

name: Jagiellonian University Medical College, Kraków, Poland;

name: Department of Paediatric Haematology and Oncology, Princess Elisabeth Children’s Hospital, Ghent University Hospital, Ghent, Belgium

name: Agia Sofia Children’s Hospital, Athens, Greece

name: Paediatric Haematology/Oncology, Our Lady’s Children’s Hospital, Crumlin, Dublin, Republic of Ireland

name: University Hospital of Aarhus, Aarhus, Denmark

name: Sydney Children’s Hospital, Randwick, New South Wales, Australia

name: Portuguese Institute of Oncology, Lisbon, Portugal

name: University College Hospital, London, United Kingdom

name: Paediatric Oncology, Great Ormond Street Hospital, London, United Kingdom

name: Institut Gustave Roussy, Villejuif, Paris, France

name: St Anna Children’s Hospital and Children’s Cancer Research Institute, Department of Paediatrics, Medical University of Vienna, Vienna, Austria

name: for the International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN)

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Viprey VF, Gregory WM, Corrias MV, Tchirkov A, Swerts K, Vicha A, Dallorso S, Brock P, Luksch R, Valteau-Couanet D, Papadakis V, Laureys G, Pearson AD, Ladenstein R, Burchill SA. Neuroblastoma mRNAs predict outcome in children with stage 4 neuroblastoma: a European HR-NBL1/SIOPEN study. J Clin Oncol. 2014 Apr 1;32(10):1074-83. doi: 10.1200/JCO.2013.53.3604. Epub 2014 Mar 3.

name: Virginie F. Viprey and Susan A. Burchill, Leeds Institute of Cancer and Pathology; Walter M. Gregory, Clinical Trials Research Unit, University of Leeds, Leeds; Penelope Brock, Great Ormond Street Hospital, London; Andrew D. Pearson, Institute of Cancer Research/Royal Marsden National Health Service Foundation Trust, Sutton, United Kingdom; Maria V. Corrias and Sandro Dallorso, Gaslini Institute, Genoa; Roberto Luksch, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei...

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

title: Neuroblastoma mRNAs Predict Outcome in Children With Stage 4 Neuroblastoma: A European HR-NBL1/SIOPEN Study

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Italy
Austria
Sweden
Switzerland
Spain
United Kingdom
France
Czechia
Greece
Israel
Poland
Norway
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Australia
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Portugal
Slovakia
Denmark
Slovenia

location_facility: Glasgow Royal Hospital for Sick Children

location_facility: Edinburgh Royal Hospital for Sick Children

location_facility: Aberdeen: Royal Aberdeen Children's Hospital

location_facility: Univ.-Klinik für Kinder- und Jugendheilkunde Graz

location_facility: Schneider Children's Medical Center of Israel

location_facility: Children's University Hospital in Lublin

location_facility: Univ.Klinik f. Kinder-u. Jugendheilkunde Innsbruck

location_facility: University Children's Hospital Ljubljana

location_facility: Istituto per l'Infanzia "Burlo Garofolo"

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location_facility: Royal Belfast Hospital for Sick Children

location_facility: Clinica di Oncoematologia Pediatrica Padova

location_facility: Upper Silesian Centre of Child and Mother's Care


type: EudraCT Number

title: A Multicenter, Open Label, Randomized Phase II Trial of the MEK Inhibitor Pimasertib or Dacarbazine in Previously Untreated Subjects With N-Ras Mutated Locally Advanced or Metastatic Malignant Cutaneous Melanoma

summary: This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lebbé C, Dutriaux C, Lesimple T, Kruit W, Kerger J, Thomas L, Guillot B, Braud F, Garbe C, Grob JJ, Loquai C, Ferraresi V, Robert C, Vasey P, Conry R, Isaacs R, Espinosa E, Schueler A, Massimini G, Dréno B. Pimasertib Versus Dacarbazine in Patients With Unresectable NRAS-Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover. Cancers (Basel). 2020 Jun 29;12(7). pii: E1727. doi: 10.3390/cancers12071727.

family: Lebbé

full_name: Celeste Lebbé

given: Celeste

sequence: first

family: Dutriaux

full_name: Caroline Dutriaux

given: Caroline

sequence: additional

family: Lesimple

full_name: Thierry Lesimple

given: Thierry

family: Kruit

full_name: Willem Kruit

given: Willem

family: Kerger

full_name: Joseph Kerger

given: Joseph

family: Thomas

full_name: Luc Thomas

given: Luc

family: Guillot

full_name: Bernard Guillot

given: Bernard

family: de Braud

full_name: Filippo de Braud

given: Filippo

family: Garbe

full_name: Claus Garbe

given: Claus

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Loquai

full_name: Carmen Loquai

given: Carmen

family: Ferraresi

full_name: Virginia Ferraresi

given: Virginia

family: Robert

full_name: Caroline Robert

family: Vasey

full_name: Paul Vasey

given: Paul

family: Conry

full_name: Robert Conry

given: Robert

family: Isaacs

full_name: Richard Isaacs

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family: Espinosa

full_name: Enrique Espinosa

given: Enrique

family: Schueler

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family: Massimini

full_name: Giorgio Massimini

given: Giorgio

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

bso_classification: Medical research

currency_apc_doaj: CHF

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cancers

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

location_country:
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South Africa
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Switzerland
Netherlands
Germany
France
Israel
Belgium
Australia
New Zealand
Spain
United States
United Kingdom

location_facility: Please contact the US Medical Information in


ReferenceCitation: Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dréno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib ± cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

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full_name: Paolo A. Ascierto

given: Paolo A.

family: Ribas

full_name: Antoni Ribas

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family: Larkin

full_name: James Larkin

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family: McArthur

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family: Lewis

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given: Karl D.

family: Hauschild

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given: Axel

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

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given: Edward

family: Zhu

full_name: Qian Zhu

given: Qian

family: Mun

full_name: Yong Mun

given: Yong

currency_apc_doaj: GBP

journal_name: Journal of Translational Medicine

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories: California Digital Library - eScholarship

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: de la Cruz-Merino L, Di Guardo L, Grob JJ, Venosa A, Larkin J, McArthur GA, Ribas A, Ascierto PA, Evans JTR, Gomez-Escobar A, Barteselli G, Eng S, Hsu JJ, Uyei A, Dréno B. Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study. J Transl Med. 2017 Jun 24;15(1):146. doi: 10.1186/s12967-017-1246-0.

family: de la Cruz-Merino

full_name: Luis de la Cruz-Merino

given: Luis

family: Di Guardo

full_name: Lorenza Di Guardo

given: Lorenza

family: Venosa

full_name: Alfredo Venosa

given: Alfredo

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Dréno B, Ribas A, Larkin J, Ascierto PA, Hauschild A, Thomas L, Grob JJ, Koralek DO, Rooney I, Hsu JJ, McKenna EF, McArthur GA. Incidence, course, and management of toxicities associated with cobimetinib in combination with vemurafenib in the coBRIM study. Ann Oncol. 2017 May 1;28(5):1137-1144. doi: 10.1093/annonc/mdx040.

ReferenceCitation: Ascierto PA, McArthur GA, Dréno B, Atkinson V, Liszkay G, Di Giacomo AM, Mandalà M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Yan Y, Wongchenko M, Chang I, Hsu JJ, Koralek DO, Rooney I, Ribas A, Larkin J. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016 Sep;17(9):1248-60. doi: 10.1016/S1470-2045(16)30122-X. Epub 2016 Jul 30.

title: Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

ReferenceCitation: Larkin J, Ascierto PA, Dréno B, Atkinson V, Liszkay G, Maio M, Mandalà M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Sovak MA, Chang I, Choong N, Hack SP, McArthur GA, Ribas A. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014 Nov 13;371(20):1867-76. doi: 10.1056/NEJMoa1408868. Epub 2014 Sep 29.

repository_institution: The University of Queensland - Queensland's institutional digital repository

title: Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

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Italy
Austria
United States
Sweden
Switzerland
Netherlands
Spain
Germany
France
Czechia
Israel
Norway
Hungary
Australia
Belgium
New Zealand
Russian Federation
Canada
United Kingdom

location_facility: London Health Sciences Centre · Victoria Hospital;Department of Pediatrics

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Rhode Island Hospital; Investigational Services

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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location_facility: Lismore Base Hospital; Cancer Care & Haematology Unit

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location_facility: TSBHI Altai Territorial oncological dispensary

location_facility: McGill University Health Centre/Glen Site / Royal Victoria Hospital

location_facility: U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology

location_facility: Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Rabin Medical Center-Beilinson Campus;Hematology-Oncology

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: FSBSI "N. N. Blokhin Russian Cancer Research Center"

location_facility: Northwestern Center For Clinical Research

location_facility: BC Cancer Agency Vancouver Island Cancer Centre

location_facility: Uni of Kansas Medical Center; Dept of Neurology

location_facility: Klinikum der Ludwigs-Maximilians-Universitaet Muenchen

location_facility: Hospital General Universitario de Valencia

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: The Ottawa Hospital Cancer Center; General Campus

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Dartmouth-Hitchcock Medical Center; Department of Medicine

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: University of California Davis Health System

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology

location_facility: Institut Jules Bordet; Department of Medical Oncology

location_facility: Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Centre Hospitalier Universitaire de Grenoble - Albert Michallon

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.


title: A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy

acronym: BEYOND

summary: The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

ipd_sharing: Yes

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Armenia
Finland
Greece
Belgium
Russian Federation
Denmark
Ukraine
Spain
France
Poland
Lithuania
Slovakia
Norway
Canada
Slovenia
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Lebanon
Czechia
Georgia
Belarus
Kazakhstan
Turkey
Latvia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary: The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

ReferenceCitation: Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019 Jan;7(1):60-68. doi: 10.1016/S2213-2600(18)30339-4. Epub 2018 Sep 14.

family: Crestani

full_name: Bruno Crestani

given: Bruno

family: Huggins

full_name: John T Huggins

given: John T

family: Kaye

full_name: Mitchell Kaye

given: Mitchell

family: Costabel

full_name: Ulrich Costabel

given: Ulrich

family: Glaspole

full_name: Ian Glaspole

given: Ian

family: Ogura

full_name: Takashi Ogura

given: Takashi

family: Song

full_name: Jin Woo Song

given: Jin Woo

family: Stansen

full_name: Wibke Stansen

given: Wibke

family: Quaresma

full_name: Manuel Quaresma

given: Manuel

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

family: Kreuter

full_name: Michael Kreuter

given: Michael

journal_name: The Lancet Respiratory Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Greece
Belgium
Australia
Russian Federation
India
France
Japan
Canada
Korea, Republic of
Chile
Netherlands
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: National Allergy Asthma Bronchitis Institute, Kolkata

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: University Hospital of Heraklion, University Pulmonology Cl

location_facility: Mehta Hospital & Cardiopulmonary Care Centre

location_facility: Scientific Research Institute of Pulmonology

location_facility: General Hospital of Shenyang Military Region

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Saitama Cardiovascular and Respiratory Center

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

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

location_facility: Xiangya Hospital, Central South University

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: General Hospital of Ningxia Medical University

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

location_facility: Kobe City Medical Center General Hospital

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Athens Hospital of Chest Diseases "Sotiria"

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: University of Texas Southwestern Medical Center


lead_sponsor: Onxeo

location_country:
United States
Switzerland
France
Hungary
Spain
Germany

location_facility: Carolinas Medical Center- Carolinas Health Care System

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

location_facility: Universitatsklinikum Freiburg Klinik fur Strahlentherapie

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Washington University School of medecine

location_facility: Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.

location_facility: University of Oklahoma Health Sciences Center

location_facility: California Cancer Associates for Researche and Excellence

source: euctr

title: A Phase II, Multi-center, Randomised, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Lauriad® 50 μg and 100 μg Mucoadhesive Buccal Tablet (MBT) Applied Once Daily to Those of Placebo in the Prevention and Treatment of Chemoradiation Therapy Induced Oral Mucositis in Patients With Head and Neck Cancer

summary: The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.


ReferenceCitation: Cohen EEW, Licitra LF, Burtness B, Fayette J, Gauler T, Clement PM, Grau JJ, Del Campo JM, Mailliez A, Haddad RI, Vermorken JB, Tahara M, Guigay J, Geoffrois L, Merlano MC, Dupuis N, Krämer N, Cong XJ, Gibson N, Solca F, Ehrnrooth E, Machiels JH. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer. Ann Oncol. 2017 Oct 1;28(10):2526-2532. doi: 10.1093/annonc/mdx344.

family: Cohen

full_name: E.E.W. Cohen

family: Licitra

full_name: L.F. Licitra

family: Burtness

full_name: B. Burtness

given: B.

family: Fayette

full_name: J. Fayette

given: J.

family: Gauler

full_name: T. Gauler

given: T.

family: Clement

full_name: P.M. Clement

family: Grau

full_name: J.J. Grau

family: del Campo

full_name: J.M. del Campo

family: Mailliez

full_name: A. Mailliez

given: A.

family: Haddad

full_name: R.I. Haddad

family: Vermorken

full_name: J.B. Vermorken

family: Tahara

full_name: M. Tahara

given: M.

family: Guigay

full_name: J. Guigay

family: Geoffrois

full_name: L. Geoffrois

given: L.

family: Merlano

full_name: M.C. Merlano

family: Dupuis

full_name: N. Dupuis

given: N.

family: Krämer

full_name: N. Krämer

family: Cong

full_name: X.J. Cong

family: Gibson

full_name: N. Gibson

family: Solca

full_name: F. Solca

given: F.

family: Ehrnrooth

full_name: E. Ehrnrooth

given: E.

family: Machiels

full_name: J.-P.H. Machiels

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Clement PM, Gauler T, Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Cohen EE, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Vermorken JB; LUX-H&N 1 investigators. Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial. Ann Oncol. 2016 Aug;27(8):1585-93. doi: 10.1093/annonc/mdw151. Epub 2016 Apr 15.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Vermorken JB, Clement PM, Gauler T, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Cohen EE; LUX-H&N 1 investigators. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):583-94. doi: 10.1016/S1470-2045(15)70124-5. Epub 2015 Apr 16.

location_country:
Italy
Austria
Brazil
South Africa
Sweden
Switzerland
Mexico
Germany
France
Czechia
Greece
Israel
Japan
Argentina
Belgium
Russian Federation
Spain
Denmark
United States

location_facility: 1200.43.03404 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.97203 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04902 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04201 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04906 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00102 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03304 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04303 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00706 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03902 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03903 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05503 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03002 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00113 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00109 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00705 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04905 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03905 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08103 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03305 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03906 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03908 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03306 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00710 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03317 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03904 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02701 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00703 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00707 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04904 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03401 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03403 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05502 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08106 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08109 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02703 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04907 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03406 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05401 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05402 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04301 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04101 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03405 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04203 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03402 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02702 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04903 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03901 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08108 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05202 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05504 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08110 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00704 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05507 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04909 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03910 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08104 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08114 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00106 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05403 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03201 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04305 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03204 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.97201 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03004 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03316 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05505 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04501 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03202 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08102 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04908 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03314 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03309 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03307 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03909 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08112 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.02704 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.97204 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03302 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03907 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03310 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08113 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08107 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04202 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00709 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05506 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03203 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04901 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00103 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03005 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.05501 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03303 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04102 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00105 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08111 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03312 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.04602 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00110 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.00107 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.03301 Boehringer Ingelheim Investigational Site

location_facility: 1200.43.08105 Boehringer Ingelheim Investigational Site

title: A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy

summary: This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate


title: Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003

summary: The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

ReferenceType: background

ReferenceCitation: Moreau P, Weisel KC, Song KW, Gibson CJ, Saunders O, Sternas LA, Hong K, Zaki MH, Dimopoulos MA. Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS). Leuk Lymphoma. 2016 Dec;57(12):2839-2847. Epub 2016 May 13.

ReferenceCitation: Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055-1066. doi: 10.1016/S1470-2045(13)70380-2. Epub 2013 Sep 3.

family: Miguel

full_name: Jesus San Miguel

given: Jesus San

family: Weisel

full_name: Katja Weisel

given: Katja

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Lacy

full_name: Martha Lacy

given: Martha

family: Song

full_name: Kevin Song

given: Kevin

family: Delforge

full_name: Michel Delforge

given: Michel

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

family: Banos

full_name: Anne Banos

given: Anne

family: Oriol

full_name: Albert Oriol

given: Albert

family: Alegre

full_name: Adrian Alegre

given: Adrian

family: Chen

full_name: Christine Chen

given: Christine

family: Cavo

full_name: Michele Cavo

given: Michele

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Ivanova

full_name: Valentina Ivanova

given: Valentina

family: Martinez-Lopez

full_name: Joaquin Martinez-Lopez

given: Joaquin

family: Belch

full_name: Andrew Belch

given: Andrew

family: Palumbo

full_name: Antonio Palumbo

given: Antonio

family: Schey

full_name: Stephen Schey

given: Stephen

family: Sonneveld

full_name: Pieter Sonneveld

given: Pieter

family: Yu

full_name: Xin Yu

given: Xin

family: Sternas

full_name: Lars Sternas

given: Lars

family: Jacques

full_name: Christian Jacques

given: Christian

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Morgan G, Palumbo A, Dhanasiri S, Lee D, Weisel K, Facon T, Delforge M, Oriol A, Zaki M, Yu X, Sternas L, Jacques C, Akehurst R, Offner F, Dimopoulos MA. Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone. Br J Haematol. 2015 Mar;168(6):820-3. doi: 10.1111/bjh.13227. Epub 2014 Nov 18.

location_country:
Italy
Sweden
Switzerland
Netherlands
Germany
France
Czechia
Greece
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: King's College Hospital - Haematology Clinical Trials

location_facility: Centre Hospitalier Départemental Vendée - Onco-hematologie

location_facility: Royal Wolverhampton Hospitals Trust - Research and Development

location_facility: Universita degli Studi di Padova - Clinical & Experimental Medicine

location_facility: A.O.U. San Giovanni Battista - Hematology

location_facility: Hospital Clinic i Provincial de Barcelona - Hematology

location_facility: Inselspital, Institut für Medizinische Onkologie

location_facility: Hôpital Saint Louis - Immuno-hematologie

location_facility: Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

location_facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

location_facility: The Alfred Hospital - Malignant Haematology & Stem Cell Transplantation

location_facility: Princess Margaret Hospital, University Health Network

location_facility: Peter McCallum Cancer Institute - Directorate of Cancer Medicine

location_facility: Universitätsklinikum Ulm - Klinik fur Innere Medizin III

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Centre Hospitalier de la côte basque - Hematologie

location_facility: Royal Adelaide Hospital - SA Pathology Haematology

location_facility: Royal Prince Alfred Hospital - Institute of Haematology

location_facility: Princess Alexandra Hospital - Haematology

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie Service des maladies du sang

location_facility: Askepios Klinik Altona-Abteilung Hamatologie und Internistische Onkologie

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie Westdeutsches Tumorzentrum

location_facility: State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

location_facility: Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

location_facility: Sahlgrenska Hospital, University of Goteborg - Hematology

location_facility: British Columbia Cancer Agency, Vancouver Centre

location_facility: Hôpital Bretonneau - Hématologie & Thérapie cellulaire

location_facility: Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

location_facility: Karolinska University Hospital Solna- medicine

location_facility: CHU Angers - Service des maladies du sang

location_facility: Cliniques Universitaires ULC de Mont-Godinne - Hematology

location_facility: Hospital Germans Trias i Pujol - Hematology

location_facility: Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

location_facility: Universitatsklinikum Carl Gustav Carus-Medizinische Klinik und Poliklinik I

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

location_facility: Royal Bournemouth Hospital - Haematology

location_facility: Hôpitaux Universitaire de Genève - Oncologie

location_facility: Russian Research Institute of Hematology and Blood Transfusion - Hematology

location_facility: Hospital Universitario Marqués de Valdecilla - Hematology

location_facility: Royal hallamshire Hospital - Haematology

location_facility: Nottingham City Hospital - Centre for Clinical Haematology

location_facility: Freeman Hospital - Northern Centre for Cancer Care

location_facility: Centre Hospitalier Lyon sud - Hematologie

location_facility: Frankston Hospital-Peninsula Health - Oncology Day Unit

location_facility: Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

location_facility: Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

location_facility: Karolinska University Hospital Huddinge - Center of hematology

location_facility: Hematological Research Center under the Russian Academy of Medical Sciences - Hematology & BMT

location_facility: Charles University Hospital - Internal Medicine

location_facility: CHU Saint Antoine - Service des maladies du sang

location_facility: AO Universitaria San Martino - hematooncology

location_facility: Royal Marsden NHS Foundation Trust - Haematology

location_facility: Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

location_facility: University of Athens - Alexandra Hospital

location_facility: Ospedale Guglielmo da Saliceto - hematooncology

location_facility: Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

location_facility: St James's University Hospital - Haematology

location_facility: Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

location_facility: CHRU de Lille - Service des maladies du sang

location_facility: Ospedale San Luigi AO Luigi Gonzaga - Hematology

location_facility: St Bartholomew's Hospital - Medical Oncology


title: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

acronym: Prospect

summary: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

ReferenceCitation: Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.

name: National Institutes of Health, Bethesda, MD

family: Gulley

full_name: James L. Gulley

given: James L.

name: Aarhus Universitetshospital, Åarhus, Denmark

family: Borre

full_name: Michael Borre

given: Michael

name: Comprehensive Cancer Centers of Nevada, Las Vegas, NV

family: Vogelzang

full_name: Nicholas J. Vogelzang

given: Nicholas J.

name: St John of God Subiaco Hospital, Subiaco, Western Australia, Australia

family: Ng

full_name: Siobhan Ng

given: Siobhan

name: University of Utah Huntsman Cancer Institute, Salt Lake City, UT

family: Agarwal

full_name: Neeraj Agarwal

given: Neeraj

name: Royal Marsden Hospital, Sutton, United Kingdom

family: Parker

full_name: Chris C. Parker

given: Chris C.

name: Monash Medical Centre, Bentleigh, Victoria, Australia

family: Pook

full_name: David W. Pook

given: David W.

family: Rathenborg

full_name: Per Rathenborg

given: Per

name: University of Colorado Cancer Center, Aurora, CO

family: Flaig

full_name: Thomas W. Flaig

given: Thomas W.

name: Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain

family: Carles

full_name: Joan Carles

given: Joan

name: Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada

family: Saad

full_name: Fred Saad

given: Fred

name: Carolina Urologic Research Center, Myrtle Beach, SC

family: Shore

full_name: Neal D. Shore

given: Neal D.

full_name: Liddy Chen

given: Liddy

family: Heery

full_name: Christopher R. Heery

given: Christopher R.

family: Gerritsen

full_name: Winald R. Gerritsen

given: Winald R.

name: Centre Hospitalier Départemental, La Roche sur Yon, France

family: Priou

full_name: Frank Priou

given: Frank

name: Aalborg Universitethospital, Aalborg, Denmark

family: Langkilde

full_name: Niels C. Langkilde

given: Niels C.

name: North-Western State Medical University, Saint Petersburg, Russia

family: Novikov

full_name: Andrey Novikov

given: Andrey

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

family: Kantoff

full_name: Philip W. Kantoff

given: Philip W.

evidence: open (via page says license)

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

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

publisher: American Society of Clinical Oncology (ASCO)

location_country:
United States
Netherlands
Spain
Germany
France
Poland
Israel
Belgium
Australia
Puerto Rico
Russian Federation
Estonia
Denmark
Canada
United Kingdom
Iceland

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Orenburg Regional Clinical Oncology Center

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: St. Petersburg Medical Academy of Postgraduate Education

location_facility: Urologic Consultants of Southeaster PA LLP

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Plymouth Hospitals NHS Trust, Derriford Hospital

location_facility: Moscow Research Oncology Institute n.a. P.A.Gertsen

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Middelheim

location_facility: James H. Quillen Veterans Affairs Medical Center

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: James A Haley Veteran Affairs Medical Center

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Central Texas Veterans Health Care System

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

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

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Centre Hospitalier Universitaire de Quebec Hotel Dieu

location_facility: Presbyterian Hospital Center for Cancer Research

location_facility: National Cancer Institute - Center for Cancer Research

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov

location_facility: Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries

location_facility: Leeds Teaching Hospitals NHS Trust, St James's University Hospital

location_facility: White River Junction Veterans Affairs Medical Center

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

location_facility: University Hospitals Case Medical Center

location_facility: Delaware Valley Urology LLC - Westhampton

location_facility: Monash Medical Centre - Moorabbin Campus

location_facility: Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Institut Jean Godinot - Centre de lutte contre le cancer

location_facility: Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o.

location_facility: Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: St. Josephs Healthcare Hamilton Research Ethics Board

location_facility: Stavropol Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario Fundación Alcorcón


title: A Phase 3, Muticenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone Versus High-dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

acronym: NIMBUS

summary: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.

ReferenceType: result

family: Miguel

full_name: Jesus San Miguel

given: Jesus San

family: Weisel

full_name: Katja Weisel

given: Katja

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Lacy

full_name: Martha Lacy

given: Martha

family: Song

full_name: Kevin Song

given: Kevin

family: Delforge

full_name: Michel Delforge

given: Michel

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

family: Banos

full_name: Anne Banos

given: Anne

family: Oriol

full_name: Albert Oriol

given: Albert

family: Alegre

full_name: Adrian Alegre

given: Adrian

family: Chen

full_name: Christine Chen

given: Christine

family: Cavo

full_name: Michele Cavo

given: Michele

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Ivanova

full_name: Valentina Ivanova

given: Valentina

family: Martinez-Lopez

full_name: Joaquin Martinez-Lopez

given: Joaquin

family: Belch

full_name: Andrew Belch

given: Andrew

family: Palumbo

full_name: Antonio Palumbo

given: Antonio

family: Schey

full_name: Stephen Schey

given: Stephen

family: Sonneveld

full_name: Pieter Sonneveld

given: Pieter

family: Yu

full_name: Xin Yu

given: Xin

family: Sternas

full_name: Lars Sternas

given: Lars

family: Jacques

repositories_institution: University of Turin - Institutional Research Information System University of Turin

title: Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial

ReferenceCitation: Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. Epub 2016 Jun 7.

ReferenceCitation: Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Knop S, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel J. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Haematologica. 2016 Jul;101(7):872-8. doi: 10.3324/haematol.2015.137083. Epub 2016 Apr 14.

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repositories:
LIRIAS (KU Leuven)
PubMed Central
cris.unibo.it
dnet

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Dimopoulos MA, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Spencer A, Knop S, Bahlis NJ, Renner C, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel JF. Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone. Haematologica. 2015 Oct;100(10):1327-33. doi: 10.3324/haematol.2014.117077. Epub 2015 Aug 6.

repository_institution: Würzburg University - Online Publication Service of Würzburg University

ReferenceCitation: San Miguel JF, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Renner C, Bahlis NJ, Yu X, Teasdale T, Sternas L, Jacques C, Zaki MH, Dimopoulos MA. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. Haematologica. 2015 Oct;100(10):1334-9. doi: 10.3324/haematol.2015.125864. Epub 2015 Jul 9.

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

ReferenceCitation: Weisel K, Dimopoulos M, Song KW, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Gibson CJ, Zaki M, Jacques C, San Miguel J. Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. Clin Lymphoma Myeloma Leuk. 2015 Sep;15(9):519-30. doi: 10.1016/j.clml.2015.05.007. Epub 2015 Jun 6.

ReferenceCitation: Song KW, Dimopoulos MA, Weisel KC, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Monzini MS, Zaki M, Jacques C, San Miguel J. Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma. Haematologica. 2015 Feb;100(2):e63-7. doi: 10.3324/haematol.2014.112557. Epub 2014 Nov 25.

repositories:
PubMed Central
Pure (Denmark)
iris.unito.it

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
France
Czechia
Greece
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Royal Victoria Hospital McGill Department of Oncology(RVH)

location_facility: Royal Hallamshire HospitalSheffield Teaching Hospitals NHS Trust

location_facility: State Institution Moscow Regional Research Clinical Institute

location_facility: Univerita La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia

location_facility: Servizio di Ematologia, A.O. - Arcispedale S.Maria Nuova

location_facility: State Educational Institution, Saint Petersburg State Medical University

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Department of Hematology Hematology Centre

location_facility: Azienda Ospedaliera San Giovanni Battista

location_facility: State Institution Hematological Research, Centre of Russian Academy of Medical Science

location_facility: Hospital Universitari Germans Trias i Pujol


title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

acronym: SEAMLESS

summary: This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

ReferenceCitation: Kantarjian, H.M.; Begna, K.H.; Altman, J.K.; Goldberg, S.L.; Sekeres, M.A.; Strickland, S.A.; Rubenstein, S.E.; Arellano, M.L.; Claxton, D.F.; Baer, M.R.; et al. Results of a Phase 3 Study of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Blood 2017, vol. 130 no. Suppl 1 891. http://www.bloodjournal.org/content/130/Suppl_1/891.

ReferenceCitation: Kantarjian HM, Begna KH, Altman JK, Goldberg SL, Sekeres MA, Strickland SA, Arellano ML, Claxton DF, Baer MR, Gautier M, Berman E, Seiter K, Solomon SR, Schiller GJ, Luger SM, Butrym A, Gaidano G, Thomas XG, Montesinos P, Rizzieri DA, Quick DP, Venugopal P, Gaur R, Maness LJ, Kadia TM, Ravandi F, Buyse ME, Chiao JH. Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS). Cancer. 2021 Dec 1;127(23):4421-4431. doi: 10.1002/cncr.33828. Epub 2021 Aug 23.

name: Department of Leukemia The University of Texas MD Anderson Cancer Center Houston Texas

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

name: Division of Hematology Mayo Clinic Rochester Minnesota

family: Begna

full_name: Kebede H. Begna

given: Kebede H.

name: Department of Medicine Northwestern University Chicago Illinois

family: Altman

full_name: Jessica K. Altman

given: Jessica K.

name: Hackensack University Medical Center Hackensack New Jersey

family: Goldberg

full_name: Stuart L. Goldberg

given: Stuart L.

name: Hematologic Oncology and Blood Disorders Cleveland Clinic Cleveland Ohio

family: Sekeres

full_name: Mikkael A. Sekeres

given: Mikkael A.

name: Vanderbilt‐Ingram Cancer Center Nashville Tennessee

family: Strickland

full_name: Stephen A. Strickland

given: Stephen A.

name: Hematology/Oncology Emory University School of Medicine Atlanta Georgia

family: Arellano

full_name: Martha L. Arellano

given: Martha L.

name: Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

family: Claxton

full_name: David F. Claxton

given: David F.

name: University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland

family: Baer

full_name: Maria R. Baer

given: Maria R.

name: Dartmouth‐Hitchcock Medical Center Lebanon New Hampshire

family: Gautier

full_name: Marc Gautier

given: Marc

name: Memorial Sloan Kettering Cancer Center New York New York

family: Berman

full_name: Ellin Berman

given: Ellin

name: Department of Medicine New York Medical College Valhalla New York

family: Seiter

full_name: Karen Seiter

given: Karen

name: Northside Hospital Cancer InstituteLeukemia Program Atlanta Georgia

family: Solomon

full_name: Scott R. Solomon

given: Scott R.

name: Hematological Malignancy/Stem Cell Transplant Program David Geffen School of Medicine at the University of California Los Angeles California

family: Schiller

full_name: Gary J. Schiller

given: Gary J.

name: Department of Hematology/Oncology Abramson Cancer Center University of Pennsylvania Philadelphia Pennsylvania

family: Luger

full_name: Selina M. Luger

given: Selina M.

name: Department of Hematology, Blood Neoplasms, and Bone Marrow Transplantation Wroclaw Medical University Wroclaw Poland

family: Butrym

full_name: Aleksandra Butrym

given: Aleksandra

name: Division of Hematology Maggiore della Carita University Hospital Novara Italy

family: Gaidano

full_name: Gianluca Gaidano

given: Gianluca

name: Hematology South Hospital Center Lyon France

family: Thomas

full_name: Xavier G. Thomas

given: Xavier G.

name: La Fe University and Polytechnic Hospital Valencia Spain

family: Montesinos

full_name: Pau Montesinos

given: Pau

name: Department of Medicine Duke University Medical Center Durham North Carolina

family: Rizzieri

full_name: David A. Rizzieri

given: David A.

name: Joe Arrington Cancer Center Lubbock Texas

family: Quick

full_name: Donald P. Quick

given: Donald P.

name: Department of Medicine, Hematology, and Oncology Rush University Medical Center Chicago Illinois

family: Venugopal

full_name: Parameswaran Venugopal

given: Parameswaran

name: St Luke's Cancer Institute Kansas City Missouri

family: Gaur

full_name: Rakesh Gaur

name: Division of Hematology‐Oncology Department of Internal Medicine University of Nebraska Medical Center Omaha Nebraska

name: International Drug Development Institute Louvain‐la‐Neuve Belgium

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

location_facility: Kings College Hospital and Guys and St Thomas' Hospital

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: The University of Chicago Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: IHT Instytut Hematologii I Transfuzjologii w Warszawie

location_facility: John Theurer Cancer Center at the Hackensack University Medical Center

location_facility: Westchester Hematology Oncology Group, PC

location_facility: Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin

location_facility: Winship Cancer Institute, Emory University

location_facility: Skåne Universitetssjukhus Univ Hospital Lund

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Centre Hospitalier de Saint-Brieuc Yves Ie Foll

location_facility: University of Maryland Greenbaum Cancer Center

location_facility: University of Alabama Comprehensive Cancer Center

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: University of Lodz N. Copernicus Memorial Hospital

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku

location_facility: Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: St. Francis Medical Group Oncology and Hematology Specialists

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu

location_facility: Shands Cancer Hospital at University of Florida


title: A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

summary: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

ReferenceCitation: Möller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.

family: Möller

full_name: Hans-Jürgen Möller

given: Hans-Jürgen

family: Demyttenaere

full_name: Koen Demyttenaere

given: Koen

family: Olausson

full_name: Bengt Olausson

given: Bengt

family: Szamosi

full_name: Johan Szamosi

given: Johan

family: Wilson

full_name: Ellis Wilson

given: Ellis

family: Hosford

full_name: David Hosford

given: David

family: Dunbar

full_name: Geoffrey Dunbar

given: Geoffrey

family: Tummala

full_name: Raj Tummala

given: Raj

family: Eriksson

full_name: Hans Eriksson

given: Hans

journal_name: The World Journal of Biological Psychiatry

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: AstraZeneca

location_country:
Brazil
Chile
South Africa
Serbia
Croatia
Bulgaria
France
Poland
Slovakia
Romania
Hungary
Argentina
Russian Federation
Spain
Germany
Colombia
Ukraine


title: Translational Research - Observational Study for Identification of New Possible Prognostic Factors and Future Therapeutic Targets in Children With Acute Lymphoblastic Leukemia (ALL)

summary:
RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help the study of cancer in the future. Studying these samples in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is collecting and looking at blood and tissue samples in children with newly diagnosed acute lymphoblastic leukemia.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

ReferenceCitation: Matthijssens F, Sharma ND, Nysus M, Nickl CK, Kang H, Perez DR, Lintermans B, Van Loocke W, Roels J, Peirs S, Demoen L, Pieters T, Reunes L, Lammens T, De Moerloose B, Van Nieuwerburgh F, Deforce DL, Cheung LC, Kotecha RS, Risseeuw MD, Van Calenbergh S, Takarada T, Yoneda Y, van Delft FW, Lock RB, Merkley SD, Chigaev A, Sklar LA, Mullighan CG, Loh ML, Winter SS, Hunger SP, Goossens S, Castillo EF, Ornatowski W, Van Vlierberghe P, Matlawska-Wasowska K. RUNX2 regulates leukemic cell metabolism and chemotaxis in high-risk T cell acute lymphoblastic leukemia. J Clin Invest. 2021 Mar 15;131(6). pii: 141566. doi: 10.1172/JCI141566.

family: Matthijssens

full_name: Filip Matthijssens

given: Filip

family: Sharma

full_name: Nitesh D. Sharma

given: Nitesh D.

family: Nysus

full_name: Monique Nysus

given: Monique

family: Nickl

full_name: Christian K. Nickl

given: Christian K.

family: Kang

full_name: Huining Kang

given: Huining

family: Perez

full_name: Dominique R. Perez

given: Dominique R.

family: Lintermans

full_name: Beatrice Lintermans

given: Beatrice

family: Van Loocke

full_name: Wouter Van Loocke

given: Wouter

family: Roels

full_name: Juliette Roels

given: Juliette

family: Peirs

full_name: Sofie Peirs

given: Sofie

family: Demoen

full_name: Lisa Demoen

given: Lisa

family: Pieters

full_name: Tim Pieters

given: Tim

family: Reunes

full_name: Lindy Reunes

given: Lindy

family: Lammens

full_name: Tim Lammens

family: De Moerloose

full_name: Barbara De Moerloose

given: Barbara

family: Van Nieuwerburgh

full_name: Filip Van Nieuwerburgh

family: Deforce

full_name: Dieter L. Deforce

given: Dieter L.

family: Cheung

full_name: Laurence C. Cheung

given: Laurence C.

family: Kotecha

full_name: Rishi S. Kotecha

given: Rishi S.

family: Risseeuw

full_name: Martijn D.P. Risseeuw

given: Martijn D.P.

family: Van Calenbergh

full_name: Serge Van Calenbergh

given: Serge

family: Takarada

full_name: Takeshi Takarada

given: Takeshi

family: Yoneda

full_name: Yukio Yoneda

given: Yukio

family: van Delft

publisher: American Society for Clinical Investigation

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

location_facility: CHRU de Besancon - Hopital Saint-Jacques

location_facility: Hopitaux Universitaires de Strasbourg - Hautepierre

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: CHU de Toulouse - C.H.U. De Toulouse - Hopital Des Enfants

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Instituto Portugues De Oncologia - Centro Do Porto

location_facility: CHU de Reims - American Memorial Hospital


title: A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

summary: This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

status: Terminated

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
United States
Brazil
Mexico
Germany
France
Poland
Slovakia
Australia
Puerto Rico
New Zealand
Spain
Canada
United Kingdom

status_simplified: Unknown


ReferenceCitation: Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2021 Sep 29. doi: 10.14309/ajg.0000000000001521. [Epub ahead of print]

family: Staller

full_name: Kyle Staller

given: Kyle

family: Hinson

full_name: Jimmy Hinson

given: Jimmy

family: Kerstens

full_name: René Kerstens

given: René

family: Spalding

full_name: William Spalding

given: William

family: Lembo

full_name: Anthony Lembo

given: Anthony

journal_name: American Journal of Gastroenterology

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Yiannakou Y, Piessevaux H, Bouchoucha M, Schiefke I, Filip R, Gabalec L, Dina I, Stephenson D, Kerstens R, Etherson K, Levine A. A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation. Am J Gastroenterol. 2015 May;110(5):741-8. doi: 10.1038/ajg.2015.115. Epub 2015 Apr 14.

family: Yiannakou

full_name: Yan Yiannakou

given: Yan

family: Piessevaux

full_name: Hubert Piessevaux

given: Hubert

family: Bouchoucha

full_name: Michel Bouchoucha

given: Michel

family: Schiefke

full_name: Ingolf Schiefke

given: Ingolf

family: Filip

full_name: Rafal Filip

given: Rafal

family: Gabalec

full_name: Libor Gabalec

given: Libor

family: Dina

full_name: Ion Dina

given: Ion

family: Stephenson

full_name: David Stephenson

given: David

family: Etherson

full_name: Kevin Etherson

given: Kevin

family: Levine

full_name: Amy Levine

given: Amy

oa_host_type: repository

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy, Safety, and Tolerability of Prucalopride in Men With Chronic Constipation

location_country:
Netherlands
France
Czechia
Bulgaria
Poland
Romania
Belgium
Denmark
Germany
United Kingdom

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Chirurgii Ogólnej i Gastroenterologii

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

location_facility: CHU - Hopital Nord, service gastro-enterologie et hepatologie

location_facility: Hopital Avicenne, Centre d'exploitation fonctionnelle et reducation digestive

location_facility: Gastroenterologie und Hepatologie am Johannisplatz

location_facility: Spitalul Clinic Judetean Cluj,Clinica Medicala I

location_facility: Krajska Nemocnice T. Bati a.s., Interni oddeleni - klinika IPVZ; Nemocnicni Lekarna

location_facility: Hopital Archet 2- service gastro-enterologie et hepatologie

location_facility: Hôpital Pontchaillou - Service des Maladies de l'Appareil Digestif

location_facility: Service de Gastroenterologie & INSERM CIC-P 803 - CHU de Dijon

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: County Durham & Darlington NHS Foundation Trust

location_facility: Instytut Medycyny Wsi im. Witolda Chodźki - Zaklad Endoskopowych Badań Kliniczncyh

location_facility: Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

title: A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation

summary:
This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.

Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.


ReferenceCitation: Martin M, Campone M, Bondarenko I, Sakaeva D, Krishnamurthy S, Roman L, Lebedeva L, Vedovato JC, Aapro M. Randomised phase III trial of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and resistant to taxane. Ann Oncol. 2018 May 1;29(5):1195-1202. doi: 10.1093/annonc/mdy063.

family: Martin

full_name: M. Martin

given: M.

family: Campone

full_name: M. Campone

family: Bondarenko

full_name: I. Bondarenko

given: I.

family: Sakaeva

full_name: D. Sakaeva

given: D.

family: Krishnamurthy

full_name: S. Krishnamurthy

given: S.

family: Roman

full_name: L. Roman

given: L.

family: Lebedeva

full_name: L. Lebedeva

family: Vedovato

full_name: J.-C. Vedovato

family: Aapro

full_name: M. Aapro

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Pierre Fabre Medicament

location_country:
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Poland
Argentina
South Africa
Switzerland
Bulgaria
Hungary
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Belarus
Spain
Estonia

title: A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant.

summary: The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.


title: A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated In Study 3133K1-3000

summary: The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

ReferenceCitation: Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.

family: Ivanoiu

full_name: Adrian Ivanoiu

given: Adrian

family: Pariente

full_name: Jérémie Pariente

given: Jérémie

family: Booth

full_name: Kevin Booth

family: Lobello

full_name: Kasia Lobello

given: Kasia

family: Luscan

full_name: Gerald Luscan

given: Gerald

family: Hua

full_name: Lisa Hua

given: Lisa

family: Lucas

full_name: Prisca Lucas

given: Prisca

family: Styren

full_name: Scot Styren

given: Scot

family: Yang

full_name: Lingfeng Yang

given: Lingfeng

family: Li

full_name: David Li

family: Black

full_name: Ronald S. Black

given: Ronald S.

family: Brashear

full_name: H. Robert Brashear

given: H. Robert

family: McRae

full_name: Thomas McRae

given: Thomas

journal_name: Alzheimer's Research & Therapy

title: Long-term safety and tolerability of bapineuzumab in patients with Alzheimer’s disease in two phase 3 extension studies

lead_sponsor: Pfizer

location_country:
Italy
South Africa
Chile
Sweden
Switzerland
Netherlands
Spain
Finland
France
Japan
Poland
Slovakia
Belgium
Australia
New Zealand
Portugal
United Kingdom