summary: This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

ReferenceCitation: Gridelli C, de Castro Carpeno J, Dingemans AC, Griesinger F, Grossi F, Langer C, Ohe Y, Syrigos K, Thatcher N, Das-Gupta A, Truman M, Donica M, Smoljanovic V, Bennouna J. Safety and Efficacy of Bevacizumab Plus Standard-of-Care Treatment Beyond Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer: The AvaALL Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e183486. doi: 10.1001/jamaoncol.2018.3486. Epub 2018 Dec 13. Erratum In: JAMA Oncol. 2018 Dec 1;4(12):1792.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Takeda M, Yamanaka T, Seto T, Hayashi H, Azuma K, Okada M, Sugawara S, Daga H, Hirashima T, Yonesaka K, Urata Y, Murakami H, Saito H, Kubo A, Sawa T, Miyahara E, Nogami N, Nakagawa K, Nakanishi Y, Okamoto I. Bevacizumab beyond disease progression after first-line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non-small cell lung cancer (West Japan Oncology Group 5910L): An open-label, randomized, phase 2 trial. Cancer. 2016 Apr 1;122(7):1050-9. doi: 10.1002/cncr.29893. Epub 2016 Feb 1.

ReferenceCitation: Gridelli C, Bennouna J, de Castro J, Dingemans AM, Griesinger F, Grossi F, Rossi A, Thatcher N, Wong EK, Langer C. Randomized phase IIIb trial evaluating the continuation of bevacizumab beyond disease progression in patients with advanced non-squamous non-small-cell lung cancer after first-line treatment with bevacizumab plus platinum-based chemotherapy: treatment rationale and protocol dynamics of the AvaALL (MO22097) trial. Clin Lung Cancer. 2011 Nov;12(6):407-11. doi: 10.1016/j.cllc.2011.05.002. Epub 2011 Jun 25.

location_facility: Chi De La Haute Saone De Vesoul; Pneumologie

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

location_facility: Eastern Ct Hema/Onco Assoc; Dept of Oncology

location_facility: Krankenhaus Der Stadt Wien Lainz; V. Medizinische Abt.

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

location_facility: Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont

location_facility: Heartland CCOP/Missouri Baptist Medical Center

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.

location_facility: SMZ - Baumgartner Hohe, Pavilion Leopold; 1.Interne Lungenabteilung, Onkologische Tagesklinik

location_facility: Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik

location_facility: National Hospital Organization Shikoku Cancer Center; Thoracic Oncology

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Cancer Care & Hematology; Specialists of Chicagoland

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

location_facility: National Cancer Center Hospital East; Thoracic Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Universitaetsklinikum des Saarlandes; Innere Medizin V

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

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

location_facility: Yokohama Municipal Citizen'S Hospital; Respiratory

location_facility: Cancer & Hematology Center of West Michigan

location_facility: Tawam Hospital; Medical Oncology Department

location_facility: Oncology Hematology Associates of Southwest Indiana

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

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

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Tufts Medical Center; Neely Cancer Center

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Antonius Ziekenhuis; Dept of Lung Diseases

location_facility: Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Ziekenhuis St Jansdal; Dept of Lung Diseases

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: National Hospital Organization Kyushu Cancer Center, Thoracic Oncology

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Hematology & Oncology Assoc; North Eastern Pennsylvania

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Signal Point Clinical; Research Center, LLC

location_facility: University of Tennessee Medical Center Cancer Institute

location_facility: University of Pennsylvania; Radiation Oncology

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC

location_facility: Centro Médico Abc the American British Cowdray Medical Center, I.A.P. - Centro de Cáncer

location_facility: Joliet Oncology Hematology Associates, Ltd.

location_facility: Inst. of Tb & Respiratory Diseases; Dep. of Oncology

location_facility: Lkh Natters; Abt. Für Atemwegs- & Lungenkrankheiten

location_facility: Stony Brook Univ Cancer Ctr; Medical Oncology Clinic

location_facility: Henry Ford Hospital; Hematology Oncology

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr

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

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: Citta Ospedaliera; Divisione Oncologia Medica

location_facility: American University of Beirut - Medical Center

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I

location_facility: East Valley Hematology ; Oncology Medical Group

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

location_facility: Catharina Ziekenhuis; Dept of Lung Diseases

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Fnsp Fdr Banska Bystrica; Dep of Pneumology&Ftizeology

location_facility: Hospital Central Sur de Alta Especialidad Petróleos Mexicanos

location_facility: College of Medicine & Sciences, Sultan Qaboos University Hospital

location_facility: Miyagi Cancer Center; Respiratory Medicine

location_facility: Centro de Estudos e Pesquisas Oncologicas - CESPO

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

location_facility: Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica

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

location_facility: Carolina Oncology Specialists, PA - Hickory

title: An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

location_country:
Germany
Italy
Slovakia
Argentina
Denmark
Japan
Brazil
Netherlands
Austria
Belgium
Lebanon
United States
Mexico
Spain
United Arab Emirates
Greece
Oman
France


title: A Registry to Collect Characteristics and Outcomes From Patients With Solid Tumors Profiled With a Next-Generation Sequencing Test (WAYFIND-R)

summary: WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour. The WAYFIND-R has three main overarching objectives: 1. To provide a platform to support the design and conduct of clinical and epidemiological research; 2. To develop an evidence-generation platform to better understand health outcomes and cancer care processes; and 3. To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may be granted access to individual patient-level data through the data sharing environment of the Registry.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Ireland
Poland
Argentina
Brazil
Thailand
Vietnam
Turkey
Chile
Canada
Serbia
France
Slovenia
Colombia
Portugal
Slovakia
India
Lebanon
Estonia
Philippines
Egypt
United Kingdom
Mexico
United Arab Emirates
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Israel

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Medicana International Atasehir Hospital

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Clínica Integral Internacional de Oncología S de RL de CV

location_facility: Universitätsklinikum Halle (Saale); Krukenberg- Krebszentrum Halle; onkologisches Zentrum

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology

location_facility: Centro de Cancer Pontificie Universidad Catolica de Chile

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: The American British Cowdray Hospital/ Hospital Abc; Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hôpital Franco-Britannique- Fondation Cognacq-Jay; Cancerologie

location_facility: HealthCare Global Enterprises Limited; Medical Oncology

location_facility: Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

location_facility: Centre Jean Perrin; Division De Recherche Clinique

location_facility: Indo-American Cancer Hospital & Research Center

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Manipal Hospital; Department of Oncology

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Special hospital for internal diseases Vesalius

location_facility: HM Sanchinarro ? CIOCC; Servicio de Oncologia

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: East Tallinn Central Hospital; Clinic of Internal Medicine

location_facility: Ac?badem Adana Hospital, Oncology Department

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Metropolitan Hospital Fourth Oncology Clinic

location_facility: Instituto Cancerologia Medellin; Clinica Las Americas

location_facility: Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Cebu Doctors' University Hospital; Research Office

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: Hôpital Privé de la Loire, Ramsay Saint Etienne

location_facility: Marien-Hospital Wesel; Klinik für Gastro., Onko. + Häma., Diabetologie und Rheumatologie

location_facility: HELIOS Klinikum Bad Saarow; Klinik Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: National Guard King Abdulaziz Medical City; Oncology

location_facility: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

location_facility: American University of Beirut - Medical Center

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology

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

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Katharinenhospital Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: International Medical Center; Oncology Department

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy

summary: This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy

status: Active, not recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Alterity Therapeutics

location_country:
Italy
New Zealand
United Kingdom
Australia
United States
France

location_facility: CHU de Bordeaux/Groupe Hospitalier Pellegrin

location_facility: CHU de Toulouse/Hôpital Pierre-Paul Riquet

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Columbia University Irving Medical Center

location_facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna

intervention_type: Drug


type: EudraCT Number

title: A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

summary: The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: AbbVie

sponsor_collaborators:
AbbVie
Idera Pharmaceuticals, Inc.

location_country:
Germany
France
Netherlands
United States
Spain
Israel

location_facility: Hospital Universitario de Fuenlabrada /ID# 214263

location_facility: Centre Antoine Lacassagne - Nice /ID# 215706

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197

location_facility: Vanderbilt Ingram Cancer Center /ID# 214040

location_facility: Barbara Ann Karmanos Cancer In /ID# 214050

location_facility: Roswell Park Comprehensive Cancer Center /ID# 215882

location_facility: Hospital Universitario 12 de Octubre /ID# 214198

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402

location_facility: The University of Chicago Medical Center /ID# 217196

location_facility: Hospital Universitario HM Sanchinarro /ID# 214110

location_facility: Universitaetsklinikum Erlangen /ID# 214196

location_facility: Hospital Clinic de Barcelona /ID# 214264

location_facility: The Chaim Sheba Medical Center /ID# 215229

location_facility: Hospital Clinico Universitario de Valencia /ID# 221401

location_facility: AP-HM - Hopital de la Timone /ID# 215657

location_facility: Gastroenterology Institute, Division of Medicine /ID# 215862

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214109

location_facility: Universitaetsklinikum Leipzig /ID# 214200

status_simplified: Completed


lead_sponsor: Takeda

summary:
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib.

The main aim of this study is to compare the number of participants on each treatment that show no signs of disease.

Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.

location_facility: University General Hospital of Athens Attikon

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: University of Kansas Medical Center Research Institute

location_facility: City Clinical Hospital named after Vikentiy Vikentyevich Veresaev

location_facility: National Research Center for Hematology, Dept. of Hematology/Oncology and BMT

location_facility: Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: University General Hospital of Patras Panagia I Voithia

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: HEMORIO Instituto Estadual de Hematologia

location_facility: Hanusch Krankenhaus Wiener Gebietskrankenkasse

location_facility: Institute of Hematology & Blood Diseases Hospital of CAMS & PUMC

location_facility: Instituto do Cancer do Estado de Sao Paulo

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurs

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation

location_facility: Centro di Ematologia Policlinico Umberto I Universita Sapienza di Roma

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: University Multiprofile Hospital for Active Treatment Saint Ivan Rilski

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Augusta University Georgia Cancer Center

location_facility: Fundacao Antonio Prudente - A.C.Camargo Cancer Center

location_facility: Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Universitaetsklinik Fuer Innere Medizin I

location_facility: Helsingin ja Uudenmaan sairaanhoitopiiri

location_facility: Center Hospitalier Universitaire d'Angers

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

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Uniwersytecki Szpital Kliniczny we Wroclawiu

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: The First Affiliated Hospital of Soochow University/Suzhou First People's Hospital

location_facility: Centre Hospitalier de Versailles Hopital Andre Mignot

title: A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

type: Other Identifier

type: Registry Identifier

source: euctr

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

location_country:
Finland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
United States
China
Italy
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation


title: A Phase 2, Open-Label Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

summary: The purpose of this study is to evaluate the percentage of participants with a response of very good partial response (VGPR) or better to IDd treatment.

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

location_country:
Poland
Netherlands
United States
Greece
Czechia
France

location_facility: University General Hospital of Patras Panagia I Voithia

location_facility: SCRI - Florida Cancer Specialists - Panhandle

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Onkologicka klinika Vseobecna fakultni nemocnice v Praze a 1

location_facility: Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: SCRI - Tennessee Oncology - Nashville - Centennial

location_facility: Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

summary: The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer [TNBC] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.

location_country:
Japan
United States
Spain
Taiwan
Puerto Rico
France

location_facility: Pan American Center for Oncology Trials, LLC /ID# 213809

location_facility: Hospital General Universitario Gregorio Maranon /ID# 205999

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 211500

location_facility: National Cancer Center Hospital East /ID# 214530

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 205996

location_facility: AP-HM - Hopital de la Timone /ID# 165036

location_facility: Moores Cancer Center at UC San Diego /ID# 201334

location_facility: University of Texas Southwestern Medical Center /ID# 201934

location_facility: National Cancer Center Hospital /ID# 214531

location_facility: Carolina BioOncology Institute /ID# 160786

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 208879

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 206973

location_facility: National Cheng Kung University Hospital /ID# 164002

location_facility: Hospital Clinico Universitario de Valencia /ID# 211499

location_facility: Virginia Cancer Specialists - Fairfax /ID# 160787

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 201342

location_facility: Taipei Medical University Hospital /ID# 164001

location_facility: National Taiwan University Hospital /ID# 164000

location_facility: South Texas Accelerated Research Therapeutics /ID# 160788


title: A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

acronym: ENDURANCE-5 6

summary: A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

ReferenceType: background

ReferenceCitation: Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2.

ReferenceType: derived

ReferenceCitation: Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
New Zealand
Singapore
Australia
Belgium
United States
Vietnam
South Africa
Canada
France

location_facility: Royal Brisbane and Women's Hospital /ID# 157025

location_facility: Zuckerberg San Francisco Gener /ID# 157040

location_facility: National University Hospital /ID# 156855

location_facility: Auckland Clinical Studies Ltd /ID# 157033

location_facility: National Hospital of Tropical Diseases /ID# 162282

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 157045


title: A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

summary: Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.

ReferenceCitation: Sarnaik AA, Hamid O, Khushalani NI, Lewis KD, Medina T, Kluger HM, Thomas SS, Domingo-Musibay E, Pavlick AC, Whitman ED, Martin-Algarra S, Corrie P, Curti BD, Olah J, Lutzky J, Weber JS, Larkin JMG, Shi W, Takamura T, Jagasia M, Qin H, Wu X, Chartier C, Graf Finckenstein F, Fardis M, Kirkwood JM, Chesney JA. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J Clin Oncol. 2021 Aug 20;39(24):2656-2666. doi: 10.1200/JCO.21.00612. Epub 2021 May 12. Erratum In: J Clin Oncol. 2021 Sep 10;39(26):2972.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Iovance Biotherapeutics, Inc.

location_country:
Germany
Italy
Hungary
United Kingdom
Switzerland
United States
Spain
France

location_facility: Providence Cancer Center Oncology and Hematology Care Clinic

location_facility: University of Florida Health Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The Angeles Clinic and Research Institute

location_facility: University of South Florida H. Lee Moffitt Cancer Center and Research Institute

location_facility: University of Pittsburgh Medical Center - Hillman Cancer Center

location_facility: HM Centro Integral Oncológico Clara Campal

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: University of California San Diego Moores Cancer Center

location_facility: University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology

location_facility: Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Consorci Hospital General Universitari de València

location_facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

location_facility: New York University Langone Medical Center

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

location_facility: Universitaetsklinikum Tuebingen (UKT) - Suedwestdeutschen Tumorzentrum - Zentrum für Neuroonkologie

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: Klinikum Rechts der Isar der Technischen Universität München

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie

intervention_type: Biological


summary: The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.

ReferenceCitation: Stodtmann S, Eckert D, Joshi R, Nuthalapati S, Ratajczak CK, Menon R, Mensing S, Xiong H. Exposure-Response Model With Time-Varying Predictors to Estimate the Effects of Veliparib in Combination With Carboplatin/Paclitaxel and as Monotherapy: Veliparib Phase 3 Study in BRCA-Mutated Advanced Breast Cancer (BROCADE3) Trial. J Clin Pharmacol. 2022 Oct;62(10):1236-1246. doi: 10.1002/jcph.2061. Epub 2022 May 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Ayoub JP, Wildiers H, Friedlander M, Arun BK, Han HS, Puhalla S, Shparyk Y, Jakobsen EH, Wu M, Bach BA, Feng D, Ratajczak CK, Maag D, Dieras V. Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: subgroup analyses by germline BRCA1/2 mutations and hormone receptor status from the phase-3 BROCADE3 trial. Ther Adv Med Oncol. 2021 Dec 9;13:17588359211059601. doi: 10.1177/17588359211059601. eCollection 2021.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
sdu.dk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;sdu.dk

publisher_dissemination: SAGE Publications

ReferenceCitation: Arun BK, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bell-McGuinn KM, Bach BA, Kundu MG, Ratajczak CK, Maag D, Dieras V. Efficacy and safety of first-line veliparib and carboplatin-paclitaxel in patients with HER2- advanced germline BRCA+ breast cancer: Subgroup analysis of a randomised clinical trial. Eur J Cancer. 2021 Sep;154:35-45. doi: 10.1016/j.ejca.2021.05.037. Epub 2021 Jul 6.

evidence: open (via crossref license)

repositories_concat: LIRIAS (KU Leuven)

publisher_dissemination: Elsevier

ReferenceCitation: Puhalla SL, Dieras V, Arun BK, Kaufman B, Wildiers H, Han HS, Ayoub JP, Stearns V, Yuan Y, Helsten T, Riley-Gillis B, Murphy E, Kundu MG, Wu M, Maag D, Ratajczak CK, Ramathal CY, Friedlander M. Relevance of Platinum-free Interval and BRCA Reversion Mutations for Veliparib Monotherapy after Progression on Carboplatin/Paclitaxel for gBRCA Advanced Breast Cancer (BROCADE3 Crossover). Clin Cancer Res. 2021 Sep 15;27(18):4983-4993. doi: 10.1158/1078-0432.CCR-21-0748. Epub 2021 Jun 15.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Dieras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palacova M, Park YH, Shparyk Y, Yanez E, Khandelwal N, Kundu MG, Dudley M, Ratajczak CK, Maag D, Arun BK. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1269-1282. doi: 10.1016/S1470-2045(20)30447-2. Epub 2020 Aug 27.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_normalized: HAL

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

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

location_facility: Nottingham University Hospitals NHS Trust /ID# 125340

location_facility: Instituto Nacional del Cancer /ID# 129343

location_facility: University Hospitals Bristol /ID# 128343

location_facility: Univ of Colorado Cancer Center /ID# 124983

location_facility: Hospital General Universitario Gregorio Maranon /ID# 124962

location_facility: Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 124887

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 124997

location_facility: Northwest Medical Specialties - Tacoma /ID# 125344

location_facility: Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728

location_facility: Centro de Estudios Clínicos Especializados /ID# 128680

location_facility: Centro Oncologico de Chihuahua /ID# 128679

location_facility: The Cancer Ctr at DeKalb Med C /ID# 125024

location_facility: Donetsk Regional Antitumor Ctr /ID# 124970

location_facility: Texas Health Physicians Group /ID# 137740

location_facility: Florida Cancer Specialists - East /ID# 125007

location_facility: Duplicate_Jewish General Hospital /ID# 124880

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948

location_facility: Linkoping University Hospital /ID# 126795

location_facility: University of Texas MD Anderson Cancer Center /ID# 125353

location_facility: National University Hospital /ID# 125315

location_facility: Medizinische Universitaet Graz /ID# 126450

location_facility: Duplicate_Flinders Centre for Innovation /ID# 127535

location_facility: Swedish Cancer Insititute - Ballard /ID# 131548

location_facility: The Chaim Sheba Medical Center /ID# 124918

location_facility: Yonsei University Health System Severance Hospital /ID# 125599

location_facility: Hospital Santa Creu i Sant Pau /ID# 124963

location_facility: Duplicate_Zala Megyei Korhaz /ID# 131341

location_facility: Sahlgrenska University Hospital /ID# 124965

location_facility: University of Arkansas for Medical Sciences /ID# 124992

location_facility: Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395

location_facility: Duplicate_Soroka University Medical Center /ID# 124917

location_facility: Swedish Cancer Institute - Edmonds /ID# 131549

location_facility: Swedish Cancer Institute - Issaquah /ID# 131534

location_facility: Haukeland University Hospital /ID# 150177

location_facility: Universitaetsklinik Heidelberg /ID# 126664

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337

location_facility: Townsville University Hospital /ID# 126731

location_facility: Bobruysk Interdistrict Onco. /ID# 137729

location_facility: Istanbul University Istanbul Medical Faculty /ID# 145144

location_facility: Univ of Mississippi Med Ctr,US /ID# 131352

location_facility: Wojewodzki Szpital Specjalistyczny /ID# 127258

location_facility: Cancer Research Collaboration /ID# 128860

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266

location_facility: Hospital Clinico Vina del Mar /ID# 130100

location_facility: Hematology and Oncology Assoc /ID# 130058

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510

location_facility: Washington University-School of Medicine /ID# 127575

location_facility: Duplicate_The Prince of Wales Hospital /ID# 124845

location_facility: Bezmi Alem Univ Med Fac Hosp /ID# 127901

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180

location_facility: Banner MD Anderson Cancer Ctr /ID# 125011

location_facility: Hacettepe University Faculty of Medicine /ID# 125336

location_facility: Spectrum Health Medical Group /ID# 133568

location_facility: Siberian State Medical University /ID# 127161

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259

location_facility: University of Vermont Medical Center /ID# 125350

location_facility: Duplicate_Karolinska Univ Sjukhuset /ID# 124964

location_facility: Maastricht Universitair Medisch Centrum /ID# 129068

location_facility: Universitair Ziekenhuis Antwerpen /ID# 124977

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 124972

location_facility: Southern Medical Day Care Centre /ID# 124844

location_facility: NorthShore University HealthSystem /ID# 124996

location_facility: Hospital Universitario Virgen de la Victoria /ID# 124961

location_facility: Spectrum Health Medical Group /ID# 148471

location_facility: University of Texas Southwestern Medical Center /ID# 124989

location_facility: University of Illinois - Chicago /ID# 127576

location_facility: Pauls Stradins Clinical University Hospital /ID# 125264

location_facility: Sverdlovsk Regional Oncology Dispensary /ID# 130950

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449

location_facility: Duplicate_Tampere University Hospital /ID# 124898

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999

location_facility: Centro di Riferimento Oncologico /ID# 126738

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263

location_facility: Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882

location_facility: Seoul National University Hospital /ID# 125600

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299

location_facility: Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943

location_facility: Belgorod Oncology Dispensary /ID# 129315

location_facility: Wojewodzki Szpital Zespolony /ID# 126998

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969

location_facility: Rutgers Cancer Institute of New Jersey /ID# 125017

location_facility: Vitebsk Regional Clinical Oncology Dispensary /ID# 125219

location_facility: Emory Midtown Infectious Disease Clinic /ID# 133192

location_facility: Universitair Ziekenhuis Leuven /ID# 124980

location_facility: Altay Regional Oncological Dispesary /ID# 127160

location_facility: Oregon Health and Science University /ID# 134229

location_facility: Norrlands University hospital /ID# 124967

location_facility: Zaporizhzhia Med. Academy MOH /ID# 129800

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 126185

location_facility: Duplicate_Akdeniz University Medical Fac /ID# 125339

location_facility: California Cancer Associates for Research & Excellence (cCARE) /ID# 136078

location_facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945

location_facility: Ad-Vance Medical Research, LLC /ID# 126043

location_facility: Instituto Nacional de Cancerología INCAN /ID# 128676

location_facility: Universitaetsklinimum Tuebingen /ID# 129968

location_facility: The Royal Melbourne Hospital /ID# 124846

location_facility: Netcare Oncology Intervent Ctr /ID# 125320

location_facility: Riga East Clinical University Hospital /ID# 125265

location_facility: Centrum Onkologii Lukaszczyka /ID# 124938

location_facility: Centro Oncologico Riojano Integral /ID# 127938

location_facility: Duplicate_archangel Clinical Oncology /ID# 126031

location_facility: IEO -Istituto Europeo di Oncologia /ID# 125260

location_facility: Tel Aviv Sourasky Medical Center /ID# 130276

location_facility: Korea University Anam Hospital /ID# 128968

location_facility: CHU UCL Namur - Sainte Elisabeth /ID# 124979

location_facility: Hospital Universitario HM Sanchinarro /ID# 124960

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256

location_facility: Instituto de Oncoloia de Rosario /ID# 127157

location_facility: Assaf Harofeh Medical Center /ID# 124915

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974

location_facility: Universitair Medisch Centrum Groningen /ID# 129069

location_facility: Hospital Clinico Universitario de Valencia /ID# 124959

location_facility: Centro Medico Imbanaco de Cali /ID# 126656

location_facility: Regional Oncology Dispensary /ID# 125936

location_facility: Volgograd Regional Clinical Oncology Dispensary /ID# 124952

location_facility: Nebraska Hematology Oncology /ID# 132711

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 125342

location_facility: Hospital Clinico Vina del Mar /ID# 148502

location_facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 126511

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911

location_facility: Sandton Oncology Medical Group PTY Ltd /ID# 125323

location_facility: Lehigh Valley Health Network /ID# 130059

location_facility: Hull University Teaching Hospitals NHS Trust /ID# 133030

location_facility: Gastroenterology Institute, Division of Medicine /ID# 124919

location_facility: Institut Curie - site CLCC René Huguenin /ID# 124904

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508

location_facility: MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939

location_facility: East Tallinn Central Hospital /ID# 126475

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298

location_facility: Cancercare Outeniqua Oncology Centre /ID# 125319

location_facility: Moores Cancer Center at UC San Diego /ID# 124991

location_facility: ME Kryviy Rih Oncology Dispensary /ID# 129806

location_facility: University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499

location_facility: Medical Oncology Ctr Rosebank /ID# 125322

location_facility: National Taiwan University Hospital /ID# 125324

location_facility: Duplicate_Helsinki Univ Central Hospital /ID# 124897

location_facility: Administradora del Country_S.A-Clinica Del Country /ID# 125255

location_facility: Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975

location_facility: Lehigh Valley Hosp/Muhlenberg /ID# 130277

location_facility: COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839

location_facility: Medizinische Universitaet Wien /ID# 126184

title: A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

location_country:
Finland
Germany
Poland
Argentina
Australia
Turkey
Chile
Czechia
Canada
France
Belarus
Lithuania
Colombia
Portugal
Hungary
Denmark
United States
Latvia
Ukraine
Romania
Belgium
Estonia
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


acronym: SUMMIT

lead_sponsor: Puma Biotechnology, Inc.

summary: This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.

ReferenceCitation: Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE Jr, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature. 2018 Feb 8;554(7691):189-194. doi: 10.1038/nature25475. Epub 2018 Jan 31. Erratum In: Nature. 2019 Feb;566(7745):E11-E12.

ReferenceCitation: Smyth LM, Piha-Paul SA, Won HH, Schram AM, Saura C, Loi S, Lu J, Shapiro GI, Juric D, Mayer IA, Arteaga CL, de la Fuente MI, Brufksy AM, Spanggaard I, Mau-Sorensen M, Arnedos M, Moreno V, Boni V, Sohn J, Schwartzberg LS, Gonzalez-Farre X, Cervantes A, Bidard FC, Gorelick AN, Lanman RB, Nagy RJ, Ulaner GA, Chandarlapaty S, Jhaveri K, Gavrila EI, Zimel C, Selcuklu SD, Melcer M, Samoila A, Cai Y, Scaltriti M, Mann G, Xu F, Eli LD, Dujka M, Lalani AS, Bryce R, Baselga J, Taylor BS, Solit DB, Meric-Bernstam F, Hyman DM. Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer. Cancer Discov. 2020 Feb;10(2):198-213. doi: 10.1158/2159-8290.CD-19-0966. Epub 2019 Dec 5.

ReferenceCitation: Shishido SN, Masson R, Xu L, Welter L, Prabakar RK, D' Souza A, Spicer D, Kang I, Jayachandran P, Hicks J, Lu J, Kuhn P. Disease characterization in liquid biopsy from HER2-mutated, non-amplified metastatic breast cancer patients treated with neratinib. NPJ Breast Cancer. 2022 Feb 18;8(1):22. doi: 10.1038/s41523-022-00390-5.

license: cc-by

license_normalized: cc-by

ReferenceCitation: Oaknin A, Friedman CF, Roman LD, D'Souza A, Brana I, Bidard FC, Goldman J, Alvarez EA, Boni V, ElNaggar AC, Passalacqua R, Do KTM, Santin AD, Keyvanjah K, Xu F, Eli LD, Lalani AS, Bryce RP, Hyman DM, Meric-Bernstam F, Solit DB, Monk BJ. Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial. Gynecol Oncol. 2020 Oct;159(1):150-156. doi: 10.1016/j.ygyno.2020.07.025. Epub 2020 Jul 25.

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

repository_institution: California Digital Library - eScholarship

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Ulaner GA, Saura C, Piha-Paul SA, Mayer I, Quinn D, Jhaveri K, Stone B, Shahin S, Mann G, Dujka M, Bryce R, Meric-Bernstam F, Solit DB, Hyman DM. Impact of FDG PET Imaging for Expanding Patient Eligibility and Measuring Treatment Response in a Genome-Driven Basket Trial of the Pan-HER Kinase Inhibitor, Neratinib. Clin Cancer Res. 2019 Dec 15;25(24):7381-7387. doi: 10.1158/1078-0432.CCR-19-1658. Epub 2019 Sep 23.

unpaywall_oa_status: bronze

ReferenceCitation: Hanker AB, Brewer MR, Sheehan JH, Koch JP, Sliwoski GR, Nagy R, Lanman R, Berger MF, Hyman DM, Solit DB, He J, Miller V, Cutler RE Jr, Lalani AS, Cross D, Lovly CM, Meiler J, Arteaga CL. An Acquired HER2T798I Gatekeeper Mutation Induces Resistance to Neratinib in a Patient with HER2 Mutant-Driven Breast Cancer. Cancer Discov. 2017 Jun;7(6):575-585. doi: 10.1158/2159-8290.CD-16-1431. Epub 2017 Mar 8. Erratum In: Cancer Discov. 2019 Feb;9(2):303.

evidence: oa repository (via page says license)

version: submittedVersion

repositories_concat: PubMed Central;aacr.figshare.com

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: AOU Citta della Salute e della Scienza di Torino

location_facility: Hospital Universitario Madrid Sanchinarro (START Madrid)

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: Davidoff Cancer Center, Rabin Medical Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Gundersen Center for Cancer and Blood Disorders

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Yonsei University Health System, Serverance Hospital

location_facility: UPMC Magee-Woman's Hospital, Women's Cancer Center

title: An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

location_country:
Ireland
Italy
Israel
United Kingdom
Denmark
Australia
Belgium
United States
Korea, Republic of
Spain
Canada
Serbia
France


summary: This was an open-label, multicenter, global study to determine the efficacy of ABT-199 (Venetoclax) monotherapy in participants with relapsed/refractory (R/R) or previously untreated chronic lymphocytic leukemia (CLL) harboring 17p deletion.

ReferenceCitation: Stilgenbauer S, Eichhorst B, Schetelig J, Coutre S, Seymour JF, Munir T, Puvvada SD, Wendtner CM, Roberts AW, Jurczak W, Mulligan SP, Bottcher S, Mobasher M, Zhu M, Desai M, Chyla B, Verdugo M, Enschede SH, Cerri E, Humerickhouse R, Gordon G, Hallek M, Wierda WG. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016 Jun;17(6):768-778. doi: 10.1016/S1470-2045(16)30019-5. Epub 2016 May 10.

ReferenceCitation: Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25.

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

ReferenceCitation: Stilgenbauer S, Eichhorst B, Schetelig J, Hillmen P, Seymour JF, Coutre S, Jurczak W, Mulligan SP, Schuh A, Assouline S, Wendtner CM, Roberts AW, Davids MS, Bloehdorn J, Munir T, Bottcher S, Zhou L, Salem AH, Desai M, Chyla B, Arzt J, Kim SY, Verdugo M, Gordon G, Hallek M, Wierda WG. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial. J Clin Oncol. 2018 Jul 1;36(19):1973-1980. doi: 10.1200/JCO.2017.76.6840. Epub 2018 May 1. Erratum In: J Clin Oncol. 2019 Sep 1;37(25):2299.

sponsor_collaborators:
AbbVie
Genentech, Inc.

location_facility: The Royal Bournemouth Hospital /ID# 118975

location_facility: University of Texas MD Anderson Cancer Center /ID# 92521

location_facility: Royal Liverpool and Broadgreen /ID# 98860

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 113256

location_facility: Northwestern University Feinberg School of Medicine /ID# 92499

location_facility: Universitaetsmedizin Goettingen /ID# 113258

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 113236

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 98849

location_facility: Columbia Univ Medical Center /ID# 103835

location_facility: Stanford University School of Med /ID# 105117

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 98848

location_facility: University of Arizona Cancer Center - North Campus /ID# 96748

location_facility: The University of Chicago Medical Center /ID# 96960

location_facility: Universitaetsklinik Heidelberg /ID# 98845

location_facility: John Fawkner Private Hospital /ID# 98835

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 113235

location_facility: Rutgers Cancer Institute of New Jersey /ID# 92513

location_facility: St Bartholomew's Hospital, Bar /ID# 98862

location_facility: St. James University Hospital /ID# 98863

location_facility: King's College Hospital NHS Foundation Trust /ID# 119975

location_facility: Duplicate_Jewish General Hospital /ID# 99476

location_facility: Universitaetsklinikum Freiburg /ID# 113276

location_facility: Moore UC San Diego Cancer Center /ID# 91793

location_facility: Georgetown University Hospital /ID# 96954

title: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion

location_country:
Germany
Poland
United Kingdom
Australia
United States
Canada
France


title: A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

summary: Study 849-017 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation

lead_sponsor: Mirati Therapeutics Inc.

location_country:
United States
Spain
Poland
France

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Institut de Cancérologie de l'Ouest - Angers - Site Paul Papin

location_facility: MemorialCare - OC Blood and Cancer Center

location_facility: USOR - Rocky Mountain Cancer Centers - Denver - Rose Medical Center Campus

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Hospital Universitario Puerta de Hierro De Majadahonda

location_facility: UKCC - Westwood/Richard and Annette Bloch Cancer Care Pavilion

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Virgen De La Macarena

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: MemorialCare - Orange Coast Medical Center

location_facility: Hematology Oncology Associates of CNY, PC


title: CLARIFY: Autosomal Dominant Hypocalcemia Types 1 And 2 (ADH1/2) Disease Monitoring Study (DMS)

summary: A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

time_perspective: Other

ipd_sharing: Undecided

lead_sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company

location_country:
Italy
Portugal
United Kingdom
Denmark
Australia
Netherlands
Belgium
United States
Canada
France

location_facility: University of California, San Francisco (UCSF) - Benioff Children's Hospital - Oakland

location_facility: Departement d'Endocrinologie et Diabetes pour Enfants - AP-HP Hopital Bicetre

location_facility: Indiana University (IU) School of Medicine - University Hospital

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: Ohio State University Medical Center (OSUMC)

location_facility: Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

location_facility: The Diabetes & Thyroid Center of Fort Worth (DTC)


title: An Observational, Longitudinal, Prospective, Long-Term Registry Of Patients With Hypophosphatasia (HPP)

summary: In this prospective, observational, long term registry patients of all ages with a diagnosis of hypophosphatasia (HPP) are followed at participating sites in multiple countries.

status: Enrolling by invitation

ReferenceCitation: Seefried L, Dahir K, Petryk A, Hogler W, Linglart A, Martos-Moreno GA, Ozono K, Fang S, Rockman-Greenberg C, Kishnani PS. Burden of Illness in Adults With Hypophosphatasia: Data From the Global Hypophosphatasia Patient Registry. J Bone Miner Res. 2020 Nov;35(11):2171-2178. doi: 10.1002/jbmr.4130. Epub 2020 Aug 10.

repository_institution: Würzburg University - Online Publication Service of Würzburg University

ReferenceCitation: Hogler W, Langman C, Gomes da Silva H, Fang S, Linglart A, Ozono K, Petryk A, Rockman-Greenberg C, Seefried L, Kishnani PS. Diagnostic delay is common among patients with hypophosphatasia: initial findings from a longitudinal, prospective, global registry. BMC Musculoskelet Disord. 2019 Feb 14;20(1):80. doi: 10.1186/s12891-019-2420-8.

repository_institution: University of Manitoba - Mspace

repositories_concat: PubMed Central;mspace.lib.umanitoba.ca

repositories_institution:
PubMed Central - Europe PMC
University of Manitoba - Mspace

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
United States
Saudi Arabia
Spain
Canada
Russian Federation
France

status_simplified: Unknown


title: A Phase 1/2 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma.

The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.

ReferenceCitation: Kumar S, Kaufman JL, Gasparetto C, Mikhael J, Vij R, Pegourie B, Benboubker L, Facon T, Amiot M, Moreau P, Punnoose EA, Alzate S, Dunbar M, Xu T, Agarwal SK, Enschede SH, Leverson JD, Ross JA, Maciag PC, Verdugo M, Touzeau C. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma. Blood. 2017 Nov 30;130(22):2401-2409. doi: 10.1182/blood-2017-06-788786. Epub 2017 Oct 10.

oa_host_type: publisher

location_country:
United States
Norway
Belgium
France

location_facility: Duplicate_CHU Grenoble - Hopital Michallon /ID# 126658

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 170007

location_facility: Swedish Cancer Institute - Edmonds /ID# 170006

location_facility: University of Nebraska Medical Center /ID# 169158

location_facility: Baylor University Medical Ctr. /ID# 170056

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 200246

location_facility: University of Arkansas for Medical Sciences /ID# 170002

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 74995

location_facility: University Hospitals - Seidman Cancer Center /ID# 204502

location_facility: Duplicate_University Hospital Leuven /ID# 170715

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 75033

location_facility: Medical College of Wisconsin /ID# 205229

location_facility: Emory University, Winship Cancer Institute /ID# 74993

location_facility: Washington University-School of Medicine /ID# 76094

location_facility: CHRU Tours - Hopital Bretonneau /ID# 126639


acronym: NEFERTT

summary: This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

ReferenceCitation: Awada A, Colomer R, Inoue K, Bondarenko I, Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, Goswami C, Deo S, Bose R, Wong A, Xu F, Yao B, Bryce R, Carey LA. Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial. JAMA Oncol. 2016 Dec 1;2(12):1557-1564. doi: 10.1001/jamaoncol.2016.0237.

location_facility: Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale

location_facility: Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii

location_facility: Samaritan Hematology and Oncology Consultants

location_facility: National Hospital Organization Beppu Medical Center

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont

location_facility: CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil

location_facility: Tazuke Kofukai Medical Research Institute Kitano Hospital

location_facility: Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital

location_facility: Chang Gung Medical Foundation, Linkou Branch

location_facility: Hakuaikai Medical Corporation Sagara Hospital

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

location_facility: Centre Hospitalier Régional de Trois-Rivières

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Rigshospitalet, Copenhagen, Onkologisk Klinik

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: Southern Medical University Nanfang Hospital

location_facility: Gaston Hematology and Oncology Associates

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Kobe City Medical Center General Hospital

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos

location_facility: Spital STS AG Onkologiezentrum Thun - Berner Oberland

location_facility: Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment

location_facility: Kantonsspital Winterthur Medizinische Onkologie

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Piejuras Hospital, Liepajas Oncological Clinic

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Hematology Oncology Associates of Treasure Coast

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă

location_facility: Ospedale San Giovanni Battista-Molinette

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Kurume Daiichi Social Insurance Hospital

location_facility: Hospital of Lithuanian University of Health sciences

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary

location_facility: North Broward Medical Center Cancer Center

location_facility: National Hospital Organization Mito Medical Center

location_facility: S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

location_facility: Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme

location_facility: District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD

location_facility: Meenakshi Mission Hospital and Research Centre

location_facility: The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials

location_facility: National University Hospital, National Cancer Institute

location_facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

location_facility: Groupe Hospitalier Paris Saint Joseph, Oncologie medicale

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD

location_facility: Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi

location_facility: Yonsei University Health System Severance Hospital

location_facility: Charleston Area Medical Center, Health, Education, and Research Institute

location_facility: Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser

location_facility: Kaposi Mor Oktato Korhoz Onkologiai Centrum

location_facility: Palm Beach Institute of Hematology and Oncology

location_facility: Semmelweis Egyetem Radiologiai és Onkoterapias Klinika

location_facility: Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil

location_facility: Szegedi Tudomanyegyetem Onkoterapias Klinika

location_facility: Centre Leon Berard Departement de Cancerologie Medicale

location_facility: National Institute of Cancer Department of Conseravtive Methods of Treatment

location_facility: N.N. Aleksandrov National Cancer Center of Belarus

location_facility: Service d'Oncologie et de Radiotherapie, Polyclinique Francheville

location_facility: Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas

location_facility: Pauls Stradiņš Clinical University Hospital

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Policlinico di Modena Oncologia ed Ematologia

location_facility: Complejo Hospitalario Universitario Santiago de Compostela

location_facility: Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie

location_facility: Institution of Healthcare Grodno Regional Clinical Hospital

location_facility: University of Witwatersrand Oncology, Donald Gordon Medical Centre

location_facility: Institution Gomel Regional Clinical Oncology Dispensary

location_facility: Clinical Hospital Osijek, Department of Radiotherapy and Oncology

location_facility: State Oncological Regional Treatment and Diagnostic Center

location_facility: Hospital da Luz Servico de Oncologia Medica

title: A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer

location_country:
Germany
Poland
Bahamas
Australia
Japan
Malta
Turkey
Croatia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Israel


acronym: FIGHT

lead_sponsor: Five Prime Therapeutics, Inc.

summary: The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.

ReferenceCitation: Wainberg ZA, Enzinger PC, Kang YK, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Borg C, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Collins H, Mitra S, Yang Y, Catenacci DVT, Lee KW. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022 Nov;23(11):1430-1440. doi: 10.1016/S1470-2045(22)00603-9. Epub 2022 Oct 14.

ReferenceCitation: Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.

sponsor_collaborators:
Five Prime Therapeutics, Inc.
Zai Lab (Shanghai) Co., Ltd.

location_facility: Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University of Pecs, Clinic of Oncotherapy

location_facility: Hyogo College of Medicine College Hospital

location_facility: Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz

location_facility: Centro Hospitalar Universitario do Porto E.P.E

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo

location_facility: Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine

location_facility: Josephine Ford Cancer Center-Henry Ford Cancer Center

location_facility: Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet

location_facility: UCLA Medical Centre - Santa Monica Hematology and Oncology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

location_facility: Azienda Sanitaria Universitaria Integrata de Udine

location_facility: Azienda Socio-Sanitaria Territoriale di Cremona

location_facility: Institut Catala d'Oncologia - Hospital Doctor Josep Trueta

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

location_facility: Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie

location_facility: Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago

location_facility: SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii

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

location_facility: Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut

location_facility: Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center

location_facility: Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin

location_facility: ASST della Valtellina e dell'Alto Lario - PO di Sondrio

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Ankara Oncology Education and Research Hospital

location_facility: Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala

location_facility: Westchester Institute For Treatment Of Cancer & Blood Disorders

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Sino Japanese Friendship Hospital of Jilin University

location_facility: Hopital Nord France Comte - Site Le Mittan

location_facility: Istanbul Madeniyet Universitesi Tip Fakultesi

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Unidade Local de Saude de Matosinhos EPE

location_facility: Seoul National University Bundang Hospital

location_facility: Institutul Clinic Fundeni - Clinica Pediatrie

location_facility: Xiangya Hospital of Central South University

location_facility: Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Ondokuz Mayis University Medicine Faculty

location_facility: Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej

location_facility: Hospital Duran I Reynals - Instituto Catalan de Oncologia

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Faculty of Medicine, Chulalongkorn University

location_facility: St. Luke's Physician Group - St. Luke's Cancer Care Associates

location_facility: Harbin Medical University Cancer Hopsital

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Servizio Oncologia Medica ed Ematologia, AOU dell'Universita

location_facility: Fondazione IRCSS Casa Sollievo Della Sofferenza

location_facility: Centro Hospitalar de Entre o Douro e Vouga EPE

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

location_facility: Centre de Radiotherapie - Clinique Sainte Anne

location_facility: Summit Medical Group. Morristown Oncology

location_facility: Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi

location_facility: Faculty of Medicine, Prince of Sonkla University

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina

location_facility: Chungnam National University Hospital (CNUH)

location_facility: Cukurova University Faculty of Medicine Paediatric Nephrology

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii

location_facility: Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung

location_facility: Universitatsmedizin Manheim, II. Medizinische Klinik

title: FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1

location_country:
Germany
Italy
Poland
Portugal
Hungary
United Kingdom
Romania
Australia
Japan
Belgium
United States
China
Korea, Republic of
Spain
Thailand
Turkey
Taiwan
France


title: Assessment of Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home: Multicentre Randomised Cluster Trial.

acronym: INR-CAP

summary: This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. The population consists of frail elderly patients for whom Anti-Vitamin K treatments are frequent, and who are consequently more prone to embolic and hemorrhagic complications.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Nîmes University Hospital, Place du Pr. Debré

intervention_type: Device

lead_sponsor_type: academique

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU NIMES

type_etablissement: CH

acronyme: INR-Cap

titre: Évaluation d'une stratégie de surveillance hebdomadaire de l'INR par ponction capillaire (INRc) versus la surveillance mensuelle par INR veineux (INRv) chez des patients âgés en EHPAD : Essai multicentrique randomisé en clusters

discipline_principale: organisation des soins

nom_porteur: Costa

prenom_porteur: David


title: A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects

acronym: FLAMINGO

summary: This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study.

ReferenceCitation: Molina JM, Clotet B, van Lunzen J, Lazzarin A, Cavassini M, Henry K, Kulagin V, Givens N, de Oliveira CF, Brennan C; FLAMINGO study team. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015 Apr;2(4):e127-36. doi: 10.1016/S2352-3018(15)00027-2. Epub 2015 Mar 10. Erratum In: Lancet HIV. 2015 Apr;2(4):e126.

ReferenceCitation: Clotet B, Feinberg J, van Lunzen J, Khuong-Josses MA, Antinori A, Dumitru I, Pokrovskiy V, Fehr J, Ortiz R, Saag M, Harris J, Brennan C, Fujiwara T, Min S; ING114915 Study Team. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014 Jun 28;383(9936):2222-31. doi: 10.1016/S0140-6736(14)60084-2. Epub 2014 Apr 1. Erratum In: Lancet. 2015 Jun 27;385(9987):2576.

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
GlaxoSmithKline

location_country:
Germany
Italy
Romania
Switzerland
United States
Spain
Puerto Rico
Russian Federation
France


title: An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients With Advanced HIV Disease

acronym: LAPTOP

summary:
The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'.

There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future.

The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV:

The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®.

The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®.

The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part.

In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters.

To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.

ReferenceCitation: DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

ReferenceCitation: Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.

ReferenceCitation: Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutierrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Sax et al. Phase 3 Randomized, Controlled, Clinical Trial of Bictegravir Coformulated With FTC/TAF in a Fixed-Dose Combination vs Dolutegravir + FTC/TAF in Treatment-Naïve HIV-1-Positive Adults: Week 48 Results. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017

ReferenceCitation: Gallant et al. A phase 3 randomized controlled clinical trial of bictegravir in a fixed dose combination, B/F/TAF, vs ABC/DTG/3TC in treatment-naïve adults at week 48. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017. MOAB0105LB

ReferenceCitation: Camoni L, Raimondo M, Regine V, Salfa MC, Suligoi B; regional representatives of the HIV Surveillance System. Late presenters among persons with a new HIV diagnosis in Italy, 2010-2011. BMC Public Health. 2013 Mar 27;13:281. doi: 10.1186/1471-2458-13-281.

ReferenceCitation: Montlahuc C, Guiguet M, Abgrall S, Daneluzzi V, de Salvador F, Launay O, Martinez V, Partisani M, Pradier C, Rouveix E, Valin N, Grabar S, Costagliola D; French Hospital Database ANRS CO4 cohort. Impact of late presentation on the risk of death among HIV-infected people in France (2003-2009). J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):197-203. doi: 10.1097/QAI.0b013e31829cfbfa.

ReferenceCitation: Antinori A, Coenen T, Costagiola D, Dedes N, Ellefson M, Gatell J, Girardi E, Johnson M, Kirk O, Lundgren J, Mocroft A, D'Arminio Monforte A, Phillips A, Raben D, Rockstroh JK, Sabin C, Sonnerborg A, De Wolf F; European Late Presenter Consensus Working Group. Late presentation of HIV infection: a consensus definition. HIV Med. 2011 Jan;12(1):61-4. doi: 10.1111/j.1468-1293.2010.00857.x.

ReferenceCitation: Raffetti E, Postorino MC, Castelli F, Casari S, Castelnuovo F, Maggiolo F, Di Filippo E, D'Avino A, Gori A, Ladisa N, Di Pietro M, Sighinolfi L, Zacchi F, Torti C. The risk of late or advanced presentation of HIV infected patients is still high, associated factors evolve but impact on overall mortality is vanishing over calendar years: results from the Italian MASTER Cohort. BMC Public Health. 2016 Aug 25;16(1):878. doi: 10.1186/s12889-016-3477-z.

ReferenceCitation: Sobrino-Vegas P, Rodriguez-Urrego J, Berenguer J, Caro-Murillo AM, Blanco JR, Viciana P, Moreno S, Bernardino I, del Amo J; CoRIS. Educational gradient in HIV diagnosis delay, mortality, antiretroviral treatment initiation and response in a country with universal health care. Antivir Ther. 2012;17(1):1-8. doi: 10.3851/IMP1939.

ReferenceCitation: Late presenters working group in COHERE in EuroCoord; Mocroft A, Lundgren J, Antinori A, Monforte Ad, Brannstrom J, Bonnet F, Brockmeyer N, Casabona J, Castagna A, Costagliola D, De Wit S, Fatkenheuer G, Furrer H, Jadand C, Johnson A, Lazanas M, Leport C, Moreno S, Mussini C, Obel N, Post F, Reiss P, Sabin C, Skaletz-Rorowski A, Suarez-Loano I, Torti C, Warszawski J, Wittkop L, Zangerle R, Chene G, Raben D, Kirk O. Late presentation for HIV care across Europe: update from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) study, 2010 to 2013. Euro Surveill. 2015;20(47). doi: 10.2807/1560-7917.ES.2015.20.47.30070.

ReferenceCitation: Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.

ReferenceCitation: Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911.

ReferenceCitation: Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.

ReferenceCitation: Mussini C, Manzardo C, Johnson M, Monforte Ad, Uberti-Foppa C, Antinori A, Gill MJ, Sighinolfi L, Borghi V, Lazzarin A, Miro JM, Sabin C; Late Presenter Investigators. Patients presenting with AIDS in the HAART era: a collaborative cohort analysis. AIDS. 2008 Nov 30;22(18):2461-9. doi: 10.1097/QAD.0b013e328314b5f1.

ReferenceCitation: Demarest J, Underwood M, St Clair M, Dorey D, Brown D, Zolopa A. Short Communication: Dolutegravir-Based Regimens Are Active in Integrase Strand Transfer Inhibitor-Naive Patients with Nucleoside Reverse Transcriptase Inhibitor Resistance. AIDS Res Hum Retroviruses. 2018 Apr;34(4):343-346. doi: 10.1089/AID.2017.0184. Epub 2018 Mar 22.

ReferenceCitation: Wijting I et al. Integrase Inhibitors are an Independent Risk Factor for IRIS: An ATHENA Cohort Study. Conference on Retroviruses and Opportunistic Infections. February 2017. Seattle, WA, USA. Abstract 731.

ReferenceCitation: Dutertre M et al. Initiation of ART Based on Integrase Inhibitors Increases the Risk of IRIS. Conference on Retroviruses and Opportunistic Infections. February 2017. Seattle, WA, USA. Abstract 732.

ReferenceCitation: Psichogiou M, Basoulis D, Tsikala-Vafea M, Vlachos S, Kapelios CJ, Daikos GL. Integrase Strand Transfer Inhibitors and the Emergence of Immune Reconstitution Inflammatory Syndrome (IRIS). Curr HIV Res. 2017;15(6):405-410. doi: 10.2174/1570162X15666171122155708.

ReferenceCitation: Hill AM, Mitchell N, Hughes S, Pozniak AL. Risks of cardiovascular or central nervous system adverse events and immune reconstitution inflammatory syndrome, for dolutegravir versus other antiretrovirals: meta-analysis of randomized trials. Curr Opin HIV AIDS. 2018 Mar;13(2):102-111. doi: 10.1097/COH.0000000000000445.

ReferenceCitation: Paredes R, Tzou PL, van Zyl G, Barrow G, Camacho R, Carmona S, Grant PM, Gupta RK, Hamers RL, Harrigan PR, Jordan MR, Kantor R, Katzenstein DA, Kuritzkes DR, Maldarelli F, Otelea D, Wallis CL, Schapiro JM, Shafer RW. Collaborative update of a rule-based expert system for HIV-1 genotypic resistance test interpretation. PLoS One. 2017 Jul 28;12(7):e0181357. doi: 10.1371/journal.pone.0181357. eCollection 2017.

ReferenceCitation: Levy et al. ANRS 146 - GeSIDA 7211 OPTIMAL phase III trial: maraviroc plus cART in advanced HIV-1-infected individuals. Journal Of The International Aids Society (Vol. 20, Pp. 6-7)

ReferenceCitation: Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabie A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10.

publisher_dissemination: Oxford University Press

lead_sponsor: NEAT ID Foundation

collaborators:
Gilead Sciences
Janssen Pharmaceuticals

sponsor_collaborators:
NEAT ID Foundation
Gilead Sciences
Janssen Pharmaceuticals

location_country:
Germany
Ireland
Italy
United Kingdom
Belgium
Spain
France

location_facility: Groupe Hospitalier Sud Ile-de-France (Melun)

location_facility: University Hospital Klinikum rechts der Isar der TUM

location_facility: Hospital General Universitatrio de Elche

location_facility: Medizinische Klinik und Poliklinik Universitätsklinikum Bonn

location_facility: Klinikum rechts der Isar der Technischen Universität München