title: A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.

summary: The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

status: Unknown status

study_type: Observational

time_perspective: Prospective

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 43
Hospital Saint Antoine
Site 32
Site 25
Centre François Baclesse
Site 22
Centre Hospitalier Universitaire
Site 14
Site 27
Centre Hospitalier Les Oudairies
Centre Hospitalier du Morvan
Site 11
Site 04
Centre Hospitalier Lyon Sud
Hôpital Yves Le Foll
Site 01
Site 06
Centre Hospitalier René Dubos
Site 33
Site 17
Site 07
Hospital du Cluzeau
Centre Hospitalier Régional
Site 05

status_simplified: Unknown


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.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

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, Oláh 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.

lead_sponsor: Iovance Biotherapeutics, Inc.

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

location_facility: University of Florida Health Cancer Center

location_facility: The Angeles Clinic and Research Institute

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: University of Pittsburgh Medical Center - Hillman Cancer Center

location_facility: Consorci Hospital General Universitari de València

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

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Providence Cancer Center Oncology and Hematology Care Clinic

location_facility: Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: University of California San Diego Moores Cancer Center

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

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

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: New York University Langone Medical Center

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

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: HM Centro Integral Oncológico Clara Campal

location_facility: Klinikum Rechts der Isar der Technischen Universität München

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

location_facility: Centro di Riferimento Oncologico di Aviano

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

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial

summary: The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.

lead_sponsor: University Hospital, Caen

location_facility:
Mignot Hospital
Clinique St André
Hospital Nord Mayenne
Poitiers University Hospital
Reims University Hospital
Hospital La Roche sur Yon
Polyclinique de Riaumont
Clinique St Jean Languedoc
Clinique St Jean
Clinique St Marie
Hospital Alençon
Caen University hospital
Clinique du Cèdre
Hospital Val D'ariège
Hospital University Lille
Hospital University Angers
Montluçon Hospital

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


ipd_sharing: Yes

intervention_type: Drug

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

lead_sponsor: AbbVie

type: EudraCT Number

source: euctr

study_start_date_type: Actual

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.

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, Diéras 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.

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.

ReferenceCitation: Puhalla SL, Diéras 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.

ReferenceCitation: Diéras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palácová M, Park YH, Shparyk Y, Yañez 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.

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

location_facility: Centro Oncologico Riojano Integral /ID# 127938

location_facility: Duplicate_Zala Megyei Korhaz /ID# 131341

location_facility: University of Illinois - Chicago /ID# 127576

location_facility: Centro Medico Imbanaco de Cali /ID# 126656

location_facility: Lehigh Valley Hosp/Muhlenberg /ID# 130277

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

location_facility: Spectrum Health Medical Group /ID# 133568

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 124887

location_facility: Maastricht Universitair Medisch Centrum /ID# 129068

location_facility: Tel Aviv Sourasky Medical Center /ID# 130276

location_facility: Northwest Medical Specialties - Tacoma /ID# 125344

location_facility: Belgorod Oncology Dispensary /ID# 129315

location_facility: Oregon Health and Science University /ID# 134229

location_facility: Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882

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

location_facility: Lehigh Valley Health Network /ID# 130059

location_facility: Hospital Clinico Universitario de Valencia /ID# 124959

location_facility: Korea University Anam Hospital /ID# 128968

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

location_facility: Bobruysk Interdistrict Onco. /ID# 137729

location_facility: ME Kryviy Rih Oncology Dispensary /ID# 129806

location_facility: Instituto Nacional de Cancerología INCAN /ID# 128676

location_facility: Universitair Ziekenhuis Leuven /ID# 124980

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

location_facility: Istanbul University Istanbul Medical Faculty /ID# 145144

location_facility: National Taiwan University Hospital /ID# 125324

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

location_facility: Universitair Medisch Centrum Groningen /ID# 129069

location_facility: Volgograd Regional Clinical Oncology Dispensary /ID# 124952

location_facility: Wojewodzki Szpital Zespolony /ID# 126998

location_facility: Hematology and Oncology Assoc /ID# 130058

location_facility: Hospital General Universitario Gregorio Maranon /ID# 124962

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

location_facility: Hospital Universitario HM Sanchinarro /ID# 124960

location_facility: Linkoping University Hospital /ID# 126795

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

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

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

location_facility: Centro di Riferimento Oncologico /ID# 126738

location_facility: Banner MD Anderson Cancer Ctr /ID# 125011

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

location_facility: Hospital Clinico Vina del Mar /ID# 130100

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

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

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

location_facility: Medizinische Universitaet Graz /ID# 126450

location_facility: Zaporizhzhia Med. Academy MOH /ID# 129800

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259

location_facility: University of Vermont Medical Center /ID# 125350

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

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

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

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

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

location_facility: Florida Cancer Specialists - East /ID# 125007

location_facility: Instituto de Oncoloia de Rosario /ID# 127157

location_facility: Universitaetsklinik Heidelberg /ID# 126664

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

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

location_facility: Hacettepe University Faculty of Medicine /ID# 125336

location_facility: Medizinische Universitaet Wien /ID# 126184

location_facility: Duplicate_Akdeniz University Medical Fac /ID# 125339

location_facility: Haukeland University Hospital /ID# 150177

location_facility: Emory Midtown Infectious Disease Clinic /ID# 133192

location_facility: Hospital Clinico Vina del Mar /ID# 148502

location_facility: Univ of Colorado Cancer Center /ID# 124983

location_facility: Assaf Harofeh Medical Center /ID# 124915

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

location_facility: Netcare Oncology Intervent Ctr /ID# 125320

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 126185

location_facility: Sverdlovsk Regional Oncology Dispensary /ID# 130950

location_facility: Donetsk Regional Antitumor Ctr /ID# 124970

location_facility: Spectrum Health Medical Group /ID# 148471

location_facility: NorthShore University HealthSystem /ID# 124996

location_facility: Seoul National University Hospital /ID# 125600

location_facility: Duplicate_Jewish General Hospital /ID# 124880

location_facility: Duplicate_archangel Clinical Oncology /ID# 126031

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

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

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

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

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

location_facility: Nebraska Hematology Oncology /ID# 132711

location_facility: Swedish Cancer Insititute - Ballard /ID# 131548

location_facility: Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728

location_facility: The Royal Melbourne Hospital /ID# 124846

location_facility: Centro Oncologico de Chihuahua /ID# 128679

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

location_facility: Riga East Clinical University Hospital /ID# 125265

location_facility: Pauls Stradins Clinical University Hospital /ID# 125264

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

location_facility: University Hospitals Bristol /ID# 128343

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

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

location_facility: Universitair Ziekenhuis Antwerpen /ID# 124977

location_facility: Duplicate_The Prince of Wales Hospital /ID# 124845

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

location_facility: Siberian State Medical University /ID# 127161

location_facility: Duplicate_Soroka University Medical Center /ID# 124917

location_facility: National University Hospital /ID# 125315

location_facility: Townsville University Hospital /ID# 126731

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

location_facility: Nottingham University Hospitals NHS Trust /ID# 125340

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

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

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

location_facility: Cancer Research Collaboration /ID# 128860

location_facility: The Chaim Sheba Medical Center /ID# 124918

location_facility: Sahlgrenska University Hospital /ID# 124965

location_facility: East Tallinn Central Hospital /ID# 126475

location_facility: Centro de Estudios Clínicos Especializados /ID# 128680

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

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

location_facility: Altay Regional Oncological Dispesary /ID# 127160

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

location_facility: Duplicate_Tampere University Hospital /ID# 124898

location_facility: Duplicate_Helsinki Univ Central Hospital /ID# 124897

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

location_facility: Swedish Cancer Institute - Edmonds /ID# 131549

location_facility: Duplicate_Karolinska Univ Sjukhuset /ID# 124964

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

location_facility: Medical Oncology Ctr Rosebank /ID# 125322

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

location_facility: Duplicate_Flinders Centre for Innovation /ID# 127535

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

location_facility: Wojewodzki Szpital Specjalistyczny /ID# 127258

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

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

location_facility: Texas Health Physicians Group /ID# 137740

location_facility: Instituto Nacional del Cancer /ID# 129343

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

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

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

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

location_facility: Cancercare Outeniqua Oncology Centre /ID# 125319

location_facility: Southern Medical Day Care Centre /ID# 124844

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

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

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

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

location_facility: Regional Oncology Dispensary /ID# 125936

location_facility: Centrum Onkologii Lukaszczyka /ID# 124938

location_facility: Vitebsk Regional Clinical Oncology Dispensary /ID# 125219

location_facility: Norrlands University hospital /ID# 124967

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

location_facility: Swedish Cancer Institute - Issaquah /ID# 131534

location_facility: Universitaetsklinimum Tuebingen /ID# 129968

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

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.


acronym: SUMMIT

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

lead_sponsor: Puma Biotechnology, Inc.

ReferenceType: background

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-Sørensen M, Arnedos M, Moreno V, Boni V, Sohn J, Schwartzberg LS, Gonzàlez-Farré 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.

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.

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.

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 HER2(T798I) 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.

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

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

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

location_facility: AOU Citta della Salute e della Scienza di Torino

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Gundersen Center for Cancer and Blood Disorders

location_facility: Winship Cancer Institute, Emory University

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: Davidoff Cancer Center, Rabin Medical Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Madrid Sanchinarro (START Madrid)

location_facility: Yonsei University Health System, Serverance Hospital

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.


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

ReferenceCitation: Stilgenbauer S, Eichhorst B, Schetelig J, Coutre S, Seymour JF, Munir T, Puvvada SD, Wendtner CM, Roberts AW, Jurczak W, Mulligan SP, Böttcher 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.

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, Böttcher 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.

location_country:
Poland
United Kingdom
Australia
Canada
United States
France
Germany

location_facility: Royal Liverpool and Broadgreen /ID# 98860

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

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

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

location_facility: Duplicate_Jewish General Hospital /ID# 99476

location_facility: St. James University Hospital /ID# 98863

location_facility: Universitaetsklinik Heidelberg /ID# 98845

location_facility: Universitaetsklinikum Freiburg /ID# 113276

location_facility: Universitaetsmedizin Goettingen /ID# 113258

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

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

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

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

location_facility: Columbia Univ Medical Center /ID# 103835

location_facility: John Fawkner Private Hospital /ID# 98835

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

location_facility: The Royal Bournemouth Hospital /ID# 118975

location_facility: Stanford University School of Med /ID# 105117

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

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

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

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

location_facility: Georgetown University Hospital /ID# 96954

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

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.


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, Högler W, Linglart A, Martos-Moreno GÁ, 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.

ReferenceCitation: Högler 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.

lead_sponsor: Alexion Pharmaceuticals

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


acronym: NEFERTT

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

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

location_facility: Policlinico di Modena Oncologia ed Ematologia

location_facility: Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: Palm Beach Institute of Hematology and Oncology

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

location_facility: Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: National University Hospital, National Cancer Institute

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial

location_facility: Hospital da Luz Servico de Oncologia Medica

location_facility: National Hospital Organization Shikoku Cancer Center

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

location_facility: Samaritan Hematology and Oncology Consultants

location_facility: National Hospital Organization Mito Medical Center

location_facility: Complejo Hospitalario Universitario Santiago de Compostela

location_facility: University of Witwatersrand Oncology, Donald Gordon Medical Centre

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Pauls Stradiņš Clinical University Hospital

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Ospedale San Giovanni Battista-Molinette

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

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

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

location_facility: Kobe City Medical Center General Hospital

location_facility: Chinese People's Liberation Army General Hospital

location_facility: State Oncological Regional Treatment and Diagnostic Center

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

location_facility: Institution Gomel Regional Clinical Oncology Dispensary

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Kantonsspital Winterthur Medizinische Onkologie

location_facility: Groupe Hospitalier Paris Saint Joseph, Oncologie medicale

location_facility: Tazuke Kofukai Medical Research Institute Kitano Hospital

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

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

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

location_facility: Chang Gung Medical Foundation, Linkou Branch

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Rigshospitalet, Copenhagen, Onkologisk Klinik

location_facility: North Broward Medical Center Cancer Center

location_facility: Kaposi Mor Oktato Korhoz Onkologiai Centrum

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

location_facility: Southern Medical University Nanfang Hospital

location_facility: Kurume Daiichi Social Insurance Hospital

location_facility: Gaston Hematology and Oncology Associates

location_facility: Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil

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

location_facility: Meenakshi Mission Hospital and Research Centre

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi

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

location_facility: Piejuras Hospital, Liepajas Oncological Clinic

location_facility: Yonsei University Health System Severance Hospital

location_facility: Centre Leon Berard Departement de Cancerologie Medicale

location_facility: National Hospital Organization Kyushu Cancer Center

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

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

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

location_facility: National Hospital Organization Nagoya Medical Center

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

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie

location_facility: Hospital Universitario Fundación Alcorcón

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

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Clinical Hospital Osijek, Department of Radiotherapy and Oncology

location_facility: Hematology Oncology Associates of Treasure Coast

location_facility: Szegedi Tudomanyegyetem Onkoterapias Klinika

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

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

location_facility: Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas

location_facility: National Hospital Organization Hokkaido Cancer Center

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

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

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont

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

location_facility: Centre Hospitalier Régional de Trois-Rivières

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

location_facility: Spital STS AG Onkologiezentrum Thun - Berner Oberland

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Hospital of Lithuanian University of Health sciences

location_facility: Semmelweis Egyetem Radiologiai és Onkoterapias Klinika

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil

location_facility: Institution of Healthcare Grodno Regional Clinical Hospital

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.


type: Other Identifier

title: A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

acronym: KarMMa

summary: This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

ReferenceCitation: Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Turka A, Lam LP, Morgan RA, Friedman K, Massaro M, Wang J, Russotti G, Yang Z, Campbell T, Hege K, Petrocca F, Quigley MT, Munshi N, Kochenderfer JN. Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226.

ReferenceCitation: Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850.

ReferenceCitation: Shah N, Mojebi A, Ayers D, Cope S, Dhanasiri S, Davies FE, Hari P, Patel P, Hege K, Dhanda D. Indirect treatment comparison of idecabtagene vicleucel versus conventional care in triple-class exposed multiple myeloma. J Comp Eff Res. 2022 Jul;11(10):737-749. doi: 10.2217/cer-2022-0045. Epub 2022 Apr 29.

ReferenceCitation: Sharma P, Kanapuru B, George B, Lin X, Xu Z, Bryan WW, Pazdur R, Theoret MR. FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma. Clin Cancer Res. 2022 May 2;28(9):1759-1764. doi: 10.1158/1078-0432.CCR-21-3803.

ReferenceCitation: Delforge M, Shah N, Miguel JSF, Braverman J, Dhanda DS, Shi L, Guo S, Yu P, Liao W, Campbell TB, Munshi NC. Health-related quality of life with idecabtagene vicleucel in relapsed and refractory multiple myeloma. Blood Adv. 2022 Feb 22;6(4):1309-1318. doi: 10.1182/bloodadvances.2021005913.

ReferenceCitation: Da Vià MC, Dietrich O, Truger M, Arampatzi P, Duell J, Heidemeier A, Zhou X, Danhof S, Kraus S, Chatterjee M, Meggendorfer M, Twardziok S, Goebeler ME, Topp MS, Hudecek M, Prommersberger S, Hege K, Kaiser S, Fuhr V, Weinhold N, Rosenwald A, Erhard F, Haferlach C, Einsele H, Kortüm KM, Saliba AE, Rasche L. Homozygous BCMA gene deletion in response to anti-BCMA CAR T cells in a patient with multiple myeloma. Nat Med. 2021 Apr;27(4):616-619. doi: 10.1038/s41591-021-01245-5. Epub 2021 Feb 22.

lead_sponsor: Celgene

location_country:
Spain
Italy
Canada
United States
France
Belgium
Japan
Germany

location_facility: Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico

location_facility: Centre Hospitalier Universitaire de Nantes - Hotel Dieu

location_facility: Tokyo Women's Medical University Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Centre Hospitalier Regional Universitaire de Lille-Hopital Calude Huriez Service des Maladies du Sang

location_facility: University of California - San Francisco


title: Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

summary:
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.

However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.

The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

status: Terminated

lead_sponsor: University Hospital, Rouen

location_facility:
Emergecy department
Emergency Department


title: Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.

ReferenceCitation: Penel N, Le Cesne A, Bui BN, Perol D, Brain EG, Ray-Coquard I, Guillemet C, Chevreau C, Cupissol D, Chabaud S, Jimenez M, Duffaud F, Piperno-Neumann S, Mignot L, Blay JY. Imatinib for progressive and recurrent aggressive fibromatosis (desmoid tumors): an FNCLCC/French Sarcoma Group phase II trial with a long-term follow-up. Ann Oncol. 2011 Feb;22(2):452-7. doi: 10.1093/annonc/mdq341. Epub 2010 Jul 9.

ReferenceCitation: Fayette J, Dufresne A, Penel N, et al.: Imatinib for the treatment of aggressive fibromatosis/desmoid tumors (AF/DT) failing local treatment: updated outcome and predictive factors for progression free survival: a FNCLCC French Sarcoma Group-GETO study. [Abstract] J Clin Oncol 25 (Suppl 18): A-10062, 560s, 2007.

ipd_sharing: No

ipd_sharing_description: Individual Participant data will not be shared at an individual level.

lead_sponsor: UNICANCER

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: Clinical Observations of Automatic Algorithms for Cardiac Pacing

summary: This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

lead_sponsor: Boston Scientific Corporation

location_country: France Guadeloupe

location_facility:
CH privé St. Martin
CHG de Dinan
Clinique Notre Dame
Clinique Paulmy
Polyclinique Sévigné
Clinique St Hilaire
Clinique de L'Ormeau
Hôpital Nord
CH Nevers
Clinique Ambroise Paré
Polyclinique Bordeaux-Cauderan
Clinique des Cèdres
CHR la Source
CHI de Castres
Clinique du Lac et d'Argonay
Polyclinique du Bois
CH DAX
Clinique A. Brillard
CHP de la Loire
Clinique Pasteur
CHG de Pau
CHU de Point à pitre
CH Emile Muller
CH Cherbourg
CH Maréchal Joffre
CHU Nîmes
Hôpital Fontenoy
CH de Laval
Polyclinique Louis Pasteur
Clinique Belledone
CH Beauvais
Hôpital de Brabois
Casamance
CH d'Arles
CHG Saint Louis - SIH Eure Seine
Nouvelles Cliniques Nantaises
CHU Albert Michalon
Clinique Cardiologique Aressy
CH de La Roche sur Yon
CHRU- Hôpital Nord

intervention_type: Device


title: A Randomized Cost-minimization Trial Comparing Pemetrexed (Alimta®) Versus Docetaxel (Taxotere®) as Second Line Treatment in Advanced Non Small Cell Lung Cancer (NSCLC): Study 05-06 of Groupe Français de Pneumo-Cancérologie (GFPC).

summary:
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature.

Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities.

However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment.

As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).

lead_sponsor: University Hospital, Limoges

location_facility: Service de Pneumologie et Réanimation ; Hôpital Hôtel Dieu - Paris

location_facility: Service de Pneumologie; Centre Hospitalier

location_facility: Service de Pneumologie ; Centre hospitalier

location_facility: Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay

location_facility: Service de Pneumologie ; Hôpital saint Antoine, Paris

location_facility: Service de Pneumologie; Hôpital de la Croix Rousse

location_facility: Service de Pathologie Respiratoire; CHU de Limoges

location_facility: Service de pneumologie; Centre Hospitalier d'Annecy

location_facility: Département des Maladies Respiratoires ; Hôpital Sainte Marguerite

location_facility: Service de Pneumologie - Hôpital St Antoine, Paris

location_facility: Service de Pneumologie-Allergologie; Centre Hospitalier Général

location_facility: Service de Pneumologie; Hôpital Bois Guillaume

location_facility: Service de Pathologie Respiratoire; Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Clinique Pneumologique; Hôpital Charles Nicolle

location_facility: Service d'Oncologie Médicale; Clinique Sainte Marguerite


title: Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma

summary:
Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples.

The investigators propose a phase II protocol for patients with refractory or relapsing nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy.

Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma who have not received asparaginase before.

ReferenceCitation: Jaccard A, Gachard N, Marin B, Rogez S, Audrain M, Suarez F, Tilly H, Morschhauser F, Thieblemont C, Ysebaert L, Devidas A, Petit B, de Leval L, Gaulard P, Feuillard J, Bordessoule D, Hermine O; GELA and GOELAMS Intergroup. Efficacy of L-asparaginase with methotrexate and dexamethasone (AspaMetDex regimen) in patients with refractory or relapsing extranodal NK/T-cell lymphoma, a phase 2 study. Blood. 2011 Feb 10;117(6):1834-9. doi: 10.1182/blood-2010-09-307454. Epub 2010 Dec 1.

location_facility: Service d'Hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière

location_facility: Service d'Hématologie Clinique - Hôpital Henri Mondor

location_facility: Département d'Oncologie - Institut Paoli Calmettes

location_facility: Service d'Hématologie Clinique, Groupe Hospitalier Necker

location_facility: Service d'Hématologie Clinique, CHU Dijon

location_facility: Département d'Immuno-Hématologie, Hôpital Saint-Louis

location_facility: Service de Radiothérapie, Polyclinique Bordeaux Nord

location_facility: Service d'Hématologie Clinique, CHU de Reims

location_facility: Service d'Immunologie Clinique 2, Hôpital Saint Louis

location_facility: Service d'Hématologie et de Thérapie Cellulaire - CHU Limoges


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.

status: Recruiting

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, Gutiérrez 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.

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, Sönnerborg 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, Rodríguez-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, Brännström J, Bonnet F, Brockmeyer N, Casabona J, Castagna A, Costagliola D, De Wit S, Fätkenheuer 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, Miró 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. Review.

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, Cabié 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.

ipd_sharing: Undecided

lead_sponsor: NEAT ID Foundation

location_country:
Spain
Italy
Ireland
United Kingdom
France
Belgium
Germany

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

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

location_facility: University Hospital Klinikum rechts der Isar der TUM


title: A Randomized, Double-Blind, Comparative Parallel Group Study of Analgesic Effectiveness and Safety of Three Different Doses of Lamaline® New Formulation vs Dafalgan® Codeine, After 10 Days Administration in Subjects With Painful Gonarthrosis.

summary: This study aims to assess the analgesic effectiveness and safety of three different doses of a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in subjects with painful gonarthrosis

lead_sponsor: Solvay Pharmaceuticals

location_facility:
Site 139
Site 43
Site 319
Site 52
Site 321
Site 318
Site 498
Site 115
Site 56
Site 63
Site 24
Site 75
Site 32
Site 104
Site 25
Site 22
Site 131
Site 5
Site 47
Site 57
Site 402
Site 506
Site 11
Site 41
Site 454
Site 16
Site 489
Site 62
Site 4
Site 302
Site 101
Site 320
Site 116
Site 50
Site 38
Site 17
Site 202
Site 228
Site 132
Site 69
Site 105
Site 495
Site 109
Site 126
Site 129
Site 120
Site 51
Site 72
Site 134
Site 19
Site 60
Site 124
Site 77
Site 136
Site 31
Site 112
Site 14
Site 118
Site 413
Site 2
Site 103
Site 137
Site 29
Site 414
Site 107
Site 54
Site 106
Site 46
Site 494
Site 79
Site 45
Site 503
Site 405
Site 39
Site 433
Site 401
Site 121
Site 119
Site 128
Site 207
Site 225
Site 33
Site 49
Site 71
Site 457
Site 26
Site 127
Site 59
Site 215
Site 28
Site 133
Site 108
Site 53
Site 9
Site 78
Site 48
Site 74
Site 140
Site 113
Site 208
Site 37
Site 102
Site 138
Site 511
Site 496
Site 301
Site 110
Site 123
Site 76
Site 68
Site 213
Site 459
Site 55
Site 70
Site 315
Site 410
Site 21
Site 65
Site 15
Site 73
Site 219
Site 209
Site 201
Site 114
Site 423
Site 34
Site 221
Site 502
Site 460
Site 35
Site 507
Site 67
Site 432
Site 7
Site 42
Site 306
Site 12
Site 40
Site 8
Site 13
Site 314
Site 316
Site 27
Site 449
Site 10
Site 125
Site 20
Site 6
Site 36
Site 44
Site 58
Site 313
Site 66
Site 462
Site 224
Site 64
Site 461
Site 135
Site 451
Site 18
Site 61
Site 117
Site 122
Site 3
Site 130
Site 23
Site 488
Site 453
Site 30
Site 204
Site 458


type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial

acronym: ESPRIT

summary:
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression.

Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.

ReferenceCitation: Chun TW, Engel D, Mizell SB, Hallahan CW, Fischette M, Park S, Davey RT Jr, Dybul M, Kovacs JA, Metcalf JA, Mican JM, Berrey MM, Corey L, Lane HC, Fauci AS. Effect of interleukin-2 on the pool of latently infected, resting CD4+ T cells in HIV-1-infected patients receiving highly active anti-retroviral therapy. Nat Med. 1999 Jun;5(6):651-5.

ReferenceCitation: Connors M, Kovacs JA, Krevat S, Gea-Banacloche JC, Sneller MC, Flanigan M, Metcalf JA, Walker RE, Falloon J, Baseler M, Feuerstein I, Masur H, Lane HC. HIV infection induces changes in CD4+ T-cell phenotype and depletions within the CD4+ T-cell repertoire that are not immediately restored by antiviral or immune-based therapies. Nat Med. 1997 May;3(5):533-40.

ReferenceCitation: Emery S, Abrams DI, Cooper DA, Darbyshire JH, Lane HC, Lundgren JD, Neaton JD; ESPRIT Study Group. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT. Control Clin Trials. 2002 Apr;23(2):198-220.

ReferenceCitation: Arduino RC, Nannini EC, Rodriguez-Barradas M, Schrader S, Losso M, Ruxrungtham K, Allende MC, Emery S, Fosdick L, Neaton J, Tavel JA, Davey RT, Lane HC; Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) Vanguard Group; ESPRIT Executive Committee. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies. Clin Infect Dis. 2004 Jul 1;39(1):115-22. Epub 2004 Jun 14.

ReferenceCitation: INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Lévy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. Interleukin-2 therapy in patients with HIV infection. N Engl J Med. 2009 Oct 15;361(16):1548-59. doi: 10.1056/NEJMoa0903175.

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

ReferenceCitation: Nordell AD, McKenna M, Borges ÁH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.

ReferenceCitation: Mocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. Epub 2012 Jul 20.

ReferenceCitation: Pett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miró JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT). HIV Med. 2011 Apr;12(4):219-27. doi: 10.1111/j.1468-1293.2010.00875.x. Epub 2010 Aug 31.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Argentina
Israel
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
Germany
Denmark
Ireland
Thailand
France
Netherlands
Morocco

location_facility: Hosp. Universitario Morales Meseguer CRS

location_facility: Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS

location_facility: St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS

location_facility: Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS

location_facility: Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS

location_facility: Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS

location_facility: Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS

location_facility: Groningen Univ. Hosp., Department of Internal Medicine CRS

location_facility: Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS

location_facility: Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS

location_facility: Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS

location_facility: George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS

location_facility: Royal Hallamshire Hosp., Dept. of GU Medicine Communicable Diseases Unit CRS

location_facility: Northwestern Memorial Physicians Group CRS

location_facility: Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS

location_facility: Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS

location_facility: Univ. Hosp. Heidelberg, Dept. of Dermatology CRS

location_facility: Hosp. Universitario Principe de Asturias CRS

location_facility: King's College Hosp., Caldecot Ctr. Dept. of Sexual Health CRS

location_facility: St. Thomas' Hosp., Dept. of GU Medicine CRS

location_facility: Hosp. la Princesa, Internal Medicine and Infectious Diseases Service CRS

location_facility: Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS

location_facility: New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

location_facility: Hopital de la Conception, Service des Maladies Infectieuses CRS

location_facility: Univ. of Colorado Health Science Ctr. CRS

location_facility: Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS

location_facility: Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS

location_facility: St. Mary's Hosp. of London, Imperial College School of Medicine CRS

location_facility: Univ. Hosp. Charite, Dept of Infectious Diseases CRS

location_facility: San Francisco VAMC, Infectious Diseases Clinic CRS

location_facility: Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS

location_facility: Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS

location_facility: Hopital de Bicetre, Service de Medecine Interne CRS

location_facility: John Hunter Hosp., Immunology & Infectious Diseases Unit CRS

location_facility: Royal Free Hosp., Dept. of Infection & Immunity, Ian Charleson Day Ctr. CRS

location_facility: Hopital Avicenne, Service de Medecine B CRS

location_facility: San Matteo Hospital - University of Pavia, Division of Infectious and Tropical Diseases CRS

location_facility: Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS

location_facility: Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS

location_facility: Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit CRS

location_facility: Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS

location_facility: Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS

location_facility: Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS

location_facility: Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS

location_facility: Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS

location_facility: Hvidovre Univ. Hosp., Dept. of Infectious Diseases CRS

location_facility: VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS

location_facility: Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS

location_facility: Windsor Regional Hosp., HIV Care Program CRS

location_facility: Hosp. Interzonal de Agudos San Juan de Dios CRS

location_facility: Tel Aviv Sourasky Med. Ctr., Clinical Immunology Unit and AIDS Ctr. CRS

location_facility: Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS

location_facility: CHRU d'Angers, Service de Maladies Infectieuses CRS

location_facility: Hosp. 12 de Octubre, Pabellon de Medicina Communitaria CRS

location_facility: Hosp. Juan Canalejo, Dept. of Internal Medicine CRS

location_facility: Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS

location_facility: Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS

location_facility: Kaiser Immune Deficiency Clinic of Portland CRS

location_facility: Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS

location_facility: Hopital Antoine Beclere Service d'Immunologie Clinique CRS

location_facility: Royal London Hosp., Ambrose King Ctr. CRS

location_facility: Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS

location_facility: Hopital Cochin, Service de Medecine Interne 2 CRS

location_facility: Hospital de Cascais, HDDI, Departamento Medicina Interna CRS

location_facility: Kaplan Med. Ctr., Ben Ari Institute of Clinical Immunology CRS

location_facility: OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS

location_facility: McMaster Univ. Med. Ctr. Hamiton Health Sciences, SIS Clinic CRS

location_facility: Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion

location_facility: Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS

location_facility: Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS

location_facility: Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS

location_facility: Multnomah County Health Dept., HIV Health Services Ctr. CRS

location_facility: Aalborg Hosp., Dept. of Infectious Diseases CRS

location_facility: Hopital Necker, Service des Maladies Infectieuses CRS

location_facility: South Texas Veterans Health Care System, Immunosuppression Clinic CRS

location_facility: Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS

location_facility: Western Gen. Hosp., Regional Infectious Diseases Unit CRS

location_facility: Ulleval Hosp., Dept. of Infectious Diseases CRS

location_facility: Hosp. Severo Ochoa, Internal Medicine and Infectious Diseases CRS

location_facility: Univ. College London Med. School, Ctr. for Sexual Health & HIV Research CRS

location_facility: Newcastle Gen. Hosp., Dept of Infection & Tropical Medicine CRS

location_facility: Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS

location_facility: Hosp. Gen. de Agudos Juan A. Fernandez CRS

location_facility: William Beaumont Hosp., Infectious Disease Research CRS

location_facility: Chonburi Regional Hosp., Dept. of Internal Medicine CRS

location_facility: SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS

location_facility: Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS

location_facility: Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS

location_facility: Hospital Nacional Professor Alejandro Posadas CRS

location_facility: Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS

location_facility: Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

location_facility: Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS

location_facility: Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS

location_facility: Rigshospitalet, Department of Infectious Diseases, M5112 CRS

location_facility: Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS

location_facility: National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS

location_facility: Osaka National Hosp. AIDS Ctr., Clinical Research Institute CRS

location_facility: Hosp. Virgen del Rocio, Infectious Diseases Service CRS

location_facility: St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS

location_facility: Civili di Brescia, 1st Division of Infectious Diseases CRS

location_facility: Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS

location_facility: UCSF PHP, Gen. Internal Medicine Practice CRS

location_facility: The Early Intervention Program at Kennedy Hosp. CRS

location_facility: Univ. of Illinois Family Ctr. for Infectious Disease CRS

location_facility: Univ. of Tokyo, Research Hosp. of the Institute of Medical Science CRS

location_facility: Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS

location_facility: Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

location_facility: Cathedral Healthcare System, St. Michael's Med. Ctr. CRS

location_facility: Hopital Foch, Service de Medecine Interne CRS

location_facility: CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS

location_facility: Hopital Sainte Marguerite, CISIH Hopital de Jour CRS

location_facility: Hopital Saint-Antoine, Service de Maladies Infectieuses CRS

location_facility: Hosp. del Mar, Internal Medicine-Infectious Diseases CRS

location_facility: Canberra Hosp., Canberra Sexual Health Clinic CRS

location_facility: Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS

location_facility: Instituto de Infectologia Emilio Ribas CRS

location_facility: Toronto Gen. Hosp. Infectious Diseases CRS

location_facility: Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS

location_facility: Hopital de La Salpetriere, Service de Medecine Interne CRS

location_facility: Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS

location_facility: Siriraj Hosp., Mahidol Univ. INSIGHT CRS

location_facility: Universita degli Studi di Modena e Reggio Emilia, Clinica delle Malattie Infettive e Tropicali CRS

location_facility: Positive Health Practice West/ Dr. Steve Deeks CRS

location_facility: Univ. of Alberta Hosp., Clinical Research Office CRS

location_facility: St. Joseph's Health Ctr. of London, HIV Care Programme CRS

location_facility: Universita La Sapienza, Clinica Universita La Sapienza CRS

location_facility: Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

location_facility: St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS

location_facility: Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS

location_facility: The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS

location_facility: Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS

location_facility: Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS

location_facility: Legacy Community Health Services, Inc., Montrose Clinic, Inc.

location_facility: Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS

location_facility: Raritan Bay Med. Ctr., Perth Amboy Division CRS

location_facility: Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS

location_facility: Edith Cavell Hosp. Dept. of Sexual Health, Clinic E CRS

location_facility: Abbott Northwestern Hosp., Clinic 42 CRS

location_facility: Royal Victoria Hosp., Montreal Chest Institute CRS

location_facility: Virginia Commonwealth Univ. Medical Ctr. CRS

location_facility: Univ. of Miami, Infectious Diseases Clinical Research Unit CRS

location_facility: Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS

location_facility: Hopital Henri Mondor, Immunopathologie Clinique CRS

location_facility: Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS

location_facility: St. George's Hosp. Clinical Infection UnitCRS

location_facility: Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS

location_facility: Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici

location_facility: Cairns Base Hosp., Sexual Health Services CRS

location_facility: Chelsea & Westminster Hosp., St. Stephens Ctr. CRS

location_facility: Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS

location_facility: Hopital Louis Mourier, Service de Medecine Interne CRS

location_facility: Hanover Med. Park (Mechanicsville, VA) CRS

location_facility: The Research & Education Group-Portland CRS

location_facility: Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS

location_facility: Lakeshore Infectious Disease Associates CRS

location_facility: Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

location_facility: Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS

location_facility: Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS

location_facility: Denver Infectious Diseases Consultants CRS

location_facility: The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS

location_facility: Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS

location_facility: Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS

location_facility: C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS


title: Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma.

PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.

ReferenceCitation: Duffaud F, Bui BN, Penel N, et al.: A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). [Abstract] J Clin Oncol 26 (Suppl 15): A-10511, 2008.

ipd_sharing_description: Individual participant data will not be shared at an individual level.

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

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b

summary: The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.

lead_sponsor: Rennes University Hospital

location_country: France Italy

location_facility: Clinica Neurologica Università di Torino

location_facility: Psichiatriche dell'Università di Bari, Policlinico

location_facility: Dipartimento di Scienze Neurologiche e Psichiatriche


title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd) in Part 1 and to evaluate the pharmacokinetics (PK), safety, and efficacy of the Tec-Dara regimen when teclistamab is administered using a alternative dosing schedule in Part 2.

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Russian Federation
Argentina
Turkey
Sweden
Brazil
Canada
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Emory University - Winship Cancer Institute

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Tianjin Medical University General Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: National Hospital Organization Sendai Medical Center

location_facility: National Hospital Organization Mito Medical Center

location_facility: Saint-Petersburg State Pavlov University

location_facility: St.-Petersburg City Clinical Hospital nr 31

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Sint Antonius Ziekenhuis - Afd.Interne - INT

location_facility: Fujian Meidical University Union Hospital

location_facility: Klinika Hematologii i Transplantologii, UCK

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: The Second Hospital To Dalian Medical University

location_facility: Università di Roma 'La Sapienza' - Ospedale Umberto 1°

location_facility: First Affiliated Hospital of Guangxi Medical University

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

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

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

location_facility: Hospitais Integradaos da Gavea S/A - DF Star

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: Shengjing Hospital of China Medical University

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

location_facility: National Hospital Organization Okayama Medical Center

location_facility: University of Athens - Evaggelismos Hospital (Evangelismos Hospital)

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: First affiliated Hospital of Zhejiang University


title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

summary: Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1, 34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.

ReferenceCitation: Soubeyran P, Fonck M, Blanc-Bisson C, Blanc JF, Ceccaldi J, Mertens C, Imbert Y, Cany L, Vogt L, Dauba J, Andriamampionona F, Houédé N, Floquet A, Chomy F, Brouste V, Ravaud A, Bellera C, Rainfray M. Predictors of early death risk in older patients treated with first-line chemotherapy for cancer. J Clin Oncol. 2012 May 20;30(15):1829-34. doi: 10.1200/JCO.2011.35.7442. Epub 2012 Apr 16.

ReferenceCitation: Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, Mertens C, Blanc-Bisson C, Imbert Y, Cany L, Vogt L, Dauba J, Houédé N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pélissier S, Soubeyran P. Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol. 2013 Nov 1;31(31):3877-82. doi: 10.1200/JCO.2012.47.7430. Epub 2013 Sep 23.

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

location_facility: Centre Hospitalier Universitaire de Mont de Marsan

location_facility: Centre Hospitalier Universitaire de Perigueux

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Bayonne

location_facility: Centre Hospitalier Universitaire de Villeneuve sur Lot


title: Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

acronym: UFT RT Phase 3

summary:
RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancérologie et d'Hématologie

location_facility: Centre d'Oncologie-radiothérapie d'Eure et Loir


title: A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.

summary: The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).

location_facility: Service de Pneumologie, Hôpital Pontchailloux

location_facility: Hôpital Charles Nicolle, Service de Pneumologie

location_facility: Service de Pneumologie - Hôpital St Antoine

location_facility: Service de Pneumologie, Hôpital Bois Guillaume

location_facility: Service de Pneumologie, Hôpital de la Croix Rousse