title: Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).

summary:
This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits.

The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations.

The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.

The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator.

Only COPD exacerbations with onset during randomised treatment will be included in the analysis.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Vogelmeier CF, Asijee GM, Kupas K, Beeh KM. Tiotropium and Salmeterol in COPD Patients at Risk of Exacerbations: A Post Hoc Analysis from POET-COPD((R)). Adv Ther. 2015 Jun;32(6):537-47. doi: 10.1007/s12325-015-0216-2. Epub 2015 Jun 23.

oa_colors: green hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Rabe KF, Fabbri LM, Israel E, Kogler H, Riemann K, Schmidt H, Glaab T, Vogelmeier CF. Effect of ADRB2 polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial. Lancet Respir Med. 2014 Jan;2(1):44-53. doi: 10.1016/S2213-2600(13)70248-0. Epub 2013 Dec 5.

ReferenceCitation: Beeh KM, Glaab T, Stowasser S, Schmidt H, Fabbri LM, Rabe KF, Vogelmeier CF. Characterisation of exacerbation risk and exacerbator phenotypes in the POET-COPD trial. Respir Res. 2013 Oct 29;14(1):116. doi: 10.1186/1465-9921-14-116.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central;iris.unimore.it

publisher_dissemination: Springer

ReferenceCitation: Rabe KF, Fabbri LM, Vogelmeier C, Kogler H, Schmidt H, Beeh KM, Glaab T. Seasonal distribution of COPD exacerbations in the Prevention of Exacerbations with Tiotropium in COPD trial. Chest. 2013 Mar;143(3):711-719. doi: 10.1378/chest.12-1277.

ReferenceCitation: Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MP, Beeh KM, Rabe KF, Fabbri LM; POET-COPD Investigators. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011 Mar 24;364(12):1093-1103. doi: 10.1056/NEJMoa1008378.

ReferenceCitation: Beeh KM, Hederer B, Glaab T, Muller A, Rutten-van Moelken M, Kesten S, Vogelmeier C. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. Int J Chron Obstruct Pulmon Dis. 2009;4:119-25. Epub 2009 Apr 15.

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Pfizer

location_country:
Finland
Germany
Poland
Turkey
France
Czech Republic
Lithuania
Slovenia
Portugal
Slovakia
Hungary
Denmark
Latvia
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Bulgaria
Russian Federation
Israel

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location_facility: 205.389.2601 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3183 Boehringer Ingelheim Investigational Site

location_facility: 205.389.2730 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3013 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1863 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3547 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3813 Boehringer Ingelheim Investigational Site

location_facility: 205.389.2709 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3193 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1882 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1598 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3609 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1946 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1824 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1903 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1823 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1213 Boehringer Ingelheim Investigational Site

location_facility: 205.389.2106 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3540 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1211 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1526 Boehringer Ingelheim Investigational Site

location_facility: 205.389.2019 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3918 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3420 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3112 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3144 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3016 Boehringer Ingelheim Investigational Site

location_facility: 205.389.1029 Boehringer Ingelheim Investigational Site

location_facility: 205.389.3430 Boehringer Ingelheim Investigational Site

location_facility: 205.389.2409 Boehringer Ingelheim Investigational Site


type: EudraCT Number

title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wojcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, Garcia MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum In: J Clin Oncol. 2021 Apr 1;39(10):1190.

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

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

host_type: repository

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repository_normalized: PubMed Central

repositories_concat: PubMed Central;www.repositoriosalud.es

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

evidence: open (via crossref license)

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repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: Elsevier

ReferenceCitation: Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.

oa_host_type: closed

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ReferenceCitation: Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Aren Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crino L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.

oa_host_type: publisher

license: publisher-specific-oa

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ReferenceCitation: Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhaeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crino L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Hungary
Hong Kong
Switzerland
United States
Romania
Peru
Italy
Norway
Singapore
Austria
Mexico
Spain
Russian Federation

location_facility:
Local Institution - 0141
Local Institution - 0011
Local Institution - 0009
Local Institution - 0077
Local Institution - 0035
Local Institution - 0072
Local Institution - 0058
Local Institution - 0124
Local Institution - 0034
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Local Institution - 0008
Local Institution
Local Institution - 0107
Swedish Cancer Institute
Local Institution - 0120
Local Institution - 0078
The Johns Hopkins University
Local Institution - 0026
Fox Chase Cancer Center
Local Institution - 0074
Local Institution - 0019
Local Institution - 0099
Local Institution - 0087
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San Francisco Oncology Associates
Vanderbilt University Medical Center
Local Institution - 0040
Local Institution - 0028
Local Institution - 0061
Local Institution - 0052
Local Institution - 0043
Local Institution - 0108
Northwest Georgia Oncology Center, P.C.
Local Institution - 0114
Local Institution - 0049
Dartmouth-Hitchcock Medical Center
Local Institution - 0050
Local Institution - 0048
Local Institution - 0010
Local Institution - 0133
Mayo Clinic Arizona
Yale University
Local Institution - 0122
Local Institution - 0030
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St. Mary Medical Center
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intervention_type: Drug

lead_sponsor: Lymphoma Study Association

summary:
The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy:

before cerebral radiotherapy for PCL
after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity

location_facility:
Hôpital Emile Muller
Hôpital Purpan
CHU Clemenceau
Hôpital Gilles de Corbeil
AZ VUB
Centre Leon Berard
UCL - Mont-Godinne
Hôpital Saint Joseph
Hôpital d'Avicenne
CH d'Annecy
Hopital Saint Vincent de Paul
Centre Francois Baclesse
Hôpital Necker
Hôpital des Chanaux
UCL- Saint Luc
CH de St Germain
Centre Hospitalier de Perpigan
Hôpital de Bayonne
CHU Le Bocage
CHR de la Citadelle
Hôpital Bon Secours
Hôpital Bicêtre
CHU Claude Huriez
Clinique Saint Pierre
CHU de Lens
Centre Antoine Lacassagne
CH de Brive
Hôpital Andre Mignot
Centre Hospitalier d'Avignon
Centre Hospitalier de Dunkerque
Hôpital Henri Mondor
Hôpital Saint Louis
ZNA Stuivenberg
Heilig Hart Ziekenhuis
CH de Chambery
CH de Chartres
CH Notre Dame
Hôpital Dupuytren
CH de Meaux
A. Z. Sint-Jan
CHU Charleroi-Vésale
Hopital Brabois
Centre Hospitalier Lyon Sud
Centre Henri Becquerel
Polyclinique Bordeaux Nord Aquitaine

title: Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis

source: euctr

location_country: Belgium France

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Completed


title: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

acronym: NATURE

summary: Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.

study_type: Observational

time_perspective: Prospective

lead_sponsor: LivaNova

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

location_facility: Kanagawa Cardiov. and Respiratory Center

location_facility: Nara Hospital, Kinki University School of Medicine

location_facility: University of Mississippi Medical Center


acronym: BEATRICE

lead_sponsor: Hoffmann-La Roche

summary:
The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.

The secondary objectives of this trial are to:

compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
evaluate the safety and tolerability of bevacizumab

An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

ReferenceCitation: Bell R, Brown J, Parmar M, Toi M, Suter T, Steger GG, Pivot X, Mackey J, Jackisch C, Dent R, Hall P, Xu N, Morales L, Provencher L, Hegg R, Vanlemmens L, Kirsch A, Schneeweiss A, Masuda N, Overkamp F, Cameron D. Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Ann Oncol. 2017 Apr 1;28(4):754-760. doi: 10.1093/annonc/mdw665.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. doi: 10.1016/S1470-2045(13)70335-8. Epub 2013 Aug 7.

title: An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.

location_country: Macedonia, The Former Yugoslav Republic of


title: A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)

acronym: AGENDA

summary: This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].

ReferenceCitation: Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. doi: 10.1200/JCO.2006.06.0483. Epub 2006 Sep 11.

lead_sponsor: Genta Incorporated

location_country:
France
Germany
Italy
Poland
United Kingdom
Australia
Switzerland
Austria
United States
Spain
Canada
Czech Republic

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum

location_facility: Medical University of Vienna, Vienna General Hospital

location_facility: Azienda Ospedaliera Universitaria di Siena

location_facility: CHU de Grenoble, Hopital Albert Michallon

location_facility: University of South Alabama Hospital, Mitchell Cancer Institute

location_facility: Morristown Memorial - Atlantic Healthcare System

location_facility: Hospital of the University of Schleswig-Holstein

location_facility: Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie

location_facility: Klinikum der Friedrich-Schiller-Universitat Jena

location_facility: San Diego Pacific Oncology and Hematology Associates Inc.

location_facility: Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie

location_facility: Nottingham University Hospitals NHS Trust, City Campus

location_facility: Klinik und Poliklinik fur Dermatologie und Venerologie

location_facility: Charles University, Dermatology Department

location_facility: Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck

location_facility: Sydney Cancer Center, Royal Prince Alfred Hospital

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: MD Anderson Cancer Center at University of Texas

location_facility: Siouxland Hematology Oncology Associates

location_facility: Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen

location_facility: Istituto Nazionale dei Tumori "G. Pascale"

location_facility: Klinik und Poliklinik fur Hautkrankheiten


title: A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

acronym: Hallmark DUAL

summary: The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

ReferenceCitation: Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128. Epub 2016 Apr 28.

publisher_dissemination: Wiley

ReferenceCitation: Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

ReferenceCitation: Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28. Erratum In: Lancet. 2014 Nov 1;384(9954):1576.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
Italy
Poland
New Zealand
Israel
Argentina
United Kingdom
Australia
Netherlands
Austria
United States
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France

location_facility: Gastrointestinal Research Institute (G.I.R.I.)

location_facility: The Health Care Authority For Baptist Health

location_facility: North Shore-Long Island Jewish Health System

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: University Of Colorado Denver And Hospital

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Toronto General Hospital-University Health Network

location_facility: Washington University School Of Medicine

location_facility: University Of North Carolina At Chapel Hill School Of Med


lead_sponsor: Alaunos Therapeutics

summary:
This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy.

The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis.

Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.

The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed.

An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.

location_facility: Peachtree Hematology Oncology Consultants

location_facility: State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Hematology Oncology Associates of the Treasure Coast

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

location_facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

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

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Hadassah Medical Organization, Ein Kerem

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum

location_facility: State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"

location_facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Medical Oncology Associates Of Wyoming Valley, PC

location_facility: State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"

location_facility: Dayton Cancer Center, Medical Oncology Hematology Associates

location_facility: Cancer Research Center n.a. N.N. Blokhin

location_facility: Centre Hospitalier Universitaire -Hôpital Morvan

location_facility: GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary

location_facility: Fairfax Northern Virginia Hematology-Oncology, PC

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: University of Texas Medical Branch at Galveston

location_facility: Centre Hospitalier Universitaire, Hopital Bretonneau

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

location_facility: Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center

location_facility: Indiana University Health Ball Memorial Hospital

location_facility: Southern Medical Day Oncology Care Centre

location_facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

location_facility: Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan

location_facility: Wisconsin Institutes for Medical Research

location_facility: Birmingham Hematology and Oncology Associates, LLC

location_facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego

status: Unknown status

title: A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study

study_completion_date_type: Anticipated

location_country:
Italy
Poland
Hungary
Israel
United Kingdom
Australia
United States
Taiwan
Canada
Russian Federation
France

status_simplified: Unknown


title: A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks.

acronym: ADMIRE-CD

summary: The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.

ReferenceCitation: Garcia-Olmo D, Gilaberte I, Binek M, D Hoore AJL, Lindner D, Selvaggi F, Spinelli A, Panes J. Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial. Dis Colon Rectum. 2022 May 1;65(5):713-720. doi: 10.1097/DCR.0000000000002325.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

repositories:
LIRIAS (KU Leuven)
PubMed Central
repositorio.uam.es

repositories_concat: LIRIAS (KU Leuven);PubMed Central;repositorio.uam.es

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24.

ReferenceCitation: Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29.

lead_sponsor: Tigenix S.A.U.

location_country: Germany France Italy Netherlands Austria Belgium Spain Israel

location_facility: Seconda Università degli Studi di Napoli

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

location_facility: Azienda Ospedaliera San Camillo-Forlanini

intervention_type: Other


title: An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers

summary: This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.

design_allocation: Non-Randomized

ReferenceCitation: Kaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309. Erratum In: N Engl J Med. 2018 Oct 18;379(16):1585.

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_country:
Germany
United Kingdom
United States
China
Spain
France

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Klinik der Uni zu Koeln; Klinik I für Innere Medizin; Onkologie

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: The Royal Marsden Hospital; Dept of Medicine

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

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

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum

location_facility: Institut Paoli-Calmettes; Oncologie Medicale 1


title: A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

summary: The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

location_country:
Germany
Italy
Poland
Israel
Argentina
Denmark
Australia
Brazil
Switzerland
Austria
United Kingdom
United States
Spain
Canada
Russian Federation
France

location_facility: Saint Louis University Gastroenterology & Hepatology

location_facility: University Of North Carolina At Chapel Hill School Of Med


type: Other Identifier

title: Phase III in Partial and Null Responders

acronym: ATTAIN

summary: The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

ReferenceCitation: Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, Villamil FG, Andreone P, George J, Dammers E, Fu M, Kurland D, Lenz O, Ouwerkerk-Mahadevan S, Verbinnen T, Scott J, Jessner W. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2015 Jan;15(1):27-35. doi: 10.1016/S1473-3099(14)71002-3. Epub 2014 Dec 5. Erratum In: Lancet Infect Dis. 2016 Apr;16(4):404.

lead_sponsor: Janssen R&D Ireland

location_country:
Germany
Poland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Portugal
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Puerto Rico
Norway
United Kingdom
Sweden
Austria
Spain
Greece
Bulgaria
Israel


acronym: ALTTO

lead_sponsor: Novartis Pharmaceuticals

summary:
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema.

The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.

ReferenceCitation: Nader-Marta G, Debien V, Eiger D, Tsourti Z, Caparica R, Kassapian M, Napoleone S, Hultsch S, Korde L, Wang Y, Chumsri S, Pritchard KI, Untch M, Bellet-Ezquerra M, Dornelles Rosa D, Moreno-Aspitia A, Piccart M, Dafni U, de Azambuja E. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1.

ReferenceCitation: Moreno-Aspitia A, Holmes EM, Jackisch C, de Azambuja E, Boyle F, Hillman DW, Korde L, Fumagalli D, Izquierdo MA, McCullough AE, Wolff AC, Pritchard KI, Untch M, Guillaume S, Ewer MS, Shao Z, Sim SH, Aziz Z, Demetriou G, Mehta AO, Andersson M, Toi M, Lang I, Xu B, Smith IE, Barrios CH, Baselga J, Gelber RD, Piccart-Gebhart M; ALTTO Steering Committee and Investigators. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23.

evidence: open (via crossref license, author manuscript)

ReferenceCitation: Sonnenblick A, Agbor-Tarh D, de Azambuja E, Hultsch S, Izquierdo M, Liu M, Pruneri G, Harbeck N, Piccart M, Moreno-Aspita A, Granit RZ, Rouas G, Fahoum I, Sotiriou C. STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial. Int J Cancer. 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385. Epub 2020 Nov 23.

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

ReferenceCitation: Eiger D, Ponde NF, Agbor-Tarh D, Moreno-Aspitia A, Piccart M, Hilbers FS, Werner O, Chumsri S, Dueck A, Kroep JR, Gomez H, Lang I, Rodeheffer RJ, Ewer MS, Suter T, de Azambuja E. Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Br J Cancer. 2020 May;122(10):1453-1460. doi: 10.1038/s41416-020-0786-x. Epub 2020 Mar 16.

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

repository_institution: Leiden University - Leiden Repository

ReferenceCitation: Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD; ALTTO Trial Study Team. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep 1;30(9):1507-1513. doi: 10.1093/annonc/mdz195.

ReferenceCitation: McCullough AE, Dell'orto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB, Andrighetto S, Chen B, Jackisch C, Untch M, Perez EA, Piccart-Gebhart MJ, Viale G. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014 Feb;143(3):485-92. doi: 10.1007/s10549-013-2827-0. Epub 2014 Jan 7.

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

sponsor_collaborators:
Novartis Pharmaceuticals
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Breast International Group
Canadian Cancer Trials Group

title: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Croatia
Chile
Pakistan
Czechia
Canada
France
Slovenia
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
China
Malaysia
Peru
Estonia
Philippines
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel