title: Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

acronym: CILAB

summary: This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

lead_sponsor: Sanofi

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
Sweden
United States
Chile
France
India
Belgium
Israel
Netherlands
South Africa
Turkey

location_facility: Sanofi-Aventis Investigational Site Number 840010

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 840030

location_facility: Sanofi-Aventis Investigational Site Number 250011

location_facility: Sanofi-Aventis Investigational Site Number 528005

location_facility: Sanofi-Aventis Investigational Site Number 840026

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 032002

location_facility: Sanofi-Aventis Investigational Site Number 840064

location_facility: Sanofi-Aventis Investigational Site Number 710003

location_facility: Sanofi-Aventis Investigational Site Number 710005

location_facility: Sanofi-Aventis Investigational Site Number 840001

location_facility: Sanofi-Aventis Investigational Site Number 840058

location_facility: Sanofi-Aventis Investigational Site Number 076007

location_facility: Sanofi-Aventis Investigational Site Number 840049

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 380006

location_facility: Sanofi-Aventis Investigational Site Number 710006

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 643005

location_facility: Sanofi-Aventis Investigational Site Number 643008

location_facility: Sanofi-Aventis Investigational Site Number 124003

location_facility: Sanofi-Aventis Investigational Site Number 840044

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 840031

location_facility: Sanofi-Aventis Investigational Site Number 376007

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 056006

location_facility: Sanofi-Aventis Investigational Site Number 250012

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 032003

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 356004

location_facility: Sanofi-Aventis Investigational Site Number 840056

location_facility: Sanofi-Aventis Investigational Site Number 840057

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840047

location_facility: Sanofi-Aventis Investigational Site Number 124006

location_facility: Sanofi-Aventis Investigational Site Number 710008

location_facility: Sanofi-Aventis Investigational Site Number 076005

location_facility: Sanofi-Aventis Investigational Site Number 076004

location_facility: Sanofi-Aventis Investigational Site Number 840065

location_facility: Sanofi-Aventis Investigational Site Number 840060

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 376001

location_facility: Sanofi-Aventis Investigational Site Number 376002

location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 840054

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 356005

location_facility: Sanofi-Aventis Investigational Site Number 124002

location_facility: Sanofi-Aventis Investigational Site Number 840050

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 724013

location_facility: Sanofi-Aventis Investigational Site Number 840002

location_facility: Sanofi-Aventis Investigational Site Number 032005

location_facility: Sanofi-Aventis Investigational Site Number 840017

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 840016

location_facility: Sanofi-Aventis Investigational Site Number 840032

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 356002

location_facility: Sanofi-Aventis Investigational Site Number 376004

location_facility: Sanofi-Aventis Investigational Site Number 724004

location_facility: Sanofi-Aventis Investigational Site Number 056005

location_facility: Sanofi-Aventis Investigational Site Number 724011

location_facility: Sanofi-Aventis Investigational Site Number 250009

location_facility: Sanofi-Aventis Investigational Site Number 840068

location_facility: Sanofi-Aventis Investigational Site Number 792006

location_facility: Sanofi-Aventis Investigational Site Number 032001

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 528004

location_facility: Sanofi-Aventis Investigational Site Number 840009

location_facility: Sanofi-Aventis Investigational Site Number 840038

location_facility: Sanofi-Aventis Investigational Site Number 840025

location_facility: Sanofi-Aventis Investigational Site Number 484004

location_facility: Sanofi-Aventis Investigational Site Number 250007

location_facility: Sanofi-Aventis Investigational Site Number 076001

location_facility: Sanofi-Aventis Investigational Site Number 376005

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 124001

location_facility: Sanofi-Aventis Investigational Site Number 840004

location_facility: Sanofi-Aventis Investigational Site Number 840019

location_facility: Sanofi-Aventis Investigational Site Number 643009

location_facility: Sanofi-Aventis Investigational Site Number 840039

location_facility: Sanofi-Aventis Investigational Site Number 032004

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 076006

location_facility: Sanofi-Aventis Investigational Site Number 376003

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 840046

location_facility: Sanofi-Aventis Investigational Site Number 840018

location_facility: Sanofi-Aventis Investigational Site Number 840021

location_facility: Sanofi-Aventis Investigational Site Number 616005

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 724006

location_facility: Sanofi-Aventis Investigational Site Number 710007

location_facility: Sanofi-Aventis Investigational Site Number 380008

location_facility: Sanofi-Aventis Investigational Site Number 356001

location_facility: Sanofi-Aventis Investigational Site Number 484005

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 840052

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 840045

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 840007

location_facility: Sanofi-Aventis Investigational Site Number 152001

location_facility: Sanofi-Aventis Investigational Site Number 643002

location_facility: Sanofi-Aventis Investigational Site Number 484003

location_facility: Sanofi-Aventis Investigational Site Number 840013

location_facility: Sanofi-Aventis Investigational Site Number 528006

location_facility: Sanofi-Aventis Investigational Site Number 616004

location_facility: Sanofi-Aventis Investigational Site Number 643010

location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 643004

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 724010

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 356007

location_facility: Sanofi-Aventis Investigational Site Number 840003

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 840024

location_facility: Sanofi-Aventis Investigational Site Number 036004

location_facility: Sanofi-Aventis Investigational Site Number 724012

location_facility: Sanofi-Aventis Investigational Site Number 840005

location_facility: Sanofi-Aventis Investigational Site Number 380005

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 356003

location_facility: Sanofi-Aventis Investigational Site Number 528007

location_facility: Sanofi-Aventis Investigational Site Number 840034

location_facility: Sanofi-Aventis Investigational Site Number 840035

location_facility: Sanofi-Aventis Investigational Site Number 076002

location_facility: Sanofi-Aventis Investigational Site Number 484007

location_facility: Sanofi-Aventis Investigational Site Number 643006

location_facility: Sanofi-Aventis Investigational Site Number 124007

location_facility: Sanofi-Aventis Investigational Site Number 840062

location_facility: Sanofi-Aventis Investigational Site Number 643003

location_facility: Sanofi-Aventis Investigational Site Number 643007

location_facility: Sanofi-Aventis Investigational Site Number 710009

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 076003

location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 724009

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 840048

location_facility: Sanofi-Aventis Investigational Site Number 724008

location_facility: Sanofi-Aventis Investigational Site Number 380004

location_facility: Sanofi-Aventis Investigational Site Number 616002

location_facility: Sanofi-Aventis Investigational Site Number 643011

location_facility: Sanofi-Aventis Investigational Site Number 840036

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 840061

location_facility: Sanofi-Aventis Investigational Site Number 792002


title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry

acronym: IHMR

summary: This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Ethicon, Inc.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
China
South Africa
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: Huadong Hospital- Affilated to Fudan University

location_facility: Owen Drive Surgical Clinic of Fayetteville

location_facility: South East Area Health Education Center (SEAHEC)

location_facility: Centre for the Advancement of Minimally Invasive Surgery (CAMIS)

location_facility: Service de Chirurgie Generale et Cancerologie Digestiv

location_facility: CH Avignon - Service de Chirurgie Digestive

location_facility: Laparoscopic Surgical Center of New York

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

summary: The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583. Review.

lead_sponsor: AstraZeneca

location_country:
Denmark
Portugal
Spain
United Kingdom
Russian Federation
Canada
France
Peru
Romania
Norway
Netherlands
Bulgaria

intervention_type: Drug

status_simplified: Completed


ipd_sharing: Yes

title: A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA

lead_sponsor: Pfizer

type: Other Identifier

type: EudraCT Number

source: euctr

ReferenceCitation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, García-Gutiérrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brümmendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

ReferenceCitation: Gambacorti-Passerini C, Cortes JE, Lipton JH, Dmoszynska A, Wong RS, Rossiev V, Pavlov D, Gogat Marchant K, Duvillié L, Khattry N, Kantarjian HM, Brümmendorf TH. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol. 2014 Oct;89(10):947-53. doi: 10.1002/ajh.23788. Epub 2014 Jul 21.

ReferenceCitation: Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10. Retraction in: Drug Metab Pharmacokinet. 2019 Apr;34(2):163.

RetractionSource: Drug Metab Pharmacokinet. 2019 Apr;34(2):163

ReferenceCitation: Trask PC, Cella D, Powell C, Reisman A, Whiteley J, Kelly V. Health-related quality of life in chronic myeloid leukemia. Leuk Res. 2013 Jan;37(1):9-13. doi: 10.1016/j.leukres.2012.09.013. Epub 2012 Oct 29.

ReferenceCitation: Cortes JE, Kim DW, Kantarjian HM, Brümmendorf TH, Dyagil I, Griskevicius L, Malhotra H, Powell C, Gogat K, Countouriotis AM, Gambacorti-Passerini C. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol. 2012 Oct 1;30(28):3486-92. Epub 2012 Sep 4.

ReferenceCitation: O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Review. Erratum in: Nat Rev Cancer. 2012 Dec;12(12):886.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
South Africa
Poland
Hong Kong
Russian Federation
Argentina
India
Turkey
Mexico
Singapore
Brazil
Canada
Hungary
China
Germany
Taiwan
Latvia
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: University Hospital Gent - Department of Hematology

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

location_facility: St-Petersburg Pavlov's State Medical University

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Study Supplies: Regional Cancer Care Associates

location_facility: Tata Memorial Center, Tata Memorial Hospital

location_facility: Charite University Medical Center - Campus Virchow Klinikum

location_facility: Stanford Hospital and Clinics Investigational Drug Services

location_facility: III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH

location_facility: Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego

location_facility: Hamamatsu Medical University Hospital Faculty of Medicine

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"

location_facility: Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"

location_facility: III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Niigata University Medical and Dental Hospital

location_facility: Ultrasaund Educational and Diagnostic Center

location_facility: Department of Cardiology, Chris Hani Baragwanath Hospital

location_facility: Centre Hospitalier de Versailles Hopital Andre Mignot

location_facility: Ospedale Ferrarotto - Divisione di Ematologia

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp

location_facility: Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"

location_facility: Institut Klinichnoi Radiologii Naukovogo

location_facility: CIOSAD Centro de Investigaciones Oncologicas

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico

location_facility: SEAROC Cancer Center, Soni Manipal Hospital

location_facility: Hammersmith Hospital Clinical Trial Units

location_facility: Complejo Hospitalario de Toledo- Servicio de Hematologia.

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Universitaetsklinikum Leipzig Zentrum fur Innere Medizin

location_facility: Department of Radiology, Chris Hani Baragwanath Hospital

location_facility: Oleksandrovska clinical hospital cardiological rehabilitation department

location_facility: Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini

location_facility: Kirov Research Institute of Hematology and Blood Transfusion of

location_facility: Centro De Hematologia E Hemoterapia Da Unicamp

location_facility: Perm Territory State Budgetary Healthcare Inst

location_facility: 3rd Floor Centre for Clinical Haematology

location_facility: Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.

location_facility: Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Samara Regional Clinical Hospital M.I. Kalinin

location_facility: Centre d'Investigation Clinique- CIC INSERM802

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia

location_facility: Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini

location_facility: Johannesburg Hospital, Department of Medical Oncology

location_facility: Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii

location_facility: Clinical Diagnostic Laboratory of Komunalnyj Zaklad

location_facility: Hematology, Oncology & Transfusion Medicine Center

location_facility: Cherkaskiy oblasniy onkologichniy dispanser

location_facility: Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital

location_facility: The Hematology Hospital of Chinese Academy of Medical Science

location_facility: Hospital Universitari Clinic de Barcelona

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

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

location_facility: Dipartimento Di Ematologia Ospedale Santo Eugenio

location_facility: Advanced Centre for Treatment, Research and Education in Cancer

location_facility: Clinical Haematology Unit - Department of Medicine

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

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

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Japanese Red Cross Nagoya First Hospital

location_facility: Department of Haematology - Level 3, Bexley Wing

location_facility: CHU de Charleroi - Hopital civil Marie Curie

location_facility: Hospital Clinico Universitario de Valencia (CHUV)

location_facility: Division of Hematology, Department of Medicine

summary: Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.


title: A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis

summary: Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15.

lead_sponsor: Astellas Pharma Inc

location_country:
Denmark
Poland
Spain
Ireland
Latvia
Netherlands
United Kingdom
Finland
Hungary
France
Belgium
Germany


acronym: Neo ALTTO

intervention_type: Biological

title: Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study: A Randomised, Multicenter Open-label Phase III Study of Neoadjuvant Lapatinib, Trastuzumab and Their Combination Plus Paclitaxel in Women With HER2/ErbB2 Positive Primary Breast Cancer

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Baselga J, Piccart M, Gelber R, di CosimoS, Viale G, Koehler M, Rojo F. Neo-ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study [BIG 1-06 /solti/EGF106903]: a phase III translational study for HER2-overexpressing early breast cancer. [Lancet]. 2012;S140-6736(11):

ReferenceCitation: Chumsri S, Li Z, Serie DJ, Norton N, Mashadi-Hossein A, Tenner K, Brauer HA, Warren S, Danaher P, Colon-Otero G, Partridge AH, Carey LA, Hilbers F, Van Dooren V, Holmes E, Di Cosimo S, Werner O, Huober JB, Dueck AC, Sotiriou C, Saura C, Moreno-Aspitia A, Knutson KL, Perez EA, Thompson EA. Adaptive immune signature in HER2-positive breast cancer in NCCTG (Alliance) N9831 and NeoALTTO trials. NPJ Breast Cancer. 2022 May 24;8(1):68. doi: 10.1038/s41523-022-00430-0.

ReferenceCitation: Pizzamiglio S, Cosentino G, Ciniselli CM, De Cecco L, Cataldo A, Plantamura I, Triulzi T, El-Abed S, Wang Y, Bajji M, Nuciforo P, Huober J, Ellard SL, Rimm DL, Gombos A, Daidone MG, Verderio P, Tagliabue E, Di Cosimo S, Iorio MV. What if the future of HER2-positive breast cancer patients was written in miRNAs? An exploratory analysis from NeoALTTO study. Cancer Med. 2022 Jan;11(2):332-339. doi: 10.1002/cam4.4449. Epub 2021 Dec 17.

ReferenceCitation: Powles RL, Redmond D, Sotiriou C, Loi S, Fumagalli D, Nuciforo P, Harbeck N, de Azambuja E, Sarp S, Di Cosimo S, Huober J, Baselga J, Piccart-Gebhart M, Elemento O, Pusztai L, Hatzis C. Association of T-Cell Receptor Repertoire Use With Response to Combined Trastuzumab-Lapatinib Treatment of HER2-Positive Breast Cancer: Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):e181564. doi: 10.1001/jamaoncol.2018.1564. Epub 2018 Nov 8.

ReferenceCitation: Fumagalli D, Venet D, Ignatiadis M, Azim HA Jr, Maetens M, Rothé F, Salgado R, Bradbury I, Pusztai L, Harbeck N, Gomez H, Chang TW, Coccia-Portugal MA, Di Cosimo S, de Azambuja E, de la Peña L, Nuciforo P, Brase JC, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C. RNA Sequencing to Predict Response to Neoadjuvant Anti-HER2 Therapy: A Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2017 Feb 1;3(2):227-234. doi: 10.1001/jamaoncol.2016.3824. Erratum in: JAMA Oncol. 2019 Jan 1;5(1):122.

ReferenceCitation: Salgado R, Denkert C, Campbell C, Savas P, Nuciforo P, Aura C, de Azambuja E, Eidtmann H, Ellis CE, Baselga J, Piccart-Gebhart MJ, Michiels S, Bradbury I, Sotiriou C, Loi S. Tumor-Infiltrating Lymphocytes and Associations With Pathological Complete Response and Event-Free Survival in HER2-Positive Early-Stage Breast Cancer Treated With Lapatinib and Trastuzumab: A Secondary Analysis of the NeoALTTO Trial. JAMA Oncol. 2015 Jul;1(4):448-54. doi: 10.1001/jamaoncol.2015.0830. Erratum in: JAMA Oncol. 2015 Jul;1(4):544. JAMA Oncol. 2015 Nov;1(8):1172. Nucifero, Paolo [corrected to Nuciforo, Paolo]. JAMA Oncol. 2019 Jan 1;5(1):122.

ReferenceCitation: Nuciforo PG, Aura C, Holmes E, Prudkin L, Jimenez J, Martinez P, Ameels H, de la Peña L, Ellis C, Eidtmann H, Piccart-Gebhart MJ, Scaltriti M, Baselga J. Benefit to neoadjuvant anti-human epidermal growth factor receptor 2 (HER2)-targeted therapies in HER2-positive primary breast cancer is independent of phosphatase and tensin homolog deleted from chromosome 10 (PTEN) status. Ann Oncol. 2015 Jul;26(7):1494-500. doi: 10.1093/annonc/mdv175. Epub 2015 Apr 7.

ReferenceCitation: de Azambuja E, Holmes AP, Piccart-Gebhart M, Holmes E, Di Cosimo S, Swaby RF, Untch M, Jackisch C, Lang I, Smith I, Boyle F, Xu B, Barrios CH, Perez EA, Azim HA Jr, Kim SB, Kuemmel S, Huang CS, Vuylsteke P, Hsieh RK, Gorbunova V, Eniu A, Dreosti L, Tavartkiladze N, Gelber RD, Eidtmann H, Baselga J. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol. 2014 Sep;15(10):1137-46. doi: 10.1016/S1470-2045(14)70320-1. Epub 2014 Aug 14.

ReferenceCitation: Yarden Y, Pines G. The ERBB network: at last, cancer therapy meets systems biology. Nat Rev Cancer. 2012 Jul 12;12(8):553-63. doi: 10.1038/nrc3309. Review.

ReferenceCitation: Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. doi: 10.1016/S0140-6736(11)61847-3. Epub 2012 Jan 17. Erratum in: Lancet. 2012 Feb 18;379(9816):616. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.

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:
Spain
Italy
United Kingdom
Lithuania
Ukraine
Peru
Romania
South Africa
Belgium
Czechia
Hong Kong
Russian Federation
Argentina
India
Norway
Sweden
Brazil
Canada
Hungary
Germany
Taiwan
Korea, Republic of
France
Pakistan

summary:
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer.

Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this biological window, patients on monotherapy arms will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m^2 for a further 12 weeks, up to definitive surgery. In the combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab 2 mg/kg IV plus weekly paclitaxel 80mg/m^2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with 5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant setting for a further 34 weeks (in the combination arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total duration of the anti-HER2 therapy one year.

Primary objective is to evaluate and compare the rate of pathological complete response (pCR) at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.


primary_purpose: Prevention

title: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.

lead_sponsor: Shire

ReferenceCitation: Raskin JB, Kamm MA, Jamal MM, Márquez J, Melzer E, Schoen RE, Szalóki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.

location_country:
Spain
United Kingdom
Australia
New Zealand
Argentina
United States
France
India
Israel
Colombia
Sweden

location_facility: Long Island Clinical Research Associates

location_facility: Lakeshore Hospital & Research Centre Ltd

location_facility: Allied Gastrointestinal Associates, P.A.

location_facility: Hospital General Universitario de Valencia

location_facility: Cabinet de Gastro-enterologie du Dr Alain Thevenin

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Aurora Advanced Healthcare, Inc. - Clinical Research Center

location_facility: Gastroenterology Associates Clinical Research

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Florida Medical Clinic/Tampa Clinical Trials

location_facility: Institute of Postgraduate Medical Education and Research

location_facility: Gastroenterology Associates of Fairfield County

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Long Island Gastrointestinal Research Group

summary: The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.


title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.

summary: Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.

location_country: Denmark Spain Greece Italy Netherlands Finland Sweden Hungary France Belgium Norway Germany

intervention_type: Device


status: Terminated

acronym: SCRIPT

title: A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy

lead_sponsor: Genentech, Inc.

ReferenceCitation: Emery P, Rigby W, Tak PP, Dörner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.

ReferenceCitation: Tak PP, Mease PJ, Genovese MC, Kremer J, Haraoui B, Tanaka Y, Bingham CO 3rd, Ashrafzadeh A, Travers H, Safa-Leathers S, Kumar S, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):360-70.

location_country:
Spain
Italy
United States
Peru
Belgium
Japan
Czechia
Poland
Slovenia
Australia
Argentina
Israel
Panama
Mexico
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
New Zealand
France
Netherlands

location_facility: Advanced Rheumatology & Arthritis Research Center

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Medical Specialists Clinical Research Center

location_facility: Hospital Clinic i Provincial; Servicio de Reumatologia

location_facility: Hospital de Jerez de la Frontera; Servicio de Reumatologia

location_facility: Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie

location_facility: Tokyo Medical & Dental University; Medicine & Rheumatology

location_facility: Sunshine Coast Rheumatology Research Unit

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza

location_facility: Hopital Maisonneuve- Rosemont; Rheumatology

location_facility: Physicians Group, LC DBA Rheumatology & Internal Medicine Associates

location_facility: Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Tampa General Hospital; Rheumatology Research Dept

location_facility: Groupe de Recherche En Rhumatologie Et Maladies Osseuses

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

location_facility: Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo

location_facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia

location_facility: Arizona Arthritis & Rheumatology Research, Pllc

location_facility: Inst. de Rehabilitacion Psicofisica; Reumathology

location_facility: Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology

location_facility: Uni of Texas Southwestern Medical Center; Internal Medicine

location_facility: Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Sierrallana; Servicio de Reumatologia

location_facility: Arthritis Rheumatic & Back Disease Associates

location_facility: St. Alexius Medical Center; Arthritis Clinic

location_facility: CHI St. Vincent Medical Group Hot Springs

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Clinsite;Research Division of Integrated Health Associates

location_facility: Jichi Medical School Hospital; Rheumatology and Clinical Immunology

location_facility: Centro de Infusion Marbella; Consultorios Royal Center Num 214

location_facility: Johns Hopkins University; Department of Rheumatology

location_facility: St. John'S Health System Inc.; St. John'S Medical Research

location_facility: Hospital Universitario Infanta Cristina; Servicio de Reumatologia

location_facility: Nashua Rheumatology - Foundation Medical Partners

location_facility: Rheumatology, P.C.; Medical Arts Building

location_facility: St. Joseph'S Health Care Centre; Rheumatology

location_facility: St. Mary'S Duluth Clinic Health System; Rheumatology Dept

location_facility: Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie

location_facility: Uni Hospital Linkoeping; Dept. of Rheumatology

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia

location_facility: Hospital Alberto Sabogal Sologuren; Remautology

location_facility: Seihoku Chuoh Hospital; Department Of Rheumatology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Reumatologia

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología

location_facility: UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Università Degli Studi Di Genova - Dimi; Reumatologia

location_facility: CHUV; Hôpital orthopédique, Rhumatologie

location_facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

location_facility: Jacksonville Center For Clinical Research

location_facility: Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia

location_facility: Hospital Abreu Sodre - AACD;Pesquisa Clinica

location_facility: Sarasota Arthritis Center; Research Dept

location_facility: Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier

location_facility: National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine

location_facility: Valerius Medical Group & Research Ctr of Greater Long Beach

location_facility: Wojewodzki Szpital Zespolony; Oddzial Reumatologii

location_facility: Rheumatology Associates of North Alabama

location_facility: Narodny Ustav Reumatickych Chorob - 34479; Rheumatology

location_facility: Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia

location_facility: Hospital de Basurto; Servicio de Reumatologia

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

location_facility: Orszagos Reumatologiai Es Fizioterapias Intezet

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia

location_facility: Uni of Southern California School of Medicine

location_facility: Arthritis & Rheumatism; Disease Specialities

location_facility: Iu Outpatient Clinical Research Facility

location_facility: Centro de Estudos em Terapias Inovadoras - CETI

location_facility: Centro Internacional de Pesquisa; Reumatologia

location_facility: Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie

location_facility: Deaconess Arthritis Center; Rheumatic Disease Study Group

location_facility: Irccs Policlinico San Matteo; Reumatologia Adulti

location_facility: Arthritis & Osteoporosis Associates, LLP

location_facility: Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik

location_facility: Princess Alexandra Hospital; Rheumatology

location_facility: Sasebo Chuo Hospital ; Internal Medicine

location_facility: Kentuckiana Center For Better Bone & Joint Healthx

location_facility: Stanford Uni Medical Center; Divison of Rheumatology

location_facility: Saitama Medical Center/School; Rheumatology, Clinical immunology

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia

location_facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Hospital General Universitario de Guadalajara; Servicio de Reumatologia

location_facility: The Governors of the Uni of Alberta; Heritage Medical Research Centre

location_facility: Universitätsspital Zürich; Klinik für Rheumatologie

location_facility: Chang Gung Medical Foundation - Kaohsiung; Rheumatology

location_facility: Evanston Northwestern Healthcare; Rheumatology

location_facility: Seacoast Arthritis and Osteoporosis Center

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Seirei Hamamatsu General Hospital; Rheumatology

location_facility: Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie

location_facility: The Ottawa Hospital - Riverside Campus; the Arthritis Centre

location_facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia

location_facility: Oklahoma Center For Arthritis Therapy & Research

location_facility: Complejo Asistencial Universitario de Burgos; Servicio de Reumatología

location_facility: Matsubara Mayflower Hospital; Rheumatology

location_facility: Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology

location_facility: Clinica San Felipe; Consultorio de Reumatología

location_facility: Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine

location_facility: University Health Network; Toronto Western Hospital

location_facility: Osaka Minami Medical Center; Rheumatoid Arthritis

location_facility: Sourasky / Ichilov Hospital; Rheumatology

location_facility: Saitama Medical University Hospital ; Rheumatology and Applied Immunology

location_facility: Hokkaido Uni Hospital; Second Department of Internal Medicine

location_facility: Arthrocare, Arthritis Care and Research, P.C.

location_facility: North Mississippi Medical Ctr; Internal Medicine Associates

location_facility: Klinik Duisburg; Klinik Für Rheumatologie

summary: This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.

status_simplified: Unknown


title: A Randomised, Parallel-group, Open-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir (Levemir®) Versus Human Insulin (NPH Insulin), Used in Combination With Insulin Aspart as Bolus Insulin, in the Treatment of Pregnant Women With Type 1 Diabetes

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: Mathiesen ER, Damm P, Jovanovic L, McCance DR, Thyregod C, Jensen AB, Hod M. Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. Diabetes Metab Res Rev. 2011 Sep;27(6):543-51. doi: 10.1002/dmrr.1213. Review.

ReferenceCitation: Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brøndsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. Epub 2012 Jul 30.

ReferenceCitation: Hod M, Mathiesen ER, Jovanovič L, McCance DR, Ivanisevic M, Durán-Garcia S, Brøndsted L, Nazeri A, Damm P. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med. 2014 Jan;27(1):7-13. doi: 10.3109/14767058.2013.799650. Epub 2013 Jun 5.

location_country:
Denmark
Croatia
Poland
Brazil
Spain
Ireland
Austria
Australia
Russian Federation
Argentina
Canada
Finland
United Kingdom
France
Israel
South Africa
Norway

summary: This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).


acronym: Beyond

title: International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg

lead_sponsor: Bayer

ReferenceCitation: Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27.

location_country:
Spain
Italy
Ukraine
United States
Belgium
Poland
Slovenia
Russian Federation
Austria
Australia
Argentina
Israel
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Ireland
Latvia
Finland
France
Netherlands

summary: The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.


title: Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.

summary: This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

ReferenceCitation: Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naïve patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. Epub 2006 May 30.

ReferenceCitation: Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. Epub 2006 Jan 30.

ReferenceCitation: S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006

ReferenceCitation: Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006

ReferenceCitation: Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45.

ReferenceCitation: Nelson DR, Benhamou Y, Chuang WL, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JW, Kryczka W, Lee CM, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-2/3 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3. Gastroenterology. 2010 Oct;139(4):1267-76. doi: 10.1053/j.gastro.2010.06.062. Epub 2010 Jul 1.

lead_sponsor: Human Genome Sciences Inc.

location_country:
Spain
United Kingdom
United States
Belgium
Poland
Australia
Argentina
Puerto Rico
India
Israel
Mexico
Sweden
Malaysia
Singapore
Brazil
Canada
Germany
Taiwan
Thailand
Korea, Republic of
France

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia

location_facility: St George Hospital Clinical School of Medicine

location_facility: NY Presbyterian Medical Center - Columbia Univ. Med Center

location_facility: Universidade Federal de São Paulo - UNIFESP

location_facility: Gallipoli Research Foundation and Greenslopes Private Hospital

location_facility: Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"

location_facility: P. D. Hinduja National Hospital and Medical Research Centre

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Maulana Azad Medical College and Associated Lok Nayak Hospital

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Complejo Hospitalario Nuestra Señora de Valme

location_facility: Seoul National University Hospital(Bundang)

location_facility: University of Manitoba Health Sciences Centre

location_facility: Jaslok Hospital and Research Centre and Breach Candy Hospital,


title: Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1

summary: This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.

ReferenceCitation: Zeuzem S, Sulkowski MS, Lawitz EJ, Rustgi VK, Rodriguez-Torres M, Bacon BR, Grigorescu M, Tice AD, Lurie Y, Cianciara J, Muir AJ, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-1 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 1. Gastroenterology. 2010 Oct;139(4):1257-66. doi: 10.1053/j.gastro.2010.06.066. Epub 2010 Jun 27.

location_country:
Poland
Spain
Italy
Austria
Australia
United Kingdom
Canada
Czech Republic
Puerto Rico
United States
France
India
Israel
Romania
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: University of California at San Francisco

location_facility: Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego

location_facility: University of Colorado Health Sciences Ctr

location_facility: Institutul de Gastroenterologie si Hepatologie

location_facility: Northwest Georgia Gastroenterology Associates

location_facility: Seconda Università di Napoli c/o Secondo Policlinico

location_facility: IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

location_facility: Azienda Ospedaliera S. Giovanni Battista Molinette

location_facility: Nottingham University Hospitals NHS Trust Queens Medical Centre Campus

location_facility: St George Hospital Clinical School of Medicine University of New South Wales

location_facility: I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Tulane University Health Sciences Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Virginia Commonwealth University Medical Ctr

location_facility: San Diego Digestive Diseases Consultants, Inc

location_facility: Imperial College London St Mary's Hospital Campus


title: A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)

acronym: Darusentan

summary: This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.

ReferenceCitation: Bakris GL, Lindholm LH, Black HR, Krum H, Linas S, Linseman JV, Arterburn S, Sager P, Weber M. Divergent results using clinic and ambulatory blood pressures: report of a darusentan-resistant hypertension trial. Hypertension. 2010 Nov;56(5):824-30. doi: 10.1161/HYPERTENSIONAHA.110.156976. Epub 2010 Oct 4.

lead_sponsor: Gilead Sciences

location_country:
Denmark
Brazil
Spain
Australia
New Zealand
Argentina
United States
France
Belgium
Germany

location_facility: Centre for Clinical Research and Effective Practice (CCRep)

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: Methodist Medical Center-Heart, Lung & Vascular Institute

location_facility: Private Practice for Internal Medicine & Cardiology

location_facility: Southeast Texas Clinical Research Center

location_facility: Region Sjaelland, Storstrommens Sygenhus, Naestved

location_facility: Hospital General de Agudos "Dr. Abel Zubizarreta"

location_facility: Castlerock Clinical Research Counsultants, LLC

location_facility: Private Practice of Dr. Geert Hollanders

location_facility: Executive Health and Research Associates

location_facility: Diabaid (Instituto de Asistencia Integral en Diabetes)

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Instituto de Investigaciones Clinicas de Quilmes

location_facility: Charite Campus Mitte, Universitatsmedizin Berlin

location_facility: Private Practice of Dr. Isabelle Schenkenberger

location_facility: Ormond Medical Arts Pharmaceutical Research center

location_facility: Private Practice of Dr. Jean Boulet-Gercourt

location_facility: Internal Medicine Associates of South Florida

location_facility: Fletcher Allen Health Care/University of Vermont

location_facility: Private Practice of Dr. Francis Vrancken

location_facility: Private Practice of Dr. Gildas Ganuchaud

location_facility: Private Practice of Dr. Bridget Bellingar

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Central Minnesota Heart Center at St. Cloud Hospital

location_facility: Private Practice of Dr. Herwig Van Aerde

location_facility: HealthFirst Physician of AR, PA dba Convenient Care Clinic

location_facility: Private Practice of Dr. Josef Junggeburth

location_facility: Northwest Florida Heart Group, PA - Research Dept

location_facility: IFG-Institut fur Gesundheitsforderung GmbH


title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine) (CGX-635) in the Treatment of Patients With Chronic Myeloid Leukemia. (CML) With the T315I BCR-ABL Gene Mutation

summary: To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.

ReferenceCitation: Cortes J, Lipton JH, Rea D, Digumarti R, Chuah C, Nanda N, Benichou AC, Craig AR, Michallet M, Nicolini FE, Kantarjian H; Omacetaxine 202 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation. Blood. 2012 Sep 27;120(13):2573-80. Epub 2012 Aug 15.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Poland
United Kingdom
Italy
Canada
Hungary
United States
France
India
Singapore
Germany

location_facility:
Teva Investigational Site 009
Teva Investigational Site 060
Teva Investigational Site 028
Teva Investigational Site 002
Teva Investigational Site 027
Teva Investigational Site 011
Teva Investigational Site 004
Teva Investigational Site 061
Teva Investigational Site 026
Teva Investigational Site 003
Teva Investigational Site 024
Teva Investigational Site 031
Teva Investigational Site 022
Teva Investigational Site 010
Teva Investigational Site 005
Teva Investigational Site 001
Teva Investigational Site 020
Teva Investigational Site 006
Teva Investigational Site 025
Teva Investigational Site 040
Teva Investigational Site 007
Teva Investigational Site 029
Teva Investigational Site 080
Teva Investigational Site 090
Teva Investigational Site 008
Teva Investigational Site 023
Teva Investigational Site 070
Teva Investigational Site 050
Teva Investigational Site 021
Teva Investigational Site 071
Teva Investigational Site 013
Teva Investigational Site 030


title: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.

summary: To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

lead_sponsor: Pharmexa A/S

location_country:
Denmark
Poland
Spain
Ireland
Italy
Australia
Sweden
United States
France
Belgium
Norway
Netherlands

location_facility: Carolinas Hematology Oncology Associates

location_facility: Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital

location_facility: Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita

location_facility: Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas

location_facility: Fundaciόn Hospital de Alcorcόn, Unidad de Oncología

location_facility: Flinders Medical Centre, Medical Oncology - Clinical Trials

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Cancer Clinical Trials Unit, Beaumont Hospital

location_facility: Sahlgrenska Hospital, Head Division for Upper GI Surgery

location_facility: Hepatogastroenterology Dpt, University Hospital Center of Grenoble

location_facility: Ullevål Universitetssykehus, Gastrokirurgisk afd.

location_facility: University Hospital, Department Of surgery and Gasterenterology

location_facility: Cancer Research Unit, Mater Misericordlae University Hospital

location_facility: Medical Oncology Department, Virgen de Las Nieves Hospital

location_facility: Department of Oncology, Karolinska Universitetssjukhuset

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Clínica Puerta de Hierro, Departamento de Oncología

location_facility: Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii

location_facility: Digestive Unit, Universitary Hospital Virgen de La Macarena

location_facility: Service de Cancerologie, Hospital Europeen Georges Pompidou

location_facility: Hospital Universitario Gregorio Marañón, Departamento de Oncología

location_facility: Tampa General Hospital Usf Digestive Disorders Centre

location_facility: Department of Oncology, Malmö University Hospital

location_facility: Hospital Universitario La Paz, Departamento de Oncología

location_facility: Policlinico Universitario "Mater Domini", Unita Oncologia

location_facility: Oncology Department, Clinic Universitary Hospital

location_facility: Centrum Onkologii, Wosewodzki Osrodek Onkologii

location_facility: Fremantle Hospital, Haemtology Department

location_facility: Karolinska Institute / Hospital Solna, Department of Oncology

location_facility: Department of Oncology, University Hospital of Northern-Norway

location_facility: Sorlandet Hospital, Senter for Kreftbehandling

location_facility: Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale

location_facility: Medical Oncology Dpt, Armoricaine Private Hospital of Radiology

location_facility: Royal Hobart Hospital, Centre for Clinical Research

location_facility: Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych

location_facility: Odense Universitetshospital, Onkologisk afd. R

location_facility: Toledo Community Hospital Oncology Program

location_facility: Oncology Hematology Associates of Central Illinois, PC

location_facility: St George Hospital, Department of Medical Oncology

location_facility: Ghent University Hospital, Digestive Oncology

location_facility: Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology

location_facility: The Townsville Hospital, Townsville Cancer Centre

location_facility: Mary Crowley Medical Research Center, Worth St.

location_facility: Service de Medicine Interne, CHRU de Lille

location_facility: Hospital Clinic I Provincial De Barcelona

location_facility: Oncology Research Team, Mater Private University Hospital

location_facility: Medical Oncology Department, General Hospital of Baza

location_facility: Oncology Trials Unit, Cork University Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii

location_facility: The Alfred Hospital, Medical Oncology Unit

location_facility: Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University

location_facility: Azienda Ospedaliera, Arcispedale S. Maria Nuova

location_facility: Oncologie Médicale, Centre Cathrine de Siennes

location_facility: Royal Perth Hospital, Department of Medical Oncology

location_facility: Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma

location_facility: Hematology Oncology Specialists, Covington

location_facility: Westmead Hospital, Dept. of Medical Oncology and Palliative Care

location_facility: Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin


title: A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment

acronym: ONYX

summary:
To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

ReferenceCitation: McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.

ReferenceCitation: Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.

ReferenceCitation: Weisler R, McIntyre RS, Bauer M. Extended-release quetiapine fumarate in the treatment of patients with major depressive disorder: adjunct therapy. Expert Rev Neurother. 2013 Nov;13(11):1183-200. doi: 10.1586/14737175.2013.846519. Review.

ReferenceCitation: Bauer M, Demyttenaere K, El-Khalili N, Thase ME, Papakostas GI, Szamosi J, Earley WR, Eriksson H. Pooled analysis of adjunct extended-release quetiapine fumarate in patients with major depressive disorder according to ongoing SSRI or SNRI treatment. Int Clin Psychopharmacol. 2014 Jan;29(1):16-25. doi: 10.1097/YIC.0000000000000011.

ReferenceCitation: Clayton AH, Locklear JC, Svedsäter H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.

ReferenceCitation: Bauer M, McIntyre RS, Szamosi J, Eriksson H. Evaluation of adjunct extended-release quetiapine fumarate on sleep disturbance and quality in patients with major depressive disorder and an inadequate response to on-going antidepressant therapy. Int J Neuropsychopharmacol. 2013 Sep;16(8):1755-65. doi: 10.1017/S146114571300031X. Epub 2013 May 14.

ReferenceCitation: Vieta E, Bauer M, Montgomery S, McIntyre RS, Szamosi J, Earley WR, Eriksson H. Pooled analysis of sustained response rates for extended release quetiapine fumarate as monotherapy or adjunct to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2013 Sep 5;150(2):639-43. doi: 10.1016/j.jad.2013.01.052. Epub 2013 Mar 14.

ReferenceCitation: Bauer M, Pretorius HW, Constant EL, Earley WR, Szamosi J, Brecher M. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009 Apr;70(4):540-9. Epub 2009 Apr 7.

location_country:
Poland
Romania
Australia
Finland
Canada
Czech Republic
Sweden
France
South Africa
Belgium
Norway
Germany


title: A Phase III Study of STI571 Versus Interferon-α (IFN-α) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

summary: The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

ReferenceCitation: Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP, Baccarani M, Deininger MW, Cervantes F, Fujihara S, Ortmann CE, Menssen HD, Kantarjian H, O'Brien SG, Druker BJ; IRIS Investigators. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017 Mar 9;376(10):917-927. doi: 10.1056/NEJMoa1609324.

ReferenceCitation: Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintás-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25.

ReferenceCitation: Larson RA, Druker BJ, Guilhot F, O'Brien SG, Riviere GJ, Krahnke T, Gathmann I, Wang Y; IRIS (International Randomized Interferon vs STI571) Study Group. Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood. 2008 Apr 15;111(8):4022-8. doi: 10.1182/blood-2007-10-116475. Epub 2008 Feb 6.

location_country:
Denmark
Spain
Italy
Austria
Australia
Netherlands
Canada
New Zealand
Switzerland
United Kingdom
Sweden
United States
France
Belgium
Norway
Germany


title: A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

summary:
This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.

This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.

ReferenceCitation: Crump M, Leppä S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. doi: 10.1200/JCO.2015.65.7171. Epub 2016 May 23.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Australia
Puerto Rico
India
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Phase 3 Multinational, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment With MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects With Mild Dementia of the Alzheimer's Type

summary: This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. Study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.

lead_sponsor: Myrexis Inc.

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Canada
Switzerland
Sweden
United States
France
Belgium
Germany


title: Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab

summary: To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab

ReferenceCitation: Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24.

ReferenceCitation: Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.

ReferenceCitation: Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.

lead_sponsor: UCB Pharma

location_country:
Denmark
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
Sweden
United States
France
Belgium
Norway
Germany


title: Long-term Safety Follow-up of REMICADE (RESULTS)

summary: This is a study evaluating the long-term safety of infliximab (Remicade)

lead_sponsor: Centocor, Inc.

location_country:
Denmark
Poland
Spain
Ireland
Austria
Netherlands
United Kingdom
Argentina
Canada
Finland
Switzerland
Sweden
Hungary
United States
France
Israel
Belgium
Norway
Germany


title: Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

summary: The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

ReferenceCitation: Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1.

ReferenceCitation: Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Portugal
Spain
Italy
Russian Federation
Estonia
Australia
Netherlands
Czech Republic
Switzerland
United Kingdom
Hungary
United States
France
South Africa
Germany
Bulgaria


title: International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

summary: To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Australia
India
Israel
Mexico
Sweden
Cyprus
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
Czech Republic
Korea, Republic of
France
Netherlands


title: Supportive Test for Acid-Related Symptoms (STARS II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.

summary: The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.

ReferenceCitation: van Zanten SV, Wahlqvist P, Talley NJ, Halling K, Vakil N, Lauritsen K, Flook N, Persson T, Bolling-Sternevald E; STARS II Investigators. Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study. Aliment Pharmacol Ther. 2011 Oct;34(7):714-23. doi: 10.1111/j.1365-2036.2011.04789.x. Epub 2011 Aug 17.

ReferenceCitation: van Zanten SV, Flook N, Talley NJ, Vakil N, Lauritsen K, Bolling-Sternevald E, Persson T, Björck E, Svedberg LE; STARS II Study Group. One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole: a randomized, placebo-controlled study. Aliment Pharmacol Ther. 2007 Sep 1;26(5):665-72.

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Austria
Mexico
Finland
Canada
Switzerland
Sweden
Hungary
France
South Africa
Belgium
Norway
Germany


title: A Multicentre, Two-part, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Tolerability and Pharmacokinetics of the iNOS Inhibitor GW274150 Administered up to 120mg Daily for 12 Weeks in the Prophylactic Treatment of Migraine.

summary: Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the prevention of migraine headache. GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. The intent of this study is to investigate the safety and efficacy of GW274150 for the prophylactic treatment of migraine headache.

lead_sponsor: GlaxoSmithKline

location_country: Denmark Spain Italy Netherlands Finland France Belgium Norway Germany

intervention_type: Other


title: A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.

summary: The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.

ReferenceCitation: Cataliotti L, Buzdar AU, Noguchi S, Bines J, Takatsuka Y, Petrakova K, Dube P, de Oliveira CT. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial. Cancer. 2006 May 15;106(10):2095-103.

ReferenceCitation: Fujiwara Y, Takatsuka Y, Imoto S, Inaji H, Ikeda T, Akiyama F, Tamura M, Miyoshi K, Iwata H, Mitsuyama S, Noguchi S. Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen. Cancer Sci. 2012 Mar;103(3):491-6. doi: 10.1111/j.1349-7006.2011.02171.x. Epub 2012 Jan 13.

location_country:
Brazil
Italy
Canada
Czech Republic
Hungary
United States
France
Belgium
Japan
Netherlands


title: CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness

summary: The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.

lead_sponsor: Janssen-Cilag International NV

location_country:
Croatia
Saudi Arabia
Spain
United Kingdom
Lithuania
Romania
Poland
Portugal
Slovenia
Austria
Israel
Turkey
Sweden
Slovakia
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
Latvia
Czech Republic
France


title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation

summary: The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

ReferenceCitation: Krämer BK, Albano L, Banas B, Charpentier B, Bäckman L, Tedesco-Silva H Jr, Lehner F, Mondragón-Ramírez GA, Glyda M, Cassuto-Viguier E, Viklický O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.

lead_sponsor: Astellas Pharma Inc

location_country:
Spain
Italy
United Kingdom
South Africa
Belgium
Poland
Austria
Australia
Argentina
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Greece
Ireland
Finland
Czech Republic
France
Netherlands


title: Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.

ReferenceCitation: Musat E, Roelofs E, Bar-Deroma R, Fenton P, Gulyban A, Collette L, Stupp R, Weber DC, Bernard Davis J, Aird E, Baumert BG. Dummy run and conformity indices in the ongoing EORTC low-grade glioma trial 22033-26033: First evaluation of quality of radiotherapy planning. Radiother Oncol. 2010 May;95(2):218-24. doi: 10.1016/j.radonc.2010.03.005. Epub 2010 Apr 6.

ReferenceCitation: Fairchild A, Weber DC, Bar-Deroma R, Gulyban A, Fenton PA, Stupp R, Baumert BG. Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review. Radiother Oncol. 2012 Jun;103(3):287-92. doi: 10.1016/j.radonc.2012.04.002. Epub 2012 May 3.

ReferenceCitation: Gao Y, Weenink B, van den Bent MJ, Erdem-Eraslan L, Kros JM, Sillevis Smitt P, Hoang-Xuan K, Brandes AA, Vos M, Dhermain F, Enting R, Ryan GF, Chinot O, Ben Hassel M, van Linde ME, Mason WP, Gijtenbeek JMM, Balana C, von Deimling A, Gorlia T, Stupp R, Hegi ME, Baumert BG, French PJ. Expression-based intrinsic glioma subtypes are prognostic in low-grade gliomas of the EORTC22033-26033 clinical trial. Eur J Cancer. 2018 May;94:168-178. doi: 10.1016/j.ejca.2018.02.023. Epub 2018 Mar 20.

ReferenceCitation: Baumert BG, Hegi ME, van den Bent MJ, von Deimling A, Gorlia T, Hoang-Xuan K, Brandes AA, Kantor G, Taphoorn MJB, Hassel MB, Hartmann C, Ryan G, Capper D, Kros JM, Kurscheid S, Wick W, Enting R, Reni M, Thiessen B, Dhermain F, Bromberg JE, Feuvret L, Reijneveld JC, Chinot O, Gijtenbeek JMM, Rossiter JP, Dif N, Balana C, Bravo-Marques J, Clement PM, Marosi C, Tzuk-Shina T, Nordal RA, Rees J, Lacombe D, Mason WP, Stupp R. Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1521-1532. doi: 10.1016/S1470-2045(16)30313-8. Epub 2016 Sep 27.

ReferenceCitation: Reijneveld JC, Taphoorn MJB, Coens C, Bromberg JEC, Mason WP, Hoang-Xuan K, Ryan G, Hassel MB, Enting RH, Brandes AA, Wick A, Chinot O, Reni M, Kantor G, Thiessen B, Klein M, Verger E, Borchers C, Hau P, Back M, Smits A, Golfinopoulos V, Gorlia T, Bottomley A, Stupp R, Baumert BG. Health-related quality of life in patients with high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1533-1542. doi: 10.1016/S1470-2045(16)30305-9. Epub 2016 Sep 27.

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

location_country:
Portugal
Luxembourg
Spain
Italy
Austria
Australia
Netherlands
Canada
New Zealand
Switzerland
United Kingdom
Sweden
Hungary
France
Israel
Singapore
Belgium
Germany
Egypt

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli

location_facility: Sir Charles Gairdner Hospital - Nedlands

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: Istituto Regina Elena / Istituti Fisioterapici Ospitalieri

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

location_facility: Mcgill University Health Centre - Gerald Bronfman Centre - Dept Of Oncology

location_facility: Rambam Health Care Campus, Oncology Institute

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Edmond Odette Cancer Centre at Sunnybrook

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Allan Blair Cancer Centre at Pasqua Hospital

location_facility: Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital

location_facility: Maastro Clinic - Maastricht Radiation Oncology

location_facility: Hospital Clinico Universitario de Barcelona

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

location_facility: Radboud University Medical Center Nijmegen

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)

intervention_type: Radiation


title: A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

summary: To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.

lead_sponsor: Pfizer

location_country:
Denmark
Spain
Greece
Ireland
Australia
Italy
Netherlands
United Kingdom
Sweden
France
Belgium
Germany


title: A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

summary: The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

ReferenceCitation: Schiff M, Pritchard C, Huffstutter JE, Rodriguez-Valverde V, Durez P, Zhou X, Li T, Bahrt K, Kelly S, Le Bars M, Genovese MC. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. doi: 10.1136/ard.2008.099218. Epub 2008 Dec 15.

ReferenceCitation: Alten R, Burkhardt H, Feist E, Krüger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.

ReferenceCitation: Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

ReferenceCitation: Hassett AL, Li T, Buyske S, Savage SV, Gignac MA. The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study. Curr Med Res Opin. 2008 May;24(5):1443-53. doi: 10.1185/030079908X297376 . Epub 2008 Apr 9.

ReferenceCitation: Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, Li T, Schmidely N, Le Bars M, Dougados M. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis. 2008 Apr;67(4):547-54. Epub 2007 Oct 5.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Ireland
Italy
Mexico
United Kingdom
Czech Republic
France
United States
Belgium
Germany


title: A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.

summary:
The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions:

Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)

Group A - Imatinib failure only (arms 2, 3 and 4)

imatinib-resistant or intolerant CML - Chronic Phase (CP)
imatinib-resistant or intolerant CML - Accelerated Phase (AP)
imatinib-resistant or intolerant CML - Blast Crisis (BC)

Group B - Imatinib and other TKI failure (arms 2, 3 and 4)

imatinib-resistant or intolerant CML - Chronic Phase (CP)
imatinib-resistant or intolerant CML - Accelerated Phase (AP)
imatinib-resistant or intolerant CML - Blast Crisis (BC)

Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)

Systemic mastocytosis (Sm) (arm 6)

ReferenceCitation: Hochhaus A, Baccarani M, Giles FJ, le Coutre PD, Müller MC, Reiter A, Santanastasio H, Leung M, Novick S, Kantarjian HM. Nilotinib in patients with systemic mastocytosis: analysis of the phase 2, open-label, single-arm nilotinib registration study. J Cancer Res Clin Oncol. 2015 Nov;141(11):2047-60. doi: 10.1007/s00432-015-1988-0. Epub 2015 May 23.

ReferenceCitation: Hochhaus A, le Coutre PD, Kantarjian HM, Baccarani M, Erben P, Reiter A, McCulloch T, Fan X, Novick S, Giles FJ. Effect of the tyrosine kinase inhibitor nilotinib in patients with hypereosinophilic syndrome/chronic eosinophilic leukemia: analysis of the phase 2, open-label, single-arm A2101 study. J Cancer Res Clin Oncol. 2013 Dec;139(12):1985-93. doi: 10.1007/s00432-013-1529-7. Epub 2013 Sep 22.

ReferenceCitation: Stein AM, Martinelli G, Hughes TP, Müller MC, Beppu L, Gottardi E, Branford S, Soverini S, Woodman RC, Hochhaus A, Kim DW, Saglio G, Radich JP. Rapid initial decline in BCR-ABL1 is associated with superior responses to second-line nilotinib in patients with chronic-phase chronic myeloid leukemia. BMC Cancer. 2013 Apr 2;13:173. doi: 10.1186/1471-2407-13-173.

ReferenceCitation: Kantarjian HM, Giles FJ, Bhalla KN, Pinilla-Ibarz J, Larson RA, Gattermann N, Ottmann OG, Hochhaus A, Radich JP, Saglio G, Hughes TP, Martinelli G, Kim DW, Shou Y, Gallagher NJ, Blakesley R, Baccarani M, Cortes J, le Coutre PD. Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results. Blood. 2011 Jan 27;117(4):1141-5. doi: 10.1182/blood-2010-03-277152. Epub 2010 Nov 22.

ReferenceCitation: Kantarjian HM, Giles F, Gattermann N, Bhalla K, Alimena G, Palandri F, Ossenkoppele GJ, Nicolini FE, O'Brien SG, Litzow M, Bhatia R, Cervantes F, Haque A, Shou Y, Resta DJ, Weitzman A, Hochhaus A, le Coutre P. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood. 2007 Nov 15;110(10):3540-6. Epub 2007 Aug 22.

ReferenceCitation: Kantarjian H, Giles F, Wunderle L, Bhalla K, O'Brien S, Wassmann B, Tanaka C, Manley P, Rae P, Mietlowski W, Bochinski K, Hochhaus A, Griffin JD, Hoelzer D, Albitar M, Dugan M, Cortes J, Alland L, Ottmann OG. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL. N Engl J Med. 2006 Jun 15;354(24):2542-51.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Hong Kong
Austria
Australia
Norway
Sweden
Singapore
Canada
Switzerland
Germany
Denmark
Taiwan
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: Wake Forest University Baptist Medical Center

location_facility: Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services

location_facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie

location_facility: University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)

location_facility: Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2)

location_facility: Roswell Park Cancer Institute Rosewell SC

location_facility: University of Michigan Health System Clinical Trials Office

location_facility: University of Illinois at Chicago Divisionof Hematology/Oncology

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt