summary: There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

ReferenceCitation: Chandarlapaty S, Chen D, He W, Sung P, Samoila A, You D, Bhatt T, Patel P, Voi M, Gnant M, Hortobagyi G, Baselga J, Moynahan ME. Prevalence of ESR1 Mutations in Cell-Free DNA and Outcomes in Metastatic Breast Cancer: A Secondary Analysis of the BOLERO-2 Clinical Trial. JAMA Oncol. 2016 Oct 1;2(10):1310-1315. doi: 10.1001/jamaoncol.2016.1279. Erratum In: JAMA Oncol. 2019 Jan 1;5(1):122.

publisher_dissemination: American Medical Association

ReferenceCitation: Hortobagyi GN, Chen D, Piccart M, Rugo HS, Burris HA 3rd, Pritchard KI, Campone M, Noguchi S, Perez AT, Deleu I, Shtivelband M, Masuda N, Dakhil S, Anderson I, Robinson DM, He W, Garg A, McDonald ER 3rd, Bitter H, Huang A, Taran T, Bachelot T, Lebrun F, Lebwohl D, Baselga J. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2. J Clin Oncol. 2016 Feb 10;34(5):419-26. doi: 10.1200/JCO.2014.60.1971. Epub 2015 Oct 26. Erratum In: J Clin Oncol. 2019 Feb 1;37(4):354. J Clin Oncol. 2019 Feb 1;37(4):355.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Piccart M, Hortobagyi GN, Campone M, Pritchard KI, Lebrun F, Ito Y, Noguchi S, Perez A, Rugo HS, Deleu I, Burris HA 3rd, Provencher L, Neven P, Gnant M, Shtivelband M, Wu C, Fan J, Feng W, Taran T, Baselga J. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2dagger. Ann Oncol. 2014 Dec;25(12):2357-2362. doi: 10.1093/annonc/mdu456. Epub 2014 Sep 17.

ReferenceCitation: Rugo HS, Pritchard KI, Gnant M, Noguchi S, Piccart M, Hortobagyi G, Baselga J, Perez A, Geberth M, Csoszi T, Chouinard E, Srimuninnimit V, Puttawibul P, Eakle J, Feng W, Bauly H, El-Hashimy M, Taran T, Burris HA 3rd. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2. Ann Oncol. 2014 Apr;25(4):808-815. doi: 10.1093/annonc/mdu009. Epub 2014 Mar 10.

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Yardley DA, Noguchi S, Pritchard KI, Burris HA 3rd, Baselga J, Gnant M, Hortobagyi GN, Campone M, Pistilli B, Piccart M, Melichar B, Petrakova K, Arena FP, Erdkamp F, Harb WA, Feng W, Cahana A, Taran T, Lebwohl D, Rugo HS. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013 Oct;30(10):870-84. doi: 10.1007/s12325-013-0060-1. Epub 2013 Oct 25. Erratum In: Adv Ther. 2014 Sep;31(9):1008-9.

ReferenceCitation: Campone M, Beck JT, Gnant M, Neven P, Pritchard KI, Bachelot T, Provencher L, Rugo HS, Piccart M, Hortobagyi GN, Nunzi M, Heng DY, Baselga J, Komorowski A, Noguchi S, Horiguchi J, Bennett L, Ziemiecki R, Zhang J, Cahana A, Taran T, Sahmoud T, Burris HA 3rd. Health-related quality of life and disease symptoms in postmenopausal women with HR(+), HER2(-) advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy. Curr Med Res Opin. 2013 Nov;29(11):1463-73. doi: 10.1185/03007995.2013.836078. Epub 2013 Sep 4.

ReferenceCitation: Noguchi S, Masuda N, Iwata H, Mukai H, Horiguchi J, Puttawibul P, Srimuninnimit V, Tokuda Y, Kuroi K, Iwase H, Inaji H, Ohsumi S, Noh WC, Nakayama T, Ohno S, Rai Y, Park BW, Panneerselvam A, El-Hashimy M, Taran T, Sahmoud T, Ito Y. Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2. Breast Cancer. 2014 Nov;21(6):703-14. doi: 10.1007/s12282-013-0444-8. Epub 2013 Feb 13.

repository_institution: Yonsei University Medical Library - YUHSpace

ReferenceCitation: Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.

location_facility: Penn State University / Milton S. Hershey Medical Center Division of Oncology (2)

location_facility: Southeast Nebraska Oncology Cancer Center

location_facility: Comprehensive Cancer Center - Boca Raton Deerfield Beach

location_facility: The Angeles Clinic and Research Institute

location_facility: Regional Cancer Care Associates Dept. of the CCHD

location_facility: University of New Mexico Cancer Research Center Dept of UNM Cancer & Research

location_facility: Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (2)

location_facility: Cancer Care Associates Dept.ofCancerCareAssoc. (2)

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

location_facility: Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA

location_facility: Weill Cornell Medical College Weill Cornell Med. Ctr.

location_facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: Hematology Oncology Clinic Hematology Oncology Clinic (2)

location_facility: Hematology Oncology Association of Rockland

location_facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)

location_facility: University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2)

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

location_facility: University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr.

location_facility: Frederick Memorial Hospital Dept. of FMH-IRB

location_facility: Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

location_facility: Sharp Memorial Hospital SharpClinicalOncologyResearch

location_facility: St Joseph Heritage Healthcare Dept. of RRMG (4)

location_facility: Oncology Specialists, SC Dept.of Oncology Specialists

location_facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

location_facility: Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)

location_facility: Mercy Medical Center Medical Oncology & Hematology

location_facility: Memorial Hospital Memorial Cancer Institute

location_facility: Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc

location_facility: Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma

location_facility: Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)

location_facility: Cancer Center of Kansas Dept.ofCancerCtr.ofKansas

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (3)

location_facility: Florida Medical Clinic PA Dept.ofFloridaMedicalClinic

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: Trinitas Comprehensive Cancer Center Dept. of Trinitas

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: Maryland Hematology/Oncology Associates, P.A.

location_facility: St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast

location_facility: University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2)

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)

location_facility: Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ

location_facility: University of Louisville / James Graham Brown Cancer Center SC

location_facility: Anne Arundel Health System Research Institute Wayson Pavilion

location_facility: Rush University Medical Center Study Coordinator

location_facility: University of California San Francisco UCSF Medical Center

title: A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Czech Republic
Hungary
Hong Kong
United States
Belgium
Egypt
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Sweden


acronym: OLLTT

intervention_type: Drug

lead_sponsor: Merz Pharmaceuticals GmbH

summary: The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study

location_facility: Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag

location_facility: Montefiore Medical Center Attn: Anxiety and Depression Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED

location_facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

location_facility: Teaching University Hospital, ORL klinika

location_facility: Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii

location_facility: Monterrey International Research Center (MIRC)

location_facility: Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje

location_facility: Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología

location_facility: Unidad Médica de Especialidades del Noroeste (UMEN)

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

location_facility: ORL oddělení , Karlovarská krajská nemocnice a. s.

location_facility: Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery

location_facility: Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.

location_facility: Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología

location_facility: University of Kansas Department of Otolaryngology Head & Neck Surgery

location_facility: Clínica Universitaria de Navarra, Dept. ORL

location_facility: Hospital Puerta del Hierro, Madrid- Servicio de ORL

location_facility: Hospital General de Chihuahua. "Dr. Salvador Anchondo"

location_facility: Clin Pharm International GmbH, Zentrum Wien

location_facility: Centre Hospitalier de Bretagne Sud Service ORL-B9

location_facility: ORL oddělení, Karlovarská krajská nemocncie a.s.

location_facility: Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)

location_facility: UC Davis Health System Department of Otolaryngology

location_facility: Hospital Universitario de Salamanca- Hospital Virgen de la Vega

location_facility: Hospital Clínico Barcelona, Dept. Of ORL

location_facility: Fundación Hospital de Alcorcón, Otorhinolaryngology

location_facility: The university Hospitals of Leicester, Leicester Royal Infirmary

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: University Hospital Leuven, ENT Department

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Erie County Medical Center, Department of Rehabilitation Medicine

location_facility: Hospital Universitario Príncipe de Asturias

location_facility: Instituto Biomédico de Investigación A.C.

status: Terminated

title: An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Non-Randomized

study_completion_date_type: Actual

location_country:
France
Germany
Poland
Portugal
United Kingdom
Brazil
Netherlands
Austria
Belgium
Mexico
United States
Spain
South Africa
Czech Republic

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency

acronym: EFFICACY-HF

summary: This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.

design_allocation: Randomized

lead_sponsor: Vifor Pharma

sponsor_collaborators:
Vifor Pharma
Socar Research SA

location_country: Germany France Denmark Netherlands Israel


lead_sponsor: Boehringer Ingelheim

summary: The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.

location_facility: 1100.1526.4904 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4910 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4903 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3307A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4908 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3304A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4405 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3312A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4906 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1013 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3306A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1014 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3301A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3308A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4905 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4902 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4909 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4404 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4914 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4901 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1012 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4907 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4402 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4911 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4915 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3302A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3311A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4403 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3310A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4912 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4913 Boehringer Ingelheim Investigational Site

status: Completed

title: An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program

location_country:
United States
United Kingdom
Germany
France

status_simplified: Completed


title: A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

summary: This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Artu Biologicals

location_country:
Germany
Poland
United Kingdom
Netherlands
Belgium
France

location_facility: Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1

location_facility: Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny

location_facility: SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela

location_facility: QMC Notthingham, Nottingham University Hospitals NHS Trust

location_facility: Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: Rijnland Ziekenhuis, Location Alphen - Poli KNO

location_facility: Royal National Throat, Nose & Ear Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 3


lead_sponsor: Novartis Pharmaceuticals

summary: This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

ReferenceType: derived

ReferenceCitation: Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Papai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. doi: 10.1016/S1470-2045(15)70105-1. Epub 2015 Apr 14.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

location_facility: University of California at Los Angeles GI Oncology Program

location_facility: New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)

location_facility: University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)

location_facility: Kootenai Medical Center Dept.ofKootenai Med.Ctr.

location_facility: Stanford University Medical Center Stanford Cancer Center

location_facility: University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)

location_facility: City of Hope National Medical Center Regulatory Document

location_facility: Vanderbilt Univeristy Ingram Cancer Ctr.

location_facility: Northwestern University Clinical Research Office (2)

location_facility: Mayo Clinic - Rochester Division of Hematology

location_facility: Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc

location_facility: Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)

location_facility: Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology

location_facility: University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)

location_facility: Ocala Oncology Center Dept. of Ocala Oncology Center

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

location_facility: University of Pennsylvania Medical Center CAMN107G2301

location_facility: New York Oncology Hematology, P.C. NYOH Amsterdam

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: Washington Hospital Center Wash Hospital

location_facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)

location_facility: Birmingham Hematology and Oncology Associates

title: A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
Hong Kong
Denmark
United States
Romania
China
Egypt
Italy
Norway
Singapore
United Kingdom
Venezuela
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

location_facility: 1220.5.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3307A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0010 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4410 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4202 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4910 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4104 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8209 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4912 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8204 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8201 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4203 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8210 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0007 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3506 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8207 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6107 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4909 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6110 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0005 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4917 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8203 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6104 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1006 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6109 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8206 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4409 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3305A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8202 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4303 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6108 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3504 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4914 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6103 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3308A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1007 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8205 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4903 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3507 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0009 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3309A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0006 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8208 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4915 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0008 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8211 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6105 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4907 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3306A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3102 Boehringer Ingelheim Investigational Site

title: Antiviral Effect, Safety and Pharmacokinetics of BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve and Treatment-experienced Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Double-blinded, Randomised, Placebo-controlled, Phase II)

location_country:
France
Germany
Portugal
United Kingdom
Argentina
Romania
Australia
Netherlands
Austria
Switzerland
United States
Korea, Republic of
Spain
Canada
Czech Republic


type: Other Identifier

title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy

summary: A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

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

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

publisher_dissemination: Springer-Nature

ReferenceCitation: Di Narzo AF, Telesco SE, Brodmerkel C, Argmann C, Peters LA, Li K, Kidd B, Dudley J, Cho J, Schadt EE, Kasarskis A, Dobrin R, Hao K. High-Throughput Characterization of Blood Serum Proteomics of IBD Patients with Respect to Aging and Genetic Factors. PLoS Genet. 2017 Jan 27;13(1):e1006565. doi: 10.1371/journal.pgen.1006565. eCollection 2017 Jan.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, Ghosh S, de Villiers WJ, Panaccione R, Greenberg G, Schreiber S, Lichtiger S, Feagan BG; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012 Oct 18;367(16):1519-28. doi: 10.1056/NEJMoa1203572.

lead_sponsor: Centocor, Inc.

location_country:
Germany
New Zealand
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Spain
Canada
France


title: ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF)

acronym: ARTEMIS-IPF

summary: The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

ReferenceType: result

ReferenceCitation: Raghu G, Behr J, Brown KK, Egan JJ, Kawut SM, Flaherty KR, Martinez FJ, Nathan SD, Wells AU, Collard HR, Costabel U, Richeldi L, de Andrade J, Khalil N, Morrison LD, Lederer DJ, Shao L, Li X, Pedersen PS, Montgomery AB, Chien JW, O'Riordan TG; ARTEMIS-IPF Investigators*. Treatment of idiopathic pulmonary fibrosis with ambrisentan: a parallel, randomized trial. Ann Intern Med. 2013 May 7;158(9):641-9. doi: 10.7326/0003-4819-158-9-201305070-00003. Erratum In: Ann Intern Med. 2014 May 6;160(9):658.

oa_host_type: closed

publisher_dissemination: American College of Physicians

ReferenceCitation: Raghu G, Lynch D, Godwin JD, Webb R, Colby TV, Leslie KO, Behr J, Brown KK, Egan JJ, Flaherty KR, Martinez FJ, Wells AU, Shao L, Zhou H, Pedersen PS, Sood R, Montgomery AB, O'Riordan TG. Diagnosis of idiopathic pulmonary fibrosis with high-resolution CT in patients with little or no radiological evidence of honeycombing: secondary analysis of a randomised, controlled trial. Lancet Respir Med. 2014 Apr;2(4):277-84. doi: 10.1016/S2213-2600(14)70011-6. Epub 2014 Feb 18.

ReferenceCitation: Chien JW, Richards TJ, Gibson KF, Zhang Y, Lindell KO, Shao L, Lyman SK, Adamkewicz JI, Smith V, Kaminski N, O'Riordan T. Serum lysyl oxidase-like 2 levels and idiopathic pulmonary fibrosis disease progression. Eur Respir J. 2014 May;43(5):1430-8. doi: 10.1183/09031936.00141013. Epub 2013 Oct 31.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

lead_sponsor: Gilead Sciences

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Czech Republic
Colombia
Switzerland
United States
Belgium
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Israel

location_facility: University of Alabama at Birmingham Hospital

location_facility: Pulmonary And Critical Care Services, P.C.

location_facility: National Jewish Medical And Research Center

location_facility: David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)

location_facility: University of Pennsylvania Health Systems

location_facility: Complejo Asistencial Universitario de León

location_facility: University of Miami Miller School of Medicine


study_start_date_type: Actual

acronym: EMERGE

lead_sponsor: Celgene

summary: To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

ReferenceType: background

ReferenceCitation: Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. doi: 10.1200/JCO.2013.49.2835. Epub 2013 Sep 3.

ReferenceCitation: Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. doi: 10.1111/bjh.13456. Epub 2015 Apr 28.

publisher_dissemination: Wiley

ReferenceCitation: Witzig TE, Luigi Zinzani P, Habermann TM, Tuscano JM, Drach J, Ramchandren R, Kalayoglu Besisik S, Takeshita K, Casadebaig Bravo ML, Zhang L, Fu T, Goy A. Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. Am J Hematol. 2017 Oct;92(10):E575-E583. doi: 10.1002/ajh.24854. Epub 2017 Aug 28.

oa_colors: green other

evidence: open (via free article)

ReferenceCitation: San-Miguel JF, Richardson PG, Gunther A, Sezer O, Siegel D, Blade J, LeBlanc R, Sutherland H, Sopala M, Mishra KK, Mu S, Bourquelot PM, Victoria Mateos M, Anderson KC. Phase Ib study of panobinostat and bortezomib in relapsed or relapsed and refractory multiple myeloma. J Clin Oncol. 2013 Oct 10;31(29):3696-703. doi: 10.1200/JCO.2012.46.7068. Epub 2013 Sep 9.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Universita Federico II di Napoli Nuovo Policlinico

location_facility: Centro De Cancer, Hospital Espanol Auxilio De Puerto Rico

location_facility: Washington University Siteman Cancer Center

location_facility: Loyola University Medical Center - Smith

location_facility: Alvin and Lois Lapidus Cancer Institute Sinai Hospital of Baltimore

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: University of Massachusetts Medical Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: University of Virginia Cancer Center Clinical Trials Office

location_facility: University of Tennessee Cancer Institute

location_facility: Duran i Reynals Institut Catala d'Oncologia

location_facility: University of Rochester Cancer Center, James P. Wilmot Cancer Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Winship Cancer Institute of Emory University

location_facility: Boca Raton Community Hospital, Inc., Research Dept.

location_facility: MD Anderson Cancer Center, Orlando Regional Healthcare

location_facility: University of Debrecen, DEOEC, Institute of Internal Medicine

title: A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

location_country:
Germany
Italy
Colombia
Hungary
Israel
Singapore
United Kingdom
Austria
Belgium
United States
Spain
Turkey
Puerto Rico
France


type: Registry Identifier

title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin

summary: This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.

ReferenceCitation: Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Volzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

ReferenceCitation: Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.

ReferenceCitation: Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

ReferenceCitation: Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
United BioSource, LLC
Tessella Inc.
Berry Consultants

location_country:
Germany
Poland
India
Romania
Mexico
United States
Korea, Republic of
Spain
Taiwan
Canada
Puerto Rico
Russian Federation
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: Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology

acronym: NSCLC

summary: The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

ReferenceCitation: Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Pfizer

location_country:
Ireland
Poland
Brazil
Chile
Canada
Serbia
France
Czech Republic
Slovenia
Hungary
Switzerland
United States
Latvia
Ukraine
Indonesia
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation


acronym: COMPLETE (see under A.3 Full title of the trial)

summary:
RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts of the HER2/neu receptor is important for breast cancer to grow and spread. Women with previously untreated metastatic breast cancer (breast cancer that has spread to other organs) and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy with one of the approved chemotherapy drugs paclitaxel or docetaxel (called "taxanes") together with another approved drug called "trastuzumab". Chemotherapy drugs, such as paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by specifically "targeting" the HER2/neu i.e. it attaches to it and "turns it off". Although some of the patients who receive this taxane plus trastuzumab treatment feel better for some months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab, it also works by specifically "targeting" the HER2/neu receptor, but it does so in a different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth. Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However, this is not known.

Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with HER2/neu positive breast cancer.

ReferenceCitation: Liu S, Chen B, Burugu S, Leung S, Gao D, Virk S, Kos Z, Parulekar WR, Shepherd L, Gelmon KA, Nielsen TO. Role of Cytotoxic Tumor-Infiltrating Lymphocytes in Predicting Outcomes in Metastatic HER2-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2017 Nov 9;3(11):e172085. doi: 10.1001/jamaoncol.2017.2085. Epub 2017 Nov 9.

ReferenceCitation: Gelmon KA, Boyle FM, Kaufman B, Huntsman DG, Manikhas A, Di Leo A, Martin M, Schwartzberg LS, Lemieux J, Aparicio S, Shepherd LE, Dent S, Ellard SL, Tonkin K, Pritchard KI, Whelan TJ, Nomikos D, Nusch A, Coleman RE, Mukai H, Tjulandin S, Khasanov R, Rizel S, Connor AP, Santillana SL, Chapman JA, Parulekar WR. Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31. J Clin Oncol. 2015 May 10;33(14):1574-83. doi: 10.1200/JCO.2014.56.9590. Epub 2015 Mar 16.

sponsor_collaborators:
Novartis Pharmaceuticals
NCIC Clinical Trials Group

title: A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer

type: Other Grant/Funding Number

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

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

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Canada
France
United States
Ukraine
India
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

ipd_sharing: Yes


lead_sponsor: Novartis

summary: This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).

location_facility:
Novartis Investigational Site
Novartis Investigative Site
Novaratis Investigative Site
Austin Health, Department of Neurology

title: An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

location_country:
Finland
Germany
Ireland
Poland
Australia
Turkey
Canada
France
Czech Republic
Slovakia
Hungary
Switzerland
Romania
Belgium
Estonia
United Kingdom
Sweden
Netherlands
Greece
South Africa
Russian Federation
Israel


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

ReferenceCitation: Chi KN, Kheoh T, Ryan CJ, Molina A, Bellmunt J, Vogelzang NJ, Rathkopf DE, Fizazi K, Kantoff PW, Li J, Azad AA, Eigl BJ, Heng DY, Joshua AM, de Bono JS, Scher HI. A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18.

ReferenceCitation: Fizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.

ReferenceCitation: Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.

ReferenceCitation: Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Scher HI, Heller G, Molina A, Attard G, Danila DC, Jia X, Peng W, Sandhu SK, Olmos D, Riisnaes R, McCormack R, Burzykowski T, Kheoh T, Fleisher M, Buyse M, de Bono JS. Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer. J Clin Oncol. 2015 Apr 20;33(12):1348-55. doi: 10.1200/JCO.2014.55.3487. Epub 2015 Mar 23.

ReferenceCitation: Mulders PF, Molina A, Marberger M, Saad F, Higano CS, Chi KN, Li J, Kheoh T, Haqq CM, Fizazi K. Efficacy and safety of abiraterone acetate in an elderly patient subgroup (aged 75 and older) with metastatic castration-resistant prostate cancer after docetaxel-based chemotherapy. Eur Urol. 2014 May;65(5):875-83. doi: 10.1016/j.eururo.2013.09.005. Epub 2013 Sep 20.

ReferenceCitation: Harland S, Staffurth J, Molina A, Hao Y, Gagnon DD, Sternberg CN, Cella D, Fizazi K, Logothetis CJ, Kheoh T, Haqq CM, de Bono JS, Scher HI; COU-AA-301 Investigators. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer. 2013 Nov;49(17):3648-57. doi: 10.1016/j.ejca.2013.07.144. Epub 2013 Aug 22.

ReferenceCitation: Ryan CJ, Molina A, Li J, Kheoh T, Small EJ, Haqq CM, Grant RP, de Bono JS, Scher HI. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol. 2013 Aug 1;31(22):2791-8. doi: 10.1200/JCO.2012.45.4595. Epub 2013 Jul 1.

ReferenceCitation: Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. doi: 10.1016/S1470-2045(12)70473-4. Epub 2012 Nov 9.

ReferenceCitation: Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18. Erratum In: Lancet Oncol. 2012 Nov;13(11):e464. Lancet Oncol. 2014 Aug;15(9):e365.

ReferenceCitation: de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

location_country:
Germany
Ireland
Hungary
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Spain
Canada
France


acronym: INTORACT

summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

ReferenceCitation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar 10;32(8):752-9. doi: 10.1200/JCO.2013.50.5305. Epub 2013 Dec 2.

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.

location_facility: Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH

location_facility: Scientific research Institute of Oncology N.N. Petrov

location_facility: Cliniques Universitaires de Mont-Godinne UCL

location_facility: Lakeshore Hospital & Research Center Limited

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia

location_facility: Farmacia del Comitato Etico Provinciale di Modena

location_facility: N.N. Blokhin Russian Cancer Research Center, Department of Urology

location_facility: "State Institution ""Institute for Occupational Health of the

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

location_facility: Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda

location_facility: Fakultna Nemocnica s poliklinikou F D Roosevelta

location_facility: Odette Cancer Centre, Sunnybrook Health Sciences Centre

location_facility: Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: University of the Witwatersrand Oncology

location_facility: Centre de Sante et de Services Sociaux de Rimouski - Neigette

location_facility: Josa Andras Oktato Korhaz Nonprofit Kft.

location_facility: N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy

location_facility: Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

location_facility: Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology

location_facility: Centrum Medyczne Ostrobramska NZOZ "Magodent"

location_facility: Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari

location_facility: Klinika pneumologie a ftiziologie FNsP LFUK

location_facility: Szegedi Tudomanyegyetem, Urologiai Klinika

location_facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP

location_facility: R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator

location_facility: Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.

location_facility: Donetske Obl. clinico-teritorial'ne medichne ob'yednannya

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Hematology Oncology Services of Arkansas

location_facility: Sezione di Oncologia Medica Centro di Ricerca Clinica

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo

location_facility: Privolzhskiy District Medical Center of Federal Biomedical Agency

location_facility: Instituto de Oncologia de Piracicaba S/S Ltda

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie

location_facility: Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON

location_facility: Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince

location_facility: Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice

location_facility: Donetskyy Oblasyy protypukhlynnyy Tsenter

location_facility: Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic

location_facility: Yonsei University Health System-Severance Hospital

location_facility: Klinikum Region Hannover, Krankenhaus Siloah

location_facility: Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni

location_facility: Fakultna Nemocnica s poliklinikou akad L Derera

location_facility: Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON

location_facility: ProCura - Centro Goiano de Pesquisa Clínica Ltda

location_facility: Moscow Scientific Research Oncology Institute P.A. Herzen

title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Canada
Serbia
France
Czech Republic
Colombia
Portugal
Slovakia
Hungary
Hong Kong
United States
Ukraine
India
Belgium
Malaysia
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


intervention_type: Biological

lead_sponsor: Bayer

summary: A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

ReferenceCitation: Di Minno G, Cerbone AM, Coppola A, Cimino E, Di Capua M, Pamparana F, Tufano A, Di Minno MN. Longer-acting factor VIII to overcome limitations in haemophilia management: the PEGylated liposomes formulation issue. Haemophilia. 2010 Jan;16 Suppl 1:2-6. doi: 10.1111/j.1365-2516.2009.02155.x.

ReferenceCitation: Powell J, Martinowitz U, Windyga J, Di Minno G, Hellmann A, Pabinger I, Maas Enriquez M, Schwartz L, Ingerslev J; LipLong Study Investigators. Efficacy and safety of prophylaxis with once-weekly BAY 79-4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients. A randomised, active-controlled, double-blind study. Thromb Haemost. 2012 Nov;108(5):913-22. doi: 10.1160/TH12-03-0188. Epub 2012 Sep 26.

title: Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Turkey
Croatia
Chile
Canada
France
Lithuania
Denmark
Switzerland
United States
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
South Africa
Taiwan
Israel


lead_sponsor: Hoffmann-La Roche

summary: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

ReferenceCitation: Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. J Clin Oncol. 2022 Feb 10;40(5):438-448. doi: 10.1200/JCO.21.00896. Epub 2021 Dec 10.

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hiroshima City Hiroshima Citizens Hospital; Breast Surgery

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kaiser Permanente - Roseville; Oncology Pharmacy

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

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

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

location_facility: St John of God Murdoch Hospital; Oncology West

location_facility: Khechinashvili University Hospital ;Breast Unit

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Saitama Medical University International Medical Center; Breast Oncology

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Florida Cancer Specialists; Saint Petersburg

location_facility: US oncology research at Minnesota Oncology

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Changhua Christian Hospital; Dept of Surgery

location_facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

location_facility: Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0

location_facility: National Cancer Center Hospital; Medical Oncology

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Hiroshima University Hospital; Breast Surgery

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: Universitetssjukhuset Örebro, Onkologiska kliniken

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

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

location_facility: Epworth HealthCare; Clinical Trials Centre

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: University of Virginia Health System; Hematology/Oncology Division

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii

location_facility: Kawasaki Medical School Hospital; Breast and Thyroid Surgery

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

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Hospital San Jose Del Tec. de Monterrey; Oncology

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Cheltenham General Hospital; Gloucestershire Oncology Centre

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)

location_facility: Scientific Research Institute n.a. N.N. Petrov

location_facility: Sourasky / Ichilov Hospital; Oncology Department

location_facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Southlake Regional Health Center; Community Care Clinic / Oncology

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Hyogo College Of Medicine; Breast And Endocrine Surgery

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Nagoya City University Hospital; Breast Surgery

location_facility: Jichi Medical University; Breast Oncology

location_facility: Gunma University Hospital; Department of Breast and Endocrine Surgery

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Haematology & Oncology Clinics of Australia Research Centre

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Kaiser Permanente - Sacramento; Oncology Pharmacy

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum

location_facility: Luzerner Kantonsspital; Medizinische Onkologie

location_facility: Städtische Kliniken Frankfurt am Main Höchst

location_facility: Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Tokai University Hospital, Breast Surgery

location_facility: Henry Ford Hospital; Hematology Oncology

location_facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Taichung Veterans General Hospital; Dept of Surgery

location_facility: Tokyo Metropolitan; Komagome Hospital, Surgery

location_facility: Yeovil District Hospital; Macmillan Cancer Unit

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: National Cancer Centre; Medical Oncology

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: Musgrove Park Hospital; Department Clinical Research, Beacon Centre

location_facility: National Cancer Center; Medical Oncology

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine

location_facility: Kaiser Permanente - Walnut Creek; Oncology Pharmacy

location_facility: Western General Hospital; Edinburgh Breast Unit

location_facility: Burnside War Memorial Hospital, Clinical Trials Centre

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre

location_facility: Showa University Hospital; Breast Surgery

location_facility: Kaiser Permanente - South SF; Oncology Clinical trials

location_facility: Humanitas Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Osaka International Cancer Institute; Breast and Endocrine Surgery

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Kumamoto Shinto General Hospital; Breast Cancer Center

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Regional health authority A vitalite health network

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Gunma Prefectural Cancer Center; Breast Oncology

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

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

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B

location_facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Institut d'oncologie de l'Orangerie; Chimiotherapie

location_facility: Maidstone Hospital; Kent Oncology Centre

title: A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

location_country:
Germany
Poland
Australia
Brazil
Japan
Bosnia and Herzegovina
Thailand
Chile
Czechia
Canada
France
Colombia
Hungary
Hong Kong
Switzerland
United States
Ukraine
Romania
Belgium
El Salvador
Peru
Philippines
Italy
Guatemala
Norway
Singapore
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Panama
Taiwan
Georgia
Russian Federation
Israel


summary: This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.

study_type: Observational

time_perspective: Retrospective

location_country:
Italy
Australia
Spain
Turkey
Czech Republic
Russian Federation
France


title: A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer

summary: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

status: Active, not recruiting

ReferenceCitation: Fizazi K, Foulon S, Carles J, Roubaud G, McDermott R, Flechon A, Tombal B, Supiot S, Berthold D, Ronchin P, Kacso G, Gravis G, Calabro F, Berdah JF, Hasbini A, Silva M, Thiery-Vuillemin A, Latorzeff I, Mourey L, Laguerre B, Abadie-Lacourtoisie S, Martin E, El Kouri C, Escande A, Rosello A, Magne N, Schlurmann F, Priou F, Chand-Fouche ME, Freixa SV, Jamaluddin M, Rieger I, Bossi A; PEACE-1 investigators. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 x 2 factorial design. Lancet. 2022 Apr 30;399(10336):1695-1707. doi: 10.1016/S0140-6736(22)00367-1. Epub 2022 Apr 8.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

ipd_sharing: No

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

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

location_country: Ireland Italy Romania Switzerland Belgium Spain France

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer - Hôpital Sainte Musse

location_facility: Adelaide and Meath incorporating National Children's hospital department

location_facility: Hôpitaux Universitaires Bordet Erasme- Institut Jules Bordet

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: AZ Groeninge Kortrijk - Campus Vercruysselaan

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Fondation Dr. Henri Dubois-Ferrière Dinu Lipatti

location_facility: 'Parc Tauli Sabadell Hospital Universitari

location_facility: Centre d'Oncologie et de Radiothérapie du Pays Basque

location_facility: Institut de Cancérologie del'Ouest - site René Gauducheau

location_facility: INSTITUT GUSTAVE ROUSSY, Cancer Campus, Grand Paris

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

status_simplified: Ongoing

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

acronyme: GETUG-AFU 21 / PEACE1

titre: Etude prospective de phase III, randomisée, d'évaluation de l'association d'un traitement hormonal avec ou sans radiothérapie avec ou sans abiratérone et prednisone chez les patients présentant un cancer de prostate métastatique hormono-naïf.

discipline_principale: radiation-oncology

nom_porteur: BOSSI

prenom_porteur: Alberto

appel_a_projets: PRTK

acronyme: GETUG-AFU 21-PEACE-1-RT

titre: Programme Translationnel de l'essai GETUG-AFU 21-PEACE-1.

discipline_principale: cancer

nom_porteur: FIZAZI

prenom_porteur: Karim


title: Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

acronym: SATURN

summary: A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

ReferenceCitation: Puri R, Nissen SE, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Libby P, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. Sex-related differences of coronary atherosclerosis regression following maximally intensive statin therapy: insights from SATURN. JACC Cardiovasc Imaging. 2014 Oct;7(10):1013-22. doi: 10.1016/j.jcmg.2014.04.019. Epub 2014 Sep 17.

ReferenceCitation: Puri R, Libby P, Nissen SE, Wolski K, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Tuzcu EM, Nicholls SJ. Long-term effects of maximally intensive statin therapy on changes in coronary atheroma composition: insights from SATURN. Eur Heart J Cardiovasc Imaging. 2014 Apr;15(4):380-8. doi: 10.1093/ehjci/jet251. Epub 2014 Jan 20.

publisher_dissemination: Oxford University Press

ReferenceCitation: Puri R, Nissen SE, Libby P, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. C-reactive protein, but not low-density lipoprotein cholesterol levels, associate with coronary atheroma regression and cardiovascular events after maximally intensive statin therapy. Circulation. 2013 Nov 26;128(22):2395-403. doi: 10.1161/CIRCULATIONAHA.113.004243. Epub 2013 Sep 16.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011 Dec 1;365(22):2078-87. doi: 10.1056/NEJMoa1110874. Epub 2011 Nov 15.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
The Cleveland Clinic

location_country:
Italy
Poland
Hungary
Argentina
Australia
Brazil
Netherlands
Mexico
Belgium
United States
Spain
Canada
Russian Federation
France


title: Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

summary: Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

ReferenceCitation: Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, Benner RJ, Scranton JR, Olszanski AJ, Jassem J. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2014 Jul 1;32(19):2059-66. doi: 10.1200/JCO.2013.54.4932. Epub 2014 Jun 2.

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

repositories_concat: PubMed Central;iris.unito.it

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Turkey
Canada
France
Czech Republic
Slovakia
Hungary
Hong Kong
Switzerland
United States
Ukraine
India
Puerto Rico
Italy
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation


acronym: DoseFlex

lead_sponsor: UCB Pharma

summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.

ReferenceCitation: Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.

title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.

location_country:
United States
Canada
France