ipd_sharing: Yes

status: Completed

primary_purpose: Treatment

acronym: PREVENT

intervention_type: Drug

title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

study_completion_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

ReferenceCitation: Braun J, Blanco R, Marzo-Ortega H, Gensler LS, van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Shete A, Richards HB, Haemmerle S, Deodhar A. Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT. Arthritis Res Ther. 2021 Sep 4;23(1):231. doi: 10.1186/s13075-021-02613-9.

ReferenceCitation: Deodhar A, Blanco R, Dokoupilová E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.

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.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Norway
Sweden
Switzerland
Hungary
Germany
Bulgaria
Korea, Republic of
France
Netherlands

summary: The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

lead_sponsor_type: industriel

status_simplified: Completed


acronym: BIBF 1120 or placebo in combination with standard chemotherapy in advanced ovarian cancer

title: Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

lead_sponsor: Boehringer Ingelheim

type: Other Identifier

type: EudraCT Number

ReferenceCitation: du Bois A, Kristensen G, Ray-Coquard I, Reuss A, Pignata S, Colombo N, Denison U, Vergote I, Del Campo JM, Ottevanger P, Heubner M, Minarik T, Sevin E, de Gregorio N, Bidziński M, Pfisterer J, Malander S, Hilpert F, Mirza MR, Scambia G, Meier W, Nicoletto MO, Bjørge L, Lortholary A, Sailer MO, Merger M, Harter P; AGO Study Group led Gynecologic Cancer Intergroup/European Network of Gynaecologic Oncology Trials Groups Intergroup Consortium. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016 Jan;17(1):78-89. doi: 10.1016/S1470-2045(15)00366-6. Epub 2015 Nov 16.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Norway
Sweden
Slovakia
Canada
Germany
Denmark
Greece
Finland
France
Netherlands

location_facility: 1199.15.35101 Instituto Portugues de Oncologia Lisboa Francisco Gentil

location_facility: 1199.15.49082 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10112 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49058 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10017 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.48006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39017 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35106 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39037 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49087 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49089 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49047 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49018 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33038 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49056 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35802 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33031 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49046 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49024 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49029 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10107 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49060 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49086 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49015 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49062 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49037 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42101 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49025 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49054 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49092 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49045 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33050 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10028 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10113 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49019 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49076 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35803 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33045 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42106 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.48001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33033 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35804 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49014 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33053 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49071 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39034 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49057 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10025 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39028 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49055 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33025 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49008 Boehringer Ingelheim Investigational Site

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location_facility: 1199.15.48003 Boehringer Ingelheim Investigational Site

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location_facility: 1199.15.61003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35801 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39039 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49040 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10108 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33042 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33037 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35805 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10104 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49041 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33039 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49059 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33035 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33015 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49017 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49052 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49064 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33048 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39031 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33051 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42103 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49090 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49083 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49080 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49036 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33027 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49065 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49031 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39040 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33055 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39027 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10110 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49093 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10014 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42105 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10102 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10016 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35108 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33018 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49042 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49085 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39022 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33047 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42104 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10019 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35102 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39036 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10103 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33052 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49095 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49027 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39024 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49050 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39026 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49073 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49022 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49063 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49034 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49081 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49061 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49067 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49084 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49068 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39029 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49033 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49023 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39019 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49048 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49079 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39018 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35104 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35109 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10024 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49026 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10105 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49016 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39014 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49051 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49035 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39033 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49043 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42102 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49070 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49066 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10029 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49039 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11006 Boehringer Ingelheim Investigational Site

summary: The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.


title: AdreView™ Myocardial Imaging for Risk Evaluation - A Multicentre Trial to Guide ICD Implantation in NYHA Class II & III Heart Failure Patients With 25%≤LVEF≤35%

acronym: ADMIRE-ICD

summary: This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure participants with 25%<=left ventricular ejection fraction (LVEF)<=35%, and in particular, for identifying participants who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.

status: Terminated

primary_purpose: Prevention

lead_sponsor: GE Healthcare

location_country:
Poland
Spain
Italy
Netherlands
Canada
Hungary
United States
France
Germany
Czechia

location_facility: Regions Hospital and Regions Heart Center Clinic

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Comprehensive Cardiovascular Medical Group

location_facility: Instituti Clinici Scientifici Maugeri Spa Societa Benefit

location_facility: Azienda Ospedaliera Universitaria G. Martino

location_facility: CHU Clermont-Ferrand, 63003 Montalembert

location_facility: Hospital Universitario San Juan de Alicante

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Venezia Mestre - Azienda ULSS 12 "Veneziana"

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Cardiologico, Cardiologia 1

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Veterans Affairs North Texas Healthcare System

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: University of Florida Health Jacksonville

location_facility: Fakultni nemocnice v Kralovske Vinohrady

location_facility: Dipartimento di Scienze Cardiovascolari, Respiratorie Neufrologiche e Geriatriche - Universita di Roma "La Sapienza"

location_facility: VA Connecticut Healthcare System (VACHS)

location_facility: Ospedale dell'Angelo, 30174, Venezia Mestre

location_facility: Institut Universitaire De Cardiologie Et De Pneumologie De Quebec

location_facility: Department of Cardiology, K-14 (Henry Ford Health System)

location_facility: Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader

location_facility: Azienda Ospedaliero-Universitaria Federico II Dipartimento ad Attivita Integrata di Cardiologia,Cardiochirurgia ed Emergenze Cardiovascolari

location_facility: Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin

location_facility: Semmelweis Egyetem Nuklearis Medicina Kozpont

location_facility: Cardiology Physicians PA/Red Clay Research, LLC

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: CIUSSS de L'Estrie - CHUS Hopital Fleurimont

location_facility: Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly

location_facility: Varosmajori Sziv es Ergyogyaszati Klinika

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino

location_facility: Vascular Biology and Hypertension Program, University of Alabama at Birmingham

intervention_type: Device

status_simplified: Unknown


title: A Multi-centre, Open Label, Single Arm, 32-week Treatment Study in Subjects With Severe Eosinophilic Asthma Not Optimally Controlled With Current Omalizumab Treatment Who Are Switched From Omalizumab to Mepolizumab 100mg Subcutaneous (Study Number 204471- the OSMO Study)

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Liu MC, Chipps B, Munoz X, Devouassoux G, Bergna M, Smith SG, Price RG, Galkin DV, Azmi J, Mouneimne D, Albers FC, Chapman KR. Benefit of switching to mepolizumab from omalizumab in severe eosinophilic asthma based on patient characteristics. Respir Res. 2021 May 10;22(1):144. doi: 10.1186/s12931-021-01733-9.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Spain
Netherlands
Argentina
Canada
Sweden
United States
France
Belgium
Germany

summary:
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic asthma. The aim of this study is to investigate whether subjects not optimally controlled on their current omalizumab treatment, who are eligible for therapy with mepolizumab can be effectively and safely switched to treatment with mepolizumab to improve asthma control. The study will provide data on the efficacy, safety, immunogenicity, and tolerability of mepolizumab when switched directly from omalizumab without any wash-out. The learnings from this study may help guide physicians when substituting one biologic with another for the treatment of patients with severe eosinophilic asthma.

The study will be a multi-centre, open-label single arm trial. Patients with severe eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be eligible to participate. Subjects will remain on their current maintenance therapy including omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit 2 (week 0) subjects will discontinue their omalizumab treatment and be switched to mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32 weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last dose of mepolizumab.


title: A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)

acronym: CheckMate 498

summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

ReferenceCitation: Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
Switzerland
United Kingdom
Sweden
United States
France
Israel
Norway
Belgium
Japan
Germany

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Johns Hopkins University School Of Medicine

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: Emory University - Winship Cancer Institute

location_facility: Montreal Neurological Institute and Hospital

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

location_facility: Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main

location_facility: University Of Texas Southwestern Medical Center

location_facility: Washington University School OF Medicine-Siteman Cancer Center

location_facility: Erlanger Oncology & Hematology - Univ. of TN

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: Columbia University Medical Center (Cumc)

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: The Regents of the University of California, San Francisco

intervention_type: Radiation


title: A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)

summary: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.

ReferenceCitation: Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1). pii: e003133. doi: 10.1136/jitc-2021-003133.

ReferenceCitation: Yau T, Park JW, Finn RS, Cheng AL, Mathurin P, Edeline J, Kudo M, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Sieghart W, Assenat E, Zaucha R, Furuse J, Abou-Alfa GK, El-Khoueiry AB, Melero I, Begic D, Chen G, Neely J, Wisniewski T, Tschaika M, Sangro B. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):77-90. doi: 10.1016/S1470-2045(21)00604-5. Epub 2021 Dec 13.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Israel
Sweden
Singapore
Canada
Switzerland
China
Germany
Taiwan
Korea, Republic of
France

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Ochsner Medical Center - Jefferson Highway

location_facility: Scott & White Memorial Hospital And Clinic

status_simplified: Ongoing


type: Other Grant/Funding Number

title: Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial

acronym: PEXIVAS

summary:
The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is as effective as a standard disease regimen.

The FDA-OOPD is one of the funding sources for this study.

ReferenceType: background

ReferenceCitation: Walsh M, Merkel PA, Peh CA, Szpirt W, Guillevin L, Pusey CD, De Zoysa J, Ives N, Clark WF, Quillen K, Winters JL, Wheatley K, Jayne D; PEXIVAS Investigators. Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial. Trials. 2013 Mar 14;14:73. doi: 10.1186/1745-6215-14-73.

ReferenceType: result

ReferenceCitation: Walsh M, Merkel PA, Peh CA, Szpirt WM, Puéchal X, Fujimoto S, Hawley CM, Khalidi N, Floßmann O, Wald R, Girard LP, Levin A, Gregorini G, Harper L, Clark WF, Pagnoux C, Specks U, Smyth L, Tesar V, Ito-Ihara T, de Zoysa JR, Szczeklik W, Flores-Suárez LF, Carette S, Guillevin L, Pusey CD, Casian AL, Brezina B, Mazzetti A, McAlear CA, Broadhurst E, Reidlinger D, Mehta S, Ives N, Jayne DRW; PEXIVAS Investigators. Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis. N Engl J Med. 2020 Feb 13;382(7):622-631. doi: 10.1056/NEJMoa1803537.

ReferenceCitation: Jayne D, Walsh M, Merkel PA, Peh CA, Szpirt W, Puéchal X, Fujimoto S, Hawley C, Khalidi N, Jones R, Flossmann O, Wald R, Girard L, Levin A, Gregorini G, Harper L, Clark W, Pagnoux C, Specks U, Smyth L, Ito-Ihara T, de Zoysa J, Brezina B, Mazzetti A, McAlear CA, Reidlinger D, Mehta S, Ives N, Brettell EA, Jarrett H, Wheatley K, Broadhurst E, Casian A, Pusey CD. Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT. Health Technol Assess. 2022 Sep;26(38):1-60. doi: 10.3310/PNXB5040.

lead_sponsor: University of Pennsylvania

location_country:
Denmark
United Kingdom
Greece
Italy
Australia
Mexico
Canada
New Zealand
United States
France
Norway
Belgium
Japan
Sweden
Czechia

location_facility: Washington University School of Medicine

location_facility: CHU De Toulouse-Hotel Dieu Saint Jacques

location_facility: Centre Hospitalier de la Region d'Annecy

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Holstebro Hospital and University of Aarhus

location_facility: Instituto Nacional de Enfermedades Respiratorias

location_facility: Brighton and Sussex University Hospitals

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: St Olavs Hospital, Trondheim University Hospital

intervention_type: Other

lead_sponsor_type: academique


acronym: OPTIC

title: A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

lead_sponsor: Takeda

type: Registry Identifier

ReferenceCitation: Cortes J, Apperley J, Lomaia E, Moiraghi B, Undurraga Sutton M, Pavlovsky C, Chuah C, Sacha T, Lipton JH, Schiffer CA, McCloskey J, Hochhaus A, Rousselot P, Rosti G, de Lavallade H, Turkina A, Rojas C, Arthur CK, Maness L, Talpaz M, Mauro M, Hall T, Lu V, Srivastava S, Deininger M. Ponatinib dose-ranging study in chronic-phase chronic myeloid leukemia: a randomized, open-label phase 2 clinical trial. Blood. 2021 Nov 25;138(21):2042-2050. doi: 10.1182/blood.2021012082.

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

location_country:
Spain
Italy
United Kingdom
United States
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Sweden
Singapore
Canada
Switzerland
Germany
Denmark
Taiwan
Korea, Republic of
France
Chile

location_facility: Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo

location_facility: Centre de Lutte Contre le Cancer - Institut Bergonie

location_facility: Emory University Winship Cancer Institute

location_facility: Royal Liverpool University Hospital NHS Trust

location_facility: GBUZ Moscow Clinical Scientific Center DZM

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Nantes Hotel Dieu

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: AOUI - Ospedale Policlinico "Giambattista Rossi" di Borgo Roma

location_facility: Hospital General de Agudo Jose Maria Ramos Mejia

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Cleveland Clinic Taussig Cancer Institute Main Campus

location_facility: Ustav Hematologie a Krevni Transfuze Praha

location_facility: Centre Hospitalier Universitaire de Nancy Hopital de Brabois

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

location_facility: Centre Hospitalier Regional Universitaire de Lille

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

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Centre Hospitalier Universitaire de Nice Hopital l'Archet

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hospital Universitario de Gran Canaria Doctor Nergrin

location_facility: Memorial Sloan-Kettering Cancer Center - New York

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: King's College Hospital NHS Foundation Trust

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

location_facility: NewYork-Presbyterian Weill Cornell Medical Center

summary: The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by <=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months.


acronym: ANNOUNCE

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Jones RL, Wagner AJ, Kawai A, Tamura K, Shahir A, Van Tine BA, Martín-Broto J, Peterson PM, Wright J, Tap WD. Prospective Evaluation of Doxorubicin Cardiotoxicity in Patients with Advanced Soft-tissue Sarcoma Treated in the ANNOUNCE Phase III Randomized Trial. Clin Cancer Res. 2021 Jul 15;27(14):3861-3866. doi: 10.1158/1078-0432.CCR-20-4592. Epub 2021 Feb 25.

ReferenceCitation: Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Pápai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. doi: 10.1001/jama.2020.1707.

ReferenceCitation: Tobias A, O'brien MP, Agulnik M. Olaratumab for advanced soft tissue sarcoma. Expert Rev Clin Pharmacol. 2017 Jul;10(7):699-705. doi: 10.1080/17512433.2017.1324295. Epub 2017 May 5. Review.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of Texas MD Anderson Cancer Center

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.

location_facility: Fairfax Northern Virginia Hematology Oncology, PC

location_facility: Moffitt Cancer Center & Research Institute

location_facility: University of Florida School of Medicine

summary: The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.


acronym: AURELIA

title: AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Roncolato FT, Gibbs E, Lee CK, Asher R, Davies LC, Gebski VJ, Friedlander M, Hilpert F, Wenzel L, Stockler MR, King M, Pujade-Lauraine E. Quality of life predicts overall survival in women with platinum-resistant ovarian cancer: an AURELIA substudy. Ann Oncol. 2017 Aug 1;28(8):1849-1855. doi: 10.1093/annonc/mdx229.

ReferenceCitation: Bamias A, Gibbs E, Khoon Lee C, Davies L, Dimopoulos M, Zagouri F, Veillard AS, Kosse J, Santaballa A, Mirza MR, Tabaro G, Vergote I, Bloemendal H, Lykka M, Floquet A, Gebski V, Pujade-Lauraine E. Bevacizumab with or after chemotherapy for platinum-resistant recurrent ovarian cancer: exploratory analyses of the AURELIA trial. Ann Oncol. 2017 Aug 1;28(8):1842-1848. doi: 10.1093/annonc/mdx228.

ReferenceCitation: Sorio R, Roemer-Becuwe C, Hilpert F, Gibbs E, García Y, Kaern J, Huizing M, Witteveen P, Zagouri F, Coeffic D, Lück HJ, González-Martín A, Kristensen G, Levaché CB, Lee CK, Gebski V, Pujade-Lauraine E; AURELIA Investigators. Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial. Gynecol Oncol. 2017 Jan;144(1):65-71. doi: 10.1016/j.ygyno.2016.11.006. Epub 2016 Nov 18.

ReferenceCitation: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31.

ReferenceCitation: Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17. Erratum in: J Clin Oncol. 2014 Dec 10;32(35):4025.

location_country:
Denmark
Bosnia and Herzegovina
Portugal
Spain
Greece
Italy
Netherlands
Finland
Sweden
France
Turkey
Belgium
Norway
Germany

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik

location_facility: Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia

location_facility: AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hopital Andre Mignot; Hematologie - Oncologie

location_facility: Örebro University Hospital; Department of Gynecologic Oncology

location_facility: Martini Ziekenhuis; Dept of Internal Medicine

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Clin Mut De Lyon Eugene Andre; Medecine 3 A

location_facility: Oulu University Hospital; Gynaecology & Obstetrics Dept

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Hospital de Terrassa; Servicio de Oncologia

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Evangelischen Krankenhauses Düsseldorf; Frauenklinik

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Centre Val Aurelle Paul Lamarque; Medecine A1 A2

location_facility: Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe

location_facility: Centre Francois Baclesse; Urologie Gynecologie

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

location_facility: Ankara Baskent University Medicine Faculty; Gynaecology

location_facility: Catharina ZKHS; Inwendige Geneeskunde Afd.

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: Ospedali Riuniti; Divisione Ostetricia e Ginecologia

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

location_facility: Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

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

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

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

location_facility: University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Hopital La Source; Onco Med Hematologie Clinique

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut Daniel Hollard; Chimiotherapie Ambulatoire

location_facility: The Norvegian Radium Hospital Montebello; Dept of Oncology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

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

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Hopital Civil; Expl Fonct Systeme Nerveux

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Regionshospitalet Herning; Onkologisk afdeling

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.


title: A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

ReferenceCitation: Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.

ReferenceCitation: Watz H, Tetzlaff K, Wouters EF, Kirsten A, Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri LM, Chanez P, Dahl R, Disse B, Finnigan H, Calverley PM. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390-8. doi: 10.1016/S2213-2600(16)00100-4. Epub 2016 Apr 7.

ReferenceCitation: Magnussen H, Disse B, Rodriguez-Roisin R, Kirsten A, Watz H, Tetzlaff K, Towse L, Finnigan H, Dahl R, Decramer M, Chanez P, Wouters EF, Calverley PM; WISDOM Investigators. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. doi: 10.1056/NEJMoa1407154. Epub 2014 Sep 8.

location_country:
Spain
Italy
United Kingdom
Ukraine
South Africa
Belgium
Philippines
Poland
Russian Federation
Australia
Tunisia
Turkey
Brazil
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
New Zealand
France
Netherlands

location_facility: 352.2046.38007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.36001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44019 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.55003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.88601 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3317A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.31003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.27004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35902 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48009 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49024 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.31001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49012 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.64002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.27003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90018 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44009 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3331C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44010 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3301A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.88608 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32016 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.55002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.64007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.27005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.38004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.64003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34013 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.55001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.2162A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49022 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90009 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.61002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.27007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34011 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30011 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44016 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.64004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.31002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35903 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32017 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49020 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44025 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3317B Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48011 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35905 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90019 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3317C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3336C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.61001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49025 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3326A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.61006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3320B Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90017 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44017 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35909 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.64006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90012 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90011 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3320C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.27006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.2163A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44012 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90014 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90016 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.38001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3332C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3302A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.38002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3314A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.27002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.38006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44026 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35906 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07011 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3320A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.2164A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34009 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.64001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.38005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3331A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.38003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32010 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3332B Boehringer Ingelheim Investigational Site

location_facility: 352.2046.64005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49021 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3302D Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49015 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3336A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.61003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44021 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32013 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.36002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3325A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3326C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49019 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90010 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49023 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.45002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3302C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49016 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49013 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07009 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3331B Boehringer Ingelheim Investigational Site

location_facility: 352.2046.55006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.36005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.36011 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30009 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35907 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3329B Boehringer Ingelheim Investigational Site

location_facility: 352.2046.88604 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35904 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.45003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30012 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.31004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.63009 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.35908 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3324A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.36004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3325C Boehringer Ingelheim Investigational Site

location_facility: 352.2046.45001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.36006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3334A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49014 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3337A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34010 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.2165A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.36003 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3329A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.61004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44018 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3333A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.07006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3336B Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.88607 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.88603 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3302B Boehringer Ingelheim Investigational Site

location_facility: 352.2046.34001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39004 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.2161A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32014 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.44028 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.61005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3335A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39008 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.55005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32015 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.90006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.39002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.88606 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.32002 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.86007 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3332A Boehringer Ingelheim Investigational Site

location_facility: 352.2046.48005 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.3325D Boehringer Ingelheim Investigational Site

location_facility: 352.2046.30006 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.27001 Boehringer Ingelheim Investigational Site

location_facility: 352.2046.49004 Boehringer Ingelheim Investigational Site

summary: This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.


title: A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

ReferenceCitation: Gadelha M, Bex M, Colao A, Pedroza García EM, Poiana C, Jimenez-Sanchez M, Yener S, Mukherjee R, Bartalotta A, Maamari R, Raverot G. Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs. Front Endocrinol (Lausanne). 2020 Feb 3;10:931. doi: 10.3389/fendo.2019.00931. eCollection 2019.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Brazil
Portugal
Romania
Colombia
Italy
Mexico
United Kingdom
Argentina
Hungary
France
Turkey
China
Belgium
Malaysia
Bulgaria

summary: This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.


ipd_sharing: No

status: Recruiting

primary_purpose: Other

acronym: Radium-223 dichloride long-term follow-up program

title: A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride

lead_sponsor: Bayer

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

enrollment_type: Anticipated

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Israel
Norway
Sweden
Singapore
Brazil
Canada
Germany
Taiwan
Finland
Korea, Republic of
France
Chile

summary: Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .


acronym: VITAL

title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis

lead_sponsor: Prothena Biosciences Ltd.

location_country:
Denmark
Poland
Spain
Greece
Austria
Australia
Italy
Canada
Netherlands
United Kingdom
United States
France
Israel
Belgium
Germany

location_facility: John Hopkins University School of Medicine

location_facility: University of North Carolina Chapel Hill Comprehensive Cancer Center

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

location_facility: Hospital of the University of Pennsylvania

location_facility: Amyloidosis Clinic Cnr Darcy Road and Bridge St. Westmead

location_facility: The University of Queensland-Princess Alexandra Hospital (PAH)

location_facility: Radiant Research Northwestern University

location_facility: Hospital Universitario Puerta de Hierro - Maiadahonda

location_facility: Policlinico S.Orsola Malpighi, Unita' Operativa di Ematologia

location_facility: Columbia University - College of Physicians & Surgeons

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Texas; MD Anderson Cancer Center

location_facility: Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken

location_facility: Sylvester Cancer Center, University of Miami

location_facility: Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital

location_facility: University of Calgary-Southern Alberta Cancer Research Institute

location_facility: University of Pittsburg - Hillman Cancer Center

location_facility: The Royal Free London NHS Foundation Trust-The Royal Free Hospital

location_facility: NNUH NHS Foundation Trust - Norfolk and Norwich University Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Princess Margaret Cancer Research Centre

location_facility: Winship Cancer Institute of Emory University

summary: This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.


acronym: The COMFORT-II Trial

title: A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

ReferenceCitation: Verstovsek S, Gotlib J, Mesa RA, Vannucchi AM, Kiladjian JJ, Cervantes F, Harrison CN, Paquette R, Sun W, Naim A, Langmuir P, Dong T, Gopalakrishna P, Gupta V. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol. 2017 Sep 29;10(1):156. doi: 10.1186/s13045-017-0527-7.

ReferenceCitation: McMullin MF, Harrison CN, Niederwieser D, Demuynck H, Jäkel N, Gopalakrishna P, McQuitty M, Stalbovskaya V, Recher C, Theunissen K, Gisslinger H, Kiladjian JJ, Al-Ali HK. The use of erythropoiesis-stimulating agents with ruxolitinib in patients with myelofibrosis in COMFORT-II: an open-label, phase 3 study assessing efficacy and safety of ruxolitinib versus best available therapy in the treatment of myelofibrosis. Exp Hematol Oncol. 2015 Sep 15;4:26. doi: 10.1186/s40164-015-0021-2. eCollection 2015.

ReferenceCitation: Vannucchi AM, Kantarjian HM, Kiladjian JJ, Gotlib J, Cervantes F, Mesa RA, Sarlis NJ, Peng W, Sandor V, Gopalakrishna P, Hmissi A, Stalbovskaya V, Gupta V, Harrison C, Verstovsek S; COMFORT Investigators. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica. 2015 Sep;100(9):1139-45. doi: 10.3324/haematol.2014.119545. Epub 2015 Jun 11.

ReferenceCitation: Cervantes F, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Sirulnik A, Stalbovskaya V, McQuitty M, Hunter DS, Levy RS, Passamonti F, Barbui T, Barosi G, Harrison CN, Knoops L, Gisslinger H; COMFORT-II investigators. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013 Dec 12;122(25):4047-53. doi: 10.1182/blood-2013-02-485888. Epub 2013 Oct 30. Erratum in: Blood. 2016 Dec 22;128(25):3013.

ReferenceCitation: Wilkins BS, Radia D, Woodley C, Farhi SE, Keohane C, Harrison CN. Resolution of bone marrow fibrosis in a patient receiving JAK1/JAK2 inhibitor treatment with ruxolitinib. Haematologica. 2013 Dec;98(12):1872-6. doi: 10.3324/haematol.2013.095109. Epub 2013 Sep 20.

ReferenceCitation: Mesa RA, Kiladjian JJ, Verstovsek S, Al-Ali HK, Gotlib J, Gisslinger H, Levy R, Siulnik A, Gupta V, Khan M, DiPersio JF, McQuitty M, Catalano JV, Hunter DS, Knoops L, Deininger M, Cervantes F, Miller C, Vannucchi AM, Silver RT, Barbui T, Talpaz M, Barosi G, Winton EF, Mendeson E, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Sun W, Sandor V, Kantarjian HM, Harrison C. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014 Feb;99(2):292-8. doi: 10.3324/haematol.2013.087650. Epub 2013 Aug 2.

ReferenceCitation: Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. doi: 10.1056/NEJMoa1110556.

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Sweden
France
Belgium
Germany

summary: This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).


title: A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

summary:
This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer

ReferenceCitation: Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, O'Regan R, Gasch C, Solovieff N, Wang C, Wang Y, Chakravartty A, Ji Y, Tripathy D. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. Clin Cancer Res. 2022 Mar 1;28(5):851-859. doi: 10.1158/1078-0432.CCR-21-3032.

ReferenceCitation: Bardia A, Su F, Solovieff N, Im SA, Sohn J, Lee KS, Campos-Gomez S, Jung KH, Colleoni M, Vázquez RV, Franke F, Hurvitz S, Harbeck N, Chow L, Taran T, Rodriguez Lorenc K, Babbar N, Tripathy D, Lu YS. Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib. JCO Precis Oncol. 2021 Sep 1;5. pii: PO.20.00445. doi: 10.1200/PO.20.00445. eCollection 2021.

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Paré L, Martinez D, Chic N, Martínez-Sáez O, Brasó-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum in: J Clin Oncol. 2021 Nov 1;39(31):3525.

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

ReferenceCitation: Im SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva-Vazquez R, Jung KH, Chakravartty A, Hughes G, Gounaris I, Rodriguez-Lorenc K, Taran T, Hurvitz S, Tripathy D. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4.

ReferenceCitation: Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24.

ipd_sharing: Undecided

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:
Saudi Arabia
Italy
Spain
United States
Belgium
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Malaysia
Singapore
Brazil
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Thailand
Korea, Republic of
France
Colombia
United Arab Emirates

location_facility: Comprehensive Blood and Cancer Center SC-2

location_facility: Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc

location_facility: Methodist Hospital / Methodist Cancer Center Dept of Oncology

location_facility: Duke University Medical Center Duke (SC)

location_facility: Cancer Therapy and Research Center UT Health Science Center SC-4

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: University of Texas MD Anderson Cancer Center SC-5

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Dept of Onc.

location_facility: University of Michigan Comprehensive Cancer Center Onc Dept

location_facility: Comprehensive Cancer Center at Saint Joseph Hospital SC

location_facility: Northwest Medical Specialties Dept of Onc

location_facility: Tennessee Oncology Tennessee Oncology (3)

location_facility: The Center for Cancer and Blood Disorders SC

location_facility: Washington University School of Medicine SC

location_facility: NorthWest Georgia Oncology Centers NW Georgia Oncology

location_facility: Moanalua Medical Center. Attn: Oncology Dept SC


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

acronym: MONARCH 3

summary: The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

ReferenceCitation: Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.

ReferenceCitation: Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, Frenzel M, Hardebeck MC, Cox J, Barriga S, Toi M, Iwata H, Goetz MP. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019 Jan 17;5:5. doi: 10.1038/s41523-018-0097-z. eCollection 2019.

ReferenceCitation: Takahashi M, Tokunaga E, Mori J, Tanizawa Y, van der Walt JS, Kawaguchi T, Goetz MP, Toi M. Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Breast Cancer. 2022 Jan;29(1):174-184. doi: 10.1007/s12282-021-01295-0. Epub 2021 Oct 18.

ReferenceCitation: Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, André VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Mexico
Sweden
Slovakia
Canada
Germany
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: California Cancer Associates Research and Excellence (cCARE)

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.

location_facility: Central Coast Medical Oncology Corporation

location_facility: Walter Reed National Military Medical Center IRB

location_facility: Scott & White Memorial Hosptial & Clinic

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Kaiser Permanente / Central Interstate Medical Office

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: St Mary's Hospital Regional Cancer Center


title: ARI103094-Follow-Up Study for REDUCE Study Subjects

summary:
ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to this REDUCE Follow-Up Study, Part A and Part B:

REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study. Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as follows: (1) REDUCE subjects who completed treatment with investigational product (dutasteride or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit 10). The objective of this observational study for eligible REDUCE subjects is to collect and summarize data on prostate cancer (the incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled study, REDUCE.
REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE study.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Grubb RL, Andriole GL, Somerville MC, Mahoney C, Manyak MJ, Castro R. The REDUCE Follow-Up Study: low rate of new prostate cancer diagnoses observed during a 2-year, observational, followup study of men who participated in the REDUCE trial. J Urol. 2013 Mar;189(3):871-7. doi: 10.1016/j.juro.2012.09.099. Epub 2012 Sep 25.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Spain
Greece
United Kingdom
Netherlands
Finland
Argentina
Canada
Sweden
United States
Chile
France
Germany