title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments

acronym: FOCUS

summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

ReferenceCitation: Nahas SJ, Naegel S, Cohen JM, Ning X, Janka L, Campos VR, Krasenbaum LJ, Holle-Lee D, Kudrow D, Lampl C. Efficacy and safety of fremanezumab in clinical trial participants aged ≥60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. J Headache Pain. 2021 Nov 24;22(1):141. doi: 10.1186/s10194-021-01351-2.

family: Nahas

full_name: Stephanie J. Nahas

given: Stephanie J.

family: Naegel

full_name: Steffen Naegel

given: Steffen

family: Cohen

full_name: Joshua M. Cohen

given: Joshua M.

family: Ning

full_name: Xiaoping Ning

given: Xiaoping

family: Janka

full_name: Lindsay Janka

given: Lindsay

family: Campos

full_name: Verena Ramirez Campos

given: Verena Ramirez

family: Krasenbaum

full_name: Lynda J. Krasenbaum

given: Lynda J.

family: Holle-Lee

full_name: Dagny Holle-Lee

given: Dagny

family: Kudrow

full_name: David Kudrow

given: David

family: Lampl

full_name: Christian Lampl

given: Christian

journal_name: The Journal of Headache and Pain

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Ashina M, Cohen JM, Galic M, Campos VR, Barash S, Ning X, Kessler Y, Janka L, Diener HC. Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study. J Headache Pain. 2021 Jul 10;22(1):68. doi: 10.1186/s10194-021-01279-7.

family: Ashina

full_name: Messoud Ashina

given: Messoud

family: Galic

full_name: Maja Galic

given: Maja

family: Barash

full_name: Steve Barash

given: Steve

family: Kessler

full_name: Yoel Kessler

given: Yoel

family: Diener

ReferenceCitation: Pazdera L, Cohen JM, Ning X, Campos VR, Yang R, Pozo-Rosich P. Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response. Cephalalgia. 2021 Sep;41(10):1075-1088. doi: 10.1177/03331024211008401. Epub 2021 May 14.

name: Vestra Clinics, Rychnov nad Kněžnou, Czech Republic

name: Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA

name: Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain

name: Headache and Neurological Pain Research Group, Vall d’Hebron Institute of Research (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain.

ReferenceCitation: Spierings ELH, Kärppä M, Ning X, Cohen JM, Campos VR, Yang R, Reuter U. Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial. J Headache Pain. 2021 Apr 16;22(1):26. doi: 10.1186/s10194-021-01232-8.

repository_institution: University of Oulu - University of Oulu Repository - Jultika

ReferenceCitation: Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16. Erratum in: Lancet. 2019 Oct 29;:.

location_country:
Italy
Sweden
Switzerland
Netherlands
Germany
Finland
France
Czechia
Poland
Belgium
Spain
Denmark
United States
United Kingdom

location_facility:
Teva Investigational Site 53425
Teva Investigational Site 42050
Teva Investigational Site 31236
Teva Investigational Site 39049
Teva Investigational Site 32695
Teva Investigational Site 14734
Teva Investigational Site 14738
Teva Investigational Site 54166
Teva Investigational Site 42054
Teva Investigational Site 53423
Teva Investigational Site 53422
Teva Investigational Site 31228
Teva Investigational Site 35239
Teva Investigational Site 38126
Teva Investigational Site 45016
Teva Investigational Site 38125
Teva Investigational Site 53418
Teva Investigational Site 53416
Teva Investigational Site 14729
Teva Investigational Site 53424
Teva Investigational Site 14742
Teva Investigational Site 32697
Teva Investigational Site 31226
Teva Investigational Site 54163
Teva Investigational Site 31227
Teva Investigational Site 14760
Teva Investigational Site 54159
Teva Investigational Site 32700
Teva Investigational Site 35240
Teva Investigational Site 14745
Teva Investigational Site 14753
Teva Investigational Site 14731
Teva Investigational Site 45017
Teva Investigational Site 31230
Teva Investigational Site 42049
Teva Investigational Site 40035
Teva Investigational Site 39051
Teva Investigational Site 38124
Teva Investigational Site 14749
Teva Investigational Site 14746
Teva Investigational Site 54158
Teva Investigational Site 53419
Teva Investigational Site 37090
Teva Investigational Site 40036
Teva Investigational Site 37092
Teva Investigational Site 30199
Teva Investigational Site 34232
Teva Investigational Site 54165
Teva Investigational Site 54161
Teva Investigational Site 14737
Teva Investigational Site 14732
Teva Investigational Site 14843
Teva Investigational Site 53420
Teva Investigational Site 54160
Teva Investigational Site 14739
Teva Investigational Site 32699
Teva Investigational Site 35236
Teva Investigational Site 14748
Teva Investigational Site 32691
Teva Investigational Site 31229
Teva Investigational Site 38127
Teva Investigational Site 35235
Teva Investigational Site 14747
Teva Investigational Site 32693
Teva Investigational Site 32689
Teva Investigational Site 14752
Teva Investigational Site 53417
Teva Investigational Site 14740
Teva Investigational Site 39050
Teva Investigational Site 14735
Teva Investigational Site 31235
Teva Investigational Site 14730
Teva Investigational Site 34231
Teva Investigational Site 39052
Teva Investigational Site 42051
Teva Investigational Site 32701
Teva Investigational Site 40034
Teva Investigational Site 40032
Teva Investigational Site 45018
Teva Investigational Site 54157
Teva Investigational Site 35237
Teva Investigational Site 14741
Teva Investigational Site 31234
Teva Investigational Site 42052
Teva Investigational Site 40033
Teva Investigational Site 14743
Teva Investigational Site 32692
Teva Investigational Site 31231
Teva Investigational Site 31233
Teva Investigational Site 14750
Teva Investigational Site 37089
Teva Investigational Site 35238
Teva Investigational Site 14733
Teva Investigational Site 54164
Teva Investigational Site 34235
Teva Investigational Site 34230
Teva Investigational Site 32690
Teva Investigational Site 31225
Teva Investigational Site 14756
Teva Investigational Site 37091
Teva Investigational Site 14751
Teva Investigational Site 14758
Teva Investigational Site 32698
Teva Investigational Site 14761
Teva Investigational Site 39048
Teva Investigational Site 54162
Teva Investigational Site 34233
Teva Investigational Site 14736
Teva Investigational Site 30204
Teva Investigational Site 40037
Teva Investigational Site 34236
Teva Investigational Site 14754
Teva Investigational Site 32694


type: EudraCT Number

title: Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)

summary: Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody, therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921 was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8 weeks to study completion at Week 60. This is a LAP to support provision of open-label mepolizumab on an individual basis to eligible subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under this LAP within a 6-month period starting from completion of study MEA115921 (that is, at Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will initiate mepolizumab at the time point that would have been Week 60 if the subject had completed the study. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject meets any of the withdrawal/stopping criteria.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: GlaxoSmithKline

location_country:
United States
Germany
France
Japan
Belgium
Canada
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

acronym: IKEMA

summary:
Primary Objective:

To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.

Secondary Objectives:

To evaluate the Overall Response Rate (ORR), rate of very good partial response (VGPR) or better and complete response (CR) rate in both arms using International Myeloma Working Group (IMWG) criteria.
To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in both arms using IMWG criteria.
To evaluate the Overall Survival (OS) in both arms.
To evaluate safety in both arms.
To evaluate duration of response (DOR) in both arms.
To evaluate the Time To Progression (TTP) in both arms.
To evaluate the Second Progression Free Survival (PFS2) in both arms.
To evaluate the Time to first response
To evaluate the Time to best response
To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.
To evaluate the immunogenicity of isatuximab in isatuximab arm.
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status in both arms.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Špička I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Risse ML, Asset G, Macé S, Martin T; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021 Jun 19;397(10292):2361-2371. doi: 10.1016/S0140-6736(21)00592-4. Epub 2021 Jun 4.

family: Moreau

full_name: Philippe Moreau

given: Philippe

sequence: first

family: Dimopoulos

full_name: Meletios-Athanasios Dimopoulos

given: Meletios-Athanasios

sequence: additional

family: Mikhael

full_name: Joseph Mikhael

given: Joseph

family: Yong

full_name: Kwee Yong

given: Kwee

family: Capra

full_name: Marcelo Capra

given: Marcelo

family: Facon

full_name: Thierry Facon

given: Thierry

family: Hajek

full_name: Roman Hajek

given: Roman

family: Špička

full_name: Ivan Špička

given: Ivan

family: Baker

full_name: Ross Baker

given: Ross

family: Kim

full_name: Kihyun Kim

given: Kihyun

family: Martinez

full_name: Gracia Martinez

given: Gracia

family: Min

full_name: Chang-Ki Min

given: Chang-Ki

family: Pour

full_name: Ludek Pour

given: Ludek

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Oriol

full_name: Albert Oriol

given: Albert

family: Koh

full_name: Youngil Koh

given: Youngil

family: Suzuki

full_name: Kenshi Suzuki

given: Kenshi

family: Risse

full_name: Marie-Laure Risse

given: Marie-Laure

family: Asset

full_name: Gaelle Asset

given: Gaelle

family: Macé

full_name: Sandrine Macé

given: Sandrine

family: Martin

full_name: Thomas Martin

given: Thomas

ReferenceCitation: Moreau P, Dimopoulos MA, Yong K, Mikhael J, Risse ML, Asset G, Martin T. Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design. Future Oncol. 2020 Jan;16(2):4347-4358. doi: 10.2217/fon-2019-0431. Epub 2019 Dec 13.

name: Department of Hematology, University Hospital, Allée de l'Ile Gloriette, Nantes, 44093, France

name: Department of Clinical Therapeutics, National & Kapodistrian University of Athens, Stadiou 5 10562 Athens, Greece

name: Department of Hematology, University College London, London, UK

name: Department of Medicine, Translational Genomics Research Institute, City of Hope Cancer Center, Phoenix, AZ, AZ 85028, USA

name: Department of Hematology, University of California at San Francisco, San Francisco, CA, CA 94143, USA

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

repository_institution: University College London - UCL Discovery

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

location_country:
Italy
Brazil
United States
France
Czechia
Greece
Japan
Hungary
Australia
Russian Federation
New Zealand
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility:
Investigational Site Number 3800001
Investigational Site Number 4100004
Investigational Site Number 7920002
Investigational Site Number 8400003
Investigational Site Number 3800003
Investigational Site Number 3920006
Investigational Site Number 1240001
Investigational Site Number 4100002
Investigational Site Number 3920003
Investigational Site Number 2030002
Investigational Site Number 0760003
Investigational Site Number 6430004
Investigational Site Number 2500002
Investigational Site Number 2030004
Investigational Site Number 0360007
Investigational Site Number 3920001
Investigational Site Number 4100001
Investigational Site Number 7240003
Investigational Site Number 7920005
Investigational Site Number 2030003
Investigational Site Number 7240002
Investigational Site Number 1240002
Investigational Site Number 2500003
Investigational Site Number 2030001
Investigational Site Number 3920007
Investigational Site Number 8260004
Investigational Site Number 7920001
Investigational Site Number 5540002
Investigational Site Number 3800004
Investigational Site Number 0760001
Investigational Site Number 3800002
Investigational Site Number 6430003
Investigational Site Number 3920005
Investigational Site Number 3480005
Investigational Site Number 3920004
Investigational Site Number 7920004
Investigational Site Number 2500001
Investigational Site Number 0360001
Investigational Site Number 2500004
Investigational Site Number 2500006
Investigational Site Number 3480003
Investigational Site Number 5540001
Investigational Site Number 0360008
Investigational Site Number 4100006
Investigational Site Number 8260005
Investigational Site Number 3000005
Investigational Site Number 3480001
Investigational Site Number 7240004
Investigational Site Number 0760005
Investigational Site Number 3920002
Investigational Site Number 0760004
Investigational Site Number 3000003
Investigational Site Number 7240005
Investigational Site Number 0360004
Investigational Site Number 8400002
Investigational Site Number 3480004
Investigational Site Number 0360005
Investigational Site Number 3000004
Investigational Site Number 0360006
Investigational Site Number 1240003
Investigational Site Number 7240001
Investigational Site Number 8260001
Investigational Site Number 0360002
Investigational Site Number 3000002
Investigational Site Number 4100005
Investigational Site Number 6430002
Investigational Site Number 3000001
Investigational Site Number 7920003
Investigational Site Number 0760002
Investigational Site Number 2500005


title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis

summary:
Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups.

The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and will be followed for 7 days post dose. A safety review committee (SRC) will convene after the completion of each cohort to evaluate safety and pharmacokinetic (PK) data.

Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or placebo daily for 7 days and will be followed for 7 days after receiving the last dose.

Also following the conclusion of the respective SAD level dose groups, healthy adult subjects will participate in the FE treatment group.

Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive days.

Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group consisting of 2 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 + PTI-801 + PTI-428 administered daily for 14 consecutive days.

Part 4 will enroll adult subjects with cystic fibrosis (CF) into 28-day cohorts. Subjects will receive PTI-808 co-administered with PTI-801 with or without PTI-428 versus matching placebo.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Proteostasis Therapeutics, Inc.

location_country:
United States
Germany
France
Belgium
Australia
New Zealand
Denmark
Canada
United Kingdom

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

location_facility: Banner University of Arizona Medical Center

location_facility: University of North Carolina at Chapel Hill

location_facility: Michigan Medicine, University of Michigan

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: Hôpital Maison Blanche Maladies respiratoires et allergologie

status_simplified: Completed


title: A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

summary: To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

ReferenceType: background

ReferenceCitation: North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici LA, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotechnol. 2016 May 20;226:24-34. doi: 10.1016/j.jbiotec.2016.03.032. Epub 2016 Mar 23.

ReferenceCitation: Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotechnol. 2016 Dec 10;239:115-125. doi: 10.1016/j.jbiotec.2016.10.010. Epub 2016 Oct 13.

ReferenceCitation: Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotechnol Rep (Amst). 2017 May 17;15:24-26. doi: 10.1016/j.btre.2017.05.002. eCollection 2017 Sep.

ipd_sharing: No

lead_sponsor: Soligenix

location_country:
France
Belgium
Spain
United States
United Kingdom

location_facility: Centre Hospitalier Universitaire de Mons

location_facility: University of Missouri-Ellis Fischel Cancer Center

location_facility: Hospital Regional Universitario de Málaga

location_facility: Des Moines Oncology Research Association

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Spartanburg Regional-Gibbs Cancer Center


title: Personalized CRT - Multiple Point Pacing Post Approval Study

summary: The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Italy
United States
Netherlands
Germany
France
Malaysia
Slovakia
Hungary
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: North Memorial Heart and Vascular Institute

location_facility: Mercy Health - Saint Vincent Medical Center

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Washington University School of Medicine

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

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: The University of Vermont Medical Center

location_facility: Institut de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

location_facility: Centre hospitalier de la région d'Annecy

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

intervention_type: Device


title: A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors

summary:
Primary Objectives:

Dose escalation (Part 1)

Part 1A (SAR439459 monotherapy)

To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors.

Part 1B (SAR439459 and cemiplimab combination therapy)

To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors.

Dose expansion (Part 2)

Part 2A (SAR439459 monotherapy)

To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1.

Part 2B (SAR439459 and cemiplimab combination therapy)

To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).

Secondary Objectives:

Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459.
Immunogenicity of SAR439459 monotherapy and combined with cemiplimab.

Dose escalation (Part 1)

Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab.
Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab.

Dose expansion (Part 2)

Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab.
To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

ReferenceCitation: Greco R, Qu H, Qu H, Theilhaber J, Shapiro G, Gregory R, Winter C, Malkova N, Sun F, Jaworski J, Best A, Pao L, Hebert A, Levit M, Protopopov A, Pollard J, Bahjat K, Wiederschain D, Sharma S. Pan-TGFβ inhibition by SAR439459 relieves immunosuppression and improves antitumor efficacy of PD-1 blockade. Oncoimmunology. 2020 Sep 13;9(1):1811605. doi: 10.1080/2162402X.2020.1811605.

name: Immuno-Oncology Research, Sanofi, 640 memorial drive, Cambridge

family: Greco

full_name: Rita Greco

given: Rita

family: Qu

full_name: Hongjing Qu

given: Hongjing

name: Oncology In Vivo Pharmacology, Sanofi, 640 memorial drive, Cambridge

full_name: Hui Qu

given: Hui

name: Precision Oncology, Sanofi, 270 albany street, Cambridge

family: Theilhaber

full_name: Joachim Theilhaber

given: Joachim

family: Shapiro

full_name: Gary Shapiro

given: Gary

family: Gregory

full_name: Richard Gregory

given: Richard

family: Winter

full_name: Christopher Winter

given: Christopher

family: Malkova

full_name: Natalia Malkova

given: Natalia

family: Sun

full_name: Frank Sun

given: Frank

name: Biologics Research, Sanofi, 49 New York Ave, Framingham

family: Jaworski

full_name: Julie Jaworski

given: Julie

family: Best

full_name: Annie Best

given: Annie

family: Pao

full_name: Lily Pao

given: Lily

name: Translational Sciences, Sanofi, Cambridge, MA, US

family: Hebert

full_name: Andrew Hebert

given: Andrew

family: Levit

full_name: Mikhail Levit

given: Mikhail

family: Protopopov

full_name: Alexei Protopopov

given: Alexei

family: Pollard

full_name: Jack Pollard

given: Jack

family: Bahjat

full_name: Keith Bahjat

given: Keith

family: Wiederschain

full_name: Dmitri Wiederschain

given: Dmitri

family: Sharma

full_name: Sharad Sharma

given: Sharad

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: OncoImmunology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

location_country:
Italy
United States
Netherlands
Germany
France
Belgium
Australia
Spain
Estonia
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility:
Investigational Site Number 3800001
Investigational Site Number 8260002
Investigational Site Number 8400003
Investigational Site Number 3800003
Investigational Site Number 4100002
Investigational Site Number 1240001
Investigational Site Number 8400008
Investigational Site Number 2500002
Investigational Site Number 8400004
Investigational Site Number 8400001
Investigational Site Number 4100001
Investigational Site Number 2760003
Investigational Site Number 7240003
Investigational Site Number 7240002
Investigational Site Number 1240002
Investigational Site Number 2500003
Investigational Site Number 5280001
Investigational Site Number 3800002
Investigational Site Number 2760001
Investigational Site Number 1580003
Investigational Site Number 2500001
Investigational Site Number 0360001
Investigational Site Number 2500004
Investigational Site Number 2500006
Investigational Site Number 0560001
Investigational Site Number 8400006
Investigational Site Number 7240004
Investigational Site Number 5280002
Investigational Site Number 7240005
Investigational Site Number 7240006
Investigational Site Number 1580002
Investigational Site Number 1240003
Investigational Site Number 0560002
Investigational Site Number 7240001
Investigational Site Number 8260001
Investigational Site Number 8400101
Investigational Site Number 2330001
Investigational Site Number 1580001
Investigational Site Number 0360002
Investigational Site Number 2500005
Investigational Site Number 8400007


title: A Global Epidemiologic Study to Determine the Prevalence of Neutralizing Antibodies and Related Adaptive Immune Responses to Adeno-Associated Virus (AAV) in Adults With Hemophilia

summary: Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia B (coagulation factor IX [FIX] ≤2%).

ipd_sharing: Yes

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.

lead_sponsor: Baxalta now part of Shire

location_country:
Italy
Austria
Germany
France
Spain
United States

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Gulf States Hemophilia and Thrombophilia Center

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Hospital Regional Universitario de Malaga

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Presidio Ospedaliero di Castelfranco Veneto

location_facility: Medical University of South Carolina (MUSC)

intervention_type: Other


title: Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

acronym: SPARTA

summary:
The primary Phase 1 purpose of this study was to assess overall safety, tolerability and recommended Phase 2 dose (RP2D) of APL-101.

The Phase 2 portion will assess efficacy of the dose determined in Phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations; individuals with cancers associated with c-Met amplifications; individuals with cancers associated with c-Met fusion

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Apollomics Inc.

location_country:
Italy
United States
Finland
France
Singapore
Hungary
Australia
Puerto Rico
Russian Federation
Spain
Canada
United Kingdom
Taiwan
Ukraine

location_facility: University of Southern California / Norris Comprehensive Cancer Center

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

location_facility: Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute

location_facility: City Hematology Center of Municipal Non-Profit Enterprise "City Clinical Hospital #4" DCC

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: West Virginia University Cancer Institute

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Private Medical Institution Euromedservice

location_facility: State Institution V.T.Zaitsev Institute of General and Urgent Surgery of National Academy of Medical Sciences of Ukraine, Department of Purulent Surgery

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Central de Asturias

location_facility: Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

location_facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Washington University School of Medicine

location_facility: University of California, Los Angeles (UCLA) Ronald Reagan Medical Center

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: The Don & Sybil Harrington Cancer Center

location_facility: McGill University Health Center - Research Institute

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Linkou Chang Gung Memorial Hospital (CGMHLK)

location_facility: Park Nicollet Institute - Frauenshuh Cancer Center

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection of Population, Department of Surger

location_facility: Lady Davis Institute for Medical Research Jewish General Hospital


title: A Study of Oral LOXO-292 in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

summary: This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

ReferenceCitation: Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardière C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. doi: 10.1056/NEJMoa2005651.

name: From Massachusetts General Hospital (L.J.W.) and Dana–Farber Cancer Institute (J. Lorch), Boston; Memorial Sloan Kettering Cancer Center, New York (E.S., A.D.); Royal North Shore Hospital, St. Leonards, NSW (B.R.), and Peter MacCallum Cancer Institute, Melbourne, VIC (B.S.) — both in Australia; University of California, San Francisco–Helen Diller Family Comprehensive Cancer Center, San Francisco (H.K.), David Geffen School of Medicine at UCLA, Los Angeles (J.W.G.), and Chao Family Comprehensive Cancer...

family: Wirth

full_name: Lori J. Wirth

given: Lori J.

family: Sherman

full_name: Eric Sherman

given: Eric

family: Robinson

full_name: Bruce Robinson

given: Bruce

family: Solomon

full_name: Benjamin Solomon

given: Benjamin

family: Kang

full_name: Hyunseok Kang

given: Hyunseok

family: Lorch

full_name: Jochen Lorch

given: Jochen

family: Worden

full_name: Francis Worden

given: Francis

family: Brose

full_name: Marcia Brose

given: Marcia

family: Patel

full_name: Jyoti Patel

given: Jyoti

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

family: Godbert

full_name: Yann Godbert

given: Yann

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Morris

full_name: John C. Morris

given: John C.

family: Owonikoko

full_name: Taofeek K. Owonikoko

given: Taofeek K.

family: Tan

full_name: Daniel S.W. Tan

given: Daniel S.W.

family: Gautschi

full_name: Oliver Gautschi

given: Oliver

family: Weiss

full_name: Jared Weiss

given: Jared

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Burkard

full_name: Mark E. Burkard

given: Mark E.

family: Laskin

full_name: Janessa Laskin

given: Janessa

family: Taylor

full_name: Matthew H. Taylor

given: Matthew H.

family: Kroiss

full_name: Matthias Kroiss

given: Matthias

family: Medioni

full_name: Jacques Medioni

ReferenceCitation: Drilon A, Oxnard GR, Tan DSW, Loong HHF, Johnson M, Gainor J, McCoach CE, Gautschi O, Besse B, Cho BC, Peled N, Weiss J, Kim YJ, Ohe Y, Nishio M, Park K, Patel J, Seto T, Sakamoto T, Rosen E, Shah MH, Barlesi F, Cassier PA, Bazhenova L, De Braud F, Garralda E, Velcheti V, Satouchi M, Ohashi K, Pennell NA, Reckamp KL, Dy GK, Wolf J, Solomon B, Falchook G, Ebata K, Nguyen M, Nair B, Zhu EY, Yang L, Huang X, Olek E, Rothenberg SM, Goto K, Subbiah V. Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Aug 27;383(9):813-824. doi: 10.1056/NEJMoa2005653.

name: From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College (A.D., E.R.) and New York University Langone Medical Center (V.V.), New York, and Roswell Park Comprehensive Cancer Center, Buffalo (G.K.D.) — all in New York; Dana–Farber Cancer Institute (G.R.O.) and Massachusetts General Hospital (J.G.), Boston; National Cancer Centre Singapore, Singapore (D.S.W.T.); the Chinese University of Hong Kong, Hong Kong, China (H.H.F.L.); Sarah Cannon Research Institute, Nashville (M.J.);...

repository_institution: Yonsei University Medical Library - YUHSpace

title: Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer

location_country:
Italy
United States
Hong Kong
Switzerland
Germany
France
Japan
Israel
Singapore
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Institut du Cancer de Montpellier - Val d'aurelle

location_facility: University of Chicago Medicine-Comprehensive Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: Sarah Cannon Research Institute at HealthOne


ReferenceCitation: Smolen JS, Sebba A, Ruderman EM, Schulze-Koops H, Sapin C, Gellett AM, Sprabery AT, Li L, de la Torre I, Gallo G, Liu-Leage S, Pillai S, Reis P, Nash P. Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study. Rheumatol Ther. 2020 Dec;7(4):1021-1035. doi: 10.1007/s40744-020-00250-3. Epub 2020 Nov 16.

family: Smolen

full_name: Josef S. Smolen

given: Josef S.

family: Sebba

full_name: Anthony Sebba

given: Anthony

family: Ruderman

full_name: Eric M. Ruderman

given: Eric M.

family: Schulze-Koops

full_name: Hendrik Schulze-Koops

given: Hendrik

family: Sapin

full_name: Christophe Sapin

given: Christophe

family: Gellett

full_name: Amanda M. Gellett

given: Amanda M.

family: Sprabery

full_name: Aubrey Trevelin Sprabery

given: Aubrey Trevelin

family: Li

full_name: Lingnan Li

given: Lingnan

family: de la Torre

full_name: Inmaculada de la Torre

given: Inmaculada

family: Gallo

full_name: Gaia Gallo

given: Gaia

family: Liu-Leage

full_name: Soyi Liu-Leage

given: Soyi

family: Pillai

full_name: Sreekumar Pillai

given: Sreekumar

family: Reis

full_name: Paulo Reis

given: Paulo

family: Nash

full_name: Peter Nash

given: Peter

journal_name: Rheumatology and Therapy

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

license_normalized: no license

repository_normalized: PubMed Central

ReferenceCitation: Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Gratacós J, Goupille P, Liu Leage S, Pillai S, Nash P. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020 Oct;79(10):1310-1319. doi: 10.1136/annrheumdis-2020-217372. Epub 2020 Jul 13.

full_name: Josef S Smolen

given: Josef S

family: Mease

full_name: Philip Mease

given: Philip

family: Tahir

full_name: Hasan Tahir

given: Hasan

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

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:
Finland
Australia
Belgium
Denmark
Ukraine
India
France
Poland
Argentina
Canada
South Africa
Sweden
Switzerland
Netherlands
Hungary
Germany
United Kingdom
Italy
Austria
Mexico
Israel
Spain

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC

location_facility: Multifield Medical Center of Odesa NMU (University Clinic#1)

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: Regional Clinical Hospital Center for Emergency medical care

location_facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Instituto de Asist Reumatologica Integral

location_facility: Organizacion Medica de Investigacion - OMI

location_facility: Regional Clinical Hospital of Zaporizhzhia

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Reumatologiska Kliniken Skånes universitetssjukhus Malmö

location_facility: Krishna Institute of Medical Sciences Ltd.

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Rheumatology, The Queen Elizabeth Hospital

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Centro Investigacion de Tratam Innovadores de Sinaloa SC

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: Municipal Institution of Ternopil Regional Council

location_facility: Aalborg Universitetshospital - Psykiatrien

location_facility: Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna

location_facility: National Scientific Center "Strazhesko institute of cardio"

location_facility: Centro de Medicina Familiar Mindout Research

location_facility: Government Medical College & Sir Sayajirao General Hospital

location_facility: Centre Hospitalier de Vendee Les Oudairies

location_facility: Zentrum für klinische Studien Dr. Ursula Hanusch GmbH

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

title: A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

summary: The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.


lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Romania
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Singapore
Portugal
China
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Turkey

acronym: CheckMate 648

location_facility: Instituto Nacional De Enfermedades Neoplasicas

location_facility: Hospital Nacional Daniel Alcides Carrion

location_facility: Hospital De Base De Sao Jose Do Rio Preto

location_facility: II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: A.O. Universitaria Pisana Ospedale Santa Chiara

location_facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.

location_facility: Interni hematologicka a onkologicka klinika

location_facility: Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III

location_facility: Hospital Municipal De Gastroenterologia Dr.Udaondo

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Baptist Health Medical Group Oncology LLC

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

source: euctr

title: A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

summary: The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin


status: Terminated

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Belgium
Australia
Taiwan
Iceland
France
Japan
Argentina
Canada
Korea, Republic of
South Africa
Chile
Switzerland
Netherlands
Singapore
Puerto Rico
Portugal
China
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain

location_facility: Yale University, One Church Street, Suite 600

location_facility: Torrance Clinical Research Institute, 25043 Narbonne Avenue

location_facility: Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave

location_facility: ATP Clinical Research Inc, 3151 Airway Avenue T 3

location_facility: Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130

location_facility: Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B

location_facility: Summit Research Network, 2701 NW Vaughn St, Suite 350

location_facility: QUEST Research Institute, 28595 Orchard Lake Road, Suite 301

location_facility: Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102

location_facility: NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226

location_facility: Inspira Clinical Research, Ave Hostos 405

location_facility: Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100

location_facility: Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209

location_facility: Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112

location_facility: Toronto Memory Program, 1 Valleybrook Drive Suite 400

location_facility: Roskamp Institute, Inc., 2040 Whitfield Avenue

location_facility: Irvine Center for Clinical Res, 2515 McCabe Way

location_facility: Denver Neurological Clinic, 950 E Harvard Ave

location_facility: Hawaii Pacific Neuroscience, 2230 Liliha st 104

location_facility: Roper Hospital, 316 Calhoun Street 5th Floor

location_facility: Banner Alzheimer's Institute, 901 East Willetta Street

location_facility: Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408

location_facility: Meridien Research, 2300 Maitland center, Pkwy Ste 230

location_facility: Advanced Clinical Research, 2950 E Magic View Dr, Suite 182

location_facility: New Horizon Research Center, 11880 SW 40 St., Suite 405

location_facility: Hattiesburg Clinic, 415 South 28th Avenue

location_facility: Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock

location_facility: Mountain Neurological Research, 350 Market Street, Suite 316

location_facility: Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200

location_facility: Compass Research, LLC,100 West Gore Street, Suite 202

location_facility: Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100

location_facility: ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road

location_facility: Brain Matters Research, Inc., 800 NW 17th Avenue

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).

summary: The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

status_simplified: Unknown


ReferenceCitation: Toi M, Shao Z, Hurvitz S, Tseng LM, Zhang Q, Shen K, Liu D, Feng J, Xu B, Wang X, Lee KS, Ng TY, Ridolfi A, Noel-Baron F, Ringeisen F, Jiang Z. Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1. Breast Cancer Res. 2017 Apr 11;19(1):47. doi: 10.1186/s13058-017-0839-0.

family: Toi

full_name: Masakazu Toi

given: Masakazu

family: Shao

full_name: Zhimin Shao

given: Zhimin

family: Hurvitz

full_name: Sara Hurvitz

given: Sara

family: Tseng

full_name: Ling-Ming Tseng

given: Ling-Ming

family: Zhang

full_name: Qingyuan Zhang

given: Qingyuan

family: Shen

full_name: Kunwei Shen

given: Kunwei

family: Liu

full_name: Donggeng Liu

given: Donggeng

family: Feng

full_name: Jifeng Feng

given: Jifeng

family: Xu

full_name: Binghe Xu

given: Binghe

family: Wang

full_name: Xiaojia Wang

given: Xiaojia

family: Lee

full_name: Keun Seok Lee

given: Keun Seok

family: Ng

full_name: Ting Ying Ng

given: Ting Ying

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Noel-baron

full_name: Florence Noel-baron

given: Florence

family: Ringeisen

full_name: Francois Ringeisen

given: Francois

family: Jiang

full_name: Zefei Jiang

given: Zefei

journal_name: Breast Cancer Research

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: Kyoto University - Kyoto University Research Information Repository

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance-too much of a good thing …. Ann Oncol. 2016 May;27(5):760-2. doi: 10.1093/annonc/mdw047. Epub 2016 Feb 9. Review.

title: Statistical controversies in clinical research: statistical significance—too much of a good thing …

ReferenceCitation: Hurvitz SA, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, Tseng LM, Zhang Q, Shen K, Liu D, Dreosti LM, Burris HA, Toi M, Buyse ME, Cabaribere D, Lindsay MA, Rao S, Pacaud LB, Taran T, Slamon D. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Lancet Oncol. 2015 Jul;16(7):816-29. doi: 10.1016/S1470-2045(15)00051-0. Epub 2015 Jun 16.

repository_institution: University of Pretoria - UpSpace Institutional Repository

location_country:
Peru
Greece
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Hong Kong
Switzerland
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Brazil
Lebanon
Mexico
Venezuela
Egypt
Turkey

location_facility: New York Oncology Hematology NYOH Amsterdam

location_facility: Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)

location_facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (2)

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

location_facility: University of California at Los Angeles Dept. of UCLA

location_facility: Northwest Cancer Specialists Vancouver Cancer Center (3)

location_facility: Central Coast Medical Oncology Corporation Onc Dept

location_facility: Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc

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

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

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: Central Indiana Cancer Centers CICC - East (3)

location_facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center

location_facility: Cancer Care Associates Medical Group Dept. of CCA

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3)

title: A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

summary: The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.


title: An Open-label Randomized Phase II Trial of Belinostat (PXD101) in Combination With Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Previously Untreated Carcinoma of Unknown Primary

summary: The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.

lead_sponsor: Onxeo

location_country:
Denmark
United States
Germany
France

location_facility: Centre Henri Becquerel, Oncologie Médicale

location_facility: Carl-Gustav-Carus Medicinische Klinik und Poliklinik I

location_facility: Tennessee Oncology Sarah Cannon Research

location_facility: Chattanooga Oncology & Hematology Associates, PC

location_facility: CRLCC Francois Baclesse, Oncologie medicale


ReferenceType: result

ReferenceCitation: Ghofrani HA, Grimminger F, Grünig E, Huang Y, Jansa P, Jing ZC, Kilpatrick D, Langleben D, Rosenkranz S, Menezes F, Fritsch A, Nikkho S, Humbert M. Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):361-71. doi: 10.1016/S2213-2600(16)30019-4. Epub 2016 Apr 8.

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: Grimminger

full_name: Friedrich Grimminger

given: Friedrich

family: Grünig

full_name: Ekkehard Grünig

given: Ekkehard

family: Huang

full_name: Yigao Huang

given: Yigao

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Jing

full_name: Zhi-Cheng Jing

given: Zhi-Cheng

family: Kilpatrick

full_name: David Kilpatrick

given: David

family: Langleben

full_name: David Langleben

family: Rosenkranz

full_name: Stephan Rosenkranz

given: Stephan

family: Menezes

full_name: Flavia Menezes

given: Flavia

family: Fritsch

full_name: Arno Fritsch

given: Arno

family: Nikkho

full_name: Sylvia Nikkho

given: Sylvia

family: Humbert

full_name: Marc Humbert

given: Marc

journal_name: The Lancet Respiratory Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2. Review.

family: Schermuly

full_name: Ralph Schermuly

given: Ralph

family: Stasch

full_name: Johannes-Peter Stasch

given: Johannes-Peter

family: Wilkins

full_name: Martin R. Wilkins

given: Martin R.

family: Klinger

full_name: James R. Klinger

given: James R.

journal_name: Chest

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

ReferenceCitation: Benza RL, Ghofrani HA, Grünig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

journal_name: The Journal of Heart and Lung Transplantation

ReferenceCitation: Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

name: Clinical Pharmacology, Pharma Research Center, Bayer Pharma, Wuppertal, Germany

title: Population Pharmacokinetics and the Pharmacokinetic/Pharmacodynamic Relationship of Riociguat in Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

ReferenceCitation: Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Rubin LJ, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh A, Langleben D, Fritsch A, Menezes F, Davie N, Ghofrani HA. Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2). Eur Respir J. 2015 May;45(5):1303-13. doi: 10.1183/09031936.00090614. Epub 2015 Jan 22.

ReferenceCitation: Ghofrani HA, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

title: Riociguat for the Treatment of Pulmonary Arterial Hypertension

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Singapore
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Turkey

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

title: Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

summary: Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.


title: Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window: a Randomized, Controlled Trial

acronym: Tension

summary: TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

ReferenceCitation: Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6:CD007574. doi: 10.1002/14651858.CD007574.pub3.

name: Brain and Circulation Research Group, Department of Clinical Medicine; UiT The Arctic University of Norway; Tromsø Norway

name: Department of Neurology; University Hospital of North Norway; Tromsø Norway

family: Roaldsen

full_name: Melinda B Roaldsen

given: Melinda B

name: Department of Neurology; Oslo University Hospital; Nydalen Norway

family: Jusufovic

full_name: Mirza Jusufovic

given: Mirza

name: Department of Internal Medicine; Oslo University Hospital; Oslo Norway

family: Berge

full_name: Eivind Berge

given: Eivind

family: Lindekleiv

full_name: Haakon Lindekleiv

given: Haakon

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Bendszus M, Bonekamp S, Berge E, Boutitie F, Brouwer P, Gizewski E, Krajina A, Pierot L, Randall G, Simonsen CZ, Zeleňák K, Fiehler J, Thomalla G. A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window. Int J Stroke. 2019 Jan;14(1):87-93. doi: 10.1177/1747493018798558. Epub 2018 Aug 29.

name: Department of Neuroradiology, University of Heidelberg, Germany

family: Bendszus

full_name: Martin Bendszus

given: Martin

family: Bonekamp

full_name: Susanne Bonekamp

given: Susanne

name: Department of Internal Medicine and Cardiology, Oslo University Hospital, Oslo, Norway

name: Service de Biostatistique, F-69003 Lyon, Hospices Civils de Lyon, France; Université Lyon 1, F-69100 Villeurbanne, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, F-69100 Villeurbanne, France

family: Boutitie

full_name: Florent Boutitie

given: Florent

name: Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden

family: Brouwer

full_name: Patrick Brouwer

given: Patrick

name: Department of Neuroradiology, Medical University Innsbruck, Austria

family: Gizewski

full_name: Elke Gizewski

given: Elke

name: Department of Radiology, Charles University Hospital, Hradec Kralove, Czech Republic

family: Krajina

full_name: Antonin Krajina

given: Antonin

name: Department of Neuroradiology, Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France

family: Pierot

full_name: Laurent Pierot

given: Laurent

name: Stroke Alliance For Europe, Brussels, Belgium

family: Randall

full_name: Gary Randall

given: Gary

name: Department of Neurology, Aarhus University Hospital, Aarhus, Denmark

family: Simonsen

full_name: Claus Z. Simonsen

given: Claus Z.

name: Department of Radiology, Comenius University’s Jessenius Faculty of Medicine and University Hospital, Martin, Slovakia

family: Zeleňák

full_name: Kamil Zeleňák

given: Kamil

name: Department of Neuroradiology, University of Hamburg, Germany

family: Fiehler

full_name: Jens Fiehler

given: Jens

name: Department of Neurology, University of Hamburg, Germany

family: Thomalla

full_name: Götz Thomalla

given: Götz

journal_name: International Journal of Stroke

oa_host_type: repository

repositories_institution:
Elsevier - Scopus
PubMed Central - Europe PMC

location_country: Austria Germany France Czechia Slovakia Norway Spain Denmark Canada

location_facility: Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz

location_facility: CHRU Hôpiteaux de Tours / Hôpital Bretonneau

location_facility: Hôpiteaux Universitaires Paris-Sud, Hôpital Bicêtre

location_facility: CHU de Rennes/Centre Urgences-Réanimations

location_facility: Klinik für Radiologie und Neuroradiologie am Klinikum Mitte

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Universitätsklinikum KK Bochum-Langendreer Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin

location_facility: Neuroradiology, Keppler University Hospital Linz

location_facility: Comprehensive stroke center,University Hospital Ostrava

location_facility: Department of Neurology, Reseach Institute of Neurointervention, Christian Doppler Clinic, Paracelsus Medical University Salzburg

location_facility: Technische Universität München / Klinikum rechts der Isar

location_facility: Comenius University's Jessenius Faculty of Medicine and University Hospital

location_facility: Gesundheit Nord gGmbH Klinikverbund Bremen

location_facility: Université Reims Champagne Ardenne/ Department of Neuroradiology, Hôpital Maison Blanche

location_facility: Universitätsinstitut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin Johannes Wesling Klinikum Minden


ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3:CD012862. doi: 10.1002/14651858.CD012862.pub2.

name: Department of Renal Medicine; Royal Infirmary of Edinburgh; Edinburgh UK

family: Pugh

full_name: Dan Pugh

given: Dan

name: Centre for Inflammation Research; Royal Infirmary of Edinburgh; Edinburgh UK

family: O'Sullivan

full_name: Eoin D O'Sullivan

given: Eoin D

family: Duthie

full_name: Fiona AI Duthie

given: Fiona AI

name: Department of Renal Medicine; Royal Free London NHS Foundation Trust; London UK

family: Masson

full_name: Philip Masson

given: Philip

name: Renal Department; Newcastle University/Freeman Hospital; Newcastle Upon Tyne UK

family: Kavanagh

full_name: David Kavanagh

given: David

ReferenceCitation: Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, Bingham C, Cohen DJ, Delmas Y, Douglas K, Eitner F, Feldkamp T, Fouque D, Furman RR, Gaber O, Herthelius M, Hourmant M, Karpman D, Lebranchu Y, Mariat C, Menne J, Moulin B, Nürnberger J, Ogawa M, Remuzzi G, Richard T, Sberro-Soussan R, Severino B, Sheerin NS, Trivelli A, Zimmerhackl LB, Goodship T, Loirat C. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013 Jun 6;368(23):2169-81. doi: 10.1056/NEJMoa1208981.

family: Legendre

full_name: C.M. Legendre

family: Licht

full_name: C. Licht

given: C.

family: Muus

full_name: P. Muus

given: P.

family: Greenbaum

full_name: L.A. Greenbaum

family: Babu

full_name: S. Babu

given: S.

family: Bedrosian

full_name: C. Bedrosian

family: Bingham

full_name: C. Bingham

family: Cohen

full_name: D.J. Cohen

family: Delmas

full_name: Y. Delmas

given: Y.

family: Douglas

full_name: K. Douglas

given: K.

family: Eitner

full_name: F. Eitner

given: F.

family: Feldkamp

full_name: T. Feldkamp

given: T.

family: Fouque

full_name: D. Fouque

given: D.

family: Furman

full_name: R.R. Furman

family: Gaber

full_name: O. Gaber

given: O.

family: Herthelius

full_name: M. Herthelius

given: M.

family: Hourmant

full_name: M. Hourmant

family: Karpman

full_name: D. Karpman

family: Lebranchu

repository_institution: Lund University - Lund University Publications

title: Terminal Complement Inhibitor Eculizumab in Atypical Hemolytic–Uremic Syndrome

location_country:
Austria
Germany
France
United States
United Kingdom

title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).


title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study to Evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients With Severe Asthma

summary: Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

ReferenceCitation: Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.

family: Anderson

full_name: Wayne H. Anderson

given: Wayne H.

family: Koshy

full_name: Beena T. Koshy

given: Beena T.

family: Huang

full_name: Lingkang Huang

given: Lingkang

family: Mosteller

full_name: Michael Mosteller

given: Michael

family: Stinnett

full_name: Sandra W. Stinnett

given: Sandra W.

family: Condreay

full_name: Lynn D. Condreay

given: Lynn D.

family: Ortega

full_name: Hector Ortega

given: Hector

journal_name: Annals of Allergy, Asthma & Immunology

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:
United States
South Africa
Netherlands
France
Poland
Norway
Germany
United Kingdom


title: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure

summary: Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

lead_sponsor: Corvia Medical

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

location_facility: Virginia Commonwealth University Medical Center

location_facility: National Cerebral and Cardiovascular Center

location_facility: Heart Center of the University of Leipzig

location_facility: The Hospital of Hyogo College of Medicine

location_facility: University of Arizona College of Medicine

location_facility: Froedtert and the Medical College of Wisconsin

location_facility: Kaiser Permanente San Francisco Medical Center

location_facility: Ohio State University College of Medicine

location_facility: Christ Hospital Ohio Heart and Vascular Institute

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Baylor University Medical Center, Dallas


ReferenceCitation: Morgensztern D, Besse B, Greillier L, Santana-Davila R, Ready N, Hann CL, Glisson BS, Farago AF, Dowlati A, Rudin CM, Le Moulec S, Lally S, Yalamanchili S, Wolf J, Govindan R, Carbone DP. Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study. Clin Cancer Res. 2019 Dec 1;25(23):6958-6966. doi: 10.1158/1078-0432.CCR-19-1133. Epub 2019 Sep 10.

ReferenceCitation: Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.

family: Tanaka

full_name: Kentaro Tanaka

given: Kentaro

family: Isse

full_name: Kumiko Isse

given: Kumiko

family: Fujihira

full_name: Tomomichi Fujihira

given: Tomomichi

family: Takenoyama

full_name: Mitsuhiro Takenoyama

given: Mitsuhiro

family: Saunders

full_name: Laura Saunders

given: Laura

family: Bheddah

full_name: Sheila Bheddah

given: Sheila

family: Nakanishi

full_name: Yoichi Nakanishi

given: Yoichi

family: Okamoto

full_name: Isamu Okamoto

given: Isamu

journal_name: Lung Cancer

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Spain
Croatia
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Belarus
Turkey
Latvia

acronym: TAHOE

location_facility: Dana-Farber Cancer Institute /ID# 160210

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325

location_facility: Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 159125

location_facility: Klinicki bolnicki centar Rijeka /ID# 159501

location_facility: Oncocenter Oncologie Clinica S /ID# 160848

location_facility: Inonu Universitesi Turgut Ozal /ID# 159241

location_facility: Centro de Investigación Clinica Chapultepec /ID# 161000

location_facility: Assistance Publique- Hopitaux /ID# 160552

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666

location_facility: Chonnam National University Hospital /ID# 159294

location_facility: Tokushima University Hospital /ID# 165812

location_facility: Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868

location_facility: Nebraska Hematology Oncology /ID# 155900

location_facility: Guy's and St Thomas' NHS Found /ID# 159581

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537

location_facility: Krajska nemocnice Liberec a.s. /ID# 159653

location_facility: Kaluga Regional Clinical Oncol /ID# 160179

location_facility: Ospedale Santa Maria delle Cro /ID# 158940

location_facility: Univ Medical Ctr Brackenridge /ID# 156967

location_facility: Cancer Specialists of North Florida - Southpoint /ID# 155828

location_facility: National Cancer Center Hospital /ID# 166768

location_facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 159641

location_facility: United Lincolnshire Hospitals /ID# 159579

location_facility: Los Angeles Hematology Oncolog /ID# 155879

location_facility: Evangelische Lungenklinik Berl /ID# 159168

location_facility: Kyungpook National University Chilgok Hospital /ID# 159292

location_facility: National Cancer Ctr Singapore /ID# 158803

location_facility: Gabrail Cancer Center Research /ID# 155920

location_facility: ME Kryviy Rih Oncology Dispensary /ID# 159119

location_facility: Riga East Clinical University /ID# 158714

location_facility: Klinika za plucne bolesti Jordanovac /ID# 159502

location_facility: Southern Medical Day Care Ctr /ID# 158853

location_facility: Copernicus PL Sp. z o. o., WCO /ID# 160538

location_facility: Christie NHS Foundation Trust /ID# 159099

location_facility: CHA Bundang Medical center CHA University /ID# 204416

location_facility: Torokbalinti Tudogyogyintezet /ID# 207053

location_facility: Health Pharma Professional Research S.A de C.V /ID# 160020

location_facility: Kanagawa Cardiovascular and Respiratory Center /ID# 164374

location_facility: Christiana Care Health Service /ID# 158171

location_facility: Hospital General Universitario Gregorio Maranon /ID# 159025

location_facility: Unidade Local Saude Matosinhos /ID# 158682

location_facility: Dup_Debreceni Egyetem Klinikai Központ /ID# 161209

location_facility: Universitair Medisch Centrum Groningen /ID# 158088

location_facility: Kansai Medical University Hospital /ID# 165055

location_facility: Aichi Cancer Center Hospital /ID# 164975

location_facility: Veszprem Megyei Tuedoegyogyint /ID# 162607

location_facility: Chungbuk National University /ID# 159291

location_facility: Hospital Clinico Universitario de Valencia /ID# 159027

location_facility: Spitalul Judetean de Urgenta A /ID# 160846

location_facility: Institut za onkologiju i radio /ID# 160058

location_facility: N.N. Petrov Research Inst Onc /ID# 159312

location_facility: West Virginia Univ School Med /ID# 155872

location_facility: Municipal institution Multifie /ID# 159121

location_facility: St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550

location_facility: Korea University Guro Hospital /ID# 159293

location_facility: Thoraxklinik Heidelberg gGmbH /ID# 159169

location_facility: The Cancer Institute Hospital Of JFCR /ID# 166249

location_facility: Oregon Health and Science University /ID# 157055

location_facility: Ege University Medical Faculty /ID# 159239

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 157001

location_facility: Moore UC San Diego Cancer Center /ID# 156965

location_facility: St Jude Hospital dba St Joseph /ID# 155899

location_facility: Szpitale Pomorskie Sp. z o.o /ID# 160536

location_facility: Istituto Europeo di Oncologia /ID# 158942

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 158687

location_facility: Institute For Pulmonary Diseas /ID# 158813

location_facility: National Medical Research Cntr /ID# 207436

location_facility: Ataturk Gogus Hastaliklari ve /ID# 160056

location_facility: CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665

location_facility: AUSL 8 Arezzo Ospedale San Don /ID# 160967

location_facility: National Taiwan University Hospital /ID# 158865

location_facility: Bobruysk Interdistrict Onco. /ID# 169394

location_facility: National University Hospital /ID# 158802

location_facility: James Cook University Hospital /ID# 159583

location_facility: Japanese Red Cross Okayama Hospital /ID# 165156

location_facility: Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931

location_facility: Volyn Regional Medical Oncology Centre /ID# 159124

location_facility: Hopital du Sacre Coeur Montreal /ID# 159515

location_facility: University Hospital of Ioannin /ID# 159163

location_facility: Rigshospitalet, Finsen Centre /ID# 158051

location_facility: National Cancer Center Hospital East /ID# 165726

location_facility: Odense Universitets Hospital /ID# 158050

location_facility: Centre Hosp Intercommunal de Creteil /ID# 162684

location_facility: Yonsei University Health System, Severance Hospital /ID# 159288

location_facility: University of Vermont Medical Center /ID# 162317

location_facility: National Cheng Kung University Hospital /ID# 158844

location_facility: Yokohama City University Hospital /ID# 165748

location_facility: Mogilev Reg. Oncologic dispe /ID# 159326

location_facility: Hospital Santa Creu i Sant Pau /ID# 159028

location_facility: Hospital Universitario HM Sanchinarro /ID# 159024

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 157054

location_facility: Petz Aladar Megyei Oktato Korh /ID# 158978

location_facility: Goshen Center for Cancer Care /ID# 155946

location_facility: UT Southwestern Medical Center /ID# 158150

location_facility: Tri-Service General Hospital /ID# 158985

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 158811

location_facility: Cliniques universitaires Saint /ID# 158751

location_facility: Duplicate_Kanazawa University Hospital /ID# 165129

location_facility: Hacettepe University Medical Faculty /ID# 159238

location_facility: Arkhangelsk clinical oncology /ID# 159309

location_facility: CHU de Quebec-Universite Laval /ID# 159093

location_facility: Liga Norte Rio Grandense Cont. /ID# 159015

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017

location_facility: Asklepios Fachkliniken M. Gaut /ID# 158791

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 158967

location_facility: Nemocnice Rudolfa a Stefanie /ID# 159652

location_facility: Taichung Veterans General Hosp /ID# 158866

location_facility: Smolensk Regional Onc Clin Dis /ID# 159314

location_facility: IFO Istituto Nazionale Tumori /ID# 158941

location_facility: Duplicate_Showa University Hospital /ID# 165574

title: A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

summary: The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.


title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination With Lumiliximab Versus FCR Alone in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

summary: This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.

lead_sponsor: Biogen

location_country:
Austria
United States
France
Poland
Australia
Belgium
Canada
United Kingdom

location_facility: University of Miami Miller School of Medicine

location_facility: University of Florida/Pulmonary, Critical Care & Sleep Medicine

location_facility: Vanderbilt University Medical Center-IPF Program


ReferenceCitation: Hollander P, Raslova K, Skjøth TV, Råstam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.

family: Hollander

full_name: P. Hollander

given: P.

family: Raslova

full_name: K. Raslova

given: K.

family: Skjøth

full_name: T. V. Skjøth

given: T. V.

family: Råstam

full_name: J. Råstam

given: J.

family: Liutkus

full_name: J. F. Liutkus

given: J. F.

journal_name: Diabetes, Obesity and Metabolism

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
France
Korea, Republic of
Slovakia
Hungary
Turkey
United States
Canada

title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

summary: This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.


title: A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

summary: This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency

lead_sponsor: Novartis

location_country:
Sweden
India
Costa Rica
Germany
Finland
France
Norway
Argentina
Australia
Russian Federation
Spain
Canada

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: City polyclinic # 17, City Diabetic Centre #3

location_facility: Hospital General de Jerez de La Frontera

location_facility: MSUMD on the base of City Clinical Hospital #67

location_facility: Tampereen lääkärikeskus Oy, Koskiklinikka

location_facility: Instituto de Investigaciones Clinicas de Mar del Plata

location_facility: Saint- Petersburg State Mtchnikov's Medical Academy

location_facility: MSU of Medicine and Dentistry on the base of CityHospital 23

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Site Management Organisation of Clinical Trials Centers

location_facility: Univ.-Klinikum München, Campus Innenstadt

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann

location_facility: M V Hospital for Diabetes and Diabetic Research Center

location_facility: Saint-Petersburg State Pavlov's Medical University

location_facility: Ciutat Sanitaria I Universitaria de Bellvitge

location_facility: Health Sciences Centre - Diabetes Research Group

location_facility: St. Olavs Hospital, Endokrinologisk seksjon

location_facility: Forschungszentrum Ruhr, KliFoCenter GmbH


title: A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

acronym: COMPETE

summary: The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

lead_sponsor: ITM Solucin GmbH

location_country:
Italy
Austria
South Africa
Switzerland
Netherlands
Germany
France
Czechia
Poland
Australia
Belgium
Spain
United States
United Kingdom

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University of Pretoria & Steve Biko Academic Hospital

location_facility: Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität

location_facility: Banner Health d.b.a. Banner MD Anderson Cancer Center

location_facility: Klinikum rechts der Isar Technische Universität München

location_facility: Beatson Oncology Centre, Gartnavel General Hospital

location_facility: LMU - Klinikum der Universität München, Campus Großhadern

location_facility: Academic Medical Center, University of Amsterdam

location_facility: Central University Hospital de Asturias (HUCA)

location_facility: Moffitt Cancer Center & Research Institute

location_facility: University Cape Town (UCT), Groote Schuur Hospital

location_facility: Azienda Ospedaliera Universitaria (AOU) Policlinico "Gaetano Martino"

location_facility: University of Kentucky Chandler Medical Center

location_facility: Institut de Recherche en Cancérologie de Montpellier (IRCM)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Excel Diagnostics & Nuclear Oncology Center

location_facility: University and Polytechnic Hospital La Fe

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl

location_facility: Olivia Newton-John Cancer & Wellness Centre, Austin Hospital

location_facility: University Medical Center, Abteilung für Nuklearmedizin


title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy

ReferenceCitation: Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Bennett B, Parry D, Spencer S, Mann H, Matulonis U. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer. 2016 Nov 22;115(11):1313-1320. doi: 10.1038/bjc.2016.348. Epub 2016 Nov 8.

family: Ledermann

full_name: Jonathan A Ledermann

given: Jonathan A

family: Harter

full_name: Philipp Harter

given: Philipp

family: Gourley

full_name: Charlie Gourley

given: Charlie

family: Friedlander

full_name: Michael Friedlander

given: Michael

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Rustin

full_name: Gordon Rustin

given: Gordon

family: Scott

full_name: Clare Scott

given: Clare

family: Meier

full_name: Werner Meier

given: Werner

family: Shapira-Frommer

full_name: Ronnie Shapira-Frommer

given: Ronnie

family: Safra

full_name: Tamar Safra

given: Tamar

family: Matei

full_name: Daniela Matei

given: Daniela

family: Fielding

full_name: Anitra Fielding

given: Anitra

family: Bennett

full_name: Bryan Bennett

given: Bryan

family: Parry

full_name: David Parry

given: David

family: Spencer

full_name: Stuart Spencer

given: Stuart

family: Mann

full_name: Helen Mann

given: Helen

family: Matulonis

full_name: Ursula Matulonis

given: Ursula

journal_name: British Journal of Cancer

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Melbourne - Minerva Access

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Rowe P, Lowe E, Hodgson D, Sovak MA, Matulonis U. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1579-1589. doi: 10.1016/S1470-2045(16)30376-X. Epub 2016 Sep 9.

ReferenceCitation: Matulonis UA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Parry D, Grinsted L, Ledermann JA. Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy. Cancer. 2016 Jun 15;122(12):1844-52. doi: 10.1002/cncr.29995. Epub 2016 Apr 8.

name: Dana-Farber Cancer Institute; Boston Massachusetts

name: Edinburgh Cancer Research UK Centre; University of Edinburgh; Edinburgh United Kingdom

name: Prince of Wales Hospital; Randwick New South Wales Australia

name: Mount Vernon Hospital; Northwood United Kingdom

name: Royal Melbourne Hospital; Melbourne Victoria Australia

name: Evangelical Hospital; Dusseldorf Germany

name: Chaim Sheba Medical Center; Tel Hashomer Israel

name: Tel Aviv Sourasky Medical Center; Tel Aviv Israel

name: Indiana University School of Medicine; Indianapolis Indiana

name: AstraZeneca; Macclesfield United Kingdom

name: University College London; London United Kingdom

title: Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and aBRCAmutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy

ReferenceCitation: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31. Erratum in: Lancet Oncol. 2015 Apr;16(4):e158.

ReferenceCitation: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. doi: 10.1056/NEJMoa1105535. Epub 2012 Mar 27.

title: Olaparib Maintenance Therapy in Platinum-Sensitive Relapsed Ovarian Cancer

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

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Austria
United States
Netherlands
Germany
France
Czechia
Poland
Israel
Romania
Australia
Belgium
Russian Federation
Spain
Estonia
Canada
United Kingdom
Ukraine