lead_sponsor: pharmaand GmbH

summary: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.

ReferenceCitation: Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.

ReferenceCitation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

sponsor_collaborators:
pharmaand GmbH
Foundation Medicine

location_facility: Kaiser Permanente Medical Center (Vallejo)

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Alegent Health Bergan Mercy Hospital , GU Research Network

location_facility: Consultants in Medical Oncology Hematology

location_facility: Rambam Health Care Campus (RHCC), Rambam Medical Center

location_facility: Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)

location_facility: Hospital General Universitario de Guadalajara

location_facility: Equipe de Recherche Clinique, Département d'Oncologie/Hématologie

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Marques de Valdecilla University Hospital (HUMV)

location_facility: IRCCS Istituto Nazionale dei Tumori (INT)

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Santa Chiara Hospital, Dept Medical Oncology

location_facility: Juravinski Cancer Centre Hamilton Health Services

location_facility: Barwon Health, University Hospital Geelong

location_facility: University of Modena and Reggio Emilia Medical Oncology

location_facility: Gemeinschaftspraxis fur Hamatologie & Onkologie

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Hospital Universitario Central de Asturias

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Premier Urology Associates dba/AdvanceMed Research

location_facility: The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

location_facility: University of Florida Health Cancer Center

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: Weill Cornell Medical College/NewYork-Presbyterian Hospital

location_facility: Adelaide & Meath Hospital, Incorporating the National Children's Hospital

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: London Health Science Center - Victoria Hospital

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Hospital Clínic i Provincial de Barcelona-Oncology

location_facility: VA Greater Los Angeles Healthcare System

title: TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

ipd_sharing_description:
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

location_country:
Germany
Ireland
Italy
Israel
United Kingdom
Denmark
Australia
Belgium
United States
Spain
Canada
France


type: Other Identifier

title: Observational, Non-interventional Registry to Assess Medication Usage Patterns in Clinical Routine Practice, in Subjects Receiving Antipsychotic Treatment With Risperidone Long Acting Injectable (Gluteal or Deltoid) or Oral Antipsychotics

summary: International Observational Registry on Schizophrenia

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
Spain
Greece
South Africa
Turkey
Czech Republic
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

summary: The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;digitalcommons.unmc.edu

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

ReferenceType: derived

ReferenceCitation: Chounta V, Snedecor SJ, Wu S, Van de Velde N. Indirect comparison of 48-week efficacy and safety of long-acting cabotegravir and rilpivirine maintenance every 8 weeks with daily oral standard of care antiretroviral therapy in participants with virologically suppressed HIV-1-infection. BMC Infect Dis. 2022 May 4;22(1):428. doi: 10.1186/s12879-022-07243-3.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Rizzardini G, Overton ET, Orkin C, Swindells S, Arasteh K, Gorgolas Hernandez-Mora M, Pokrovsky V, Girard PM, Oka S, Andrade-Villanueva JF, Richmond GJ, Baumgarten A, Masia M, Latiff G, Griffith S, Harrington CM, Hudson KJ, St Clair M, Talarico CL, Patel P, Cutrell A, Van Eygen V, D'Amico R, Mrus JM, Wu S, Ford SL, Chow K, Roberts J, Wills A, Walters N, Vanveggel S, Van Solingen-Ristea R, Crauwels H, Smith KY, Spreen WR, Margolis DA. Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):498-506. doi: 10.1097/QAI.0000000000002466.

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

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

ReferenceCitation: Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: Yes

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline

sponsor_collaborators:
ViiV Healthcare
Janssen Pharmaceuticals
GlaxoSmithKline

location_country:
Germany
Italy
Argentina
Australia
Sweden
Mexico
United States
Korea, Republic of
Spain
South Africa
Canada
Russian Federation
France

status_simplified: Ongoing


title: A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

summary: The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.

ReferenceCitation: Orkin C, Arasteh K, Gorgolas Hernandez-Mora M, Pokrovsky V, Overton ET, Girard PM, Oka S, Walmsley S, Bettacchi C, Brinson C, Philibert P, Lombaard J, St Clair M, Crauwels H, Ford SL, Patel P, Chounta V, D'Amico R, Vanveggel S, Dorey D, Cutrell A, Griffith S, Margolis DA, Williams PE, Parys W, Smith KY, Spreen WR. Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection. N Engl J Med. 2020 Mar 19;382(12):1124-1135. doi: 10.1056/NEJMoa1909512. Epub 2020 Mar 4.

ReferenceCitation: Jeffrey JL, St Clair M, Wang P, Wang C, Li Z, Beloor J, Talarico C, Fridell R, Krystal M, White CT, Griffith S, D'Amico R, Smith K, Van Eygen V, Vingerhoets J, Vandermeulen K, Spreen W, van Lunzen J. Impact of Integrase Sequences from HIV-1 Subtypes A6/A1 on the In Vitro Potency of Cabotegravir or Rilpivirine. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0170221. doi: 10.1128/AAC.01702-21. Epub 2022 Jan 3.

evidence: open (via crossref license)

repositories_concat: PubMed Central

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Orkin C, Bernal Morell E, Tan DHS, Katner H, Stellbrink HJ, Belonosova E, DeMoor R, Griffith S, Thiagarajah S, Van Solingen-Ristea R, Ford SL, Crauwels H, Patel P, Cutrell A, Smith KY, Vandermeulen K, Birmingham E, St Clair M, Spreen WR, D'Amico R. Initiation of long-acting cabotegravir plus rilpivirine as direct-to-injection or with an oral lead-in in adults with HIV-1 infection: week 124 results of the open-label phase 3 FLAIR study. Lancet HIV. 2021 Nov;8(11):e668-e678. doi: 10.1016/S2352-3018(21)00184-3. Epub 2021 Oct 14.

oa_host_type: repository

repositories_institution: Queen Mary University of London - Queen Mary Research Online

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Orkin C, Oka S, Philibert P, Brinson C, Bassa A, Gusev D, Degen O, Garcia JG, Morell EB, Tan DHS, D'Amico R, Dorey D, Griffith S, Thiagarajah S, St Clair M, Van Solingen-Ristea R, Crauwels H, Ford SL, Patel P, Chounta V, Vanveggel S, Cutrell A, Van Eygen V, Vandermeulen K, Margolis DA, Smith KY, Spreen WR. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study. Lancet HIV. 2021 Apr;8(4):e185-e196. doi: 10.1016/S2352-3018(20)30340-4. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.

oa_host_type: closed

repositories_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

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

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
United States
Spain
South Africa
Canada
Russian Federation
France


intervention_type: Biological

acronym:
BAX 111 rVWF in Pediatrics

 BAX 111 rVWF dans la population pédiatrique

lead_sponsor: Baxalta now part of Shire

summary:
The main aim of the study is to check effectiveness, side effects, and tolerability of recombinant von Willebrand Factor (rVWF), with or without ADVATE, in the treatment and control of nonsurgical bleeding events in pediatric participants (less than (<)18 years of age) with severe hereditary von Willebrand disease (VWD).

The participants will be treated with rVWF for 12-18 months. Their von Willebrand Disease will be treated by their doctor according to their doctor's usual clinical practice. During the study, participants will be followed up at clinics or over telephone calls.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of Florida College of Medicine

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: SBEI HPE Altai State Medical University of MoH and SD

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Azienda Ospedaliera Pediatrica Santobono Pausillipon

location_facility: Hospital General Universitario de Alicante

location_facility: Comprehensive Center for Bleeding Disorders

location_facility: Texas Children's Cancer and Hematology Center

location_facility: St. Jude Affiliate Clinic at Novant Health

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

location_facility: Comprehensive Cancer Center of Wake Forest Unversity

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA

location_facility: Bleeding and Clotting Disorders Institute

status: Recruiting

title: A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF With or Without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed With Severe Von Willebrand Disease

source: euctr

enrollment_type: Anticipated

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.

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Turkey
Czechia
Ukraine
Russian Federation
France


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

lead_sponsor: Boehringer Ingelheim

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

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

location_facility: 1199.15.49010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35105 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49054 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42101 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39040 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10014 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39039 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49055 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49026 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39026 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33038 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33045 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49036 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49048 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39037 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33025 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10024 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49095 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10112 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39027 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39032 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49087 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49067 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10100 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33042 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33031 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39036 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49019 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49079 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42102 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49046 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49015 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33027 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10110 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33035 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33033 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49085 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39033 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49031 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.48003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33051 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49052 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35803 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49061 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49059 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42106 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49045 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49035 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49029 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10107 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10105 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10113 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49040 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33053 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49042 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42103 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35802 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49022 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49058 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42105 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.48006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33050 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49082 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39017 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39019 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33047 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10104 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33018 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49041 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49086 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35101 Instituto Portugues de Oncologia Lisboa Francisco Gentil

location_facility: 1199.15.61007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49043 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39034 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49081 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.46004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33055 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49014 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49083 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49089 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10017 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33015 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49070 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33039 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35801 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49080 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49027 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39028 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49073 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33052 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39024 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49039 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10013 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35805 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49093 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49047 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39023 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35804 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35102 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10019 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.31005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10025 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10028 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10029 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35108 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49063 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49090 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35106 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34009 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35104 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39022 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.61006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49033 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49034 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49030 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10108 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.35109 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33008 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.45001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49084 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49056 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49018 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10103 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33048 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49071 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49023 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49050 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49037 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49060 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.42104 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39018 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49064 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49076 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49051 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49024 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39014 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49016 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39029 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39031 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10005 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49062 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.47003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49068 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49057 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33021 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49066 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10102 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33037 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49017 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.33011 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.34002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.44002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10012 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.11001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49025 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49065 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.43010 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.38003 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.48001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.49092 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.30002 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.70001 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.39020 Boehringer Ingelheim Investigational Site

location_facility: 1199.15.10016 Boehringer Ingelheim Investigational Site

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

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


title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents

summary: A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

ipd_sharing: No

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Japan
Sweden
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University Hospital-Kyoto Prefectural University of Medicine

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: West Virginia University Mary Babb Randolph Cancer Center

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Fundació Hospital de la Santa Creu i Sant Pau

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Onkologická klinika Všeobecná fakultní nemocnice v Praze a 1

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Hospital General Universitario de Alicante

location_facility: National Hospital Organization Disaster Medical Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Maisonneuve-Rosemont Hôpital Service d'Hematologie et d'Oncologie Medicale

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Sahlgrenska Universitetssjukhuset, Östra sjukhuset

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Desert Hematology Oncology Medical Group, Inc.


title: Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

acronym: TRuST

summary:
This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy.

The aim of the study will be to assess the long-term safety of tezemetostat.

status: Enrolling by invitation

lead_sponsor: Epizyme, Inc.

location_country:
Poland
United Kingdom
Australia
Belgium
United States
Ukraine
France

location_facility: Oncology and Haematology Clinical Trials Unit

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej

location_facility: S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"

status_simplified: Unknown


title: An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.

summary: This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

ReferenceCitation: Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.

license: publisher-specific license

license_normalized: publisher-specific

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Wiley

ReferenceCitation: Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Dohner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.

lead_sponsor: Hoffmann-La Roche

collaborators:
German CLL Study Group
Genentech, Inc.

sponsor_collaborators:
Hoffmann-La Roche
German CLL Study Group
Genentech, Inc.

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Thailand
Croatia
Czechia
Canada
France
Slovakia
Hong Kong
Denmark
Switzerland
United States
Romania
Estonia
Egypt
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation


title: A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

acronym: SOLID-TIMI 52

summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

ReferenceCitation: Correa S, Morrow DA, Braunwald E, Davies RY, Goodrich EL, Murphy SA, Cannon CP, O'Donoghue ML. Cystatin C for Risk Stratification in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2018 Oct 16;7(20):e009077. doi: 10.1161/JAHA.118.009077.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Barger LK, Rajaratnam SMW, Cannon CP, Lukas MA, Im K, Goodrich EL, Czeisler CA, O'Donoghue ML. Short Sleep Duration, Obstructive Sleep Apnea, Shiftwork, and the Risk of Adverse Cardiovascular Events in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2017 Oct 10;6(10):e006959. doi: 10.1161/JAHA.117.006959.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repositories_concat: PubMed Central;dash.harvard.edu

ReferenceCitation: Eisen A, Cannon CP, Braunwald E, Steen DL, Zhou J, Goodrich EL, Im K, Dalby AJ, Spinar J, Daga S, Lukas MA, O'Donoghue ML. Predictors of Nonuse of a High-Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) Trial. J Am Heart Assoc. 2017 Jan 11;6(1):e004332. doi: 10.1161/JAHA.116.004332.

ReferenceCitation: O'Donoghue ML, Braunwald E, White HD, Lukas MA, Tarka E, Steg PG, Hochman JS, Bode C, Maggioni AP, Im K, Shannon JB, Davies RY, Murphy SA, Crugnale SE, Wiviott SD, Bonaca MP, Watson DF, Weaver WD, Serruys PW, Cannon CP; SOLID-TIMI 52 Investigators; Steen DL. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1006-15. doi: 10.1001/jama.2014.11061. Erratum In: JAMA. 2014 Oct 8;312(14):1473. Dylan P. Steen[corrected to Dylan L. Steen].

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

publisher_dissemination: American Medical Association

ReferenceCitation: O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. doi: 10.1016/j.ahj.2011.07.018. Epub 2011 Sep 15.

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:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Colombia
Slovakia
Hungary
Denmark
United States
Ukraine
India
Romania
Belgium
China
Peru
Philippines
Italy
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

summary: This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

ReferenceCitation: Mehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.

oa_colors: green other

evidence: open (via free pdf)

ipd_sharing_description: The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint

lead_sponsor: Biosensors Europe SA

location_country:
Germany
Italy
United Kingdom
Denmark
United States
Canada
France

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: Service de Cardiologie Interventionnelle - Pôle Santé République

location_facility: Columbia University Medical Center/New York Presbyterian Hospital

location_facility: Penn State - Milton S. Hershey Medical Center

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: The University of Ottawa Heart Institute

location_facility: CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke

location_facility: Missouri Cardiovascular Specialists, LLP

location_facility: Novant Health Heart and Vascular Institute

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: Pinnacle Health Cardiovascular Institute

location_facility: Centre Hospitalier de l'université de Montréal

location_facility: Royal Bournemouth Hospital, Dorset Heart Centre

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec

location_facility: Weill Cornell Medical College-New York Presbyterian

intervention_type: Device


type: Other Grant/Funding Number

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

acronym: PEXIVAS

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

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

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

ReferenceType: result

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

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

version: acceptedVersion

repositories:
PubMed Central
Pure (Denmark)
ora.ox.ac.uk

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

license: publisher-specific-oa

publisher_dissemination: National Institute for Health and Care Research

lead_sponsor: University of Pennsylvania

collaborators: Cambridge University Hospitals NHS Foundation Trust

collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: CHU De Toulouse-Hotel Dieu Saint Jacques

location_facility: Centre Hospitalier de la Region d'Annecy

location_facility: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

location_facility: Holstebro Hospital and University of Aarhus

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Washington University School of Medicine

location_facility: St Olavs Hospital, Trondheim University Hospital

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Instituto Nacional de Enfermedades Respiratorias

location_facility: Brighton and Sussex University Hospitals

intervention_type: Procedure

lead_sponsor_type: academique


title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

acronym: STELLAR

summary: The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

status: Unknown status

lead_sponsor: Orbus Therapeutics, Inc.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
United States
Canada
France

location_facility: University of California Irvine Medical Center

location_facility: Institut de Cancerologie de l'Ouest - Angers

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Texas Oncology Austin Brain Tumor Center

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Hôpital Pierre Wertheimer - Hospices Civils de Lyon

location_facility: The Cleveland Clinic, Richard E. Jacobs Health Center

location_facility: Medical University of South Carolina, Hollings Cancer Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: OhioHealth Research and Innovation Institute

location_facility: University of California San Francisco Medical Center

location_facility: Fondazione IRCCS - Instituto Neurologico Carlo Besta

location_facility: Edinburgh Cancer Centre - Western General Hospital

location_facility: Dana Farber Cancer Institute, Brigham and Women's Hospital

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: University of North Carolina - Chapel Hill

location_facility: University of Kentucky Chandler Medical Center

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Columbia University Medical Center, The Neurological Institute

location_facility: Louisiana State University Health Sciences Center New Orleans

location_facility: Cliniques Universitaires UCL De Mont-Godinne

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg

location_facility: Vrije Universiteit Medisch Centrum (VUMC)


title: A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase Alfa in Treatment naïve Patients With Late-onset Pompe Disease

acronym: COMET

summary:
Primary Objective:

To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa.

Secondary Objective:

To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12).

ReferenceCitation: Diaz-Manera J, Kishnani PS, Kushlaf H, Ladha S, Mozaffar T, Straub V, Toscano A, van der Ploeg AT, Berger KI, Clemens PR, Chien YH, Day JW, Illarioshkin S, Roberts M, Attarian S, Borges JL, Bouhour F, Choi YC, Erdem-Ozdamar S, Goker-Alpan O, Kostera-Pruszczyk A, Haack KA, Hug C, Huynh-Ba O, Johnson J, Thibault N, Zhou T, Dimachkie MM, Schoser B; COMET Investigator Group. Safety and efficacy of avalglucosidase alfa versus alglucosidase alfa in patients with late-onset Pompe disease (COMET): a phase 3, randomised, multicentre trial. Lancet Neurol. 2021 Dec;20(12):1012-1026. doi: 10.1016/S1474-4422(21)00241-6. Erratum In: Lancet Neurol. 2022 Apr;21(4):e4.

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

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://vivli.org

lead_sponsor: Genzyme, a Sanofi Company

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

location_facility:
Investigational Site Number 8260005
Investigational Site Number 7920001
Investigational Site Number 7920002
Investigational Site Number 2500010
Investigational Site Number 7560002
Investigational Site Number 8400006
Investigational Site Number 3800006
Investigational Site Number 8400007
Investigational Site Number 0760004
Investigational Site Number 2760006
Investigational Site Number 8400012
Investigational Site Number 8400008
Investigational Site Number 2030001
Investigational Site Number 8400019
Investigational Site Number 8400010
Investigational Site Number 2760003
Investigational Site Number 8400016
Investigational Site Number 4100002
Investigational Site Number 2500008
Investigational Site Number 2760001
Investigational Site Number 8260003
Investigational Site Number 8260001
Investigational Site Number 8400020
Investigational Site Number 8400025
Investigational Site Number 0560001
Investigational Site Number 0560003
Investigational Site Number 1240002
Investigational Site Number 2500005
Investigational Site Number 2500001
Investigational Site Number 6430001
Investigational Site Number 8400009
Investigational Site Number 4840001
Investigational Site Number 0760001
Investigational Site Number 8400011
Investigational Site Number 8400026
Investigational Site Number 8400024
Investigational Site Number 1580001
Investigational Site Number 7240003
Investigational Site Number 0320001
Investigational Site Number 2500011
Investigational Site Number 8400014
Investigational Site Number 8400005
Investigational Site Number 2500004
Investigational Site Number 3800002
Investigational Site Number 5280001
Investigational Site Number 6160001
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 2500007
Investigational Site Number 2760002
Investigational Site Number 6200001
Investigational Site Number 2500006
Investigational Site Number 7240002
Investigational Site Number 8260002
Investigational Site Number 8260004
Investigational Site Number 8400017
Investigational Site Number 8400023
Investigational Site Number 2080003
Investigational Site Number 3800001
Investigational Site Number 3800007
Investigational Site Number 4100001
Investigational Site Number 8400015
Investigational Site Number 8400018
Investigational Site Number 0400001
Investigational Site Number 3920002
Investigational Site Number 0360001
Investigational Site Number 3480001
Investigational Site Number 3800003
Investigational Site Number 1240003


title: Phase 3 Randomized Study Comparing X-396 (Ensartinib) to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

summary: The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.

ReferenceCitation: Horn L, Wang Z, Wu G, Poddubskaya E, Mok T, Reck M, Wakelee H, Chiappori AA, Lee DH, Breder V, Orlov S, Cicin I, Cheng Y, Liu Y, Fan Y, Whisenant JG, Zhou Y, Oertel V, Harrow K, Liang C, Mao L, Selvaggi G, Wu YL. Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):1617-1625. doi: 10.1001/jamaoncol.2021.3523.

lead_sponsor: Xcovery Holding Company, LLC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Hong Kong
United States
Belgium
China
Peru
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Russian Federation
Israel

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The University of Hong Kong/Queen Mary Hospital

location_facility: Klinik Löwenstein gGmbH Med. Klinik II Onkologie

location_facility: Rabin Medical Center Institute of Oncology, Davidoff Center

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: North Shore Hematology-Oncology Associates, PC

location_facility: Azienda Socio Sanitaria Territoriale (ASST) della Valtellina e dell'Alto Laria

location_facility: The First Hospital of China Medical University

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Tianjin Medical University General Hospital Mailing No.154 Anshan Avenue Heping District

location_facility: The University of Hong Kong, Queen Mary Hospital

location_facility: Centro Operativo Studi Clinici S.C.Oncologia Medica

location_facility: State Budgetary Institution of Healthcare of the city of Moscow "MOSCOW CITY ONCOLOGY HOSPITAL # 62"

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Union Hospital of Tongji Medical College of Huazhong Science and Techology University

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Federal State Budgetary Scientific Institution Russian Oncological Scientific Center named after N.N. Blokhin

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

location_facility: Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Kaiser Permanente Hawaii- Moanalua Medical Center

location_facility: Praxis Hämatologie und Onkologie Stolberg

location_facility: The First Bethune Hospital of Jilin University

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

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

location_facility: Washington University School of Medicine

location_facility: University of Wisconsin Clinical Science Center

location_facility: The Affiliated Hospital of Qingdao University

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Rambam Health Care Campus/ Oncology Institute

location_facility: Centro Riferimento Oncologico CRO Aviano

location_facility: Trakya University Balkan Oncology Hospital

location_facility: Krajská zdravotní, a.s., Masarykova nemocnice

location_facility: Maastricht University Medical Centre (MUMC)

location_facility: Klinik m. S. Infektiologie & Pneumologie

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Beijing Chest Hospital,Capital Medical University

location_facility: Fundacao do ABC Faculdade de Medicina do ABC

location_facility: ICO Girona - Hospital Doctor Josep Trueta


title: A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

acronym: SQUIRE

summary: The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

ReferenceCitation: Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafranski W, Ramlau R, Balint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13.

ReferenceCitation: Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20.

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Reck M, Socinski MA, Luft A, Szczesna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12.

ReferenceCitation: Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.

repository_institution: University of Liège - Open Repository and Bibliography

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Parexel
PPD
Medidata Solutions
Laboratory Corporation of America
University of Colorado, Denver
Thermo Fisher Scientific FS
ICON Clinical Research
Pacific Biomarkers
Sysmex Inostics GmbH
Intertek

location_country:
Germany
Poland
Australia
Brazil
Thailand
Croatia
Canada
Serbia
France
Portugal
Slovakia
Hungary
United States
Romania
Belgium
Philippines
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation

location_facility:
ImClone Investigational Site
ImClone Investigational site


acronym: AURELIA

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

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

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

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

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

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: American Society of Clinical Oncology (ASCO)

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

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

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

location_facility: Centre Hospitalier Departemental Les Oudairies

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

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Centre Francois Baclesse; Urologie Gynecologie

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

location_facility: Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

location_facility: Evangelischen Krankenhauses Düsseldorf; Frauenklinik

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

location_facility: Hopital Andre Mignot; Hematologie - Oncologie

location_facility: Oulu University Hospital; Gynaecology & Obstetrics Dept

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Hopital La Source; Onco Med Hematologie Clinique

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

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

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

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

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

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

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Catharina ZKHS; Inwendige Geneeskunde Afd.

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

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

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

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

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

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

location_facility: Clinique Sainte Catherine; Hopital De Semaine

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

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Hospital de Terrassa; Servicio de Oncologia

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

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

location_facility: Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz

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

location_facility: Ospedali Riuniti; Divisione Ostetricia e Ginecologia

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

location_facility: Regionshospitalet Herning; Onkologisk afdeling

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe

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

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Martini Ziekenhuis; Dept of Internal Medicine

location_facility: Institut Daniel Hollard; Chimiotherapie Ambulatoire

location_facility: The Norvegian Radium Hospital Montebello; Dept of Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Örebro University Hospital; Department of Gynecologic Oncology

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

location_facility: Hopital Civil; Expl Fonct Systeme Nerveux

location_facility: Ankara Baskent University Medicine Faculty; Gynaecology

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

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

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

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

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

location_facility: Centre Val Aurelle Paul Lamarque; Medecine A1 A2

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

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

location_facility: IPO de Lisboa; Servico de Oncologia Medica

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

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik

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

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