title: A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy and Safety of Orally Administered BI 425809 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Spain
Greece
Austria
Italy
United Kingdom
Finland
Canada
Hungary
United States
France
Norway
Japan
Germany

location_facility: Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen

location_facility: Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun

location_facility: Hospital Universitari General de Catalunya

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: CHU La Grave-Casselardit - Cité de la Santé

location_facility: Northeastern Pennsylvania Memory and Alzheimer Center

location_facility: Oslo Universitetssykehus HF, Hukommelsesklinikken

location_facility: National Center Neurology and Psychiatry

location_facility: Private Practice for Psychiatry and Neurology

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: University of Eastern Finland, Brain Research Unit

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center

location_facility: True North Clinical Research Halifax, Inc.

location_facility: True North Clinical Research Kentville, Inc.

location_facility: St. Olavs Hospital, Universitetssykehuset i Trondheim

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o

location_facility: Hospital Universitario Marqués de Valdecilla

summary: The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.


ipd_sharing: No

status: Completed

primary_purpose: Treatment

intervention_type: Drug

acronym: Phase 3 Study of Epacadostat and Pembrolizumab in Melanoma

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

study_completion_date_type: Actual

lead_sponsor: Incyte Corporation

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Long GV, Dummer R, Hamid O, Gajewski TF, Caglevic C, Dalle S, Arance A, Carlino MS, Grob JJ, Kim TM, Demidov L, Robert C, Larkin J, Anderson JR, Maleski J, Jones M, Diede SJ, Mitchell TC. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study. Lancet Oncol. 2019 Aug;20(8):1083-1097. doi: 10.1016/S1470-2045(19)30274-8. Epub 2019 Jun 17.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Poland
Russian Federation
Australia
Israel
Mexico
Sweden
Canada
Switzerland
Germany
Denmark
Ireland
New Zealand
Korea, Republic of
France
Chile
Netherlands

summary: The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma

lead_sponsor_type: industriel

status_simplified: Completed


status: Active, not recruiting

acronym: CheckMate 577

intervention_type: Other

title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

study_completion_date_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

type: EudraCT Number

ReferenceCitation: Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Singapore
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Korea, Republic of
France
Netherlands

location_facility:
Local Institution - 0068
Local Institution - 0148
Local Institution - 0197
Local Institution - 0036
Local Institution - 0078
Local Institution - 0138
Local Institution - 0011
Local Institution - 0157
Local Institution - 0127
Local Institution - 0247
Local Institution - 0069
Local Institution - 0181
Local Institution - 0218
Local Institution - 0029
Local Institution - 0033
Local Institution - 0179
Local Institution - 0093
Local Institution - 0003
Local Institution - 0042
Local Institution - 0237
Local Institution - 0075
Local Institution - 0038
Local Institution - 0196
Local Institution - 0026
Local Institution - 0103
Local Institution - 0213
Local Institution - 0243
Local Institution - 0223
Local Institution - 0001
Local Institution - 0180
Local Institution - 0203
Local Institution - 0052
Local Institution - 0081
Local Institution - 0250
Local Institution - 0227
Local Institution - 0149
Local Institution - 0097
Local Institution - 0050
Local Institution - 0164
Local Institution - 0066
Local Institution - 0043
Local Institution - 0178
Local Institution - 0077
Local Institution - 0117
Local Institution - 0189
Local Institution - 0006
Local Institution - 0195
Local Institution - 0192
Local Institution - 0022
Local Institution - 0107
Local Institution - 0106
Local Institution - 0175
Local Institution - 0119
Local Institution - 0139
Local Institution - 0239
Local Institution - 0040
Local Institution - 0162
Local Institution - 0165
Local Institution - 0062
Local Institution - 0185
Local Institution - 0131
Local Institution - 0112
Local Institution - 0137
Local Institution - 0170
Local Institution - 0144
Local Institution - 0224
Local Institution - 0176
Local Institution - 0141
Local Institution - 0183
Local Institution - 0034
Local Institution - 0188
Local Institution - 0230
Local Institution - 0251
Local Institution - 0214
Local Institution - 0173
Local Institution - 0161
Local Institution - 0060
Local Institution - 0084
Local Institution - 0182
Pacific Hematology Oncology Associates
Local Institution - 0168
Local Institution - 0163
Local Institution - 0109
Local Institution - 0035
Local Institution - 0064
Local Institution - 0039
Local Institution - 0046
Local Institution - 0234
Local Institution - 0121
Local Institution - 0055
Local Institution - 0058
Local Institution - 0045
Local Institution - 0204
Local Institution - 0089
Local Institution - 0116
Local Institution - 0104
Local Institution - 0233
Local Institution - 0094
Local Institution - 0047
Local Institution - 0135
Local Institution - 0177
Local Institution - 0166
Local Institution - 0057
Local Institution - 0061
Local Institution - 0207
Local Institution - 0186
Local Institution - 0160
Local Institution - 0051
Local Institution - 0208
Local Institution - 0194
Local Institution - 0025
Local Institution - 0110
Local Institution - 0030
Local Institution - 0171
Local Institution - 0209
Local Institution - 0082
Local Institution - 0114
Local Institution - 0087
Local Institution - 0151
Local Institution - 0101
Local Institution - 0123
Local Institution - 0085
Local Institution - 0198
Local Institution - 0156
Local Institution - 0028
Local Institution - 0241
Local Institution - 0054
Local Institution - 0065
Local Institution - 0193
Local Institution - 0129
Local Institution - 0099
Local Institution - 0133
Local Institution - 0007
Local Institution - 0083
Local Institution - 0063
Local Institution - 0174
Local Institution - 0079
Local Institution - 0095
Local Institution - 0072
Local Institution - 0153
Local Institution - 0032
Local Institution - 0200
Local Institution - 0187
Local Institution - 0212
Local Institution - 0240
Local Institution - 0152
Local Institution - 0130
Local Institution - 0232
Local Institution - 0017
Local Institution - 0049
Local Institution - 0037
Local Institution - 0111
Local Institution - 0056
Local Institution - 0012
Local Institution - 0027
Local Institution - 0217
Local Institution - 0221
Local Institution - 0205
Local Institution - 0096
Local Institution - 0113
Local Institution - 0059
Local Institution - 0005
Local Institution - 0048
Local Institution - 0248
Local Institution - 0132
Local Institution - 0125
Local Institution - 0105
Local Institution - 0154
Local Institution - 0219
Local Institution - 0088
Local Institution - 0080
Local Institution - 0098
Local Institution - 0190
Local Institution - 0018
Local Institution - 0143
Local Institution - 0024
Local Institution - 0092
Local Institution - 0226
Local Institution - 0053
Local Institution - 0167
Local Institution - 0202
Local Institution - 0191
Local Institution - 0134
Local Institution - 0120
Local Institution - 0136
Local Institution - 0031
Local Institution - 0238
Local Institution - 0142
Local Institution - 0222
Local Institution - 0225
Local Institution - 0146
Local Institution - 0074
Local Institution - 0216
Local Institution - 0086
Local Institution - 0091
Local Institution - 0118
Local Institution - 0169
Local Institution - 0184
Local Institution - 0172
Local Institution - 0008
Local Institution - 0215
Local Institution - 0145
Local Institution - 0067
Local Institution - 0228

summary: The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

status_simplified: Ongoing


type: Other Identifier

title: Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer

summary: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

ReferenceCitation: Valle JW, Vogel A, Denlinger CS, He AR, Bai LY, Orlova R, Van Cutsem E, Adeva J, Chen LT, Obermannova R, Ettrich TJ, Chen JS, Wasan H, Girvan AC, Zhang W, Liu J, Tang C, Ebert PJ, Aggarwal A, McNeely SC, Moser BA, Oliveira JM, Carlesi R, Walgren RA, Oh DY. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1468-1482. doi: 10.1016/S1470-2045(21)00409-5. Erratum in: Lancet Oncol. 2021 Nov;22(11):e472.

ipd_sharing: Yes

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.

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
Taiwan
Spain
United Kingdom
Austria
Australia
Mexico
Argentina
Russian Federation
Sweden
Hungary
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Germany
Czechia

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

location_facility: University of Southern Florida School of Medicine

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Central Roentgenoradiological Research Institute MZ RF

location_facility: Hospital Clínico Universitario de Valencia


acronym:
Fixed dose combination versus free combination of tiotropium and olodaterol in COPD

 Comparaison de l’association fixe du tiotropium et de l’olodatérol versus association libre en BPCO

title: A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)

location_country: Denmark Slovenia Austria Finland France

location_facility: Verboten Kopriva Renata - Private practice, Litija

location_facility: Univ. Clinic of Respiratory and Allergic Diseases, Golnik

location_facility: Ordination Dr. Robert Voves, 8330 Feldbach

summary:
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.

Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

summary: This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

ReferenceType: background

ReferenceCitation: González-Martín A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Pérez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.

ReferenceCitation: Lorusso D, Guy H, Samyshkin Y, Hawkes C, Estenson K, Coleman RL. Feasibility Study of a Network Meta-Analysis and Unanchored Population-Adjusted Indirect Treatment Comparison of Niraparib, Olaparib, and Bevacizumab as Maintenance Therapies in Patients with Newly Diagnosed Advanced Ovarian Cancer. Cancers (Basel). 2022 Mar 2;14(5). pii: 1285. doi: 10.3390/cancers14051285. Review.

ReferenceCitation: Barretina-Ginesta MP, Monk BJ, Han S, Pothuri B, Auranen A, Chase DM, Lorusso D, Anderson C, Abadie-Lacourtoisie S, Cloven N, Braicu EI, Amit A, Redondo A, Shah R, Kebede N, Hawkes C, Gupta D, Woodward T, O'Malley DM, González-Martín A. Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial. Ther Adv Med Oncol. 2022 Sep 22;14:17588359221126149. doi: 10.1177/17588359221126149. eCollection 2022.

ReferenceCitation: O'Cearbhaill RE, Pérez-Fidalgo JA, Monk BJ, Tusquets I, McCormick C, Fuentes J, Moore RG, Vulsteke C, Shahin MS, Forget F, Bradley WH, Hietanen S, O'Malley DM, Dørum A, Slomovitz BM, Baumann K, Selle F, Calvert PM, Artioli G, Levy T, Kumar A, Malinowska IA, Li Y, Gupta D, González-Martín A. Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study. Gynecol Oncol. 2022 Jul;166(1):36-43. doi: 10.1016/j.ygyno.2022.04.012. Epub 2022 May 9.

lead_sponsor: Tesaro, Inc.

location_country:
Denmark
Poland
Spain
Ireland
Italy
Russian Federation
United Kingdom
Canada
Finland
Switzerland
Ukraine
Sweden
Hungary
United States
France
Israel
Belgium
Norway
Germany
Czechia


title: A Multicenter, Randomized, Open-label Phase 2 Study Evaluating the Safety and Efficacy of Three Different Regimens of Oral Panobinostat in Combination With Subcutaneous Bortezomib and Oral Dexamethasone in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma Who Have Been Previously Exposed to Immunomodulatory Agents

summary:
The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression.

Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons.

Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks.

All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3 year survival follow-up or discontinued earlier.

ReferenceCitation: Laubach JP, Schjesvold F, Mariz M, Dimopoulos MA, Lech-Maranda E, Spicka I, Hungria VTM, Shelekhova T, Abdo A, Jacobasch L, Polprasert C, Hájek R, Illés Á, Wróbel T, Sureda A, Beksac M, Gonçalves IZ, Bladé J, Rajkumar SV, Chari A, Lonial S, Spencer A, Maison-Blanche P, Moreau P, San-Miguel JF, Richardson PG. Efficacy and safety of oral panobinostat plus subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (PANORAMA 3): an open-label, randomised, phase 2 study. Lancet Oncol. 2021 Jan;22(1):142-154. doi: 10.1016/S1470-2045(20)30680-X. Epub 2020 Dec 7.

ipd_sharing: Undecided

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

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

lead_sponsor: SecuraBio

location_country:
Spain
Italy
United States
Belgium
Czechia
Poland
Portugal
Russian Federation
Australia
Turkey
Norway
Sweden
Brazil
Lebanon
Canada
Hungary
Germany
Greece
Thailand
Korea, Republic of
France
Netherlands

location_facility: Albert Schweitzer ziekenhuis, Hematology


title: Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary:
The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1

design_allocation: Non-Randomized

lead_sponsor: Innate Pharma

location_country:
United States
France

location_facility: University of California, Moores Cancer Center

location_facility: Washington University School of Medicine

location_facility: Institut Regional du Cancer de Montpellier

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

intervention_type: Biological


acronym: SEAL

title: A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

lead_sponsor: Karyopharm Therapeutics Inc

ReferenceCitation: Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Gröschel S, Hatcher H, Duffaud F, Herráez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Götze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.

location_country:
Spain
Italy
United Kingdom
Canada
Sweden
United States
France
Israel
Belgium
Germany

location_facility: Cross Cancer Center - Alberta Health Services

location_facility: Institut Régional du Cancer de Montpellier (ICM)

location_facility: Hospital Universitario Clínico San Carlos

location_facility: National Center for Tumor Diseases, Univeristy Hospital Heidelberg

location_facility: James Cancer Center, Ohio State University

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie Klinikum rechts der Isar der TU Muenchen

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: U.O.C. Oncologia Medica Oncology Department

location_facility: Technische Universitaet Dresden Med. Fakultaet Carl Gustav Carus Med. Klinik u. Poliklinik I

location_facility: Policlinico Universitario Campus Biomedico

location_facility: "Germans Trias Pujol" University Hospital

summary: This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).


status: Terminated

acronym: ReTHINK

title: A Randomized, Double Blind, Placebo-controlled, Multicenter, Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Belgium
Japan
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Sweden
Singapore
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
France

summary: Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.

status_simplified: Unknown


title: A Randomized, Open Label, Phase 2 Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for Relapsed or Refractory CD30-Positive Diffuse Large B-Cell Lymphoma

lead_sponsor: Seagen Inc.

location_country:
Poland
Spain
Italy
United Kingdom
United States
France
Czechia

location_facility: Greenville Health System Institutional Review Board

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Hematology and Oncology Associates of Northern New Jersey, P.A.

location_facility: University Hospital's Birmingham NHS Foundation trust-Queen Elizabeth Hospital

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan

location_facility: Centre Hospitalier Universitaire de Nantes (CHU Nantes) - Hotel Dieu

location_facility: Centre Hospitalier Universitaire (CHU) de Poitier- Hopital de la Miletrie - Hopital Jean Bernard

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: The Oncology Institute of Hope and Innovation

location_facility: A.O Ospadale Di Circolo E Fondazione Macchi

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

summary: This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).


acronym: ODYSSEY DM-Insulin

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

lead_sponsor: Sanofi

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

ReferenceCitation: Ray KK, Del Prato S, Müller-Wieland D, Cariou B, Colhoun HM, Tinahones FJ, Domenger C, Letierce A, Mandel J, Samuel R, Bujas-Bobanovic M, Leiter LA. Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies. Cardiovasc Diabetol. 2019 Nov 9;18(1):149. doi: 10.1186/s12933-019-0951-9.

ReferenceCitation: Leiter LA, Cariou B, Müller-Wieland D, Colhoun HM, Del Prato S, Tinahones FJ, Ray KK, Bujas-Bobanovic M, Domenger C, Mandel J, Samuel R, Henry RR. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial. Diabetes Obes Metab. 2017 Dec;19(12):1781-1792. doi: 10.1111/dom.13114. Epub 2017 Oct 10.

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Switzerland
United States
France
Belgium
Germany

location_facility:
Investigational Site Number 056002
Investigational Site Number 250-003
Investigational Site Number 840027
Investigational Site Number 276009
Investigational Site Number 826003
Investigational Site Number 840006
Investigational Site Number 040003
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Investigational Site Number 840012
Investigational Site Number 840028
Investigational Site Number 380012
Investigational Site Number 380003
Investigational Site Number 276018
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Investigational Site Number 276013
Investigational Site Number 840013
Investigational Site Number 250-005
Investigational Site Number 724005
Investigational Site Number 276019
Investigational Site Number 250-002
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Investigational Site Number 528004
Investigational Site Number 724003
Investigational Site Number 826001
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Investigational Site Number 528005
Investigational Site Number 528001
Investigational Site Number 724009
Investigational Site Number 380007
Investigational Site Number 724004
Investigational Site Number 040005
Investigational Site Number 724008
Investigational Site Number 724012
Investigational Site Number 724013
Investigational Site Number 826010
Investigational Site Number 756003
Investigational Site Number 826007
Investigational Site Number 276022
Investigational Site Number 826015
Investigational Site Number 840004
Investigational Site Number 826002
Investigational Site Number 840025
Investigational Site Number 276005
Investigational Site Number 724010
Investigational Site Number 276003
Investigational Site Number 276017
Investigational Site Number 826004
Investigational Site Number 276014
Investigational Site Number 276016
Investigational Site Number 840026
Investigational Site Number 840002
Investigational Site Number 724014
Investigational Site Number 840003
Investigational Site Number 756001
Investigational Site Number 250-008
Investigational Site Number 840014
Investigational Site Number 276021
Investigational Site Number 826011
Investigational Site Number 276015
Investigational Site Number 826012
Investigational Site Number 840001
Investigational Site Number 826006
Investigational Site Number 250-007
Investigational Site Number 380009
Investigational Site Number 840029
Investigational Site Number 380011
Investigational Site Number 276011
Investigational Site Number 528002
Investigational Site Number 840020
Investigational Site Number 380006
Investigational Site Number 276008
Investigational Site Number 276004
Investigational Site Number 724011
Investigational Site Number 840007
Investigational Site Number 840011
Investigational Site Number 724006
Investigational Site Number 380004
Investigational Site Number 840015
Investigational Site Number 826008
Investigational Site Number 040002
Investigational Site Number 250-009
Investigational Site Number 276002
Investigational Site Number 276006
Investigational Site Number 380008
Investigational Site Number 250-006
Investigational Site Number 724007
Investigational Site Number 840017
Investigational Site Number 840016
Investigational Site Number 250-004
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Investigational Site Number 380002
Investigational Site Number 040001
Investigational Site Number 528003
Investigational Site Number 840019
Investigational Site Number 840008
Investigational Site Number 380001
Investigational Site Number 826005
Investigational Site Number 840021
Investigational Site Number 276010
Investigational Site Number 826009
Investigational Site Number 250-001
Investigational Site Number 724002
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 724001
Investigational Site Number 840010
Investigational Site Number 056001
Investigational Site Number 056003
Investigational Site Number 840005
Investigational Site Number 380005

summary:
Primary Objectives:

To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy.
To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin.

Secondary Objective:

To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle number and size).


title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER

lead_sponsor: Pfizer

ReferenceCitation: Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.

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

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Israel
Norway
Singapore
Canada
Switzerland
Hungary
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Netherlands

location_facility: Clinical Trial Pharmacy, Mackay Memorial Hospital

location_facility: Fondazione Poliambulanza Istituto Ospedelario

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: Poliambulatorio Specialistico Villa Salute

location_facility: Universitatsspital Zurich, Clinical Trials Center

location_facility: lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta

location_facility: Center of Hope at Renown Regional Medical Center

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna

location_facility: Oncology Pharmacy McGill University Health Centre

location_facility: The University of Pennsylvania Health System

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: The University of Kansas Clinical Research Center

location_facility: Hillcrest Hospital Hirsch Cancer Center Pharmacy

location_facility: Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika

location_facility: Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie

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

location_facility: State Budgetary Healthcare Institution of Nizhegorogsky region

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Clinical Trial Pharmacy, Taipei Veterans General Hospital

location_facility: Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w

location_facility: National Cancer Centre Singapore Pharmacy

location_facility: Regione Lombardia, A O Istituti Ospitalieri di Cremona

location_facility: State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"

location_facility: Epic Pharmacy,Newcastle Private Hospital

location_facility: State Budgetary Healthcare Institution "Clinical oncology dispensary #1"

location_facility: Humanitas, Unita Operativa di Cardiologia 2

location_facility: Congregazione delle Suore Infermiere dell'Addolorata

location_facility: The University of Kansas Cancer Center, CCP - North

location_facility: Universitaetsspital Zurich, Klinik fuer Gynakologie

location_facility: Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Department of Obstetrics and Gynecology, Haukeland University Hospital

location_facility: Institut Catala d'Oncologia - Hospital Duran y Reynalds

location_facility: Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology

location_facility: Clinical Trial Pharmacy, National Cheng Kung University Hospital

location_facility: Fairview Hospital Moll Pavilion Pharmacy

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Apteka Szpitalna

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Nottingham University Hospital NHS Trust

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna

location_facility: British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

location_facility: State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary

location_facility: State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center

location_facility: Spire Healthcare Limited (St. Anthony's Hospital)

location_facility: State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Medizinische Universitat Graz, LKH-Univ. Klinikum Graz

location_facility: Guy's & St. Thomas' NHS Foundation Trust

location_facility: Saitama Medical University International Medical Center

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: Servizio Sanitario Regionale Emilia-Romagna

location_facility: University College London Hospital NHS Foundation Trust

location_facility: The Christie Hospital NHS Foundation Trust

location_facility: Ambulatorio dott. Francesco Cavanna, Medico Chirurgo

location_facility: Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center

location_facility: Orszagos Onkologiai Intezet, Gyogyszertar

location_facility: Fairview Hospital Moll Pavilion Cancer Center

location_facility: Norton Cancer Institute, Norton Healthcare Pavilion

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"

location_facility: Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre

location_facility: Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Keimyung University Dongsan Medical Center

location_facility: National Defense Medical College Hospital

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Texas Oncology -Fort Worth Cancer Center

location_facility: Vseobecna fakultni nemocnice v Praze, Neurologicka klinika

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch

location_facility: University of California, Irvine/UC Irvine Health

location_facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

location_facility: Azienda Unita Sanitaria Locale di Piacenza

location_facility: Norton Cancer Institute, Brownsboro Hospital Campus

location_facility: Nippon Medical School Musashikosugi Hospital

location_facility: McGill University Health Centre - Glen Site

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Universitatsspital Zurich, Universitares Herzzentrum Zurich

location_facility: US Oncology Investigational Products Center

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"

location_facility: Investigational Drug Services, University of Pennsylvania

summary: A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.


title: An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

acronym: ASCENT

summary: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

ReferenceCitation: Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.

ReferenceType: result

ReferenceCitation: Huvitz SA, Tolaney SM, Punie K, et al. 2020 SABCS GS3-06. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Dieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Rugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

ReferenceCitation: Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05

ReferenceCitation: O'Shaughnessy J, Brufsky A, Rugo HS, Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia A, Henry S, Mayer I, Zhu Y, Phan S, Cortés J. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11.

ReferenceCitation: Bardia A, Hurvitz SA, Rugo HS, Brufsky A, Cortes J, Loibl S, Piccart M, Cowden J, Spears P, Carey LA. A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer. Future Oncol. 2021 Oct 1;17(30):3911-3924. doi: 10.2217/fon-2021-0868. Epub 2021 Sep 1.

ReferenceCitation: Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortés J, O'Shaughnessy J, Diéras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.

ReferenceCitation: McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671. Review.

ReferenceCitation: Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021 Jul;55(7):921-931. doi: 10.1177/1060028020966548. Epub 2020 Oct 17. Review.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

lead_sponsor: Gilead Sciences

location_country:
Spain
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450

location_facility: Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level

location_facility: Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway

location_facility: Rocky Mountain Cancer Centers, 1700 South Potomac Street

location_facility: Praxis für Hämatologie und Internistische Onkologie

location_facility: West Cancer Center, 7945 Wolf River Blvd

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie GbR

location_facility: Florida Cancer Specialists & Research Institute, 100 Highland Avenue

location_facility: Florida Cancer Specialists & Research Institute, 1630 SE 18th ST

location_facility: Florida Cancer Specialists & Research Institute, 765 Image Way

location_facility: Florida Cancer Specialists & Research Institute, 403 S. King Ave

location_facility: UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza

location_facility: Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01

location_facility: The Royal Surrey County Hospital NHS Foundation Trust

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Florida Cancer Specialists & Research Institute, 4100 Waterman Way

location_facility: Virginia G. Piper Cancer Center at HonorHealth

location_facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology

location_facility: Rocky Mountain Cancer Centers, 8820 Huron Street

location_facility: Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100

location_facility: Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road

location_facility: Southern Cancer Center, 29653 Anchor Cross Blvd

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400

location_facility: Tennessee Oncology - Chattanooga Oncology & Hematology Associates

location_facility: Rocky Mountain Cancer Centers, 1800 Williams St.

location_facility: Nebraska Cancer Specialists - Midwest Cancer Center - Paillion

location_facility: Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Souther Cancer Center, 3719 Dauphin St., 5 Floor

location_facility: Rocky Mountain Cancer Centers, 22 West Dry Creek Circle

location_facility: The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: The County Hospital, Wye Valley NHS Trust

location_facility: Mass General - North Shore Cancer Center ( NSCC )

location_facility: Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90

location_facility: Florida Cancer Specialists & Research Institute1309 N Flagler Dr

location_facility: Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing

location_facility: Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232

location_facility: Cross Cancer Institute, 11560 University Avenue

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Florida Cancer Specialists & Research Institute, 70 W Gore Street

location_facility: Rocky Mountain Cancer Centers, 4715 Arapahoe Ave

location_facility: UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard

location_facility: Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road

location_facility: Jewish General Hospital, 3755 Côte-Sainte-Catherine

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Florida Cancer Specialists & Research Institute - 3730 7th Terrace

location_facility: Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital

location_facility: MidAmerica Division Inc. c/o Menorah Medical Center

location_facility: Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin

location_facility: The Arden Cancer Centre- University Hospital Coventry

location_facility: Houston Methodist Hospital - 6565 Fannin St

location_facility: University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street

location_facility: Nebraska Cancer Specialists - Midwest Cancer Center - Papillion

location_facility: UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200

location_facility: University Cancer & Blood Center, 3320 Old Jefferson Rd

location_facility: North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16

location_facility: Florida Cancer Specialists & Research Institute - 325 Clyde Morris

location_facility: UPMC Hillman Cancer Center Upper Saint Clair

location_facility: Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421

location_facility: Texas Oncology- Medical City Dallas Building D

location_facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd

location_facility: Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210

location_facility: University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive

location_facility: Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B

location_facility: Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400

location_facility: County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham

location_facility: Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000

location_facility: The Ohio State University Wexner Medical Center, 1145 Olentangy River Road

location_facility: Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard

location_facility: Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive

location_facility: Washington University School of Medicine in St. Louis

location_facility: North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road

location_facility: Florida Cancer Specialists & Research Institute, 560 Jackson St

location_facility: UPMC Hillman Cancer Center UPMC Passavant

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Sarah Cannon Cancer Institute/Tennessee Oncology

location_facility: Allegheny-Singer Research Institute, 320 East North Avenue

location_facility: UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion

location_facility: Hospital Quirón Barcelona, Plaza Alfonso Comín 5

location_facility: Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd

location_facility: UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Nebraska Cancer Specialists- Midwest Cancer Center- Papillion

location_facility: Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North

location_facility: Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350

location_facility: Southern Cancer Center, 3 Mobile Infirmary Circle

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: The Ohio State University Wexner Medical Center, 460 W 10th Ave

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario

location_facility: Florida Cancer Specialists & Research Institute, 1400 US highway 441 N

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court

location_facility: University of Chicago Medical Center 5841 S. Maryland Ave

location_facility: UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320


acronym: INSPIRE

title: A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent

lead_sponsor: Onconova Therapeutics, Inc.

publications_result: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

ReferenceCitation: Garcia-Manero G, Fenaux P, Al-Kali A, Baer MR, Sekeres MA, Roboz GJ, Gaidano G, Scott BL, Greenberg P, Platzbecker U, Steensma DP, Kambhampati S, Kreuzer KA, Godley LA, Atallah E, Collins R Jr, Kantarjian H, Jabbour E, Wilhelm FE, Azarnia N, Silverman LR; ONTIME study investigators. Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):496-508. doi: 10.1016/S1470-2045(16)00009-7. Epub 2016 Mar 9.

ReferenceCitation: Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell. 2016 Apr 21;165(3):643-55. doi: 10.1016/j.cell.2016.03.045.

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15. Review.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
India
Israel
Sweden
Canada
Switzerland
Hungary
Germany
Ireland
Estonia
France

location_facility: Sahyadri Clinical Research and Development Center

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Tokai Central Hospital of the Mutual Aid Association of Public School Teachers

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Cittá della Salute e della Scienza di Torino

location_facility: Institute Of Hematology And Transfusion Medicine

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Loyola University Chicago at Loyola University Medical Center

location_facility: Niigata University Medical and Dental Hospital

location_facility: Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn

location_facility: Hospital of the University of Pennsylvania

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità

location_facility: Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology

location_facility: University Hospital Ostrava, Department of Hematooncology

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa

location_facility: Mid Florida Hematology and Oncology Centers

location_facility: Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Somogy County Kaposi Mór Teaching Hospital

location_facility: University of Wisconsin Clinical Science Center

location_facility: Institute of Hematology and Blood Transfusion

location_facility: University of Minnesota Physicians Bone Marrow Transplant Clinic

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: State Budgetary Healthcare Institution of Moscow City

location_facility: Klinički bolnicki centar Sestre milosrdnice

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Ospedale S. Eugenio - S. Eugenio Hospital

location_facility: State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev",

location_facility: National Hospital Organization Okayama Medical Center

location_facility: FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency"

location_facility: Hospital Duran i Reynals - Instituto Catalán de Oncología

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

location_facility: Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: University Hospital and University of Bern; Inselspital Bern

location_facility: Skåne University Hospital, Department of Hematology

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Albert Einstein Medical Center, Cancer Center

location_facility: Greenville Health System (GHS) Cancer Institute

location_facility: Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow

location_facility: King's College Hospital NHS Foundation Trust

location_facility: St Bartholomew's Hospital, Barts Health NHS Trust

location_facility: University of Pécs 1st Department of Internal Medicine

location_facility: National Hospital Organization Kumamoto Medical Center

summary: The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.


title: A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

summary: The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

status: Withdrawn

location_country: Canada France


title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

ReferenceCitation: Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24.

location_country:
Spain
United Kingdom
Lithuania
United States
Belgium
Philippines
Iceland
Romania
Poland
Austria
Australia
Argentina
Singapore
Brazil
Switzerland
Guatemala
Hungary
China
Germany
Denmark
Greece
Ireland
Estonia
Latvia
Finland
Vietnam
France

summary:
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)
patients with inadequately controlled severe asthma (overall study population)

Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).


title: A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

acronym: CheckMate 451

summary: In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

ReferenceCitation: Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4). pii: e004273. doi: 10.1136/jitc-2021-004273.

ReferenceCitation: Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodríguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. doi: 10.1200/JCO.20.02212. Epub 2021 Mar 8.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Singapore
Sweden
Brazil
Canada
Switzerland
China
Germany
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France
Colombia
Netherlands

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: University of Kansas Cancer Center - Clinical Research Center

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi


acronym: EMERGE

title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

lead_sponsor: Biogen

ReferenceCitation: Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.

location_country:
Poland
Spain
Italy
Netherlands
Finland
Canada
Switzerland
Sweden
United States
France
Belgium
Japan
Germany

location_facility: Associated Neurologists of Southern Connecticut, PC

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: True North Clinical Research Kentville, Inc

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: Centre Neurologique & de Réadaptation Fonctionnelle

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Universitären Psychiatrischen Kliniken Basel (UPK)

location_facility: University of California San Diego Medical Center

location_facility: Josephson, Wallack, Munshower Neurology, PC

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Lehigh Center for Clinical Research, LLC

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: NZOZ "SENIOR" Poradnia Psychogeriatryczna

location_facility: University of Utah Health Sciences Center

location_facility: Clinical Neuroscience Research Association, Inc

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien

location_facility: The Methodist Hospital Research Institute

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Centre de Recherche Clinique du Gérontopôle - Cité de la Santé

location_facility: Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.

location_facility: Medical Research Health and Education Foundation, Inc

location_facility: True North Clinical Research - Halifax Inc.

summary: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].


title: A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

summary: The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

ReferenceCitation: Ackaert O, McDougall D, Pérez-Ruixo C, Pérez-Ruixo JJ, Jezorwski J, Crauwels HM. Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). AAPS J. 2021 Jun 7;23(4):82. doi: 10.1208/s12248-021-00607-8.

ReferenceCitation: Orkin C, Eron JJ, Rockstroh J, Podzamczer D, Esser S, Vandekerckhove L, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Opsomer M; AMBER study group. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2020 Apr 1;34(5):707-718. doi: 10.1097/QAD.0000000000002463.

ReferenceCitation: Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, De Meyer S; AMBER and EMERALD Study Groups. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials. AIDS Res Hum Retroviruses. 2020 Jan;36(1):48-57. doi: 10.1089/AID.2019.0111. Epub 2019 Oct 21.

ReferenceCitation: Rashbaum B, Spinner CD, McDonald C, Mussini C, Jezorwski J, Luo D, Van Landuyt E, Brown K, Wong EY. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1: subgroup analyses of the phase 3 AMBER study. HIV Res Clin Pract. 2019 Feb;20(1):24-33. doi: 10.1080/15284336.2019.1608714. Epub 2019 May 29.

ReferenceCitation: Eron JJ, Orkin C, Gallant J, Molina JM, Negredo E, Antinori A, Mills A, Reynes J, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Vanveggel S, Opsomer M; AMBER study group. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018 Jul 17;32(11):1431-1442. doi: 10.1097/QAD.0000000000001817.

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Poland
Spain
United Kingdom
Russian Federation
Canada
Puerto Rico
United States
France
Belgium
Germany


title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression

summary: The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

ReferenceCitation: Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Brazil
Spain
United Kingdom
Finland
Lithuania
United States
France
South Africa
Belgium
Sweden
Bulgaria


title: A Randomized, Open-label, Phase 3 Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing

acronym: ARROW

summary: The purpose of the study is to compare the progression-free survival (PFS) of once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in adults with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).

ReferenceCitation: Moreau P, Mateos MV, Berenson JR, Weisel K, Lazzaro A, Song K, Dimopoulos MA, Huang M, Zahlten-Kumeli A, Stewart AK. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018 Jul;19(7):953-964. doi: 10.1016/S1470-2045(18)30354-1. Epub 2018 Jun 1. Erratum in: Lancet Oncol. 2018 Aug;19(8):e382.

ReferenceCitation: Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.

ReferenceCitation: Dimopoulos MA, Niesvizky R, Weisel K, Siegel DS, Hajek R, Mateos MV, Cavo M, Huang M, Zahlten-Kumeli A, Moreau P. Once- versus twice-weekly carfilzomib in relapsed and refractory multiple myeloma by select patient characteristics: phase 3 A.R.R.O.W. study subgroup analysis. Blood Cancer J. 2020 Mar 9;10(3):35. doi: 10.1038/s41408-020-0300-y.

ReferenceCitation: Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.

ReferenceCitation: Moreau P, Kumar S, Boccia R, Iida S, Goldschmidt H, Cocks K, Trigg A, Zahlten-Kumeli A, Yucel E, Panjabi SS, Dimopoulos M. Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m(2) vs. twice-weekly 27 mg/m(2) carfilzomib (randomized A.R.R.O.W. study). Leukemia. 2019 Dec;33(12):2934-2946. doi: 10.1038/s41375-019-0480-2. Epub 2019 May 15.

ReferenceCitation: Kumar SK, Majer I, Panjabi S, Medhekar R, Campioni M, Dimopoulos MA. Cost-effectiveness of once weekly carfilzomib 70 mg/m2 plus dexamethasone in patients with relapsed and refractory multiple myeloma in the United States. Expert Rev Hematol. 2020 Jun;13(6):687-696. doi: 10.1080/17474086.2020.1746639. Epub 2020 Apr 6.

ReferenceCitation: Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.

lead_sponsor: Amgen

location_country:
Denmark
Poland
Romania
Spain
Greece
Italy
Australia
New Zealand
Canada
Finland
United Kingdom
Sweden
Hungary
United States
France
Norway
Belgium
Japan
Germany
Czechia

location_facility: John Theurer Cancer Center at Hackensack University Medical Center


title: A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

summary: This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.

study_type: Observational

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Hungary
United States
France
Germany

location_facility: University Health Network Toronto Western Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Centre Odeon; Exploration Ophtalmologique

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)


acronym: PORTICO

title: A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

lead_sponsor: Actelion

ReferenceCitation: Raevens S, Fallon MB. PORTICO: First Randomized Controlled Trial of Vasomodulator Therapy in Portopulmonary Hypertension. Hepatology. 2020 May;71(5):1870-1872. doi: 10.1002/hep.31166.

ReferenceCitation: Sitbon O, Bosch J, Cottreel E, Csonka D, de Groote P, Hoeper MM, Kim NH, Martin N, Savale L, Krowka M. Macitentan for the treatment of portopulmonary hypertension (PORTICO): a multicentre, randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2019 Jul;7(7):594-604. doi: 10.1016/S2213-2600(19)30091-8. Epub 2019 Jun 6.

location_country:
Brazil
Spain
United Kingdom
France
United States
Germany
Czechia

location_facility: Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033"

location_facility: IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)

location_facility: Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie

location_facility: Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination

location_facility: Hospital Clinico i Provincial Servicio de Neumología

location_facility: Medizinische Hochschule Hannover, Abteilung Pneumologie

location_facility: Hôpital Kremlin Bicêtre Service de Pneumologie

location_facility: The Royal Free Hospital/ Cardiology Department

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine

location_facility: University of Florida College of Medicine

location_facility: Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U

location_facility: University of New Mexico Health Science Center

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

location_facility: Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex"

location_facility: Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392

location_facility: Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex"

location_facility: CHU Côte de Nacre, Service de Pneumologie

location_facility: Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Cleveland Clinic - Department of Cardiovascular Medicine

location_facility: University of Colorado Health Sciences Center Aurora

location_facility: CHRU de Grenoble, Hôpital Albert Michallon

location_facility: University of Florida - Divison of Pulmonary Critical Care & Sleep

location_facility: University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550

summary: 24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.


title: A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)

lead_sponsor: ViiV Healthcare

ReferenceCitation: Kozal M, Aberg J, Pialoux G, Cahn P, Thompson M, Molina JM, Grinsztejn B, Diaz R, Castagna A, Kumar P, Latiff G, DeJesus E, Gummel M, Gartland M, Pierce A, Ackerman P, Llamoso C, Lataillade M; BRIGHTE Trial Team. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020 Mar 26;382(13):1232-1243. doi: 10.1056/NEJMoa1902493.

ReferenceCitation: Gartland M, Cahn P, DeJesus E, Diaz RS, Grossberg R, Kozal M, Kumar P, Molina JM, Mendo Urbina F, Wang M, Du F, Chabria S, Clark A, Garside L, Krystal M, Mannino F, Pierce A, Ackerman P, Lataillade M. Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0175121. doi: 10.1128/aac.01751-21. Epub 2022 May 3.

ReferenceCitation: Anderson SJ, Murray M, Cella D, Grossberg R, Hagins D, Towner W, Wang M, Clark A, Pierce A, Llamoso C, Ackerman P, Lataillade M. Patient-Reported Outcomes in the Phase III BRIGHTE Trial of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals. Patient. 2022 Jan;15(1):131-143. doi: 10.1007/s40271-021-00534-y. Epub 2021 Jun 28.

ReferenceCitation: Lataillade M, Lalezari JP, Kozal M, Aberg JA, Pialoux G, Cahn P, Thompson M, Molina JM, Moreno S, Grinsztejn B, Diaz RS, Castagna A, Kumar PN, Latiff GH, De Jesus E, Wang M, Chabria S, Gartland M, Pierce A, Ackerman P, Llamoso C. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020 Nov;7(11):e740-e751. doi: 10.1016/S2352-3018(20)30240-X.

ReferenceCitation: Lagishetty C, Moore K, Ackerman P, Llamoso C, Magee M. Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure-Response Analysis. Clin Transl Sci. 2020 Jul;13(4):769-776. doi: 10.1111/cts.12763. Epub 2020 Mar 19.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Belgium
South Africa
Poland
Portugal
Russian Federation
Australia
Argentina
Puerto Rico
Mexico
Brazil
Canada
Germany
Taiwan
Greece
Ireland
France
Chile
Colombia
Netherlands

summary: The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.


acronym: ESTAIR

title: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study

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

location_country:
Denmark
Portugal
Spain
Greece
Italy
Australia
Mexico
Argentina
Canada
United Kingdom
Korea, Republic of
United States
Chile
France
Israel
Colombia
Turkey
Germany
Czechia

location_facility:
Investigational Site Number 826003
Investigational Site Number 840006
Investigational Site Number 032001
Investigational Site Number 840022
Investigational Site Number 840012
Investigational Site Number 380003
Investigational Site Number 840013
Investigational Site Number 170005
Investigational Site Number 376002
Investigational Site Number 724005
Investigational Site Number 170004
Investigational Site Number 840024
Investigational Site Number 724003
Investigational Site Number 620004
Investigational Site Number 826001
Investigational Site Number 620003
Investigational Site Number 208001
Investigational Site Number 250007
Investigational Site Number 724004
Investigational Site Number 250004
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 792001
Investigational Site Number 250003
Investigational Site Number 376001
Investigational Site Number 484003
Investigational Site Number 410005
Investigational Site Number 032004
Investigational Site Number 826002
Investigational Site Number 376003
Investigational Site Number 276005
Investigational Site Number 276003
Investigational Site Number 484001
Investigational Site Number 826004
Investigational Site Number 840026
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 792002
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 152003
Investigational Site Number 376004
Investigational Site Number 208002
Investigational Site Number 840001
Investigational Site Number 203002
Investigational Site Number 484005
Investigational Site Number 840020
Investigational Site Number 032002
Investigational Site Number 152001
Investigational Site Number 250008
Investigational Site Number 380006
Investigational Site Number 410001
Investigational Site Number 410006
Investigational Site Number 276004
Investigational Site Number 792004
Investigational Site Number 410004
Investigational Site Number 840011
Investigational Site Number 203004
Investigational Site Number 724006
Investigational Site Number 170001
Investigational Site Number 380004
Investigational Site Number 036003
Investigational Site Number 124003
Investigational Site Number 840015
Investigational Site Number 484002
Investigational Site Number 792006
Investigational Site Number 152006
Investigational Site Number 276002
Investigational Site Number 032007
Investigational Site Number 250009
Investigational Site Number 032005
Investigational Site Number 840017
Investigational Site Number 724007
Investigational Site Number 792005
Investigational Site Number 792003
Investigational Site Number 380002
Investigational Site Number 152002
Investigational Site Number 032009
Investigational Site Number 152004
Investigational Site Number 840008
Investigational Site Number 410002
Investigational Site Number 380001
Investigational Site Number 250002
Investigational Site Number 152007
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 036001
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 724001
Investigational Site Number 840010
Investigational Site Number 036005
Investigational Site Number 376005
Investigational Site Number 203001
Investigational Site Number 300001
Investigational Site Number 410003
Investigational Site Number 036004
Investigational Site Number 203003
Investigational Site Number 380005
Investigational Site Number 036002

summary:
Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.

To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.


title: A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome

acronym: GEMINI ACS 1

summary: The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

ReferenceCitation: Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.

ReferenceCitation: Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Güray Ü, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.

ReferenceCitation: Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.

location_country:
Denmark
Poland
Brazil
Spain
Russian Federation
Australia
Argentina
Canada
Ukraine
Sweden
Hungary
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Netherlands
Bulgaria
Czechia


acronym: PRESIDE

title: A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone

lead_sponsor: Astellas Pharma Europe Ltd.

ReferenceCitation: Merseburger AS, Attard G, Åström L, Matveev VB, Bracarda S, Esen A, Feyerabend S, Senkus E, López-Brea Piqueras M, Boysen G, Gourgioti G, Martins K, Chowdhury S. Continuous enzalutamide after progression of metastatic castration-resistant prostate cancer treated with docetaxel (PRESIDE): an international, randomised, phase 3b study. Lancet Oncol. 2022 Nov;23(11):1398-1408. doi: 10.1016/S1470-2045(22)00560-5. Epub 2022 Oct 18.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Poland
Spain
Greece
Austria
Italy
Netherlands
Russian Federation
United Kingdom
Switzerland
Sweden
France
Turkey
Belgium
Norway
Germany
Czechia

location_facility:
Site TR90001
Site BE32004
Site FR33003
Site CZ42004
Site IT39010
Site DE49017
Site ES34007
Site DE49002
Site FR33008
Site PL48002
Site IT39002
Site NO47001
Site GB44007
Site FR33002
Site CZ42002
Site IT39012
Site FR33004
Site GR30005
Site SE46002
Site RU70004
Site IT39008
Site NL31004
Site AT43004
Site IT39003
Site PL48004
Site DE49004
Site GB44015
Site PL48005
Site ES34009
Site GR30003
Site CH41009
Site DE49003
Site GB44004
Site IT39001
Site DE49001
Site NL31010
Site GR30004
Site RU70002
Site GB44017
Site BE32002
Site ES34010
Site IT39005
Site TR90003
Site NL31003
Site ES34002
Site PL48006
Site DE49006
Site FR33014
Site RU70003
Site FR33011
Site GB44002
Site CH41005
Site CZ42003
Site TR90002
Site FR33005
Site DE49010
Site PL48003
Site SE46004
Site ES34001
Site NO47004
Site GB44014
Site ES34008
Site GB44003
Site GB44018
Site DE49015
Site ES34003
Site AT43001
Site FR33012
Site FR33013
Site NL31002
Site ES34006
Site CZ42001
Site RU70005
Site IT39004
Site GR30001
Site ES34004
Site RU70001
Site NL31007
Site GB44010
Site SE46003
Site DE49008
Site GB44020
Site BE32003
Site RU70006
Site NO47005
Site DE49018
Site GR30006
Site SE46005
Site ES34005

summary: The purpose of the study was to understand if there was benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer had gotten worse when treated with enzalutamide alone.


title: A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

lead_sponsor: MedImmune LLC

location_country:
Spain
United Kingdom
Netherlands
Canada
Korea, Republic of
United States
Israel
France
Germany