title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

ReferenceCitation: Strand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012 Oct;51(10):1860-9. Epub 2012 Jun 28.

ReferenceCitation: Karsdal MA, Schett G, Emery P, Harari O, Byrjalsen I, Kenwright A, Bay-Jensen AC, Platt A. IL-6 receptor inhibition positively modulates bone balance in rheumatoid arthritis patients with an inadequate response to anti-tumor necrosis factor therapy: biochemical marker analysis of bone metabolism in the tocilizumab RADIATE study (NCT00106522). Semin Arthritis Rheum. 2012 Oct;42(2):131-9. doi: 10.1016/j.semarthrit.2012.01.004. Epub 2012 Mar 6.

ReferenceCitation: Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14. Erratum in: Ann Rheum Dis. 2009 Feb;68(2):296.

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
Italy
Australia
Mexico
Canada
Netherlands
Switzerland
Sweden
Puerto Rico
United States
France
Belgium
Iceland
Germany


type: EudraCT Number

title: A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

acronym: SHARP

summary: The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

ReferenceType: derived

ReferenceCitation: Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies. J Hepatol. 2017 Nov;67(5):999-1008. doi: 10.1016/j.jhep.2017.06.026. Epub 2017 Jul 4. Erratum in: J Hepatol. 2018 Oct;69(4):990-991.

lead_sponsor: Bayer

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Peru
Romania
Belgium
Poland
Russian Federation
Australia
Argentina
Israel
Mexico
Brazil
Canada
Switzerland
Germany
Bulgaria
Greece
New Zealand
France
Chile

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

ReferenceCitation: Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. Erratum in: Clin Ther. 2006 Nov;28(11):1967.

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
Spain
Italy
United States
France
Norway
Netherlands


title: Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison With Placebo

summary: The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients.

ReferenceCitation: Stoffers-Winterling JM, Storebø OJ, Pereira Ribeiro J, Kongerslev MT, Völlm BA, Mattivi JT, Faltinsen E, Todorovac A, Jørgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11:CD012956. doi: 10.1002/14651858.CD012956.pub2. Review.

ReferenceCitation: Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.

ReferenceCitation: Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.

ReferenceCitation: Schulz SC, Zanarini MC, Bateman A, Bohus M, Detke HC, Trzaskoma Q, Tanaka Y, Lin D, Deberdt W, Corya S. Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study. Br J Psychiatry. 2008 Dec;193(6):485-92. doi: 10.1192/bjp.bp.107.037903.

lead_sponsor: Eli Lilly and Company

location_country:
Portugal
Spain
United Kingdom
Sweden
United States
France
Belgium
Norway
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician


title: A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer

acronym: ENRICH

summary:
RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.

RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.

This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Croatia
Brazil
Spain
Greece
Austria
Italy
United Kingdom
Argentina
Canada
Lithuania
Hungary
United States
Chile
France
Peru

location_facility: Centre Hospitalier Universitarie de Service de Radio-Oncologie

location_facility: Washington University School of Medicine

location_facility: Emory University Winship Cancer Institute

location_facility: Hygeia Diagnostic and Therapeutic Center of Athens

location_facility: Hospital Edgardo Rebagliati Martins (ESSALUD)

location_facility: Hospital Santa Rita da Irmandade da Santa Casa

location_facility: Fundação Pio XII - Hospital do Câncer de Barretos

location_facility: Instituto Brasileiro de Controle do Cancer

location_facility: Centro de Terapia Radiante Cumbres (CAICI)

location_facility: University of Cincinnati Division of Hematology-Oncology

location_facility: Azienda Ospedaliera Maggiore della Carita

location_facility: University of South Florida - H. Lee Moffitt Cancer Center

location_facility: Instituto Privado de Radioterapia y Oncologia

location_facility: Virginia G. Piper Cancer Center, Arizona Oncology Services

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Institute of Oncology, Vilnius University

location_facility: CHU Zagreb University School of Medicine

location_facility: Radiooncologia, Radiation Oncology Center

location_facility: Instituto de Enfermedades Neoplasicas (INEN)

location_facility: The University of Arkansas for Medical Sciences

location_facility: University of North Carolina Breast Center

location_facility: Arizona Cancer Center, University of Arizona

intervention_type: Radiation


title: A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

summary: The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

ReferenceCitation: Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.

ReferenceCitation: Bellmunt J, Eisen T, Fishman M, Quinn D. Experience with sorafenib and adverse event management. Crit Rev Oncol Hematol. 2011 Apr;78(1):24-32. doi: 10.1016/j.critrevonc.2010.03.006. Epub 2010 Apr 18. Review.

ReferenceCitation: Massard C, Zonierek J, Gross-Goupil M, Fizazi K, Szczylik C, Escudier B. Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol. 2010 May;21(5):1027-31. doi: 10.1093/annonc/mdp411. Epub 2009 Oct 22.

ReferenceCitation: Negrier S, Jäger E, Porta C, McDermott D, Moore M, Bellmunt J, Anderson S, Cihon F, Lewis J, Escudier B, Bukowski R. Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Med Oncol. 2010 Sep;27(3):899-906. doi: 10.1007/s12032-009-9303-z. Epub 2009 Sep 12.

ReferenceCitation: Peña C, Lathia C, Shan M, Escudier B, Bukowski RM. Biomarkers predicting outcome in patients with advanced renal cell carcinoma: Results from sorafenib phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. Clin Cancer Res. 2010 Oct 1;16(19):4853-63. doi: 10.1158/1078-0432.CCR-09-3343. Epub 2010 Jul 22.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. doi: 10.1200/JCO.2008.19.5511. Epub 2009 May 18.

ReferenceCitation: Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B; TARGET Study Group. Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. J Natl Cancer Inst. 2008 Oct 15;100(20):1454-63. doi: 10.1093/jnci/djn319. Epub 2008 Oct 7.

ReferenceCitation: Bukowski R, Cella D, Gondek K, Escudier B; Sorafenib TARGETs Clinical Trial Group. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007 Jun;30(3):220-7.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res. 2006 Dec 15;12(24):7271-8. Review.

ReferenceCitation: Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclère J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. Epub 2006 Sep 11. Erratum in: Eur J Cancer. 2007 May;43(8):1336.

ReferenceCitation: Quintanilha JCF, Geyer S, Etheridge AS, Racioppi A, Hammond K, Crona DJ, Peña CE, Jacobson SB, Marmorino F, Rossini D, Cremolini C, Sanoff HK, Abou-Alfa GK, Innocenti F. KDR genetic predictor of toxicities induced by sorafenib and regorafenib. Pharmacogenomics J. 2022 Apr 28. doi: 10.1038/s41397-022-00279-3. [Epub ahead of print]

ReferenceCitation: Quintanilha JCF, Racioppi A, Wang J, Etheridge AS, Denning S, Peña CE, Skol AD, Crona DJ, Lin D, Innocenti F. PIK3R5 genetic predictors of hypertension induced by VEGF-pathway inhibitors. Pharmacogenomics J. 2022 Feb;22(1):82-88. doi: 10.1038/s41397-021-00261-5. Epub 2021 Nov 13. Erratum in: Pharmacogenomics J. 2021 Dec 21;:.

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
Ukraine
Hungary
United States
Chile
France
Israel
Belgium
South Africa
Germany


title: A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)

summary:
The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled.

See study AZA PH GL 2003 CL 001 E for information about the extension to this study.

study_start_date_type: Actual

primary_purpose: Other

ReferenceCitation: Fenaux P, Mufti GJ, Hellström-Lindberg E, Santini V, Gattermann N, Germing U, Sanz G, List AF, Gore S, Seymour JF, Dombret H, Backstrom J, Zimmerman L, McKenzie D, Beach CL, Silverman LR. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010 Feb 1;28(4):562-9. doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21.

ReferenceCitation: Fenaux P, Gattermann N, Seymour JF, Hellström-Lindberg E, Mufti GJ, Duehrsen U, Gore SD, Ramos F, Beyne-Rauzy O, List A, McKenzie D, Backstrom J, Beach CL. Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: azacitidine compared with low dose ara-C. Br J Haematol. 2010 Apr;149(2):244-9. doi: 10.1111/j.1365-2141.2010.08082.x. Epub 2010 Feb 5. Erratum in: Br J Haematol. 2010 Jun;149(6):919.

ReferenceCitation: Santini V, Fenaux P, Mufti GJ, Hellström-Lindberg E, Silverman LR, List A, Gore SD, Seymour JF, Backstrom J, Beach CL. Management and supportive care measures for adverse events in patients with myelodysplastic syndromes treated with azacitidine*. Eur J Haematol. 2010 Aug;85(2):130-8. doi: 10.1111/j.1600-0609.2010.01456.x. Epub 2010 Apr 12.

ReferenceCitation: Seymour JF, Fenaux P, Silverman LR, Mufti GJ, Hellström-Lindberg E, Santini V, List AF, Gore SD, Backstrom J, McKenzie D, Beach CL. Effects of azacitidine compared with conventional care regimens in elderly (≥ 75 years) patients with higher-risk myelodysplastic syndromes. Crit Rev Oncol Hematol. 2010 Dec;76(3):218-27. doi: 10.1016/j.critrevonc.2010.04.005. Epub 2010 May 6.

ReferenceCitation: Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.

ReferenceCitation: Gore SD, Fenaux P, Santini V, Bennett JM, Silverman LR, Seymour JF, Hellström-Lindberg E, Swern AS, Beach CL, List AF. A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial. Haematologica. 2013 Jul;98(7):1067-72. doi: 10.3324/haematol.2012.074831. Epub 2013 Apr 12.

lead_sponsor: Celgene

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
Russian Federation
United Kingdom
Sweden
Hungary
United States
France
Germany
Bulgaria
Czechia

location_facility: MHAT "St George" Clinic of Hematology, Plovdiv

location_facility: Washington University School of Medicine

location_facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: Ospedale Casa Sollievo Della Sofferenza - Irrc

location_facility: Institute of Haematology & Blood Transfusion

location_facility: Instituto Nazionale Tumori "Regina Elena"

location_facility: University General Hospital of Heraklio Voutes

location_facility: Samodzelny Publiczny Centralny Szpital Kliniczny

location_facility: The Newcastle Mater Miseriecordiae Hospital

location_facility: University of Alabama School of Medicine

location_facility: University General Hospital of Patra Rio

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: National Centre of Hematology and Transfusiology, Sofia

location_facility: III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)

location_facility: First Clinical Base - Clinic of Hematology, MHAT - Pleven

location_facility: University of Pecs, 1st Dept of Internal Medicine

location_facility: Multiprofile Hospital for Active Treatment (MHAT), "St. Marina" Clinic of Hematology

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Burdenko Central Military Clinical Hospital

location_facility: University of Szeged, 2nd Department of Internal Medicine

intervention_type: Other


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum

summary: The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.

ReferenceCitation: Van Cutsem E, Bajetta E, Valle J, Köhne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. Epub 2011 Apr 4.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Brazil
Hong Kong
Portugal
Italy
Austria
Australia
New Zealand
Canada
Spain
Switzerland
United Kingdom
Sweden
United States
France
Belgium
Germany
Slovakia

location_facility: Center for Oncology Research & Treatment

location_facility: Washington University School of Medicine

location_facility: Hematology & Oncology Associates of NE PA

location_facility: Sansum Santa Barbara Foundation Medical Clinic

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: California Oncology of the Central Valley

location_facility: Synergy Hematology-Oncology Medical Associates

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: Oncology/Hematology Group of South Florida

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Consultants in Medical Oncology & Hematology

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Hematology/Oncology Associates of Central NY

location_facility: University of Chicago medical Center, Hematology/Oncology

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Cancer Treatment Centers of America in Hampton Roads

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: West Virginia University Health Sciences Center

location_facility: Vanderbilt University School of Medicine

location_facility: Fallon Clinic at Worcester Medical Center

location_facility: Center for Cancer and Hematologic Disease

location_facility: Oncology Hematology Associates of Central Illinois, PC

location_facility: Maine Center for Cancer Medicine & Blood Disorders

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Tulane University Health Sciences Center

location_facility: North Central Montana Professional Building

location_facility: Hematology Oncology Associates of Treasure Coast

location_facility: Hematology-Oncology Associates of Rockland

location_facility: University of Tennessee Cancer Institute

location_facility: St. Vincent's Catholic Medical Centers of New York


title: Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy

summary: The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.

ReferenceType: background

ReferenceCitation: Mehta MP, Shapiro WR, Glantz MJ, Patchell RA, Weitzner MA, Meyers CA, Schultz CJ, Roa WH, Leibenhaut M, Ford J, Curran W, Phan S, Smith JA, Miller RA, Renschler MF. Lead-in phase to randomized trial of motexafin gadolinium and whole-brain radiation for patients with brain metastases: centralized assessment of magnetic resonance imaging, neurocognitive, and neurologic end points. J Clin Oncol. 2002 Aug 15;20(16):3445-53.

ReferenceCitation: Carde P, Timmerman R, Mehta MP, Koprowski CD, Ford J, Tishler RB, Miles D, Miller RA, Renschler MF. Multicenter phase Ib/II trial of the radiation enhancer motexafin gadolinium in patients with brain metastases. J Clin Oncol. 2001 Apr 1;19(7):2074-83.

ReferenceCitation: Rosenthal DI, Nurenberg P, Becerra CR, Frenkel EP, Carbone DP, Lum BL, Miller R, Engel J, Young S, Miles D, Renschler MF. A phase I single-dose trial of gadolinium texaphyrin (Gd-Tex), a tumor selective radiation sensitizer detectable by magnetic resonance imaging. Clin Cancer Res. 1999 Apr;5(4):739-45.

ReferenceCitation: Magda D, Lepp C, Gerasimchuk N, Lee I, Sessler JL, Lin A, Biaglow JE, Miller RA. Redox cycling by motexafin gadolinium enhances cellular response to ionizing radiation by forming reactive oxygen species. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):1025-36.

ReferenceCitation: Miller RA, Woodburn K, Fan Q, Renschler MF, Sessler JL, Koutcher JA. In vivo animal studies with gadolinium (III) texaphyrin as a radiation enhancer. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):981-9.

lead_sponsor: Pharmacyclics LLC.

location_country:
Austria
Australia
Netherlands
Canada
United States
France
Belgium
Germany


title: An International, Multi-Center, Randomized, Open-Label Study of PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

summary: This study will compare the efficacy of PS-341 versus high dose dexamethasone.

ReferenceCitation: Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

ReferenceCitation: Lichter DI, Danaee H, Pickard MD, Tayber O, Sintchak M, Shi H, Richardson PG, Cavenagh J, Bladé J, Façon T, Niesvizky R, Alsina M, Dalton W, Sonneveld P, Lonial S, van de Velde H, Ricci D, Esseltine DL, Trepicchio WL, Mulligan G, Anderson KC. Sequence analysis of β-subunit genes of the 20S proteasome in patients with relapsed multiple myeloma treated with bortezomib or dexamethasone. Blood. 2012 Nov 29;120(23):4513-6. doi: 10.1182/blood-2012-05-426924. Epub 2012 Sep 27.

ReferenceCitation: van Duin M, Broyl A, de Knegt Y, Goldschmidt H, Richardson PG, Hop WC, van der Holt B, Joseph-Pietras D, Mulligan G, Neuwirth R, Sahota SS, Sonneveld P. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: prognostic markers and potential targets for immunotherapy. Haematologica. 2011 Nov;96(11):1662-9. doi: 10.3324/haematol.2010.037978. Epub 2011 Jul 26.

ReferenceCitation: Vogl DT, Stadtmauer EA, Richardson PG, Sonneveld P, Schuster MW, Irwin D, Facon T, Harousseau JL, Boral A, Neuwirth R, Anderson KC. Impact of prior therapies on the relative efficacy of bortezomib compared with dexamethasone in patients with relapsed/refractory multiple myeloma. Br J Haematol. 2009 Nov;147(4):531-4. doi: 10.1111/j.1365-2141.2009.07875.x. Epub 2009 Sep 1.

lead_sponsor: Millennium Pharmaceuticals, Inc.

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

location_facility: Toronto General Research Institute, Princess Margaret Hospital

location_facility: Department of Internal Medicine, Univ. of Michigan Comp. Cancer Center

location_facility: Washington University School of Medicine

location_facility: Eberhard-Karls Universitat, Medizinische Klinik

location_facility: Department of Haematology, Queen Elizabeth Hospital

location_facility: St. Marien Hospital, Klinik fur Hamatologie und Onkologie

location_facility: Department of Haematology, St. Bartholomew's Hospital

location_facility: Rochester General Hospital, Lipson Cancer Blood Center

location_facility: Hopital de Brabois, Service Hematologie et Medecine Interne

location_facility: Lombardi Cancer Center, Georgetown University Medical Center

location_facility: Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie

location_facility: Department of Haematology, Huddinge University Hospital M54

location_facility: UZ Gasthuisberg, Department of Hematology

location_facility: Hospital Clinico Universitario de Barcelona, Haematology Department

location_facility: Institut Gustave-Roussy, Service d'Hematologie

location_facility: Texas Oncology at Medical City Dallas Hospital

location_facility: H. Lee Moffitt Cancer Center, University of S. Florida

location_facility: Instituto di Ematologia e Oncologia Medica, Lorenzo e Ariosto Seragnoli

location_facility: Azienda Ospedaliera, S. Giovanni Battista

location_facility: Hopital Antoine Beclere, Hopital de Jour de Medecine Interne

location_facility: VA Medical Center, Sections of Hematology/Oncology

location_facility: St. Vincent's Comprehensive Cancer Center, Research Department

location_facility: Dept. Hematology, University Medical Centre

location_facility: Hospital Claude Huriez, Service des Maladies du Sang

location_facility: Long Island Jewish Medical Center, Division of Hematology/Oncology

location_facility: Loyola University Medical Center: Cardinal Bernardin Cancer Center

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia

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

location_facility: Kaiser Permanente Oncology Clinical Trials

location_facility: Med Star Institute, Washington Cancer Center

location_facility: Dept. of Clinical Hematology, Academic Medical Center

location_facility: Baylor Institute for Immunology Research

location_facility: Hopital Saint-Louis, Direction Financiere

location_facility: Beth Israel Deaconess Medical Center, Kirstein Room 135

location_facility: Division of Hematology/Stem Cell Transplant

location_facility: Universitatsklinikum Charite, Abt. Fuer Haematologie/Onkologie

location_facility: Karolinska Hospital, Dept. of Hematology

location_facility: Department of Haematology, ICSM, Hammersmith Hospital

location_facility: Cliniques Universitaires U.C.L de Mont Godinne, Hopital de Jour

location_facility: Royal Marsden Hospital, Leukaemia and Myeloma Units

location_facility: Johannes Gutenberg-Universitat Mainz, III. Med Klinik und Poliknik

location_facility: Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique

location_facility: RAMBAM Medical Center, Department of Hematology and Bone

location_facility: University of Pennsylvania Cancer Center

location_facility: Freiburg University Medical Center, Dept. of Hemayology/Oncology

location_facility: Universitatsklinikum Heidelberg, Abt. Fur Haematologie und Onkologie

location_facility: Hackensack University Medical Center, David Jurist Research Building

location_facility: Department of Hematology, Erasmus MC, 1a, Daniel Den Hoed

location_facility: Medical University Clinic (Oncology/Haematology)

location_facility: University of Essen Medical School, Dept. of Internal Medicine

location_facility: Hopital Hotel Dieu, Service d'hematologie et oncologie medicale

location_facility: Western Pennsylvania Hospital, Dept. of Human Oncology

location_facility: Dipartmento Clinico esperimentale Di Oncologia et Ematolgia

location_facility: CHU Erasme / ULB University, Hematology 7th Floor

location_facility: University of Erlangen-Nurenberg, Division of Hematology/Oncology


title: PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma.

enrollment_type: Anticipated

ReferenceCitation: Idbaih A, Dalmasso C, Kouwenhoven M, Jeuken J, Carpentier C, Gorlia T, Kros JM, French P, Teepen J, Broët P, Delattre O, Mokhtari K, Sanson M, Delattre JY, van den Bent M, Hoang-Xuan K. Genomic aberrations associated with outcome in anaplastic oligodendroglial tumors treated within the EORTC phase III trial 26951. J Neurooncol. 2011 Jun;103(2):221-30. doi: 10.1007/s11060-010-0380-9. Epub 2010 Sep 6.

ReferenceCitation: Mokhtari K, Ducray F, Kros JM, Gorlia T, Idbaih A, Taphoorn M, Wesseling P, Hoang-Xuan K, Van den Bent M, Sanson M. Alpha-internexin expression predicts outcome in anaplastic oligodendroglial tumors and may positively impact the efficacy of chemotherapy: European organization for research and treatment of cancer trial 26951. Cancer. 2011 Jul 1;117(13):3014-26. doi: 10.1002/cncr.25827. Epub 2011 Jan 18.

ReferenceCitation: van den Bent MJ, Gravendeel LA, Gorlia T, Kros JM, Lapre L, Wesseling P, Teepen JL, Idbaih A, Sanson M, Smitt PA, French PJ. A hypermethylated phenotype is a better predictor of survival than MGMT methylation in anaplastic oligodendroglial brain tumors: a report from EORTC study 26951. Clin Cancer Res. 2011 Nov 15;17(22):7148-55. doi: 10.1158/1078-0432.CCR-11-1274. Epub 2011 Sep 13.

ReferenceCitation: Preusser M, Hoeftberger R, Woehrer A, et al.: Prognostic value and analytical performance (reproducibility) of Ki67 index in anaplastic oligodendroglial tumors: A translational study of the EORTC Brain Tumor Group. [Abstract] J Clin Oncol 28 (Suppl 15): A-2029, 2010.

ReferenceCitation: van den Bent MJ, Dubbink HJ, Marie Y, Brandes AA, Taphoorn MJ, Wesseling P, Frenay M, Tijssen CC, Lacombe D, Idbaih A, van Marion R, Kros JM, Dinjens WN, Gorlia T, Sanson M. IDH1 and IDH2 mutations are prognostic but not predictive for outcome in anaplastic oligodendroglial tumors: a report of the European Organization for Research and Treatment of Cancer Brain Tumor Group. Clin Cancer Res. 2010 Mar 1;16(5):1597-604. doi: 10.1158/1078-0432.CCR-09-2902. Epub 2010 Feb 16.

ReferenceCitation: Kouwenhoven MC, Gorlia T, Kros JM, Ibdaih A, Brandes AA, Bromberg JE, Mokhtari K, van Duinen SG, Teepen JL, Wesseling P, Vandenbos F, Grisold W, Sipos L, Mirimanoff R, Vecht CJ, Allgeier A, Lacombe D, van den Bent MJ. Molecular analysis of anaplastic oligodendroglial tumors in a prospective randomized study: A report from EORTC study 26951. Neuro Oncol. 2009 Dec;11(6):737-46. doi: 10.1215/15228517-2009-011.

ReferenceCitation: van den Bent MJ, Dubbink HJ, Sanson M, van der Lee-Haarloo CR, Hegi M, Jeuken JW, Ibdaih A, Brandes AA, Taphoorn MJ, Frenay M, Lacombe D, Gorlia T, Dinjens WN, Kros JM. MGMT promoter methylation is prognostic but not predictive for outcome to adjuvant PCV chemotherapy in anaplastic oligodendroglial tumors: a report from EORTC Brain Tumor Group Study 26951. J Clin Oncol. 2009 Dec 10;27(35):5881-6. doi: 10.1200/JCO.2009.24.1034. Epub 2009 Nov 9.

ReferenceCitation: Kros JM, Gorlia T, Kouwenhoven MC, Zheng PP, Collins VP, Figarella-Branger D, Giangaspero F, Giannini C, Mokhtari K, Mørk SJ, Paetau A, Reifenberger G, van den Bent MJ. Panel review of anaplastic oligodendroglioma from European Organization For Research and Treatment of Cancer Trial 26951: assessment of consensus in diagnosis, influence of 1p/19q loss, and correlations with outcome. J Neuropathol Exp Neurol. 2007 Jun;66(6):545-51.

ReferenceCitation: Mauer ME, Taphoorn MJ, Bottomley A, Coens C, Efficace F, Sanson M, Brandes AA, van der Rijt CC, Bernsen HJ, Frénay M, Tijssen CC, Lacombe D, van den Bent MJ; EORTC Brain Cancer Group. Prognostic value of health-related quality-of-life data in predicting survival in patients with anaplastic oligodendrogliomas, from a phase III EORTC brain cancer group study. J Clin Oncol. 2007 Dec 20;25(36):5731-7.

ReferenceCitation: Taphoorn MJ, van den Bent MJ, Mauer ME, Coens C, Delattre JY, Brandes AA, Sillevis Smitt PA, Bernsen HJ, Frénay M, Tijssen CC, Lacombe D, Allgeier A, Bottomley A; European Organisation for Research and Treatment of Cancer. Health-related quality of life in patients treated for anaplastic oligodendroglioma with adjuvant chemotherapy: results of a European Organisation for Research and Treatment of Cancer randomized clinical trial. J Clin Oncol. 2007 Dec 20;25(36):5723-30.

ReferenceCitation: van den Bent MJ, Carpentier AF, Brandes AA, Sanson M, Taphoorn MJ, Bernsen HJ, Frenay M, Tijssen CC, Grisold W, Sipos L, Haaxma-Reiche H, Kros JM, van Kouwenhoven MC, Vecht CJ, Allgeier A, Lacombe D, Gorlia T. Adjuvant procarbazine, lomustine, and vincristine improves progression-free survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Research and Treatment of Cancer phase III trial. J Clin Oncol. 2006 Jun 20;24(18):2715-22.

ReferenceCitation: van den Bent MJ, Delattre JY, Brandes AA, et al.: First analysis of EORTC trial 26951, a randomized phase III study of adjuvant PCV chemotherapy in patients with highly anaplastic oligodendroglioma. [Abstract] J Clin Oncol 23 (Suppl 16): A-1503, 114s, 2005.

ReferenceCitation: Lassman AB, Hoang-Xuan K, Polley MC, Brandes AA, Cairncross JG, Kros JM, Ashby LS, Taphoorn MJB, Souhami L, Dinjens WNM, Laack NN, Kouwenhoven MCM, Fink KL, French PJ, Macdonald DR, Lacombe D, Won M, Gorlia T, Mehta MP, van den Bent MJ. Joint Final Report of EORTC 26951 and RTOG 9402: Phase III Trials With Procarbazine, Lomustine, and Vincristine Chemotherapy for Anaplastic Oligodendroglial Tumors. J Clin Oncol. 2022 Aug 10;40(23):2539-2545. doi: 10.1200/JCO.21.02543. Epub 2022 Jun 22.

ReferenceCitation: Erdem-Eraslan L, Gravendeel LA, de Rooi J, Eilers PH, Idbaih A, Spliet WG, den Dunnen WF, Teepen JL, Wesseling P, Sillevis Smitt PA, Kros JM, Gorlia T, van den Bent MJ, French PJ. Intrinsic molecular subtypes of glioma are prognostic and predict benefit from adjuvant procarbazine, lomustine, and vincristine chemotherapy in combination with other prognostic factors in anaplastic oligodendroglial brain tumors: a report from EORTC study 26951. J Clin Oncol. 2013 Jan 20;31(3):328-36. doi: 10.1200/JCO.2012.44.1444. Epub 2012 Dec 26.

ReferenceCitation: van den Bent MJ, Brandes AA, Taphoorn MJ, Kros JM, Kouwenhoven MC, Delattre JY, Bernsen HJ, Frenay M, Tijssen CC, Grisold W, Sipos L, Enting RH, French PJ, Dinjens WN, Vecht CJ, Allgeier A, Lacombe D, Gorlia T, Hoang-Xuan K. Adjuvant procarbazine, lomustine, and vincristine chemotherapy in newly diagnosed anaplastic oligodendroglioma: long-term follow-up of EORTC brain tumor group study 26951. J Clin Oncol. 2013 Jan 20;31(3):344-50. doi: 10.1200/JCO.2012.43.2229. Epub 2012 Oct 15.

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

location_country:
Portugal
United Kingdom
Italy
Austria
Netherlands
Finland
Switzerland
Sweden
Hungary
France
Belgium
Germany

location_facility: Neurologische Klinik der Henriettenstiftung

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks in Women With Hormone-receptor Positive Breast Cancer:

summary:
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy.

VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer.

It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy.

The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes.

The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it.

To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment.

To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment.

The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant.

All participants will continue taking the anti-cancer therapy they have been using when entering the study.

Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks.

Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between.

During the study, the participants will:

record information about their hot flashes
answer questions about their quality of life and other symptoms.

The doctors and their study team will:

check the participants health and vital signs
take blood and urine samples
examine heart health using electrocardiogram (ECG)
examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs
make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable)
check the health of the participant's cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable)
take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis.
ask the participants questions about what medicines they are taking and if they are having adverse events.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants' health.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

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

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

location_country:
Poland
Portugal
Romania
Spain
Ireland
Austria
Italy
United Kingdom
Finland
Hungary
Kazakhstan
France
Israel
Belgium
Germany

location_facility: Health Corporation of Galilee Medical Center

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

location_facility: Evangelisches Krankenhaus Bergisch Gladbach

location_facility: CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

location_facility: Multifield medical center | Chemotherapy department No 1

location_facility: H Univ. 12 de Octubre | Ginecología y Obstetricia

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Barmhzg Schwestern | Brust-Gesundheitszentrum

location_facility: ICANS - Institut de Cancérologie de Strasbourg Europe

location_facility: Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

location_facility: Uniklinik Ulm / Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe

location_facility: Spitalul Clinic Judetean de Urgenta Constanta

location_facility: Hospital General Universitario de Valencia

location_facility: CHUC - Hospitais da U. Coimbra - Servico de Ginecologia

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Kaz. Inst. of oncology and radiology | Dept. of gynecology

location_facility: AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Gabinet Ginekologiczny Janusz Tomaszewski

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Hospital General Universitario Gregorio Marañón | Oncología

location_facility: Hospital Universitario Virgen de las Nieves|Oncologia

location_facility: MedUni Innsbruck | Brust Gesundheit Zentrum

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

status_simplified: Ongoing


type: Other Identifier

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

acronym: ASTRO

summary: The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Serbia
Spain
Italy
United States
Belgium
Japan
Czechia
Poland
Portugal
Australia
Argentina
Israel
Turkey
Malaysia
Sweden
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Taiwan
New Zealand
Korea, Republic of
France

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: New Hope Research Development in Southern California

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Gastroenterology Associates of Tidewater

location_facility: Gastroenterologie, s.r.o., Hradec Kralove

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Shaare Zedek Medical Center - Jerusalem, ISRAEL

location_facility: Hospital General de Agudos José Maria Ramos Mejía

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Sai Clinic, Gastrointestinal and Protology Divisions

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Gastroenterology Associates of Orangeburg, SC

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: Tokyo Medical and Dental University Hospital

location_facility: University of Mississippi Medical Center

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: The Catholic university of Korea, ST Vincent Hospital

location_facility: GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Ruijin Hospital, Shanghai Jiao Tong University


title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache

summary:
Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications.

Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.

primary_purpose: Prevention

lead_sponsor: H. Lundbeck A/S

location_country:
Denmark
Spain
Italy
United States
France
Netherlands

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

location_facility: Clinical Research of Central Florida - ClinEdge - PPDS

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Legacy Clinical Solutions: Tandem Clinical Research, LLC - Clinedge - Louisiana - PPDS

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hospital General Universitario Dr. Balmis

location_facility: Hôpital Pierre Wertheimer - Hôpital Neurologique


title: A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

summary: This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
Japan
South Africa
Poland
Argentina
India
Turkey
Mexico
Singapore
Brazil
Canada
Hungary
China
Germany
Taiwan
Thailand
Korea, Republic of
France


title: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

summary: DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

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

location_country:
Denmark
Poland
Taiwan
Brazil
Hong Kong
Spain
Italy
Austria
Mexico
Netherlands
Canada
Korea, Republic of
United States
France
China
India
Belgium
Japan
Germany
Turkey


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

acronym: Phoenix

summary: The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS

lead_sponsor: Amylyx Pharmaceuticals Inc.

location_country:
Poland
Portugal
Spain
Ireland
Italy
Netherlands
United Kingdom
Sweden
United States
France
Belgium
Germany

location_facility: Università degli Studi della Campania Luigi Vanvitelli

location_facility: University of North Carolina at Chapel Hill

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Di Modena

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer Cellule Mutualisée de Recherche Clinique (CMRC)

location_facility: Salford Royal Hospital Barnes Clinical Research Team

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Hopital Gabriel Montpied Service de Neurologie

location_facility: Centro Hospitalar Universitário Lisboa-Norte

location_facility: Trinity College Dublin/Beaumont Hospital

location_facility: Healey & AMG Center for ALS Research at Massachusetts General Hospital

location_facility: Hospital Universitari de Bellvitge-IDIBELL

location_facility: Biodonostia Health Research Institute; Hospital Universitario Donostia

location_facility: Le Centre Hospitalier Régional Universitaire de Tours

location_facility: Sheffield Institute for Translational Neuroscience (SITraN)

location_facility: California Pacific Medical Center Research Institute

location_facility: Università degli Studi di Bari Aldo Moro

location_facility: Johns Hopkins University School of Medicine Outpatient Center


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia

summary: The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).

status: Active, not recruiting

lead_sponsor: Kronos Bio

location_country:
Poland
Brazil
Spain
Italy
Canada
Hungary
Korea, Republic of
France
United States
Israel
Germany
Czechia

location_facility: Instituto Brasileiro de Controle do Câncer - São Camilo Oncologia - Unidade Mooca

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Uniwersyteckie Centrum Kliniczne WUM - Centralny Szpital Kliniczny

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: A Beneficência Portuguesa de São Paulo - Unidade Mirante

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku

location_facility: Daegu Catholic University Medical Center

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Catholic University of Korea Seoul Saint Mary's Hospital

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr im. Prof. Tadeusza Sokołowskiego

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

location_facility: Hospital Universitario Central de Asturias

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut D'Investigacions Biomédiques August Pi I Sunyer

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Hospital de Base - São José do Rio Preto

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

location_facility: Ospedale Santa Maria delle Croci di Ravenna

location_facility: UCLA - Jonsson Comprehensive Cancer Center


type: Registry Identifier

title: A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients

acronym: EVEREST

summary:
Primary Objective

-To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell

Secondary Objectives

To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab
To evaluate the safety of dupilumab and omalizumab

ReferenceCitation: De Prado Gomez PharmD MSc L, Khan Mbbs Mph AH, Peters Md AT, Bachert Md PhD C, Wagenmann Md M, Heffler Md PhD E, Hopkins BMBCh C, Hellings Md PhD PW, Zhang PhD M, Xing PhD J, Rowe Md P, Jacob-Nara Md Mph DHSc JA. Efficacy and Safety of Dupilumab Versus Omalizumab in Chronic Rhinosinusitis With Nasal Polyps and Asthma: EVEREST Trial Design. Am J Rhinol Allergy. 2022 Nov;36(6):788-795. doi: 10.1177/19458924221112211. Epub 2022 Jul 15.

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

lead_sponsor: Sanofi

location_country:
Denmark
Poland
Portugal
Romania
Spain
Italy
United Kingdom
Finland
Sweden
Hungary
United States
France
Belgium
Germany
Czechia

location_facility: University of Rochester-Site Number:8400015

location_facility: Advanced ENT and Allergy-Site Number:8400013

location_facility: University of Missouri Health Care - University Hospital-Site Number:8400016

location_facility: Novak Clinical Research-Site Number:8400018

location_facility: The University Of Texas Health Science Center At Houston-Site Number:8400019

location_facility: Optimed Research, LTD-Site Number:8400014

location_facility: University of Florida-Site Number:8400027

location_facility: Eastern Virginia Medical School-Site Number:8400010

location_facility: Cleveland Clinic Foundation-Site Number:8400029

location_facility: Cedars Sinai Medical Center-Site Number:8400026

location_facility: Chryaslis Clinical Research-Site Number:8400017

location_facility: Dept of Otolaryngology, Head and Neck Surgery-Site Number:8400028


title: Deep Learning-Enabled Exploration of Predictive Signatures in a Multicenter Retrospective and Prospective Observational Study Allowing the Analysis of the Aggregation of Multimodal Clinical, Biological, Genomic and Radiomics Data Associated With the Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer

acronym: DEEP-Lung-IV

summary: Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.

study_type: Observational

time_perspective: Other

lead_sponsor: Sophia Genetics SAS

location_country:
Spain
Italy
Canada
United States
Israel
France
Germany

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Carbone Comprehensive Cancer Center at University of Wisconsin

location_facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

location_facility: Holden Comprehensive Cancer Center at University of Iowa Health Care

location_facility: Sunnybrook Health Sciences Centre Toronto


title: A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma

acronym: MANTRA

summary: Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

lead_sponsor: Rain Therapeutics Inc.

location_country:
Poland
Taiwan
Hong Kong
Spain
Ireland
Austria
Georgia
Italy
Canada
United Kingdom
Korea, Republic of
United States
France
Belgium
Germany

location_facility: The James Cancer Hospital and Solove Research Institute

location_facility: University General Hospital Gregorio Marañon

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Asan Medical Center, Department of Oncology

location_facility: The Christie NHS Foundation Trust, Department of Medical Oncology

location_facility: Washington University School of Medicine

location_facility: M. Curie National Research Institute of Oncology, Department of Soft Tissue/Bone Sarcoma and Melanoma

location_facility: Severance Hospital, Yonsei University Health System Seoul

location_facility: Abramson Cancer Center at Pennsylvania Hospital

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University Hospital Mannheim, Mannheim Cancer Center

location_facility: Medical University Vienna, Department of Internal Medicine I

location_facility: Institute of Cancer Research and Treatment of Candiolo - IRCCS

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicin Center LLC

location_facility: Helios Hospital Bad Saarow, Clinic for Hematology, Oncology and Palliative Medicine

location_facility: University Hospitals Leuven Campus Gasthuisberg

location_facility: Duke University School of Medicine, Duke Cancer Institute

location_facility: National Cancer Institute-IRCCS "Fondazione G. Pascale"

location_facility: University Hospital Foundation Jimenez Diaz

location_facility: CU Anschutz Medical Campus, Anschutz Cancer Pavilion

location_facility: University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center

location_facility: The Royal Marsden Hospital NHS Foundation Trust

location_facility: University Polyclinic Hospital "Paolo Giaccone" Palermo

location_facility: UCLA Department of Medicine - Hematology/ Oncology

location_facility: Georges-Francois Leclerc Cancer Research Center

location_facility: Santo Stefano Hospital of Prato - USL Company Toscana Center


title: A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer

summary:
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.

Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Taiwan
Brazil
Spain
Russian Federation
Ukraine
Guatemala
Hungary
Korea, Republic of
United States
France
Peru
South Africa
Romania
Japan
Turkey

location_facility: Spitalul Universitar de Urgenta Bucuresti ( Site 1305)

location_facility: Kanazawa University Hospital ( Site 3004)

location_facility: Hospital Universitario La Paz ( Site 1601)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)

location_facility: Juntendo University Hospital ( Site 3011)

location_facility: Cancer Blood and Specialty Clinic ( Site 0105)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0101)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0102)

location_facility: National Cheng Kung University Hospital ( Site 2105)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 3001)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)

location_facility: Hospital Juan Ramon Jimenez ( Site 1602)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 3002)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 1409)

location_facility: Medical Center Dobrobut Clinic ( Site 1808)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)

location_facility: Semmelweis University-Pulmonológiai Klinika ( Site 1114)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)

location_facility: The University of Tennessee Medical Center ( Site 0050)

location_facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)

location_facility: Korea University Guro Hospital ( Site 2003)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: PIH Health Hematology Medical Oncology ( Site 0106)

location_facility: Medical Center Mriya Med-Service ( Site 1805)

location_facility: Clinica Internacional Sede San Borja ( Site 0705)

location_facility: Centro Regional de Sub Especialidades Médicas SA ( Site 0600)

location_facility: Hopital Guillaume & Rene Laennec ( Site 1007)

location_facility: Hospital Insular de Gran Canaria-Oncology ( Site 1604)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)

location_facility: Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3017)

location_facility: Tokushima University Hospital ( Site 3019)

location_facility: Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)

location_facility: Kansai Medical University Hospital ( Site 3016)

location_facility: Clínica Peruano-Americana de Trujillo ( Site 0701)

location_facility: Ukrainian Center of Tomotherapy ( Site 1807)

location_facility: National Taiwan University Hospital ( Site 2101)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)

location_facility: Montefiore Medical Center [Bronx, NY] ( Site 0040)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1111)

location_facility: Kremenchuk Regional Oncology Center ( Site 1811)

location_facility: Okayama University Hospital ( Site 3012)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2102)

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)

location_facility: Marry Potter Oncology Centre ( Site 1502)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 3014)

location_facility: Millennium Physicians - Oncology ( Site 0097)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)

location_facility: Spitalul Municipal Ploiesti ( Site 1308)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 3003)

location_facility: Kyiv City Clinical Oncology Centre ( Site 1809)

location_facility: SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)

location_facility: Hospital Universitario Lucus Augusti ( Site 1603)

location_facility: Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)

location_facility: Taipei Veterans General Hospital ( Site 2106)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)

location_facility: St. Vincent Frontier Cancer Center ( Site 0058)

location_facility: Tudogyogyintezet Torokbalint ( Site 1105)

location_facility: HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)

location_facility: Centre Hospitalier Sud Réunion ( Site 1020)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 1108)

location_facility: Changhua Christian Hospital ( Site 2104)

location_facility: St Luke's Hospital - Kansas City ( Site 0033)

location_facility: Osaka International Cancer Institute ( Site 3018)

location_facility: Chungnam National University Hospital ( Site 2002)

location_facility: Hospital Sao Vicente de Paulo ( Site 0311)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1505)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1500)

location_facility: St. Bernards Medical Center ( Site 0103)

location_facility: Fujita Health University Hospital ( Site 3007)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1003)

location_facility: Steve Biko Academic Hospital ( Site 1506)

location_facility: Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0700)

location_facility: Medical Center Asklepion LLC ( Site 1804)

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181

location_facility: Clinica Privada Dr. Rixci Ramirez ( Site 0601)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 1307)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1110)

intervention_type: Biological


title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

acronym: CADENCE

summary:
This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.

The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

lead_sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

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

location_facility: Hospital Clinic de Barcelona ( Site 1602)

location_facility: Cedars Sinai Medical Center ( Site 1082)

location_facility: Centre Hospitalier Universitaire de Grenoble ( Site 1303)

location_facility: The George Washington University Medical Faculty Associates ( Site 1025)

location_facility: Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514)

location_facility: Piedmont Physicians Georgia Lung ( Site 1085)

location_facility: Norton Pulmonary Specialists ( Site 1066)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: Lady Davis Carmel Medical Center ( Site 1705)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

location_facility: University of Toledo Medical Center ( Site 1070)

location_facility: University of California Irvine ( Site 1086)

location_facility: University of Iowa Hospital and Clinics ( Site 1050)

location_facility: Hospital Universitario Virgen Macarena ( Site 1612)

location_facility: South Denver Cardiology Associates ( Site 1091)

location_facility: IU Health Advanced Heart and Lung Care ( Site 1092)

location_facility: Medical College of Wisconsin Inc CRS ( Site 1051)

location_facility: Shamir Medical Center Assaf Harofeh ( Site 1713)

location_facility: Medical University of South Carolina - PPDS ( Site 1003)

location_facility: CHRU de Nancy Hopitaux de Brabois ( Site 1308)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 3201)

location_facility: University of Nebraska Medical Center ( Site 1053)

location_facility: Ascension Medical Group St. Vincent ( Site 1076)

location_facility: Weill Cornell Medical College ( Site 1046)

location_facility: AOU di Bologna Policliico S Orsola Malpighi ( Site 2409)

location_facility: CHU de Nantes - Hôptal Nord Laennec ( Site 1309)

location_facility: Centre Hospitalier Universitaire de Bicetre ( Site 1304)

location_facility: Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107)

location_facility: University of Minnesota Hospitals ( Site 1062)

location_facility: University Hospitals Cleveland Medical Center ( Site 1005)

location_facility: Washington University School of Medicine [Saint Louis, MO] ( Site 1022)

location_facility: Statcare Pulmonary Consultants - Knoxville ( Site 1031)

location_facility: Intermountain Medical Center ( Site 1079)

location_facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)

location_facility: Pulmonary Associates of Richmond Inc. ( Site 1069)

location_facility: Fondazione IRCCS-Policlinico San Matteo ( Site 2401)

location_facility: Pulmonary Health Physicians ( Site 1080)


title: A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)

lead_sponsor: Amgen

source: euctr

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Denmark
Spain
Italy
Netherlands
Sweden
United States
France
Turkey
Belgium
Germany

location_facility: Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Allegheny Health Network Cancer Institute at Allegheny General Hospital

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

location_facility: Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Medical University of South Carolina, Hollings Cancer Center

location_facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Duke University Medical Center, Morris Cancer Clinic

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: State University of New York Upstate Medical University

location_facility: Laura and Isaac Perlmutter Cancer Center at New York University Langone

location_facility: Northport Veterans Affairs Medical Center

location_facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Centre Hospitalier de Nantes - Hôpital Nord Laënnec

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Asklepios - Fachkliniken München-Gauting

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Centre Hospitalier Universitaire de Montpellier - Val d Aurelle

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

location_facility: Arizona Oncology Associates Professional Corporation

summary: The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation.


title: A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis

acronym: Rhapsody

summary:
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)

The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.

The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

lead_sponsor: ALK-Abelló A/S

location_country: Poland Latvia Estonia Lithuania France Czechia

location_facility: Ambulance alergologie a klinicke imunologie - Ceske Budejovice

location_facility: Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.

location_facility: JSC Center for Diagnosis and Treatment of Allergic Diseases

location_facility: ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.

location_facility: Daugavpils Regional hospital, Outpatient clinic

location_facility: The Centre of Investigation and Treatment of Allergic Diseases

location_facility: Vevere Viktorija - Doctor's Practice in Pneumology and Allergology

location_facility: Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne

location_facility: Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii

location_facility: Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń

location_facility: Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz

location_facility: Lekarze Specjaliści Malolepszy i Partnerzy

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos


title: The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

acronym: ESSENCE

summary:
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.

Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.

Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week.

The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day.

Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Malaysia
Slovakia
Brazil
Canada
Switzerland
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Netherlands


acronym: The COASTAL Study

title: A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study

lead_sponsor: MEI Pharma, Inc.

location_country:
Poland
Taiwan
Serbia
Spain
Greece
Georgia
Australia
Italy
Canada
New Zealand
United Kingdom
Hungary
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Netherlands

location_facility: University General Hospital of Ioannina, Department of Haematology

location_facility: LTD Israeli-Georgian Medical Research Clinic "Helsicore"

location_facility: Chonnam National University Hwasun Hospital

location_facility: Klinika Hematologii, Szpital Uniwersytecki

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: Karadeniz Technical University Medical Faculty Department of Hematology

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: University Hospitals Plymouth NHS Trust, Derriford Hopital

location_facility: Dunedin Hospital, Southern Blood and Cancer Service

location_facility: UOC Ematologia, Presidio Ospedaliero Papardo

location_facility: CHU de Bordeaux - Maladies Du Sang, Centre François Magendie

location_facility: Kobe City Medical Center General Hospital

location_facility: Institut Catalá d'Oncologia, Hospital Duran i Reynals

location_facility: UO Ematologia, Ospedale Civile S.Maria delle Croci

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: ARS Medical - Szpital, Oddzial hematologiczny

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: University Clinical Center of Serbia, Clinic for Hematology

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital

location_facility: Albert Schweizer Ziekenhuis, Hematology Department

location_facility: Istanbul University Istanbul Medical Faculty, Hematology Department

location_facility: Department of Haematology St. George's University of London

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Oncology Institute of Vojvodina, Clinic for Internal Oncology

location_facility: SOC Oncologia Medica e dei Tumori Immunocorrelati

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,

location_facility: U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle

location_facility: Zvezdara University Medical Center, Clinical department for Hematology and Oncology

location_facility: University Clinical Center Kragujevac, Clinic for Hematology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: Severance Hospital, Yonsei University Health System

location_facility: UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna

location_facility: Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology

location_facility: U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi

location_facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie

location_facility: Gazi University Health Research and Application Hospital, Hematology Department

location_facility: Centre Hospitalier De Dunkerque - Service d'hématologie

location_facility: Clinical Center of Vojvodina, Clinic for Hematology

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Ondokuz Mayis University Medical Faculty, Hematology Department

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: S.C. Oncoematologia Azienda Ospedaliera Santa Maria

location_facility: J.S.C. K. Eristavi National Center of Experimental and Clinic

location_facility: LTD "Medinvest" Institute of Hematology and Transfusiology

location_facility: Canterbury District Health Board, Haematology Department

location_facility: National University Corporation Tohoku University Hospital

location_facility: General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation

location_facility: University General Hospital of Patras "Panagia H. Voitheia"

location_facility: UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi

location_facility: Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology

location_facility: Divisione Oncoematologia, Istituto Europeo di Oncologia

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

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

location_facility: Centre Henri Becquerel, Service d'Hematologie

location_facility: Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center

location_facility: Azienda Ospedaliera Ospedali Riuniti Via Sofia

location_facility: Dipartimento di Oncoematologia, Unità Linfomi, Ospedale

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

location_facility: Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,

location_facility: UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre

location_facility: Erciyes University Medical Faculty, Department of Hematology

summary: This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.