title: A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM.

Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world.

Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

lead_sponsor: AbbVie

location_country:
Spain
Italy
United States
France
Japan
Germany

location_facility: Emory University, Winship Cancer Institute /ID# 222922

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 223839

location_facility: National Cancer Center Hospital East /ID# 239436

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222372

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 222303

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 223014

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 222258

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 222302

location_facility: Universitaetsklinikum Muenster /ID# 222504

location_facility: Dana-Farber Cancer Institute /ID# 222174

location_facility: Nagoya City University Hospital /ID# 222408

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 223224

location_facility: University of Texas Southwestern Medical Center /ID# 223811


title: A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

summary:
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.

The primary objective is response duration (MDS or AML)

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
CHU Angers
CHU Pontchaillou
Hopital Saint Louis
Hopital Purpan
Hopital Hotel Dieu
CHU de Caen
CHU Brabois
Hopital d'Instruction des Armées Percy
Hopital Haut Leveque
Hopital Paoli Calmette
CH d'Avignon
Hopital Edouard Herriot
CHU d'Amiens
CHRU de Limoges
Hopital Henri Mondor
Hopital Cochin
CH Versailles
CHU Albert Michallon
Hopital Saint Antoine
CHU de Dijon
CHRU Hurriez
Hopital Archet
Hopital Jean-Bernard
CHRU de Reims
Hopital Hautepierre

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


status: Completed

acronym: EURTAC

title: Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR

lead_sponsor: Spanish Lung Cancer Group

type: EudraCT Number

source: euctr

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Muñoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

ReferenceType: derived

ReferenceCitation: Karachaliou N, Mayo-de las Casas C, Queralt C, de Aguirre I, Melloni B, Cardenal F, Garcia-Gomez R, Massuti B, Sánchez JM, Porta R, Ponce-Aix S, Moran T, Carcereny E, Felip E, Bover I, Insa A, Reguart N, Isla D, Vergnenegre A, de Marinis F, Gervais R, Corre R, Paz-Ares L, Morales-Espinosa D, Viteri S, Drozdowskyj A, Jordana-Ariza N, Ramirez-Serrano JL, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group. Association of EGFR L858R Mutation in Circulating Free DNA With Survival in the EURTAC Trial. JAMA Oncol. 2015 May;1(2):149-57. doi: 10.1001/jamaoncol.2014.257.

ReferenceCitation: Karachaliou N, Gimenez-Capitan A, Drozdowskyj A, Viteri S, Moran T, Carcereny E, Massuti B, Vergnenegre A, de Marinis F, Molina MA, Teixido C, Rosell R. ROR1 as a novel therapeutic target for EGFR-mutant non-small-cell lung cancer patients with the EGFR T790M mutation. Transl Lung Cancer Res. 2014 Jun;3(3):122-30. doi: 10.3978/j.issn.2218-6751.2014.03.02.

ReferenceCitation: Costa C, Molina MA, Drozdowskyj A, Giménez-Capitán A, Bertran-Alamillo J, Karachaliou N, Gervais R, Massuti B, Wei J, Moran T, Majem M, Felip E, Carcereny E, Garcia-Campelo R, Viteri S, Taron M, Ono M, Giannikopoulos P, Bivona T, Rosell R. The impact of EGFR T790M mutations and BIM mRNA expression on outcome in patients with EGFR-mutant NSCLC treated with erlotinib or chemotherapy in the randomized phase III EURTAC trial. Clin Cancer Res. 2014 Apr 1;20(7):2001-10. doi: 10.1158/1078-0432.CCR-13-2233. Epub 2014 Feb 3.

location_country: France Spain Italy

location_facility: Università di Roma "La Sapienza" Az.Policlinico Umb.I°

location_facility: Centre Hospitalier Universitaire D'Angers

location_facility: Centre Hospitalier de La Région D'Annecy

summary: A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.

status_simplified: Completed


title: Study Multicentric, Randomised, in Duplicate Blind Person of the Impact of a Per Operatory Strategy of Optimization of the Cardiac Output on the Forecast of the Old Subjects Operated for Fracture of the Upper End of the Femur " FRACTALE "

acronym: FRACTALE

summary: The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de La Cote de Nacre

intervention_type: Procedure

lead_sponsor_type: academique


title: A Phase II Study of Darbepoetin Alpha in Myelodysplastic Syndromes (MSD)

summary: This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS patients with an International Prognostic Scoring System (IPSS) score of low or intermediate 1.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Kelaidi C, Beyne-Rauzy O, Braun T, Sapena R, Cougoul P, Adès L, Pillard F, Lamberto C, Charniot JC, Guerci A, Choufi B, Stamatoullas A, Slama B, De Renzis B, Ame S, Damaj G, Boyer F, Chaury MP, Legros L, Cheze S, Testu A, Gyan E, Béné MC, Rose C, Dreyfus F, Fenaux P. High response rate and improved exercise capacity and quality of life with a new regimen of darbepoetin alfa with or without filgrastim in lower-risk myelodysplastic syndromes: a phase II study by the GFM. Ann Hematol. 2013 May;92(5):621-31. doi: 10.1007/s00277-013-1686-4. Epub 2013 Jan 29. Erratum in: Ann Hematol. 2013 May;92(5):633. Lambert, Christine [corrected to Lamberto, C].

location_facility:
Hopital Henri Becquerel
CHU Pontchaillou
CHU d'Avignon
Hopital Purpan
Hopital Hotel Dieu
CHU de Caen
CHU Nancy-Brabois
CH de la Cote Basque
CHRU Limoges
Hopital Bretonneau
Hopital St Louis
CHU Robert Debre
Hopital Paoli Calmette
CHU Archet
Hopital Percy
Hopital Edouard Herriot
CHU d'Amiens
Hopital Henri Mondor
Hopital Cochin
CHU Albert Michallon
CHU d'Angers
Hopital Saint Antoine
CHU de Dijon
CHRU Hurriez
Hopital Jean-Bernard
Hopital Hautepierre
CHU de Brest - Hopital Morvan


title: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand

summary: Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relapse, with variable delay. Objective of this study was to compare efficacy between a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence. Addition of methotrexate (MTX)to infliximab was also tested.

ReferenceCitation: Fautrel B, Benhamou M, Breban M, Roy C, Lenoir C, Trape G, Baleydier A, Ravaud P, Dougados M. Cost effectiveness of two therapeutic regimens of infliximab in ankylosing spondylitis: economic evaluation within a randomised controlled trial. Ann Rheum Dis. 2010 Feb;69(2):424-7. doi: 10.1136/ard.2008.103887. Epub 2009 Sep 9.

ReferenceCitation: Breban M, Ravaud P, Claudepierre P, Baron G, Henry YD, Hudry C, Euller-Ziegler L, Pham T, Solau-Gervais E, Chary-Valckenaere I, Marcelli C, Perdriger A, Le Loët X, Wendling D, Fautrel B, Fournié B, Combe B, Gaudin P, Jousse S, Mariette X, Baleydier A, Trape G, Dougados M; French Ankylosing Spondylitis Infliximab Network. Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment. Arthritis Rheum. 2008 Jan;58(1):88-97. doi: 10.1002/art.23167.

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_facility:
Groupe Hospitalier du Havre
Hôpital Bicêtre
Hôpital Cochin
Hôpital Ambroise Paré
CHU Côte de Nacre
CHU - Hôpital Sud
Hôpital Avicenne
Hôpital Gilles de Corbeil
CHRU Hôpital Roger Salengro
CHU Dupuytren
CHU Amiens
Hôpital de la Pitié
CHU Hautepierre
Hôpital Pellegrin
CHU - Hôpital de Bois Guillaume
CHU Nancy-Brabois
CHU de la Cavale Blanche
Centre Hospitalier Saint Philibert
CHU Hôpital Trousseau
CHU l'Archet 1
CHU Hôpital Minjoz
Hôpital Porte Madeleine
CH St Joseph - St Luc
Hôpital de Purpan
Hôpital Général
Hôpital de la Conception
CHU A. Michallon
CHU Saint-Etienne
CHU de Poitiers
Hôpital Lapeyronie
Hôpital Henri Mondor


title: Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

summary:
The purpose of this study is

To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
To evaluate the tolerance of this treatment

location_facility:
Hopital Henri Becquerel
Chu Purpan
CHU d'Avignon
CH de Cournouaille
Hopital Hotel Dieu
CHU de Caen
CHU Brabois
Hopital Avicenne
CHRU Limoges
CHU Bretoneau
Institut Paoli Calmette
CHU Robert Debre
CHU Archet
HOPITAL Cochin
CHU Edouard Herriot
Hopital Percy
CHU d'Amiens
CHU Albert Michallon
CHU d'Angers
Hopital Saint Antoine
Hopital Necker
Hopital Hautepierre
CHU Dijon
CH de la cote Basque


type: Other Identifier

title: A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.

summary:
Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA

ReferenceCitation: Ferrera G, Gajdos V, Thomas S, Tran C, Fiquet A. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. Hum Vaccin. 2009 Jul;5(7):455-60. Epub 2009 Jul 23.

lead_sponsor: Merck Sharp & Dohme LLC

location_country: France Italy

intervention_type: Biological


type: Other Grant/Funding Number

title: Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.

summary: Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.

ReferenceType: background

ReferenceCitation: Jover JA, Hernández-García C, Morado IC, Vargas E, Bañares A, Fernández-Gutiérrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Jan 16;134(2):106-14.

ReferenceCitation: Chevalet P, Barrier JH, Pottier P, Magadur-Joly G, Pottier MA, Hamidou M, Planchon B, El Kouri D, Connan L, Dupond JL, De Wazieres B, Dien G, Duhamel E, Grosbois B, Jego P, Le Strat A, Capdeville J, Letellier P, Agron L. A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients. J Rheumatol. 2000 Jun;27(6):1484-91.

ReferenceCitation: Mazlumzadeh M, Hunder GG, Easley KA, Calamia KT, Matteson EL, Griffing WL, Younge BR, Weyand CM, Goronzy JJ. Treatment of giant cell arteritis using induction therapy with high-dose glucocorticoids: a double-blind, placebo-controlled, randomized prospective clinical trial. Arthritis Rheum. 2006 Oct;54(10):3310-8.

ReferenceCitation: Le Guennec P, Dromer C, Sixou L, Marc V, Coustals P, Fournié B. [Treatment of Horton disease. Value of synthetic antimalarials. Apropos of a retrospective study of 36 patients]. Rev Rhum Ed Fr. 1994;61(7-8):485-90. Review. French.

ReferenceCitation: David-Chaussé J, Dehais J, Leman A. [Results of a regional survey on the treatment of rhizomelic pseudopolyarthritis and temporal arteritis. Apropos of 242 cases treated by various modalities with synthetic antimalarials, corticoids and non-steroidal anti-inflammatory agents]. Rev Rhum Mal Osteoartic. 1983 Jul-Sep;50(8-9):563-71. French.

ReferenceCitation: Hoffman GS, Cid MC, Hellmann DB, Guillevin L, Stone JH, Schousboe J, Cohen P, Calabrese LH, Dickler H, Merkel PA, Fortin P, Flynn JA, Locker GA, Easley KA, Schned E, Hunder GG, Sneller MC, Tuggle C, Swanson H, Hernández-Rodríguez J, Lopez-Soto A, Bork D, Hoffman DB, Kalunian K, Klashman D, Wilke WS, Scheetz RJ, Mandell BF, Fessler BJ, Kosmorsky G, Prayson R, Luqmani RA, Nuki G, McRorie E, Sherrer Y, Baca S, Walsh B, Ferland D, Soubrier M, Choi HK, Gross W, Segal AM, Ludivico C, Puechal X; International Network for the Study of Systemic Vasculitides. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum. 2002 May;46(5):1309-18.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bichat
Saint Louis Hospital
University Hospital Toulouse
University Hospital
University Hospital Côte de Nacre
University Hospital Saint Antoine
Hospital Avignon
Hospital Suresnes
Hospital Auch
University Hospital Besançon
University Hospital Dupuytren
Hospital Béziers
Hospital
University Hospital Dijon
University Hospital Bretonneau


title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

acronym: GRECCAR 2

summary: Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.

study_start_date_type: Actual

primary_purpose: Supportive Care

ReferenceCitation: Teste B, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sielezneff I, Prudhomme M, Marchal F, Dubois A, Capdepont M, Denost Q, Rullier E. Early and late morbidity of local excision after chemoradiotherapy for rectal cancer. BJS Open. 2021 May 7;5(3). pii: zrab043. doi: 10.1093/bjsopen/zrab043.

ReferenceCitation: Rullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7.

ReferenceCitation: Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming

location_facility: Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt

location_facility: Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux

location_facility: Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet

location_facility: Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot

location_facility: Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré

location_facility: Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne

location_facility: Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre

location_facility: Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron

location_facility: Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne

location_facility: Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne

location_facility: Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert

location_facility: Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet

location_facility: Service de Chirurgie Digestive - Hôpital Hautepierre

location_facility: Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac

location_facility: Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque

location_facility: Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale

location_facility: Service de Chirurgie Générale - Hôpital Archet II

location_facility: Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine

location_facility: Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron

location_facility: Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer

location_facility: Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose

location_facility: Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet

location_facility: Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod

location_facility: Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital

location_facility: Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux

location_facility: Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre

location_facility: Département de Chirurgie Oncologique - CRLC Val d'Aurelle

location_facility: Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine

location_facility: Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens

location_facility: Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec

location_facility: Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont

location_facility: Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle

location_facility: Service de Chirurgie Générale - Hôpitaux Civils de Lyon


title: Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ 2cm [GERICO]

summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.

lead_sponsor: UNICANCER

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.

ReferenceCitation: Carrie C, Magné N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16.

ReferenceCitation: Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Créhange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6. Erratum in: Lancet Oncol. 2016 Jun;17 (6):e223. Erratum in: Lancet Oncol. 2019 Jun;20(6):e293.

ReferenceCitation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prisé E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

intervention_type: Radiation


title: An Eight-Week, Randomized, Double Blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 Per Day in Patients Hospitalized for Severe Depression

summary: An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.

ReferenceCitation: Brecht S, Desaiah D, Marechal ES, Santini AM, Podhorna J, Guelfi JD. Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. J Clin Psychiatry. 2011 Aug;72(8):1086-94. doi: 10.4088/JCP.09m05723blu. Epub 2010 Sep 21.

ReferenceCitation: Demyttenaere K, Desaiah D, Raskin J, Cairns V, Brecht S. Suicidal thoughts and reasons for living in hospitalized patients with severe depression: post-hoc analyses of a double-blind randomized trial of duloxetine. Prim Care Companion CNS Disord. 2014;16(3). pii: PCC.13m01591. doi: 10.4088/PCC.13m01591. Epub 2014 May 1.

lead_sponsor: Eli Lilly and Company

location_country:
Russian Federation
France
South Africa
Italy

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


title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.

summary: The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression

study_type: Observational

time_perspective: Prospective

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 43
Site 19
Site 42
Site 02
Site 32
Site 25
Site 22
Site 12
Site 14
Site 27
Site 20
Site 11
Site 00
Site 41
Site 04
Site 01
Site 06
Site 33
Site 17
Site 26
Site 07
Site 30
Site 05


title: A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

acronym: ENDURANCE-5 6

summary: A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

ReferenceCitation: Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2.

ReferenceCitation: Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.

ipd_sharing: Yes

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

location_country:
Australia
New Zealand
Canada
Vietnam
United States
France
South Africa
Belgium
Singapore

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 157045

location_facility: Auckland Clinical Studies Ltd /ID# 157033

location_facility: Royal Brisbane and Women's Hospital /ID# 157025

location_facility: National University Hospital /ID# 156855

location_facility: Zuckerberg San Francisco Gener /ID# 157040

location_facility: National Hospital of Tropical Diseases /ID# 162282


title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ Gemcitabine When Progression.

summary: The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.

location_facility:
Site 48
Site 19
Site 02
Site 32
Site 25
Site 22
Site 12
Site 14
Site 27
Site 20
Site 11
Site 00
Site 41
Site 04
Site 01
Site 06
Site 18
Site 33
Site 17
Site 26
Site 07
Site 30


title: Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy

summary: This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Chevaliez S, Hézode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-α and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24.

lead_sponsor: Hoffmann-La Roche


title: DEPISTORL - THANCS (Trial of Head And Neck Cancer Screening) Randomized Multicenter Trial to Assess the Impact of a Screening Program for Heavy Alcohol Drinkers and Smokers Treated in Alcohol Addiction Clinics on Upper Aerodigestive Tract Cancer Mortality.

summary: Randomized multicenter trial to assess the impact of a screening program for heavy alcohol drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer mortality.

primary_purpose: Prevention

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Centre Paul Cézanne
Centre ANPAA 51 de Reims
CHU le Bocage
Ch Saint-Egreve
CHBS Lorient
Centre Hospitalier des Chanaux
Hopital de Saint Cloud
CHIAB Annemasse Bonneville
Centre Hospitalier d'ARRAS
Hôpital de la Source
Centre ANPAA d'Orléans
Hopital Paul Brousse
Clinique Philae
Chba Vannes
CHR de la Réunion
Centre Hospitalier Louis Sevestre
Centre hospitalier Lyon sud
Centre Hospitalier de LENS
Institut_Gustave-Roussy
CHU de Lille
Centre Hospitalier du Centre Bretagne
Centre de soins de suite Marienbronn
CHS de L'Yonne
Centre Hospitalier du Mans
Chg Beziers
CHU Hôpital Gabriel Montpied
Hôpital ARCHET II
Centre Hospitalier de DIEPPE
CHU de Strasbourg - Hôpital Hautepierre
Centre Hospitalier MONTPERRIN
CHU de Nantes
Hôpitaux du Leman
C.A.S.A.
CHU Hôpital Pontchaillou
CHU de Nancy


title: Evaluation of the Efficacy of the Thermal Cure in the Prevention of the Post-Thrombotic Syndrome After a Deep Venous Thrombosis of Lower Limbs.

summary: The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

ReferenceCitation: Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7.

ReferenceCitation: Kahn SR, Kearon C, Julian JA, Mackinnon B, Kovacs MJ, Wells P, Crowther MA, Anderson DR, Van Nguyen P, Demers C, Solymoss S, Kassis J, Geerts W, Rodger M, Hambleton J, Ginsberg JS; Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005 Apr;3(4):718-23. Epub 2005 Feb 23.

ReferenceCitation: Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. Review.

ReferenceCitation: Asbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005 Apr;24(4):475-82.

ReferenceCitation: Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Domaine d'heurteboise
Christus
Saint-Pierre
Etablissmeent thermal
Les thermes
Les arènes
Le Splendid
Etablissement thermal
Bérot
Dax thermal
Borda
Foch
Le miradour
Sarrailh
Le Grand Hôtel
L'avenue
Les écureuils
Le Regina
Caliceo
Chênes


title: An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin in Patients With Type 2 Diabetes and Dyslipidemia

summary: The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

lead_sponsor: Solvay Pharmaceuticals

location_facility:
Site 34
Site 24
Site 7
Site 32
Site 25
Site 12
Site 5
Site 8
Site 13
Site 27
Site 2
Site 10
Site 20
Site 29
Site 11
Site 4
Site 21
Site 1
Site 33
Site 17
Site 26
Site 23
Site 28
Site 30
Site 9


title: A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions

summary: To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.

lead_sponsor: Pfizer


title: A Prospective Randomised Single-Blinded Multicentric and Pivotal Phase III Study Comparing the Efficacy, Safety and Acceptability of a New 2 Litres Gut Lavage Solution NRL994 Versus a Sodium Phosphate Solution for Colonoscopy Preparation

summary: The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

ReferenceCitation: Fordtran JS, Santa Ana CA, Cleveland MvB. A low-sodium solution for gastrointestinal lavage. Gastroenterology. 1990 Jan;98(1):11-6.

lead_sponsor: Norgine

location_facility: Centre Hospitalier De Montpellier Hôpital St Eloi

location_facility: Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré


title: The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).

summary: The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

lead_sponsor: Bayer


title: Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer.

PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.

ReferenceCitation: Phelip JM, Vendrely V, Rostain F, Subtil F, Jouve JL, Gasmi M, Michel P, Le Malicot K, Smith D, Seitz JF, Fauchart JP, Martin P, Bennouna J, Morin T, Bonnet I, Maingon P, Lepage C, Chauffert B. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Fédération Francophone de Cancérologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014 Nov;50(17):2975-82. doi: 10.1016/j.ejca.2014.08.013. Epub 2014 Sep 17.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier General de Mont de Marsan


title: Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .

ReferenceCitation: Aparicio T, Jouve J, Teillet L, et al.: Geriatric factors to predict toxicity and dose-intensity reduction in FFCD 2001-02 phase III study comparing a first-line chemotherapy of LV5FU2 or FOLFIRI in treatment of metastatic colorectal cancer (mCRC) in elderly patients. [Abstract] J Clin Oncol 29 (Suppl 15): A-9111, 2011.

ReferenceCitation: Mitry E, Phelip JM, Bonnetain F, et al.: Phase III trial of chemotherapy with or without irinotecan in the front-line treatment of metastatic colorectal cancer in elderly patients (FFCD 2001-02 trial): results of a planned interim analysis. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-281, 2008.

ReferenceCitation: Aparicio T, Lavau-Denes S, Phelip JM, Maillard E, Jouve JL, Gargot D, Gasmi M, Locher C, Adhoute X, Michel P, Khemissa F, Lecomte T, Provençal J, Breysacher G, Legoux JL, Lepère C, Charneau J, Cretin J, Chone L, Azzedine A, Bouché O, Sobhani I, Bedenne L, Mitry E; FFCD investigators. Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001-02). Ann Oncol. 2016 Jan;27(1):121-7. doi: 10.1093/annonc/mdv491. Epub 2015 Oct 20.

ReferenceCitation: Aparicio T, Jouve JL, Teillet L, Gargot D, Subtil F, Le Brun-Ly V, Cretin J, Locher C, Bouché O, Breysacher G, Charneau J, Seitz JF, Gasmi M, Stefani L, Ramdani M, Lecomte T, Mitry E. Geriatric factors predict chemotherapy feasibility: ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients. J Clin Oncol. 2013 Apr 10;31(11):1464-70. doi: 10.1200/JCO.2012.42.9894. Epub 2013 Mar 4.

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Centre Hospitalier de Chalons-en-Champagne

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Pole Sante Sarthe et Loir Hopital Pierre Daguet

location_facility: Hopital d'Instruction des Armees du Val de Grace

location_facility: Centre Hospitalier Intercommunal de la Haute-Saone

location_facility: Centre hospitalier de Charleville Mezieres

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Fédération Francophone de Cancérologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135.

location_facility: Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne

location_facility: Centre Hospitalier Regional et Universitaire de Lille


title: Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

location_facility: Centre Hospitalier General - St. Nicolas


title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

summary: The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.

ReferenceCitation: Guérin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384.

ReferenceCitation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Saint-Louis - Réanimation médicale

location_facility: Hôpital Sainte-Marguerite - Réanimation médicale

location_facility: Réanimation Polyvalente - Hôpital Sainte-Marguerite

location_facility: Hôpital Jean Minjoz - Réanimation médicale

location_facility: Hôpital Pellegrin - Réanimation médicale

location_facility: Hôpital de la croix rousse - Réanimation médicale

location_facility: Hôpital Pontchaillou - Réanimation médicale

location_facility: Hôpital de la Tronche - Réanimation médicale


title: Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study

acronym: RIGHT

summary: Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.


title: Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

acronym: GATA

summary: The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.

primary_purpose: Diagnostic

ReferenceCitation: Renaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupré PF, Fritel X, Ngô C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Institut Bergonié
Hospîtal
centre Léon Berard
Centre Alexis Vautrin
Institut Jean Godinot
Centre Hospitalier
Centre René Gauducheau
Hopital Européen Georges Pompidou
Centre Claudius Regaud
Institut Paoli Calmette
Hopital Lariboisière
Centre Oscar Lambret
Hôpital Tenon
Hospital
Centre Eugène Marquis


title: A Phase I/II Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
The phase 1 primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study will also assess the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma.

The phase 2 primary objective is to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.

ReferenceCitation: Kumar S, Kaufman JL, Gasparetto C, Mikhael J, Vij R, Pegourie B, Benboubker L, Facon T, Amiot M, Moreau P, Punnoose EA, Alzate S, Dunbar M, Xu T, Agarwal SK, Enschede SH, Leverson JD, Ross JA, Maciag PC, Verdugo M, Touzeau C. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma. Blood. 2017 Nov 30;130(22):2401-2409. doi: 10.1182/blood-2017-06-788786. Epub 2017 Oct 10.

lead_sponsor: AbbVie

location_country:
Norway
United States
France
Belgium

location_facility: Washington University-School of Medicine /ID# 76094

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 170007

location_facility: Swedish Cancer Institute - Edmonds /ID# 170006

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 200246

location_facility: University of Nebraska Medical Center /ID# 169158

location_facility: University of Arkansas for Medical Sciences /ID# 170002

location_facility: Medical College of Wisconsin /ID# 205229

location_facility: Baylor University Medical Ctr. /ID# 170056

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 75033

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 74995

location_facility: Duplicate_University Hospital Leuven /ID# 170715

location_facility: CHRU Tours - Hopital Bretonneau /ID# 126639

location_facility: Duplicate_CHU Grenoble - Hopital Michallon /ID# 126658

location_facility: Emory University, Winship Cancer Institute /ID# 74993

location_facility: University Hospitals - Seidman Cancer Center /ID# 204502


title: FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1

acronym: FIGHT

summary: The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.

ReferenceCitation: Wainberg ZA, Enzinger PC, Kang YK, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Borg C, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Collins H, Mitra S, Yang Y, Catenacci DVT, Lee KW. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022 Nov;23(11):1430-1440. doi: 10.1016/S1470-2045(22)00603-9. Epub 2022 Oct 14.

ReferenceCitation: Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.

lead_sponsor: Five Prime Therapeutics, Inc.

location_country:
Poland
Taiwan
Portugal
Romania
Spain
Italy
United Kingdom
Australia
Thailand
Hungary
Korea, Republic of
United States
France
China
Turkey
Belgium
Japan
Germany

location_facility: ASST della Valtellina e dell'Alto Lario - PO di Sondrio

location_facility: Summit Medical Group. Morristown Oncology

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie

location_facility: UCLA Medical Centre - Santa Monica Hematology and Oncology

location_facility: University of Pecs, Clinic of Oncotherapy

location_facility: Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine

location_facility: Hopital Nord France Comte - Site Le Mittan

location_facility: Faculty of Medicine, Chulalongkorn University

location_facility: Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

location_facility: Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut

location_facility: Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Westchester Institute For Treatment Of Cancer & Blood Disorders

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina

location_facility: St. Luke's Physician Group - St. Luke's Cancer Care Associates

location_facility: Chungnam National University Hospital (CNUH)

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Harbin Medical University Cancer Hopsital

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Cukurova University Faculty of Medicine Paediatric Nephrology

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Unidade Local de Saude de Matosinhos EPE

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Fondazione IRCSS Casa Sollievo Della Sofferenza

location_facility: Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej

location_facility: Universitatsmedizin Manheim, II. Medizinische Klinik

location_facility: Hyogo College of Medicine College Hospital

location_facility: Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

location_facility: Ankara Oncology Education and Research Hospital

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet

location_facility: Azienda Sanitaria Universitaria Integrata de Udine

location_facility: Azienda Socio-Sanitaria Territoriale di Cremona

location_facility: Policlinico Universitario Campus Bio-Medico di Roma

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

location_facility: Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago

location_facility: Centre de Radiotherapie - Clinique Sainte Anne

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: Hospital Duran I Reynals - Instituto Catalan de Oncologia

location_facility: Istanbul Madeniyet Universitesi Tip Fakultesi

location_facility: Ondokuz Mayis University Medicine Faculty

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc

location_facility: University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)

location_facility: Xiangya Hospital of Central South University

location_facility: Sino Japanese Friendship Hospital of Jilin University

location_facility: Institutul Clinic Fundeni - Clinica Pediatrie

location_facility: Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny

location_facility: Centro Hospitalar de Entre o Douro e Vouga EPE

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz

location_facility: Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center

location_facility: Josephine Ford Cancer Center-Henry Ford Cancer Center

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Servizio Oncologia Medica ed Ematologia, AOU dell'Universita

location_facility: Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica

location_facility: Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala

location_facility: Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centro Hospitalar Universitario do Porto E.P.E

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

location_facility: SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii

location_facility: Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca

location_facility: Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly

location_facility: Institut Catala d'Oncologia - Hospital Doctor Josep Trueta

location_facility: Faculty of Medicine, Prince of Sonkla University


title: Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer

acronym: TEAM

summary:
To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

ReferenceCitation: Bayani J, Kornaga EN, Crozier C, Jang GH, Bathurst L, Kalatskaya I, Trinh QM, Yao CQ, Livingstone J, Boutros PC, Spears M, McPherson JD, Stein LD, Rea D, Bartlett JMS. Identification of Distinct Prognostic Groups: Implications for Patient Selection to Targeted Therapies Among Anti-Endocrine Therapy-Resistant Early Breast Cancers. JCO Precis Oncol. 2019 Dec;3:1-13. doi: 10.1200/PO.18.00373.

ReferenceCitation: Derks MGM, Bastiaannet E, van de Water W, de Glas NA, Seynaeve C, Putter H, Nortier JWR, Rea D, Hasenburg A, Markopoulos C, Dirix LY, Portielje JEA, van de Velde CJH, Liefers GJ. Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial. Eur J Cancer. 2018 Aug;99:1-8. doi: 10.1016/j.ejca.2018.04.009. Epub 2018 Jun 6.

ReferenceCitation: Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM, Liefers GJ, Putter H, Kroep JR, Rea D, Hasenburg A, Markopoulos C, Paridaens R, Smeets JBE, Dirix LY, van de Velde CJH. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1211-1220. doi: 10.1016/S1470-2045(17)30419-9. Epub 2017 Jul 18.

ReferenceCitation: Kalatskaya I, Trinh QM, Spears M, McPherson JD, Bartlett JMS, Stein L. ISOWN: accurate somatic mutation identification in the absence of normal tissue controls. Genome Med. 2017 Jun 29;9(1):59. doi: 10.1186/s13073-017-0446-9.

ReferenceCitation: Bartlett JM, Brookes CL, Piper T, van de Velde CJ, Stocken D, Lyttle N, Hasenburg A, Quintayo MA, Kieback DG, Putter H, Markopoulos C, Kranenbarg EM, Mallon EA, Dirix LY, Seynaeve C, Rea DW. Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial. Br J Cancer. 2013 Oct 29;109(9):2453-61. doi: 10.1038/bjc.2013.609. Epub 2013 Oct 3.

ReferenceCitation: van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. doi: 10.1016/S0140-6736(10)62312-4.


title: Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.

summary: The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.

lead_sponsor: Ipsen

location_facility:
Hôpital Henri Mondor
Hôpital Neurologique
Centre Hospitalier
Hôpital Delafontaine
Groupe Hospitalier Pellegrin
Hôpital Civil de Colmar
Centre Hospitalier du Pays d'Aix
Hôpital Universitaire Dupuytren
Hôpital Laënnec
Hôpital Guillaume et Réne
Hôpital Léopold Bellan
Hôpital Gui de Chauliac
Hôpital de la cavale Blanche
Hôpital Charles Nicolle
Hôpital J. Minjoz
CHU Hôpital de Pontchaillou
Cabinet Médical
Centre Hospitalier René Dubos
Centre Hospitalier François
Hôpital Saint Joseph
CHU Hôpital Gabriel Montpied
CHU de Reims - Hôpital Maison Blanche
CHU de Bordeaux
CHG Dijon
14 bis Rue du Chapeau Rouge
Hôpital Pasteur
Hôpital Nord - CHU d'Amiens
Hopital Nord
Hôpital Central


title: Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

ReferenceCitation: Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, André T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Clinique Victor Hugo
Hopital Louis Pasteur - Le Coudray
Hopital Duffaut
Clinique des Jockeys
Hopital Drevon
Polyclinique De Courlancy
Infirmerie Protestante
Clinique Saint Jean
Centre Medico-Chirurgical Foch
Hopital Europeen Georges Pompidou
Hopital Saint Antoine
C.H. Senlis
Hopital Tenon
Hopital Robert Boulin
Intercommunal Hospital
Centre Hospitalier de Dreux
Institut Sainte Catherine


title: Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX

acronym: MIROX

summary: PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.

ReferenceCitation: Hamidou Z, Chibaudel B, Hebbar M, Hug de Larauze M, André T, Louvet C, Brusquant D, Garcia-Larnicol ML, de Gramont A, Bonnetain F. Time to Definitive Health-Related Quality of Life Score Deterioration in Patients with Resectable Metastatic Colorectal Cancer Treated with FOLFOX4 versus Sequential Dose-Dense FOLFOX7 followed by FOLFIRI: The MIROX Randomized Phase III Trial. PLoS One. 2016 Jun 16;11(6):e0157067. doi: 10.1371/journal.pone.0157067. eCollection 2016.

ReferenceCitation: Hebbar M, Chibaudel B, André T, Mineur L, Smith D, Louvet C, Dutel JL, Ychou M, Legoux JL, Mabro M, Faroux R, Auby D, Brusquant D, Khalil A, Truant S, Hadengue A, Dalban C, Gayet B, Paye F, Pruvot FR, Bonnetain F, Landi B, Flesch M, Carola E, Martin P, Vaillant E, de Gramont A; Group Coopérateur Multidisciplinaire en Oncologie (GERCOR) Group. FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI in patients with resectable metastatic colorectal cancer (MIROX): a pragmatic approach to chemotherapy timing with perioperative or postoperative chemotherapy from an open-label, randomized phase III trial. Ann Oncol. 2015 Feb;26(2):340-7. doi: 10.1093/annonc/mdu539. Epub 2014 Nov 17. Erratum in: Ann Oncol. 2015 May;26(5):1040. Taieb, J [removed]; Brucker, P [removed].

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Clinique Specialise du Littoral-Cote d'Opale


title: Status Epilepticus in the Critically Ill Patients

summary:
Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus prospective registry.

Data collection using a standardized form : demographic data and data related to the SE, including circumstances of onset, dates and times of onset and of seizure control, on-scene clinical findings, clinical features of the seizures, pre-hospital and hospital care providers, timing of antiepileptic and supportive treatments, results of etiological investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview.

status: Recruiting

ReferenceCitation: Jacq G, Chelly J, Quenot JP, Soulier P, Lesieur O, Beuret P, Holleville M, Bruel C, Bailly P, Sauneuf B, Sejourne C, Rigaud JP, Galbois A, Arrayago M, Plantefeve G, Stoclin A, Schnell D, Fontaine C, Perier F, Bougouin W, Pichon N, Mongardon N, Ledoux D, Lascarrou JB, Legriel S. Multicentre observational status-epilepticus registry: protocol for ICTAL. BMJ Open. 2022 Feb 15;12(2):e059675. doi: 10.1136/bmjopen-2021-059675.

ipd_sharing: Undecided

lead_sponsor: Ictal Group

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale

location_facility: Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire

location_facility: CH Brive La Gaillarde - Service de réanimation - USC

location_facility: CH de Bethune - Service de Réanimation et Surveillance continue

location_facility: CH Public du Cotentin - Service de Réanimation - Médecin intensive

location_facility: Centre Hospitalier Universitaire Régional

location_facility: CH de Beauvais - Service de réanimation polyvalente

location_facility: Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive

location_facility: CH de La Rochelle - Service de réanimation - USC

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre hospitalier de Roanne - Service de Réanimation - Soins continus

location_facility: Intensive Care Unit - Versailles Hospital

location_facility: Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale

location_facility: CH Angouleme - Service de réanimation polyvalente

location_facility: HP Claude Galien - Service de Réanimation Polyvalente

status_simplified: Ongoing


title: Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin

summary: The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

lead_sponsor: University Hospital, Angers

location_facility:
H Dreux
H Orléans
UH Rennes
UH Grenoble
UH Angers
H Le Mans
Arnault Tzanck Institute
H Créteil
UH Brest
H Freyming-Merlebach
UH Poitiers
H Saint-Joseph
UH Lyon
H Châteauroux
H Creil
UH Caen
H Montauban
H Grasse
H Avignon
H Pau
UH Tours
H La Roche sur Yon
UH Toulouse
UH Dijon
UH Clermont Ferrand
UH Montpellier
H Aix en Provence
H Tourcoing
H montélimar
H Saint-Dizier
UH Limoges
H Corbeil-Essonnes
H Tenon
UH Rouen
H Bourgoin-Jallieu
H saint-Antoine
UH Nantes


title: A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients With Metabolic Syndrome

summary:
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.

An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).

lead_sponsor: Boehringer Ingelheim

location_facility: 502.486.3316A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3309A Cabinet Médical Jean Charcot

location_facility: 502.486 3301A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3322A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3303A Boehringer Ingelheim Investigational Site


title: Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

ReferenceCitation: Gérard JP, Azria D, Gourgou-Bourgade S, Martel-Laffay I, Hennequin C, Etienne PL, Vendrely V, François E, de La Roche G, Bouché O, Mirabel X, Denis B, Mineur L, Berdah JF, Mahé MA, Bécouarn Y, Dupuis O, Lledo G, Montoto-Grillot C, Conroy T. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol. 2010 Apr 1;28(10):1638-44. doi: 10.1200/JCO.2009.25.8376. Epub 2010 Mar 1.

ReferenceCitation: Azria D, Doyen J, Jarlier M, Martel-Lafay I, Hennequin C, Etienne P, Vendrely V, François E, de La Roche G, Bouché O, Mirabel X, Denis B, Mineur L, Berdah J, Mahé M, Bécouarn Y, Dupuis O, Lledo G, Seitz J, Bedenne L, Gourgou-Bourgade S, Juzyna B, Conroy T, Gérard J. Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer. Ann Oncol. 2017 Oct 1;28(10):2436-2442. doi: 10.1093/annonc/mdx351.

lead_sponsor: UNICANCER

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Centre Hospitalier General Andre Boulloche


title: A Prospective, Multinational Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMID, and CD38 Monoclonal Antibody Treatment

acronym: LocoMMotion

summary: The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

status: Active, not recruiting

ReferenceCitation: Mateos MV, Weisel K, De Stefano V, Goldschmidt H, Delforge M, Mohty M, Cavo M, Vij R, Lindsey-Hill J, Dytfeld D, Angelucci E, Perrot A, Benjamin R, van de Donk NWCJ, Ocio EM, Scheid C, Gay F, Roeloffzen W, Rodriguez-Otero P, Broijl A, Potamianou A, Sakabedoyan C, Semerjian M, Keim S, Strulev V, Schecter JM, Vogel M, Wapenaar R, Nesheiwat T, San-Miguel J, Sonneveld P, Einsele H, Moreau P. LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma. Leukemia. 2022 May;36(5):1371-1376. doi: 10.1038/s41375-022-01531-2. Epub 2022 Mar 24.

lead_sponsor: Janssen-Cilag Ltd.

location_country:
Poland
Spain
Italy
Russian Federation
Netherlands
United Kingdom
United States
France
Belgium
Germany

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Washington University School of Medicine

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: North Shore Hematology Oncology Associates, P.C.

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

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

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

location_facility: The Cancer Institute at St. Francis Hospital

location_facility: Oncology Institute of Hope and Innovation

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Pa

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

intervention_type: Other


title: Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.

ReferenceCitation: Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. doi: 10.1200/JCO.2008.17.3146. Epub 2008 Sep 22.

ipd_sharing_description: Individual participant data will not be shared at an individual level.

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed

summary: hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.

lead_sponsor: The Netherlands Cancer Institute

location_country: Netherlands France

location_facility:
Institut Bergonié
Centre René Gauducheau
Centre Paul Strauss
Institut Paoli Calmettes
Centre Antoine Lacassagne
CHU Henri Mondor
Centre René Huguenin
Hôpital J-Minjoz
Hôpital Saint Louis
Centre Eugène Marquis
CHU de Tours
Centre Oscar Lambret
The Netherlands Cancer Institute
Institut Gustave Roussy
Centre Henri Becquerel
Centre Hospitalier Lyon Sud
Institut Curie
Centre Val d'Aurelle


title: A Post Marketing Surveillance Study of Dysport Formulated With a Batch of Bulk Active Substance From a New Primary Manufacturing Facility at the Centre for Applied Microbiology & Research (CAMR)

summary: The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

location_country:
Russian Federation
Germany
France

location_facility: Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences

location_facility: Klinikum der Stadt Villingen-Schwenningen

location_facility: Institute of Medical Aestetic "Vallex-M"

location_facility: Scientific Research Institute of Neurology

location_facility: Alma-Ata State Institute of Postgraduate Education

location_facility: Centre of plastic surgery "Reconstruction and Recreation"

location_facility: Federal Centre "Pediatric Rehabilitology"


title: A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

lead_sponsor: Janssen Research & Development, LLC

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

location_country:
Denmark
Poland
Spain
Greece
Italy
Australia
Netherlands
United Kingdom
Sweden
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Washington University School of Medicine

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

location_facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

location_facility: Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu

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

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

location_facility: Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge

location_facility: University of Miami Leonard M. Miller School of Medicine - Sylvester Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

location_facility: Attikon University General Hospital of Attica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Wisconsin Carbone Cancer Center

summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).


title: Assessment of Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home: Multicentre Randomised Cluster Trial.

acronym: INR-CAP

summary: This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. The population consists of frail elderly patients for whom Anti-Vitamin K treatments are frequent, and who are consequently more prone to embolic and hemorrhagic complications.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Nîmes University Hospital, Place du Pr. Debré

intervention_type: Device


title: Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment

summary: The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.

lead_sponsor: Eli Lilly and Company

location_facility: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician


title: WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation

acronym: CHAMPION-AF

summary: The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Poland
Saudi Arabia
Italy
Spain
Australia
Netherlands
Canada
United Kingdom
Switzerland
United States
France
Israel
Belgium
Japan
Germany

location_facility: King Fahed Medical City- Prince Salman Cardiac Center

location_facility: Memorial Health University Medical Center

location_facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

location_facility: Memorial Hermann Memorial City Medical Center

location_facility: Novant Health Presbyterian Medical Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Sparrow Health System - Sparrow Hospital

location_facility: Providence Regional Medical Center Everett

location_facility: Christus Trinity Mother Frances Health System

location_facility: Virginia Commonwealth University Health System

location_facility: University of Iowa Hospitals and Clinics


title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

ReferenceCitation: Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.

lead_sponsor: Novartis

location_country: Germany France


title: Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.

summary: To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

lead_sponsor: Pfizer


acronym: RECITE

title: RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

lead_sponsor: Amgen

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:
Poland
Brazil
Portugal
Romania
Greece
Austria
Italy
Mexico
Argentina
Canada
Russian Federation
Spain
Ukraine
Hungary
United States
France
Peru
Turkey
Colombia
Bulgaria

location_facility: The Center for Cancer and Blood Disorders

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida

location_facility: Centro de Pesquisa da Serra Gaucha - Cepesg

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: University of California at Irvine Medical Center

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Hospital Universitario Arnau de Vilanova Lleida

location_facility: Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan

location_facility: American Oncology Partners of Maryland, PA

location_facility: Grand River Regional Cancer Centre at Grand River Hospital

location_facility: Leningrad Regional Oncology Dispensary na L D Roman

location_facility: Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

location_facility: Centro de Investigaciones Clínicas Clínica Viedma

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

location_facility: Transcarpathian Regional Clinical Oncological Dispensary

location_facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: State budget institution of public health Pyatigorsk oncology dispensary

location_facility: Clinical hospital 2, Group of companies medsi

location_facility: SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation

location_facility: Omsk Regional Clinical Oncology Dispensary

location_facility: State Institution of Public Health Tambov Regional Oncology Dispensary

location_facility: Spitalul Clinic al Cailor Ferate Cluj Napoca

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

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

location_facility: Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real

location_facility: Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Centro de Atencion e Investigacion Cardiovascular del Potosi Sc

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont

location_facility: Szpital Kliniczny im Heliodora Swiecickiego UM im Karola Marcinkowskiego w Poznaniu

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

location_facility: CHRISTUS Highland Cancer Treatment Center

location_facility: Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

location_facility: Loema Instituto de Pesquisa Clinica & Consultores Ltda

location_facility: Colorado West Healthcare System dba Grand Valley Oncology

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Cape Breton Cancer Centre, Nova Scotia Health Authority

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan

location_facility: Specialized Hospital for Active Treatment of Oncology EAD

location_facility: Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Oncology and Hematology Associates of West Broward, PA

location_facility: Hospital Clinico Universitario San Cecilio

location_facility: Mid Florida Hematology and Oncology Centers PA

summary: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer


title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ 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

location_country:
Poland
Spain
Netherlands
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany

location_facility: First Affiliated Hospital, SooChow University

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

location_facility: Washington University School of Medicine

location_facility: Klinikum Großhadern der Ludwig-Maximilians-Universität

location_facility: Kobe City Medical Center General Hospital

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chonnam National University Hwasun Hospital

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

location_facility: Emory University - Winship Cancer Institute

location_facility: The Ohio State University Wexner Medical Center - James Cancer Hospital

location_facility: University of Arkansas for Medical Sciences

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

location_facility: Second Affiliated Hospital of Army Medical University

location_facility: National Hospital Organization Okayama Medical Center

location_facility: National Hospital Organization Matsumoto Medical Center

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

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: First affiliated Hospital of Zhejiang University

summary: The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).