title: Sorin Universal REgistry on Aortic Valve Replacement

acronym: SURE-AVR

summary:
Multi-center, International, Prospective, Non comparative, Non randomized, Open label.

5,000 patients to be enrolled approximately worldwide.

The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).

This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

lead_sponsor: LivaNova

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
United States
France
Israel
Singapore
Belgium
Germany
Bulgaria
Slovakia
Czechia

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine

location_facility: Baylor Scott and White Research Institute

location_facility: Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

location_facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: Center of Cardiovascular Surgery and Transplantation Brno

location_facility: Foothill Medical Centre - Calgary, Alberta


title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus

summary:
The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response.

The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

ReferenceCitation: Houssiau FA, Thanou A, Mazur M, Ramiterre E, Gomez Mora DA, Misterska-Skora M, Perich-Campos RA, Smakotina SA, Cerpa Cruz S, Louzir B, Croughs T, Tee ML. IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study. Ann Rheum Dis. 2020 Mar;79(3):347-355. doi: 10.1136/annrheumdis-2019-216379. Epub 2019 Dec 23.

lead_sponsor: Neovacs

location_country:
Croatia
Italy
United States
Peru
Belgium
Philippines
Poland
Russian Federation
Argentina
Tunisia
Mexico
Switzerland
Germany
Moldova, Republic of
Taiwan
Georgia
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility:
Research site
Research Site

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

title: An Open-Label, Single-Arm, Multicenter, Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)

summary: The primary purpose of the study is to evaluate objective response rate ([ORR]: complete response [CR] and partial response [PR]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.

ReferenceCitation: Wirth LJ, Brose MS, Sherman EJ, Licitra L, Schlumberger M, Sherman SI, Bible KC, Robinson B, Rodien P, Godbert Y, De La Fouchardiere C, Newbold K, Nutting C, Misir S, Xie R, Almonte A, Ye W, Cabanillas ME. Open-Label, Single-Arm, Multicenter, Phase II Trial of Lenvatinib for the Treatment of Patients With Anaplastic Thyroid Cancer. J Clin Oncol. 2021 Jul 20;39(21):2359-2366. doi: 10.1200/JCO.20.03093. Epub 2021 May 7.

ipd_sharing: Yes

ipd_sharing_description: Eisai IPD sharing statement: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

location_country:
United Kingdom
Italy
Australia
United States
France

intervention_type: Drug


type: Other Identifier

title: A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

summary:
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency.

The trial consists of a 26 week main trial period, followed by a 26 week extension trial period, a 104 week safety extension period, a 208 week longterm safety extension trial period and a 30 day follow up period. Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods. Two additional age groups, cohort II (age below 2 years and 26 weeks at screening) and cohort III (above 9 years (girls)/ above 10 years (boys) and equal to or below 17 years at screening) are included in the 208 week long-term safety extension trial period only.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Sävendahl L, Battelino T, Højby Rasmussen M, Brod M, Saenger P, Horikawa R. Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1357-1367. doi: 10.1210/clinem/dgab928.

ReferenceCitation: Sävendahl L, Battelino T, Brod M, Højby Rasmussen M, Horikawa R, Juul RV, Saenger P; REAL 3 study group. Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4). pii: dgz310. doi: 10.1210/clinem/dgz310. Erratum in: J Clin Endocrinol Metab. 2020 Dec 1;105(12):.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Brazil
Slovenia
Austria
Ukraine
Sweden
France
United States
India
Israel
Belgium
Japan
Germany
Turkey

status_simplified: Ongoing


status: Completed

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

lead_sponsor: Gilead Sciences

source: euctr

ReferenceType: result

ReferenceCitation: Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

ReferenceCitation: Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.

ReferenceCitation: Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5). pii: e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.

ReferenceCitation: Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in art-naïve participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.

ReferenceCitation: Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.

ReferenceCitation: White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.

ReferenceCitation: Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.

ReferenceCitation: Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.

ReferenceCitation: Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

ReferenceCitation: Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age ≥50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

ReferenceCitation: Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged ≥ 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual.

ReferenceCitation: Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom.

ReferenceCitation: Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

ReferenceCitation: Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115.

ReferenceCitation: Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

ReferenceCitation: Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naïve Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

ReferenceCitation: Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

ReferenceCitation: Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual.

ReferenceCitation: Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG + F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29-October 3; Virtual.

ReferenceCitation: Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG + F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.

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

location_country:
Spain
Dominican Republic
Italy
United Kingdom
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center

location_facility: Wake Forest Baptist Medical Center - PPDS

location_facility: Southampton Clinical Research Group, Inc.

location_facility: North Texas Infectious Diseases Consultants PA

location_facility: Alameda Health System- Highland Hospital

location_facility: Louisiana State University Health Sciences Center

location_facility: Diagnostic Clinic of Longview Center For Clinical Research (DCOL)

location_facility: North Manchester General Hospital - PPDS

location_facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

location_facility: Medical University of South Carolina PPDS

location_facility: Multicare Rockwood HIV Critical Care Clinic

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Hospital General Universitario de Alicante

location_facility: Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: North Shore University Hospital-(Manhasset)

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Instituto Dominicano de Estudios Virologicos IDEV

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research

summary: The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

status_simplified: Completed


title: A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3

summary: The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

location_country: Canada France


ipd_sharing: No

status: Active, not recruiting

intervention_type: Other

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Furie RA, Aroca G, Cascino MD, Garg JP, Rovin BH, Alvarez A, Fragoso-Loyo H, Zuta-Santillan E, Schindler T, Brunetta P, Looney CM, Hassan I, Malvar A. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-107. doi: 10.1136/annrheumdis-2021-220920. Epub 2021 Oct 6.

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Brazil
Spain
Italy
Mexico
Argentina
United States
Costa Rica
France
Israel
Colombia
Panama
Peru

location_facility: Hospital General De Mexico; Rheumatology

location_facility: Centro de Investigación Delgado; Clinica Delgado

location_facility: Hospital Nacional Cayetano Heredia; Rheumatology

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Ospedale San Giovanni Bosco; entro di Ricerche di Immunopatologia e Documentazione su Malattie Rare

location_facility: Hopital Bichat Claude Bernard; Nephrologie

location_facility: North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology

location_facility: HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

location_facility: Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia

location_facility: Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

location_facility: Suny Downstate Medical Center; Rheumatology

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Ohio State University; Division of Nephrology

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

location_facility: Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Reumatologia

location_facility: Centro de Investigación Clínica de Morelia S.C.

location_facility: Hopital europeen Marseille; Service de medecine interne

summary: This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.


title: An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in Patients With Muscle Invasive Bladder Cancer (MIBC) Who Have Progressed on Prior Treatment (BISCAY).

acronym: BISCAY

summary:
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents.

The study will consist of a number of study modules (sub-studies), each evaluating the safety and tolerability of a specific agent or combination.

ReferenceCitation: Powles T, Carroll D, Chowdhury S, Gravis G, Joly F, Carles J, Fléchon A, Maroto P, Petrylak D, Rolland F, Cook N, Balar AV, Sridhar SS, Galsky MD, Grivas P, Ravaud A, Jones R, Cosaert J, Hodgson D, Kozarewa I, Mather R, McEwen R, Mercier F, Landers D. An adaptive, biomarker-directed platform study of durvalumab in combination with targeted therapies in advanced urothelial cancer. Nat Med. 2021 May;27(5):793-801. doi: 10.1038/s41591-021-01317-6. Epub 2021 May 3.

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

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

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Spain
Canada
United States
France


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

ReferenceType: background

ReferenceCitation: Shah et al A phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of andecaliximab combined with mFOLFOX6 as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma (GAMMA-1)

location_country:
Poland
Belgium
Romania
Spain
Italy
United Kingdom
Australia
Hungary
United States
Chile
France
Peru
Colombia
Turkey
Germany
Czechia

location_facility: Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali

location_facility: Egyesített Szent István és Szent László Kórház -Rendelőintézet

location_facility: Izmir Universitesi Hastanesi Yeni Girne Vulvari

location_facility: Klinikum rechts der Isar Technical University of Ismaninger

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio

location_facility: DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie

location_facility: Clinica Anglo Americana Calle Alfredo Salazar

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi Elazi

location_facility: Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Zentrum fur Innere Medizin Stauferklinikum Schwab

location_facility: Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali

location_facility: Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK

location_facility: CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie

location_facility: Indiana University Goshen Center for Cancer Care

location_facility: Centrul de Oncologie Sfantul Nectarie SRL, Oncologie

location_facility: Borsod County Hospital Clinical Oncological and Radiotheraputic Center

location_facility: Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

location_facility: Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica

location_facility: Regional Cancer Care Associates LLC - Sparta

location_facility: Cancer Center Heilbronn-Franken, SLK-Kliniken

location_facility: Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Staedtisches Klinikum Muenchen Bogenhausen

location_facility: Ankara University Medical Faculty Ibni Sina Hospital

location_facility: Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung

location_facility: Charleston Hematology Oncology Associates

location_facility: Hospital Regional Universitario de Malaga

location_facility: University Hospital Gent Department of Gastroenterology

location_facility: Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut

location_facility: Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal

location_facility: Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie

location_facility: SC Centrul de Oncologie Euroclinic SRL, Oncologie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust

location_facility: Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul

location_facility: Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali

summary: The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.


title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).

summary: To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

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

lead_sponsor: Bayer

location_country:
Poland
Portugal
Spain
Italy
Austria
United Kingdom
Canada
Lithuania
Switzerland
Hungary
France
Germany
Slovakia
Czechia


title: An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients With Relapsed/Refractory Multiple Myeloma

summary:
Primary Objective:

Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM).
Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab.

Secondary Objectives:

Part A:
To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.
Part B:
To evaluate the safety of SAR650984 (isatuximab).
To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS).
To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline.
To evaluate the immunogenicity of SAR650984 (isatuximab).

ReferenceCitation: Mikhael J, Belhadj-Merzoug K, Hulin C, Vincent L, Moreau P, Gasparetto C, Pour L, Spicka I, Vij R, Zonder J, Atanackovic D, Gabrail N, Martin TG, Perrot A, Bensfia S, Weng Q, Brillac C, Semiond D, Macé S, Corzo KP, Leleu X. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab. Blood Cancer J. 2021 May 12;11(5):89. doi: 10.1038/s41408-021-00478-4.

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

lead_sponsor: Sanofi

location_country:
United States
France
Czechia

location_facility:
Investigational Site Number 840015
Investigational Site Number 840011
Investigational Site Number 250006
Investigational Site Number 840004
Investigational Site Number 840001
Investigational Site Number 840002
Investigational Site Number 203002
Investigational Site Number 250002
Investigational Site Number 840010
Investigational Site Number 840006
Investigational Site Number 840005
Investigational Site Number 840003
Investigational Site Number 250004
Investigational Site Number 840013
Investigational Site Number 203001
Investigational Site Number 250005
Investigational Site Number 250008
Investigational Site Number 250001


title: An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

summary: This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

design_allocation: Non-Randomized

ReferenceCitation: Budde LE, Sehn LH, Matasar M, Schuster SJ, Assouline S, Giri P, Kuruvilla J, Canales M, Dietrich S, Fay K, Ku M, Nastoupil L, Cheah CY, Wei MC, Yin S, Li CC, Huang H, Kwan A, Penuel E, Bartlett NL. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1055-1065. doi: 10.1016/S1470-2045(22)00335-7. Epub 2022 Jul 5.

ReferenceCitation: Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, O'Hear C, Huang H, Kwan A, Li CC, Piccione EC, Wei MC, Yin S, Bartlett NL. Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491. doi: 10.1200/JCO.21.00931. Epub 2021 Dec 16.

lead_sponsor: Genentech, Inc.

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

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: BC Cancer Agency Vancouver Centre - PARENT

location_facility: University of California San Diego Moores Cancer Center

location_facility: Hôpital St Louis - Service de Dermatologie II

location_facility: Universitatsklinikum Koln; Apotheke Uniklinik Koln

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: University of Pennsylvania; School of Medicine

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Monash Health Clinical Trial Pharmacy department

location_facility: Willamette Valley Cancer Insitute and Research Center

location_facility: DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

location_facility: CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme

location_facility: Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores

location_facility: Washington University; Wash Uni. Sch. Of Med


title: A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)

acronym: Open PRIDE-HD

summary: The purpose of the study is to collect and assess long term data on the safety, tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).

ReferenceCitation: Cohen S, Waks Z, Elm JJ, Gordon MF, Grachev ID, Navon-Perry L, Fine S, Grossman I, Papapetropoulos S, Savola JM. Characterizing patient compliance over six months in remote digital trials of Parkinson's and Huntington disease. BMC Med Inform Decis Mak. 2018 Dec 20;18(1):138. doi: 10.1186/s12911-018-0714-7.

lead_sponsor: Prilenia

location_country:
Poland
United Kingdom
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
United States
France
Germany

location_facility:
Teva Investigational Site 35123
Teva Investigational Site 50213
Teva Investigational Site 32407
Teva Investigational Site 50214
Teva Investigational Site 33027
Teva Investigational Site 12210
Teva Investigational Site 53148
Teva Investigational Site 12196
Teva Investigational Site 11036
Teva Investigational Site 53150
Teva Investigational Site 30082
Teva Investigational Site 50215
Teva Investigational Site 12203
Teva Investigational Site 35121
Teva Investigational Site 12211
Teva Investigational Site 78055
Teva Investigational Site 35125
Teva Investigational Site 35122
Teva Investigational Site 35124
Teva Investigational Site 34056
Teva Investigational Site 33021
Teva Investigational Site 12208
Teva Investigational Site 12206
Teva Investigational Site 34058
Teva Investigational Site 78057
Teva Investigational Site 34055
Teva Investigational Site 12200
Teva Investigational Site 34057
Teva Investigational Site 38059
Teva Investigational Site 12209
Teva Investigational Site 34059
Teva Investigational Site 12204
Teva Investigational Site 12201
Teva Investigational Site 30081
Teva Investigational Site 30083
Teva Investigational Site 53151
Teva Investigational Site 34054
Teva Investigational Site 12198
Teva Investigational Site 32410
Teva Investigational Site 53149
Teva Investigational Site 32409
Teva Investigational Site 34061
Teva Investigational Site 78058
Teva Investigational Site 35165
Teva Investigational Site 32408
Teva Investigational Site 30080


primary_purpose: Prevention

acronym: INEXAS

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Phase IIa Study in Asthma Patients Comparing the Efficacy and Safety of Once Daily Inhaled Interferon Beta-1a to Placebo, Administered for 14 Days After the Onset of Symptoms of an Upper Respiratory Tract Infection for the Prevention of Severe Exacerbations

ReferenceCitation: McCrae C, Olsson M, Gustafson P, Malmgren A, Aurell M, Fagerås M, Da Silva CA, Cavallin A, Paraskos J, Karlsson K, Wingren C, Monk P, Marsden R, Harrison T. INEXAS: A Phase 2 Randomized Trial of On-demand Inhaled Interferon Beta-1a in Severe Asthmatics. Clin Exp Allergy. 2021 Feb;51(2):273-283. doi: 10.1111/cea.13765. Epub 2020 Nov 3.

location_country:
Spain
United Kingdom
Australia
Argentina
Korea, Republic of
France
Colombia

summary: A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of symptoms of common cold or influenza


title: An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Norway
Brazil
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Chile

location_facility: Washington University School Of Medicine

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera - Nuovo Ospedale San Gerardo

location_facility: Klinika Nowotworow Pluca i Klatki Piersiowej

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: Smilow Cancer Hospital. At Yale New Haven

summary: The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.


title: A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

summary: This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.

ReferenceCitation: Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536. Review.

ReferenceCitation: Byrd JC, Hillmen P, Ghia P, Kater AP, Chanan-Khan A, Furman RR, O'Brien S, Yenerel MN, Illés A, Kay N, Garcia-Marco JA, Mato A, Pinilla-Ibarz J, Seymour JF, Lepretre S, Stilgenbauer S, Robak T, Rothbaum W, Izumi R, Hamdy A, Patel P, Higgins K, Sohoni S, Jurczak W. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. J Clin Oncol. 2021 Nov 1;39(31):3441-3452. doi: 10.1200/JCO.21.01210. Epub 2021 Jul 26.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: Acerta Pharma BV

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
New Zealand
Hungary
United States
France
Israel
Turkey
Belgium
Germany


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus

summary: This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).

ipd_sharing_description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

lead_sponsor: Sage Therapeutics

location_country:
Denmark
Serbia
Spain
Italy
Austria
Estonia
Netherlands
Canada
Finland
United Kingdom
Sweden
Hungary
United States
France
Israel
Germany

location_facility:
Sage investigational Site
Sage Investigational Site


title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)

acronym: CEDAR

summary: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

lead_sponsor: Allergan

location_country:
Hong Kong
Spain
Latvia
Austria
New Zealand
Argentina
Switzerland
Korea, Republic of
United States
Chile
France
Israel
Colombia
Philippines
Germany
Singapore
Czechia

location_facility: Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: Stiftung für wissenschaftliche Forschung am Stadtspital Triemli

location_facility: Instituto Oftalmologico de Buenos Aires - Oftalmos

location_facility: Hopital de la Croix Rousse, Service d'Opthalmologie

location_facility: Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica

location_facility: Instituto Oftalmologica Profesor Arentsen

location_facility: Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika

location_facility: University Retina and Macula Associates, PC

location_facility: Clinica Universidad de Navarra Servicio de Oftalmologia

location_facility: TASMC (The Tel-Aviv Sourasky Medical Centre)

location_facility: Kellog Eye Center - University of Michigan Health System

location_facility: The Catholic Univ. Of Seoul St. Mary's Hospital

location_facility: Fundacion Oftalmologica Nacional - FUNDONAL

location_facility: Northern California Retina Vitreous Associates Medical Group, INC.

location_facility: University of Virginia - Department of Ophthalmology

location_facility: Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie

location_facility: Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde

location_facility: Clinic and policlinic of ophthalmology, University of Regensburg

location_facility: Retina Vitreous Associates of Florida - Saint Petersburg

location_facility: Vseobecna fakultni nemocnice v Praze Ocni Klinika

location_facility: Houston Eye Associates (HEA) - Gramercy Location

location_facility: Carmel Medical Center Ophthalmology Clinic

location_facility: Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)

location_facility: The Bert M Glaser National Retina Institute

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Seoul National University Bundang Hospital

location_facility: Universitatsklinik fur Augenheilkunde, Inselspital

location_facility: Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg

location_facility: Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas

location_facility: Yonsei University Health System Serverance Hospital

location_facility: Konventhospital Barmherzige Brueder Linz

location_facility: Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology

location_facility: The Chinese University of Hong Kong Hongkong eye hospital

location_facility: Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital General de Valencia Unidad de Investigacion Clinica

location_facility: Medizinische Universitat Innsbruck, Univ.

location_facility: Instituto Clínico Quirúrgico de Oftalmología (ICQO)

location_facility: Atlantis Retina Institute (Atlantis Eyecare)

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Pauls Stradins Clinical University Hospital Opthalmology Clinic


title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

acronym: MYSTIC

summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

ReferenceCitation: Garon EB, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, Robinet G, Le Moulec S, Natale R, Schneider J, Shepherd FA, Garassino MC, Geater SL, Szekely ZP, Van Ngoc T, Liu F, Scheuring U, Patel N, Peters S, Rizvi NA. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). Clin Lung Cancer. 2021 Jul;22(4):301-312.e8. doi: 10.1016/j.cllc.2021.02.010. Epub 2021 Feb 19.

ReferenceCitation: Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. doi: 10.1001/jamaoncol.2020.0237. Erratum in: JAMA Oncol. 2020 Nov 1;6(11):1815.

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
Thailand
Switzerland
Vietnam
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany


title: Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study

acronym: PROMIZING

summary: For adult patients with acute respiratory failure requiring invasive mechanical ventilation, does a ventilation strategy using proportional assist ventilation with load-adjustable gain factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a ventilation strategy using pressure support ventilation (PSV)?

primary_purpose: Supportive Care

lead_sponsor: Lawson Health Research Institute

location_country:
Saudi Arabia
Italy
Greece
Spain
Argentina
Canada
France

location_facility: Sunnybrook Hospital - Health Sciences Centre

location_facility: El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"

location_facility: Centre Hospitalier Universitaire (CHU) de Rouen

location_facility: Centre Hospitalier Universitaire (CHU) de Angers

location_facility: Centre Hospitalier Universitaire (CHU) de Nice

location_facility: Hôpital Henri Mondor (Assistance Publique-Hôpitaux de Paris)

location_facility: San Giovanni Battista University Hospital

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: London Health Sciences Centre - University Hospital

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

location_facility: Institut Universitaire de cardiologie et de pneumologie de Quebec


title: Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second-Line Gastric or Gastroesophageal Junction Adenocarcinoma

lead_sponsor: Eli Lilly and Company

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Poland
United Kingdom
Russian Federation
Australia
New Zealand
Argentina
Hungary
United States
France
Turkey
Romania
Slovakia

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

summary: The main purpose of this study was to evaluate the safety and pharmacokinetics of administering various dose regimens of ramucirumab in participants with advanced gastric cancer whose disease has progressed during or following prior chemotherapy.


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache

ReferenceCitation: Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.

location_country:
Denmark
Spain
Greece
Italy
Netherlands
United Kingdom
Finland
Canada
United States
France
Belgium
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: Klinikum der Universität München Campus Großhadern

location_facility: Michigan Head, Pain and Neurological Institute

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

location_facility: New England Institute for Clinical Research

summary: The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

acronym: RANGE

summary: The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.

ReferenceCitation: van der Heijden MS, Powles T, Petrylak D, de Wit R, Necchi A, Sternberg CN, Matsubara N, Nishiyama H, Castellano D, Hussain SA, Bamias A, Gakis G, Lee JL, Tagawa ST, Vaishampayan U, Aragon-Ching JB, Eigl BJ, Hozak RR, Rasmussen ER, Xia MS, Rhodes R, Wijayawardana S, Bell-McGuinn KM, Aggarwal A, Drakaki A. Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial. Nat Commun. 2022 Apr 6;13(1):1878. doi: 10.1038/s41467-022-29441-y.

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Necchi A, Nishiyama H, Matsubara N, Lee JL, Petrylak DP, de Wit R, Drakaki A, Liepa AM, Mao H, Bell-McGuinn K, Powles T. Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE). BMC Urol. 2020 Nov 7;20(1):181. doi: 10.1186/s12894-020-00752-w.

ReferenceCitation: Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain SA, Fléchon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Géczi L, Ou YC, Coskun HS, Su WP, Bedke J, Gakis G, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Garcia Del Muro X, Rodriguez-Vida A, Cicin I, Harputluoglu H, Tagawa ST, Vaishampayan U, Aragon-Ching JB, Hamid O, Liepa AM, Wijayawardana S, Russo F, Walgren RA, Zimmermann AH, Hozak RR, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):105-120. doi: 10.1016/S1470-2045(19)30668-0. Epub 2019 Nov 18.

ReferenceCitation: Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain S, Fléchon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Géczi L, Ou YC, Coskun HS, Su WP, Hegemann M, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Del Muro XG, Rodriguez-Vida A, Cicin I, Harputluoglu H, Widau RC, Liepa AM, Walgren RA, Hamid O, Zimmermann AH, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial. Lancet. 2017 Nov 18;390(10109):2266-2277. doi: 10.1016/S0140-6736(17)32365-6. Epub 2017 Sep 12.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Poland
Russian Federation
Australia
Israel
Turkey
Mexico
Canada
Hungary
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: The Center for Cancer and Blood Disorders

location_facility: Ivanovo regional clinical oncology dispensary

location_facility: Republic Oncology Dispensary of MoH of Republic Tatarstan

location_facility: Central Coast Medical Oncology Corporation

location_facility: University of California, Davis - Health Systems

location_facility: Scientific research oncology institute n.a. P. A. Herzen

location_facility: Saint-Petersburg city clinical oncology dispensary

location_facility: Inova Comprehensive Cancer Care & Research Institute

location_facility: University of Oklahoma Health Sciences Center

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

location_facility: St Mary's Hospital Regional Cancer Center

location_facility: University of Maryland- Biological Sciences


title: A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects With Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) Inhibitor

lead_sponsor: Geron Corporation

ReferenceCitation: Mascarenhas J, Komrokji RS, Palandri F, Martino B, Niederwieser D, Reiter A, Scott BL, Baer MR, Hoffman R, Odenike O, Vannucchi AM, Bussolari J, Zhu E, Rose E, Sherman L, Dougherty S, Sun L, Huang F, Wan Y, Feller FM, Rizo A, Kiladjian JJ. Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis. J Clin Oncol. 2021 Sep 10;39(26):2881-2892. doi: 10.1200/JCO.20.02864. Epub 2021 Jun 17.

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

summary: The purpose of this study is to evaluate the efficacy and safety of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) whose disease is relapsed after or is refractory to Janus Kinase (JAK) inhibitor treatment. Key secondary endpoint includes overall survival.


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

lead_sponsor: ViiV Healthcare

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum in: Lancet. 2018 Feb 1;:.

ReferenceCitation: Aboud M, Orkin C, Podzamczer D, Bogner JR, Baker D, Khuong-Josses MA, Parks D, Angelis K, Kahl LP, Blair EA, Adkison K, Underwood M, Matthews JE, Wynne B, Vandermeulen K, Gartland M, Smith K. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019 Sep;6(9):e576-e587. doi: 10.1016/S2352-3018(19)30149-3. Epub 2019 Jul 12.

ReferenceCitation: McComsey GA, Lupo S, Parks D, Poggio MC, De Wet J, Kahl LP, Angelis K, Wynne B, Vandermeulen K, Gartland M, Cupo M, Aboud M; 202094 Sub-Study Investigators. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

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

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
United States
France
Germany

summary: The aim of this study is to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.


title: A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

lead_sponsor: Astellas Pharma Global Development, Inc.

ReferenceCitation: Smith CC, Levis MJ, Perl AE, Hill JE, Rosales M, Bahceci E. Molecular profile of FLT3-mutated relapsed/refractory patients with AML in the phase 3 ADMIRAL study of gilteritinib. Blood Adv. 2022 Apr 12;6(7):2144-2155. doi: 10.1182/bloodadvances.2021006489.

ReferenceCitation: Perl AE, Larson RA, Podoltsev NA, Strickland S, Wang ES, Atallah E, Schiller GJ, Martinelli G, Neubauer A, Sierra J, Montesinos P, Récher C, Yoon SS, Hosono N, Onozawa M, Chiba S, Kim HJ, Hasabou N, Lu Q, Tiu R, Levis MJ. Follow-up of patients with R/R FLT3-mutation-positive AML treated with gilteritinib in the phase 3 ADMIRAL trial. Blood. 2022 Jun 9;139(23):3366-3375. doi: 10.1182/blood.2021011583.

ReferenceCitation: Perl AE, Martinelli G, Cortes JE, Neubauer A, Berman E, Paolini S, Montesinos P, Baer MR, Larson RA, Ustun C, Fabbiano F, Erba HP, Di Stasi A, Stuart R, Olin R, Kasner M, Ciceri F, Chou WC, Podoltsev N, Recher C, Yokoyama H, Hosono N, Yoon SS, Lee JH, Pardee T, Fathi AT, Liu C, Hasabou N, Liu X, Bahceci E, Levis MJ. Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. N Engl J Med. 2019 Oct 31;381(18):1728-1740. doi: 10.1056/NEJMoa1902688. Erratum in: N Engl J Med. 2022 May 12;386(19):1868.

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

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Japan
Germany

location_facility:
Site US10072
Site US10058
Site TR90001
Site JP81022
Site TW88608
Site IT39010
Site KR82003
Site ES34014
Site KR82004
Site US10012
Site US10014
Site IL97206
Site DE49002
Site FR33008
Site PL48002
Site IT39002
Site JP81002
Site KR82009
Site IT39007
Site US10084
Site US10041
Site US10074
Site US10006
Site FR33002
Site US10075
Site ES34016
Site US10022
Site US10013
Site TW88601
Site DE49009
Site JP81021
Site TW88609
Site US10087
Site JP81014
Site PL48004
Site FR33010
Site CA15015
Site US10057
Site GB44015
Site PL48005
Site ES34009
Site US10027
Site DE49003
Site KR82001
Site US10080
Site JP81025
Site IT39001
Site KR82007
Site JP81013
Site US10023
Site US10035
Site IL97209
Site JP81005
Site TW88611
Site KR82008
Site US10073
Site IL97210
Site US10081
Site BE32002
Site JP81016
Site TW88602
Site ES34010
Site JP81018
Site DE49011
Site IT39005
Site JP81023
Site JP81024
Site JP81012
Site US10045
Site JP81011
Site TW88606
Site US10046
Site KR82011
Site FR33014
Site US10008
Site US10005
Site IL97203
Site ES34011
Site DE49010
Site JP81027
Site GB44014
Site US10044
Site JP81006
Site US10011
Site TW88610
Site GB44003
Site CA15004
Site US10078
Site US10067
Site JP81020
Site US10024
Site JP81007
Site GB44013
Site IL97201
Site FR33013
Site US10010
Site IT39004
Site JP81010
Site JP81004
Site TR90004
Site US10048
Site KR82005
Site US10063
Site IT39011
Site US10076
Site JP81017
Site IL97208
Site CA15001
Site US10077
Site KR82002
Site TW88605
Site US10037
Site FR33009
Site JP81008
Site ES34012
Site CA15003
Site TW88603
Site JP81026
Site KR82010
Site TW88604
Site US10034
Site ES34017
Site JP81009
Site ES34005
Site US10085
Site US10001

summary:
The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants.

This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.


title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to inSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

summary: Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.

ReferenceCitation: Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Poland
Taiwan
Spain
United Kingdom
Austria
Australia
Netherlands
Canada
Finland
Sweden
United States
France
Belgium
Norway
Germany
Czechia

location_facility: HOP les Portes du Sud, Diabéto, Vénissieux

location_facility: Oslo Universitetssykehus HF, Aker Sykehus

location_facility: Royal Brisbane & Women's Hospital-Endocrinology

location_facility: VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie

location_facility: Albany Medical Center / Albany Medical College

location_facility: The Center for Diabetes and Endocrine Care

location_facility: Southern New Hampshire Diabetes and Endocrinology

location_facility: General Univ.hosp.in Prague (VFN), Diabetes ambulance

location_facility: The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital

location_facility: Allgemeinmedizinische und Diabetologische Schwerpunktpraxis

location_facility: Diabetes/Lipid Management and Research Center

location_facility: Diabetology and Internal Practice Dr. Vladimir Lelek

location_facility: Wellcome Trust Clinical Research Facility

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Diabetes and Obesity Clinical Trials Center

location_facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis

location_facility: Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH

location_facility: LMC Endocrinology Centres (Calgary) Ltd.

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: MultiCare Institute for Research and Innovation

location_facility: University Physicians Group Research Division

location_facility: Desert Endocrinology Clinical Research Center

location_facility: Helse Møre og Romsdal HF, Ålesund sjukehus

location_facility: Albert Schweitzer Ziekenhuis, Zwijndrecht

location_facility: NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom


title: A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations

summary: This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.

lead_sponsor: Grifols Therapeutics LLC

location_country:
Poland
Romania
Latvia
Russian Federation
Estonia
Argentina
Canada
Hungary
France
South Africa
Belgium
Czechia

location_facility: Fakultni nemocnice Brno, Neurologicka klinika

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

location_facility: University Health Network (UHN) - Toronto General Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures

location_facility: State Budgetary Institution of Healthcare of Nizhniy Novgorod region. Nizhniy Novgorod Regional Clinical Hospital named after N.A.Semashko

location_facility: University of Szeged, Faculty of Medicine

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare. City Multi-field Hospital # 2

location_facility: Fakultni nemocnice Ostrava, Neurologická klinika

location_facility: State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital. V.D.Seredavin


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis

summary: The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

ReferenceCitation: Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
United Kingdom
Russian Federation
Australia
Mexico
Argentina
Ukraine
Hungary
Korea, Republic of
France
Belgium
Germany
Czechia


title: An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.

summary: To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

ReferenceCitation: Lenz G, Hawkes E, Verhoef G, Haioun C, Thye Lim S, Seog Heo D, Ardeshna K, Chong G, Haaber J, Shi W, Gorbatchevsky I, Lippert S, Hiemeyer F, Piraino P, Beckmann G, Peña C, Buvaylo V, Childs BH, Salles G. Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma. Leukemia. 2020 Aug;34(8):2184-2197. doi: 10.1038/s41375-020-0743-y. Epub 2020 Feb 14.

location_country:
Denmark
United Kingdom
Italy
Australia
Canada
Korea, Republic of
France
Singapore
Belgium
Germany


acronym: CheckMate 238

title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Larkin J, Weber J, Del Vecchio M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Márquez-Rodas I, Butler MO, Di Giacomo AM, Middleton MR, De la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Mandalá M. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria. Eur J Cancer. 2022 Sep;173:285-296. doi: 10.1016/j.ejca.2022.06.041. Epub 2022 Aug 11.

ReferenceCitation: Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.

ReferenceCitation: Mandala M, Larkin J, Ascierto PA, Del Vecchio M, Gogas H, Cowey CL, Arance A, Dalle S, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Lutzky J, De La Cruz-Merino L, Atkinson V, Arenberger P, Hill A, Fecher L, Millward M, Khushalani NI, de Pril V, Lobo M, Weber J. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021 Aug;9(8):e003188. doi: 10.1136/jitc-2021-003188. Erratum In: J Immunother Cancer. 2021 Nov;9(11):

ReferenceCitation: Ascierto PA, Del Vecchio M, Mandalá M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Márquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19. Erratum in: Lancet Oncol. 2021 Oct;22(10):e428.

ReferenceCitation: Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbé C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.

location_country:
Spain
Italy
United Kingdom
United States
Romania
South Africa
Belgium
Japan
Czechia
Poland
Austria
Australia
Argentina
Norway
Sweden
Canada
Switzerland
Hungary
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility:
Local Institution - 0078
University of Tsukuba Hospital
Local Institution - 0036
Local Institution - 0148
Local Institution - 0138
Local Institution - 0157
Local Institution - 0127
Local Institution - 0128
Local Institution - 0181
Local Institution - 0029
Local Institution - 0033
Local Institution - 0179
Local Institution - 0003
Local Institution - 0042
Local Institution - 0075
Local Institution - 0038
Local Institution - 0026
Local Institution - 0016
Local Institution - 0108
Local Institution - 0100
Local Institution - 0001
Local Institution - 0159
Local Institution - 0180
Local Institution - 0052
Local Institution - 0081
Local Institution - 0019
Local Institution - 0149
Local Institution - 0013
Local Institution - 0097
Local Institution - 0050
Local Institution - 0043
Local Institution - 0077
Local Institution - 0117
Local Institution - 0189
Local Institution - 0006
Local Institution - 0147
Local Institution - 0022
Local Institution - 0107
Local Institution - 0106
Local Institution - 0175
Local Institution - 0119
Local Institution - 0040
Local Institution - 0162
Local Institution - 0165
Local Institution - 0010
Local Institution - 0112
Local Institution - 0131
Local Institution - 0137
Local Institution - 0170
Local Institution - 0122
Local Institution - 0102
Local Institution - 0144
Local Institution - 0176
Local Institution - 0161
Local Institution - 0115
Local Institution - 0060
Local Institution - 0163
Local Institution - 0168
Local Institution - 0109
Local Institution - 0039
Local Institution - 0064
Local Institution
Local Institution - 0046
Local Institution - 0121
Local Institution - 0002
Local Institution - 0045
Local Institution - 0055
Local Institution - 0004
Local Institution - 0116
Local Institution - 0094
Local Institution - 0047
Local Institution - 0135
Local Institution - 0177
Local Institution - 0166
Local Institution - 0057
Local Institution - 0160
Local Institution - 0051
Local Institution - 0015
Local Institution - 0025
Local Institution - 0110
Local Institution - 0030
Local Institution - 0171
Local Institution - 0082
Local Institution - 0114
Local Institution - 0087
Local Institution - 0085
Local Institution - 0101
Local Institution - 0123
Local Institution - 0156
Local Institution - 0054
Local Institution - 0041
Local Institution - 0129
Local Institution - 0099
Local Institution - 0133
Local Institution - 0083
Local Institution - 0079
Local Institution - 0063
Local Institution - 0095
Local Institution - 0126
Local Institution - 0032
Local Institution - 0153
Local Institution - 0017
Local Institution - 0152
Local Institution - 0130
Local Institution - 0037
Local Institution - 0111
Local Institution - 0056
Local Institution - 0012
Local Institution - 0027
Local Institution - 0096
Local Institution - 0113
Local Institution - 0005
Local Institution - 0048
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Local Institution - 0105
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Local Institution - 0098
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Local Institution - 0140
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Local Institution - 0142
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Local Institution - 0169
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Local Institution - 0084

summary: The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.


title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis

summary: The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

ReferenceCitation: Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.

ReferenceCitation: Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

ReferenceCitation: Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

ReferenceCitation: Orbai AM, Gratacós J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.

ReferenceCitation: Schweikert B, Malmberg C, Núñez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

ReferenceCitation: Combe B, Rahman P, Kameda H, Cañete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

ReferenceCitation: Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

ReferenceCitation: Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

ReferenceCitation: Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

ReferenceCitation: Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.

ReferenceCitation: Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
United States
France
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum

location_facility: Rheumatology Associates of South Florida

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

location_facility: Basildon and Thurrock University Hospital

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Arthritis and Osteoporosis Consultants of the Carolinas

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Clinical Research Center of Reading, LLC

location_facility: Hospital Regional Universitario de Málaga

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Arthritis & Osteoporosis Treatment Center, PA

location_facility: Albuquerque Rehabilitation & Rheumatology, PC

location_facility: Pennsylvania Regional Center for Arthritis & Osteoarthritis

location_facility: Arthritis, Rheumatic & Back Disease Associates

location_facility: Allergy Asthma Immunology of Rochester, AAIR Research Ctr

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: PV-MEDICAL s.r.o. Revmatologicka ambulance

location_facility: Hospital Universitario Marques De Valdecilla


title: A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

lead_sponsor: Jazz Pharmaceuticals

ReferenceCitation: Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.

ReferenceCitation: Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.

ReferenceCitation: Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2). pii: zsz220. doi: 10.1093/sleep/zsz220.

location_country:
Netherlands
Finland
Canada
United States
France
Germany

location_facility: Southwest Cleveland Sleep Research Center

location_facility: Center for Sleep and Circadian Neurobiology

location_facility: So Cal Institute For Respiratory Diseases, Inc.

location_facility: Mercy St. Anne & Mercy St. Charles Sleep Disorders Center

location_facility: University of Illinois at Chicago Nursing School

location_facility: Clinical Research Group of St. Petersburg

location_facility: The Research Center of Southern California

location_facility: Henry Ford Hospital Sleep Disorders & Research Center

location_facility: Hickory Research Center, ARSM Research, LLC

location_facility: Ohio Sleep Medicine & Neuroscience Institute

location_facility: Stanford University Center for Narcolepsy

location_facility: Sleep Medicine & Research center, St. Lukes Hospital

location_facility: University of Turku , Sleep Research Centre

location_facility: Sleep Med of South Carolina Clinical Research Solutions

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Critical care Pulmonary & Sleep Associates, LLC

summary: This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.


title: A Phase II, Multi-center, Open-label, Five-arm Study to Evaluate the Efficacy and Safety of Oral Ceritinib Treatment for Patients With ALK-positive Non-small Cell Lung Cancer (NSCLC) Metastatic to the Brain and/or to Leptomeninges

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Chow LQM, Barlesi F, Bertino EM, van den Bent MJ, Wakelee HA, Wen PY, Chiu CH, Orlov S, Chiari R, Majem M, McKeage M, Yu CJ, Garrido P, Hurtado FK, Arratia PC, Song Y, Branle F, Shi M, Kim DW. ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges. Clin Cancer Res. 2022 Jun 13;28(12):2506-2516. doi: 10.1158/1078-0432.CCR-21-1838.

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

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

location_country:
Taiwan
Brazil
Hong Kong
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Korea, Republic of
United States
France
Singapore
Turkey
Belgium
Germany

location_facility: USC Kenneth Norris Comprehensive Cancer Center SC-3

location_facility: NKI-AVL, Department of Thoracic-Oncology

location_facility: The Ohio State University Comprehensive Cancer Center Ohio State University

summary: This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.


title: A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma

ReferenceCitation: Tolaney SM, Sahebjam S, Le Rhun E, Bachelot T, Kabos P, Awada A, Yardley D, Chan A, Conte P, Diéras V, Lin NU, Bear M, Chapman SC, Yang Z, Chen Y, Anders CK. A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5310-5319. doi: 10.1158/1078-0432.CCR-20-1764. Epub 2020 Jul 21. Erratum in: Clin Cancer Res. 2021 Mar 1;27(5):1582.

location_country:
Spain
Italy
Austria
Australia
Canada
United States
France
Israel
Belgium

location_facility: University of North Carolina at Chapel Hill

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Kaiser Permanente Center for Health Research

summary: The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.


title: Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

lead_sponsor: Amgen

location_country:
Spain
Italy
United Kingdom
United States
Romania
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Singapore
Brazil
Canada
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital Enfants de Brabois

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

location_facility: Childrens Healthcare of Atlanta, Egleston

location_facility: FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation

location_facility: SBEI of HPE Saint Petersburg State Medical University na academic I P Pavlov of MoH of RF

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL EAD

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Levine Childrens Hospital at Carolinas Medical Center d/b/a Atrium Health

location_facility: Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

location_facility: Hospital Universitario Infantil NiÃ±o Jesus

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital des enfants

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza Torino Ospedale Infantile Regina Margherita

location_facility: University of Texas Health Science Center at San Antonio

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: FSBI FSCC of pediatric hematology, oncology and immunology n a Dmitry Rogachev

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: Itaci Instituto de Tratamento do Cancer Infantil

location_facility: Childrens Hospital of New York Presbyterian

location_facility: CSK Uniwersytetu Medycznego w Lodzi Uniwersyteckie Centrum Pediatrii im Marii Konopnickiej

location_facility: University of Utah Medical Center Primary Childrens Medical Center

location_facility: SPSK nr 1 im Prof Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Childrens Hospital and Clinics of Minnesota

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

location_facility: Erciyes Universitesi Tip Fakultesi Mustafa Eraslan ve Fevzi Mercan Cocuk Hastanesi

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

location_facility: UCK WUM Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego

location_facility: Hospital da Crianca Santo Antonio Irmandade Santa Casa de Misericordia de Porto Alegre

summary:
The purpose of Phase 1b of this study is to:

Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy.

The purpose of Phase 2 of this study is to compare the rate of complete response (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.


title: Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).

acronym: LAPACT

summary: This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

ReferenceCitation: Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, López-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

lead_sponsor: Celgene

location_country:
Spain
Italy
Canada
United States
France

location_facility: Ospedale Sacro Cuore di Gesu FatebeneFratelli

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Smilow Cancer Hospital At Yale-New Haven

location_facility: Cancer Treatment Centers of America - Southeastern Regional Medical Center

location_facility: State University of New York Upstate Medical Center

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Karmanos Cancer Center Wayne State University

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Georgetown University Medical Center Lombardi Cancer Center

intervention_type: Procedure